2 HANSONRESEARCH.COM

Transcription

1 2016 BUYER S GUIDE

2 2 HANSONRESEARCH.COM

3 SETTING THE STANDARD SINCE 1951 When Hanson Research built the first dissolution tester, we didn t realize we were laying the foundation of modern quality testing for pharmaceuticals. Here we are, half a century later, pioneering the next generation of equipment that will keep tomorrow s medications safe and effective. HANSONRESEARCH.COM

4 SALES AND SUPPORT OUR HEADQUARTERS Hanson Research Corporation 9810 Variel Avenue Chatsworth, CA USA CALL US Press 1 for Technical Support Press 4 for Customer Support Press 5 for Sales Support FAX ORDERS TO US sales@hansonresearch.com orders@hansonresearch.com VISIT US ONLINE hansonresearch.com 1 - YEAR WARRANTY Hanson products are warranted for one full year, including parts and labor (except for glass and consumables). International dealer warranties may vary. A variety of HRCare service and preventive maintenance contracts are available to maintain peak operation of your Hanson equipment. Consult your Hanson representative for details. NOTE: Minimum order $100 Hanson Research is a certified ISO 9001 : 2008 corporation 4 HANSONRESEARCH.COM

5 TABLE OF CONTENTS DISSOLUTION TESTING Vision G2 Classic 6 Vision G2 Elite 8 Vision G2 Elite 8-2 L Vision AutoPlus Vision AutoFill Vision AutoFilter Changer Media-Mate Plus Legacy SR8-Plus Accessories Legacy AutoPlus Accessories DIFFUSION TESTING Vision Microette Automated Test System 6-Cell Manual Diffusion Test System Vertical Diffusion Cells PHYSICAL TESTING Flodex Legacy QC-21 Accessories HRCare Service ASTM Program Service & Validation Plans Validation, Calibration, Reference Please see next page for full list of contents. HANSONRESEARCH.COM

6 TABLE OF CONTENTS DISSOLUTION TESTING 8 DISSOLUTION TESTERS 10 Vision G2 Classic 6 10 Vision G2 Elite 8 10 Vision G2 Elite 8 2 L 11 Conversion Kits for Vision Dissolution Testers 11 DISSOLUTION TESTER ACCESSORIES 14 VESSELS 16 Media Replace Beaker System 18 UV Bath Clean 19 VESSEL COVERS 20 APPARATUSES 22 Apparatus Trays 25 USP App. 1: Baskets and Shafts 23 USP App. 2: Paddles 24 USP App. 5: Paddle Over Disk 26 USP App. 6: Rotating Cylinder 26 Immersion Cells 27 PROBE OPTIONS 28 Cannulas and Syringe 29 Vessel-Mount Probes Return Port Fitting 31 Magazines 32 Auto-Probes 33 Recirculating Auto-Probes 34 Digital Temperature Probes 34 Conversion Kits for Digital Temperature Probes 34 SINKERS 35 FILTERS 36 Tip Filters 36 Cartridge Filters 37 In-Line/Syringe Filters 37 Filter Kits 37 AUTOSAMPLERS 38 Vision AutoPlus DissoScan 38 Vision AutoPlus Maximizer 38 Vision AutoPlus Autosampling Systems SAMPLE COLLECTION 42 Vision AutoFill 42 RACKS, TUBES, VIALS 44 Collection Racks Test Tubes and Vials 47 Retrieval Reservoir 47 Sampler Tray 47 ON-LINE UV SYSTEM 48 Shimadzu UV ARGUS/Dissolution 49 On-Line UV-Vis System Configurations Flow Cells 51 SAMPLE FILTRATION 52 Vision AutoFilter Changer MEDIA PREP SYSTEM 54 Media-Mate Plus Media-Mate Plus Accessories 57 LEGACY ACCESSORIES 58 SR8-PLUS 58 Vessels AccuCenter System 59 Circulating Water Pump 60 Vessel Covers 60 Vessel Carriers 61 Apparatus Trays 62 USP App. 1: Baskets and Shafts 61 USP App. 2: Paddles 62 USP App. 5: Paddle Over Disk 63 USP. App. 6: Rotating Cylinder 63 6 HANSONRESEARCH.COM

7 Small Volume Kits 63 Temperature Probes 64 Manual Sampling Cannulas 65 Manual Sampling Probes 66 Automated Sampling Probes 66 Auto Pill Droppers 67 Volumetric Flasks 67 Firmware Upgrade Kits 67 Spare Parts Kit 67 AUTOPLUS 68 AutoPlus Accessories DIFFUSION TESTING 70 DIFFUSION TEST SYSTEMS 72 Vision Microette Automated Test System 72 6-Cell Manual Diffusion Test System 73 Single Group vs. Multi-Group 74 Diffusion System Accessories 74 How the System Works 75 VERTICAL DIFFUSION CELLS Standard Cell Tops 79 Double Thick Dosage Wafers Open Cell Tops 82 Special Application Cells & Cell Tops 83 PHYSICAL TESTING HRCARE SERVICE 89 ASTM Program 90 Service & Validation Plans 91 VALIDATION, CALIBRATION, REFERENCE 92 Q-Pak Self-Installation Guidelines 93 Vision Heater 94 Printers and Supplies 94 Calibration Accessories 94 Tools 94 Handbook of Dissolution Testing 95 Recalibration Service 96 Spare Parts Kits 96 Certificates & Replacement Services 96 TERMS & CONDITIONS 97 PACKAGING INFORMATION 98 TRADEMARKS 99 NOTICES 99 POWDER FLOWABILITY 86 Flodex LEGACY ACCESSORIES 88 QC HANSONRESEARCH.COM

8 DISSOLUTION TESTING DISSOLUTION DIFFUSION TESTING TESTING Dissolution testing determines the release rate of an active PHYSICAL TESTING pharmaceutical ingredient in tablet or capsule form as it dissolves into solution. Dissolution replicates the process of oral dosage formulations as they dissolve and are assimilated into the GI tract. PAGE 10 DISSOLUTION TESTERS PAGE 14 DISSOLUTION TESTER ACCESSORIES PAGE 38 AUTOSAMPLERS PAGE 42 SAMPLE COLLECTION PAGE 48 ON-LINE UV SYSTEM PAGE 52 SAMPLE FILTRATION PAGE 54 MEDIA PREP SYSTEM PAGE 58 LEGACY ACCESSORIES 50 YEARS LEADERSHIP IN DISSOLUTION TECHNOLOGY 8 HANSONRESEARCH.COM

9 DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING HANSONRESEARCH.COM

10 DISSOLUTION TESTING DIFFUSION TESTING DISSOLUTION TESTERS Vision G2 dissolution testers are designed with over 60 years of dissolution expertise and know-how. The modular design is plug-and-play ready making these systems upgradeable or automated without the need for separate firmware. They come standard with a full color touchscreen and intuitive menus, giving users the confidence of precision control for speeds rpm and temperature C. Powerful programming, backed by a robust security system for 25 users, features the ability to create up to 100 unique protocols that can be conveniently transferred by flash drive to other Vision G2 testers, resulting in higher throughput and sample analysis. Vision G2 dissolution testers meet and exceed worldwide standards including compliance with USP, US FDA, ASTM, EP, JP, CE, CSA, RoHS, and 21 CFR Part 11. PHYSICAL TESTING VISION G2 CLASSIC 6 Precision engineered to ease the rigors of manual dissolution testing with its award-winning footprint designed for ease of use and saving space. VISION G2 ELITE 8 A versatile performance machine ideal for automation and extended applications as well as 8-sample manual testing. 10 HANSONRESEARCH.COM

11 Easy to operate Customizable reports that allow users to define the report style Hand-held digital temperature probe for convenient use in vessels and waterbath Quick, no-tools-needed access to internal components for time-saving maintenance Low variation in spindle speed: 0.6 rpm max (typical performance) Independent Vision heater circulator with low vibration and space-saving location Molded waterbath with fast heat-up & low level drain Rugged, chip-proof vessels Free technical support for the life of the instrument Numerous user-defined configurations for ultimate control and flexibility, including user-defined speed and temperature tolerances, alarms, and much more! Classic 6 Dissolution Tester, Vision G2 DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING VISION G2 ELITE 8 2 L Designed with a deeper waterbath, the High Stand accommodates traditional 1 L testing as well as largevolume 2 L testing, preferred for high-concentration drug formulations. Order direct from our factory, or purchase a conversion kit to field retrofit existing 1 L systems Elite 8 Dissolution Tester, 1 L, Vision G Elite 8 High Stand Dissolution Tester, 2 L, Vision G2 Accessories are ordered separately Conversion Kit, Elite 8, 2 L High Stand, Vision G2 (converts a Vision G2 Elite 8 from a 1 L to 2 L dissolution tester) Conversion Kit, Ellite 8, Vision G2 (upgrades an original Elite 8 to a G2 Elite 8) Conversion Kit, Classic 6, Vision G2 (upgrades an original Classic 6 to a G2 Classic 6) Firmware Upgrade, Vision G2 Tester (free firmware upgrades) HANSONRESEARCH.COM

12 VISION CLASSIC 6 VISION ELITE 8 VISION ELITE 8 2L PHYSICAL TESTING DIFFUSION TESTING DISSOLUTION TESTING G2 CLASSIC 6 FEATURES Award-winning design (2 across x 3 deep) provides easy access to all vessels Compact footprint saves valuable bench space 6-position Easi-Lock vessel plate ensures proper vessel centering Superior coating protects vessel plate from corrosion Fixed drive head guarantees repeatable, drive head positioning No tools or adjustments needed to switch among USP App. 1, 2, 5, 6, and 150 ml and 250 ml small volumes Quick Test feature begins tests immediately with the push of a button Adaptable for automated sampling 12 HANSONRESEARCH.COM

13 VISION CLASSIC 6 VISION ELITE 8 VISION ELITE 8 2L DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING G2 ELITE 8 FEATURES Scalable design easily configured for automated, hands-free sampling 8-position Easi-Lock vessel plate ensures proper per vessel centering Superior coating protects vessel plate from corrosionrosion Easi-Lift drive head with multi-lock positions allows for quick, repeatable position changes No tools or adjustments needed to switch among USP App. 1, 2, 5, 6, and 150 ml and 250 ml small volumes Can be configured for unattended automatic introduction of the dosage form when media has reached the user-specified temperature or time Quick Test feature begins tests immediately with the push of a button Optional Auto-Probes reduce hydrodynamic interference by automatically exiting the vessels s after sampling, unlike stationary probes that remain in the vessel throughout the dissolution process HANSONRESEARCH.COM

14 DISSOLUTION TESTER ACCESSORIES DIFFUSION TESTING PHYSICAL TESTING DISSOLUTION TESTING 14 HANSONRESEARCH.COM

15 DESIGN YOUR COMPLETE DISSOLUTION TESTER CHOOSE A DISSOLUTION TESTER MODEL: CHOOSE VESSELS CHOOSE VESSEL COVERS CHOOSE APPARATUS TYPE CHOOSE SAMPLING PROBES & ACCESSORIES: MANUAL SAMPLING AUTOMATED SAMPLING CHOOSE TEMPERATURE PROBES: AUTOMATED SAMPLING ENHANCE YOUR TESTER WITH: FILTERS SINKERS APPARATUS TRAYS MEDIA REPLACE BEAKER SYSTEM UV BATH CLEAN CHOOSE VALIDATION, CALIBRATION, REFERENCE ACCESSORIES SUCH AS: PRINTERS Q-PAKS TOOLS DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING HANSONRESEARCH.COM

16 DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING VESSELS Hanson Research offers a complete line of borosilicate glass dissolution vessels to accommodate a vast array of testing applications, including traditional small volume, Chinese small volume, standard one liter, and large-volume 2 liter. Our Precision dissolution vessels meet or exceed USP vessel dimensions and are an excellent choice for dissolution testing, including ASTM requirements. Easi-Lock vessels come with individual serial numbers and a USP Certificate of Conformance (COC). Amber and Peak vessel options also available. VISION EASI-LOCK VESSELS are designed with rugged, chipproof rims to prevent accidental chipping of glass vessel lids and for easy lock-in position in the vessel plate. They come with individual serial numbers and a USP Certificate of Conformity (COC). HANSON CHINESE SMALL VOLUME is based on the official method listed in the Chinese Pharmacopoeia and provides a mid-range volume for applications requiring less media than standard 500 or 900 ml dissolution tests but more than traditional small volume. VOLUMETRIC GRADUATION MARKS and serial numbers come standard on all vessels. 16 HANSONRESEARCH.COM

17 a. b. c. d. e. f. a. b. c. d. e. f. 1 L VESSELS Vessel, Easi-Lock, USP, Precision, 1 L, Glass, Vision (serialized) Vessel, Easi-Lock, USP, Precision, 1 L, Glass, Amber, Vision (serialized) (Special Order min order 6) Vessel, Easi-Lock, Peak, USP Precision, 1 L Glass, Vision (serialized) (Special Order min order 6) Vessel, Easi-Lock, Peak, USP Precision, 1 L, Glass, Amber, Vision (serialized) (Special Order min order 6) 2 L VESSELS Vessel, Easi-Lock, USP, Precision, 2 L, Glass, Vision G2 Elite ML VESSELS SMALL VOLUME only for Vision Elite 8-2 L Vessel, Easi-Lock, USP, Precision, 2 L, Glass, Amber, Vision G2 Elite 8 (Special Order min order 6) DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING g. h. i. j. g. h. i. j Vessel, Round Bottom, 150 ml, Glass, Small Volume, Vision (serialized) Vessel, Round Bottom, 150 ml, Glass, Amber, Small Volume, Vision (serialized) (Special Order min order 6) Vessel, Flat Bottom, 150 ml, Glass, Small Volume, Vision (serialized) Vessel, Flat Bottom, 150 ml, Glass, Amber, Small Volume, Vision (serialized) (Special Order min order 6) 250 ML VESSELS CHINESE SMALL VOLUME k. l. k. l Vessel, Round Bottom, 250 ml, Glass, Chinese Small Volume, Vision G2 (serialized) (Special Order min order 6) Vessel, Round Bottom, 250 ml, Amber Glass, Chinese Small Volume, Vision G2 (serialized) (Special Order min order 6) HANSONRESEARCH.COM

18 DISSOLUTION TESTING MEDIA REPLACE BEAKER SYSTEM Vision Classic 6 PHYSICAL TESTING DIFFUSION TESTING The Vision G2 Classic 6 is an award-winning 6-position dissolution tester. With the addition of the new Media Replace Beaker system, the Classic 6 can now simultaneously warm an additional 1 liter of media while performing a six-sample dissolution test. The warmed media can then be replaced either manually into the dissolution vessels or automatically using the Vision AutoPlus autosampler. The Media Replace Beaker system consists of a jacketed beaker that warms media to the intended test media temperature. The two ports in the beaker s jacket connect it to both the Classic 6 waterbath and Vision Heater, which allows warmed water to continuously flow through the entire system, creating a stabilized temperature environment for media. The Media Replace Beaker system is an optional accessory available for your new or existing Classic 6 dissolution tester. FEATURES: Media Replace Beaker System (shown installed on a Classic 6 ) Adds a seventh position for warmed media Jacketed exterior keeps media warm for immediate use during your test Holds 1 L of solution Comes complete with a cover and 6 probes to connect to your Vision AutoPlus Includes all the tubing and quick-disconnect fittings to connect to your Classic 6 Field retrofit option available Media Replace Beaker System, Classic 6 (includes Beaker p/n , Beaker Cover p/n , Tubing p/n and six Probes p/n ) 18 HANSONRESEARCH.COM

19 UV BATH CLEAN Keeps your waterbath crystal clear for up to 6 months or more! Tired of frequent waterbath cleanings? The Hanson UV Bath Clean will help you maintain a clean waterbath for months on end. The UV Bath Clean is a non-chemical, water purification system that incorporates an Aqua Ultraviolet sterilizer into your waterbath s circulation system. The sterilizer contains an ultraviolet lamp that safely emits a germicidal ray that alters or disrupts the DNA or RNA of singlecelled organisms, such as algae, bacteria, and protozoa, helping to maintain a consistently clean waterbath. The UV Bath Clean system is easily connected to your Hanson Vision Classic 6 and Elite 8 dissolution testers. FEATURES: Increases instrument uptime resulting in higher throughput Cuts down on the use of costly, high purity water Effectively lowers water s bacterial count Enhances visual observation of the dissolution process Cap glows to tell you when lamp is on UV Bath Clean (shown installed on an Elite 8 ) Does not require chemicals that can destroy waterbath s tubing and pumps Reduces labor time involved in bath cleaning and maintenance UV Bath Clean, 115 V UV Bath Clean, 230 V Bulb Replacement, 8 Watt DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING AFTER MONTHS OF NO CLEANING AFTER 6 MONTHS WITH UV BATH CLEAN HANSONRESEARCH.COM

20 DISSOLUTION TESTING VESSEL COVERS Vision vessel covers minimize evaporation to help control media volume during dissolution tests. Designed for seamless integration with Vision dissolution testers, these vessel covers can accommodate a variety of sample probes, digital temperature probes, and dissolution apparatuses. Automatic dosage delivery is also available with ADD (Auto-Dosage Delivery) covers. Vessel covers for use with 150 and 250 ml vessels require an adapter ring. EASI-LOCK ADD VESSEL COVER allows for the automatic dosage delivery of suspensions, solid dosage forms, and sinkers. The trigger delivers the dosage automatically via the Hanson AutoMag or SuperMag magazine, or by touch for manual sampling and staggered start times. PHYSICAL TESTING DIFFUSION TESTING 20 HANSONRESEARCH.COM

21 FOR 1 L & 2 L VESSELS Vessel Cover, Easi-Lock, Vision Vessel Cover, Easi-Lock ADD, Vision Vessel Cover, Stationary Basket, Vision (for Stationary Basket p/n ) (Special Order min order 6) Shown with Pion fiber-optic adapter and probe Vessel Cover, Fiber Optic ADD, Vision DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING FOR 150 ML VESSELS a. b. a. b Vessel Cover, Vision G2 (for 150 ml vessels; compatible w/ SuperMag) Adapter Ring, Easi-Lock, Vision (for 150 ml vessels) FOR 250 ML VESSELS c. c Vessel Cover CSV, Chinese Small Volume, Vision G2 (Special Order min order 6) (compatible w/ SuperMag) d. d Adapter Ring Assembly, CSV, Vision G2 (Special Order min order 6) (required for 250 ml Chinese Small Volume) HANSONRESEARCH.COM

22 DISSOLUTION TESTING DIFFUSION TESTING APPARATUSES Choose from a variety of baskets (USP App. 1), paddles (USP App. 2), and dissolution apparatuses commonly used for transdermal testing such as the paddle over disk (USP App. 5), rotating cylinder (USP App. 6), and immersion cells. The spin-shaft design of Hanson paddles, baskets, and rotating cylinder allows you to easily detach the lower apparatus portion from the upper shaft. The upper shaft remains firmly in place to maintain accurate height measurements when switching among different apparatuses. PHYSICAL TESTING USP APP. 1 BASKETS AND SHAFTS USP APP. 2 PADDLES USP APP. 5 PADDLE OVER DISK USP APP. 6 ROTATING CYLINDER IMMERSION CELLS APPARATUS TRAYS 22 HANSONRESEARCH.COM

23 USP APP. 1 - BASKETS AND SHAFTS a. b. c. g. d. a. b. c. d. e. Vision Classic 6 Vision Elite 8 Vision Elite 8-2 L FOR 150 ML SMALL VOLUME Basket, Mini, 40-Mesh, 316 SS, Vision (Special Order min order 6) (serialized; for Small Volume, requires Basket Shaft p/n ) Spin-Basket Shaft, Mini, 316 SS, Vision (Special Order min order 6) (serialized; for Small Volume; requires Mini Basket p/n ) FOR 1 L & 2 L Basket, USP, Precision, 40 Mesh, 316 SS, SR8-Plus/Vision (serialized) Basket, 10 Mesh, 316 SS, SR8-Plus/ Vision (Special Order min order 6) Basket, 20 Mesh, 316 SS, SR8-Plus/Vision (Special Order min order 6) DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING e. f. h. f. g. h Basket, Suppository, SR8-Plus/ Vision (not serialized) Spin-Basket Shaft, USP, 316 SS, 1 L Vision (serialized) Spin-Basket Shaft, USP, 316 SS, 2 L, Vision The Stationary Basket complies with USP Monograph for Felodipine Extended-Release tablets. It helps with problems associated with floating, sticking, and swelling dosage forms. For manual sampling only. i. i Basket, Stationary, USP, 8 Mesh, 316 SS (uses Stationary Basket Vessel Cover p/n ) Shown attached to Stationary Basket Cover HANSONRESEARCH.COM

24 USP APP. 2 PADDLES DISSOLUTION TESTING Vision Classic 6 Vision Elite 8 Vision Elite 8-2 L PHYSICAL TESTING DIFFUSION TESTING 1 L PADDLES 2 L PADDLES Spin-Paddle, USP, PVDF, Vision (serialized) Spin-Paddle, USP, 316 SS, Vision (serialized) Spin-Paddle, USP, PVDF, 2 L, Vision G2 (serialized) Spin-Paddle, USP, 316 SS, 2 L, Vision G2 (serialized) 150 ML PADDLES 250 ML PADDLES Spin-Paddle, Mini, PTFE Coated, Vision (serialized; for Small Volume) Spin-Paddle, Mini, 316 SS, Vision (serialized; for Small Volume) Spin-Paddle, Mini, 316 SS, CSV, Vision G2 (Special Order min order 6) 24 HANSONRESEARCH.COM

25 APPARATUS TRAYS NUMBERED LOCATIONS help maintain USP/ASTM compliance for apparatus positioning with respect to the dissolution tester. BUILT-IN DRAINAGE allows paddles and baskets to be washed and dried in place. DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING Protect your investment by protecting the integrity of your apparatus. Made from sturdy PVC, these compact, stackable trays are the safest and most convenient method of storing USP paddles, baskets, and basket shafts. The Vision 1 Apparatus Tray is designed to hold Vision 1 L spin-basket shafts and spin-paddles, and will also accommodate many other brands of shafts up to 216 mm (8.5 in.) in length. The Vision 2 Apparatus Tray is designed to hold the longer shafts for Vision 2 L and SR8-Plus, and will also accommodate many other brands of shafts up to 380 mm (15 in.) in length Apparatus Tray - Vision 1, Stackable, Vision (holds paddles, baskets shafts, and baskets for Vision 1 L or Small Volume) Apparatus Tray - Vision 2, Stackable, Vision (holds paddles, baskets shafts, and baskets for Vision 2 L or SR8-Plus) HANSONRESEARCH.COM

26 DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING USP APP. 5 PADDLE OVER DISK USP APP. 6 ROTATING CYLINDER For 1 L Vessels and Paddles The Hanson Transdermal Sandwich (USP App. 5) is a convenient disk assembly recommended by the US FDA for testing patch dosage forms in a standard dissolution test station. It consists of a glass watchglass (on which the patch is placed, delivery side up), a 17 mesh PVDF screen to hold the patch, and PVDF clips to hold the disk assembly together. Accommodates patches up to 90 mm diameter. Used on all Hanson dissolution testers Transdermal Sandwich for Patch (1), App. 5 (Vision requires Spacer p/n one per position) Transdermal Sandwich, App. 5 (set/6) (Vision requires Spacer p/n one per position) Spacer, Height, for App. 5, Vision (1 per position required with p/n /093 for Vision) For 1 L Vessels The Rotating Cylinder complies with USP <724> and is used with standard 1 L vessels and dissolution equipment as described in USP <711>. The Rotating Cylinder holds patches up to 5 x 14 cm in size. For larger patches up to 10 x 14 cm in size, a Rotating Cylinder with Extension is available (both pieces are matched and must be purchased together). The Rotating Cylinder and Extension are serialized and come with a Certificate of Conformance. Height Spacer shown on upper spindle shaft Apparatus 6 Rotating Cylinder only, Vision (Special Order min order 6) (serialized) Apparatus 6 Rotating Cylinder w/ Extension, Vision (Special Order min order 6) (serialized; requires Height Spacer p/n per position) Spacer, Height, App. 6 Rotating Cylinder, Vision (Special Order min order 6) (for App. 6 Rotating Cylinder w/ Extension p/n per position) 26 HANSONRESEARCH.COM

27 IMMERSION CELL IMMERSION CELL (cross section) Membrane Area (for standard 25 mm filter disks) Dosage Area (provides for true repeatable volume) Convenient assembly - tools available for cell preparation and removal a. For 1 50 ml Flat Bottom Vessels DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING b. The Hanson Immersion Cell is designed for release-rate testing of ointments and other topical preparations in the convenience of standard dissolution test equipment. It is designed for use with the 150 ml Flat Bottom Vessels to eliminate dead volume. The Immersion Cell uses standard 25 mm filter disks, and its 3 mm deep dosage area provides for testing of infinite dose topical applications. Immersion Cells with convenient assembly tools are available as a set. Extra Immersion Cells may be ordered separately. See USP <1724> for more information. a. b Immersion Cell only, 15 mm Immersion Cell w/ tools, 15 mm (single cell) Immersion Cell w/ tools, 15 mm, (set/6) HANSONRESEARCH.COM

28 PROBE OPTIONS DISSOLUTION TESTING 1 DIFFUSION TESTING MANUAL SAMPLING AUTOMATED SAMPLING WITH VESSEL-MOUNT PROBES 2 PHYSICAL TESTING 3 AUTOMATED SAMPLING WITH MAGAZINES 28 HANSONRESEARCH.COM

29 1 MANUAL SAMPLING Vision Classic 6 Vision Elite 8 Vision Elite 8-2 L DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING CANNULAS AND SYRINGE Vision Classic 6 Vision Elite 8 Vision Elite 8-2 L Cannula, Manual Sampling, Adjustable, 1/8 in., PEEK (for all Vision manual sampling, except 2 L; uses Tip Filters or In-Line/Syringe Filters) Cannula, Manual Sampling, 2 L, 1/8 in., PEEK, Vision G2 Elite 8 (uses Tip Filters or In-Line/ Syringe Filters) Syringe, Disposable, Luer Type, 10 ml HANSONRESEARCH.COM

30 DISSOLUTION TESTING 2 AUTOMATED SAMPLING WITH Vision Elite 8 Vision Elite 8-2 L VESSEL-MOUNT PROBES DIFFUSION TESTING Vessel-Mount Probes are stationary probes mounted directly into your vessel's cover. Adjustable styles allow you to set your exact sampling height. Use the Return Port Fitting to return rinse media back into the vessel. PHYSICAL TESTING To automate sampling, both Vessel-Mount Probes and the Return Port Fitting require a Tubing Harness to connect to the Vision AutoPlus. VESSEL-MOUNT PROBES - NON-ADJUSTABLE (CARTRIDGE FILTER) Probe, Sample, Fixed Vessel- Mount, 500 ml, 1/16 in., 316 SS, Vision (uses Cartridge Filters; requires 3 ft Tubing Harness p/n /708) Probe, Sample, Fixed Vessel- Mount, 900 ml, 1/16 in., 316 SS, Vision (uses Cartridge Filters, requires 3 ft Tubing Harness p/n /708) Probe, Sample, Fixed Vessel- Mount, 2 L, 316 SS, Vision G2 Elite (requires Tubing Harness p/n /708) 30 HANSONRESEARCH.COM

31 a. b. c. a. b. c. VESSEL-MOUNT PROBES - ADJUSTABLE (CARTRIDGE FILTER) Probe, Fixed-Vessel Mount Sample, Adjustable, 1/16 in., 316 SS, Vision (small volume only; uses Cartridge Filters; requires 3 ft Tubing Harness p/n /708) Probe, Sample, Fixed Vessel-Mount, Adjustable, 1/16 in., 316 SS, Vision (App. 5 and other volumes except small volume; uses Cartridge Filters, requires 3 ft Tubing Harness p/n /708) VESSEL-MOUNT PROBES - ADJUSTABLE (IN- LINE/SYRINGE FILTER) Probes, Sample, Fixed Vessel-Mount, Adjustable, 1/16 in., 900 ml, SS, Vision G2 (set/6) (uses In-Line/Syringe Filters; requires 3 ft Tubing Harness p/n ) Probes, Sample, Fixed Vessel-Mount, Adjustable, 1/16 in., 900 ml SS, Vision G2 (set/8) (uses In-Line/Syringe Filters; requires 3 ft Tubing Harness p/n ) DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING d. e. d. e. RETURN PORT FITTING Return Port Fitting, Vision (for return to vessel; 3 ft Tubing Harness p/n /708 recommended) TUBING Tubing Harness, PTFE, 3 ft, 6-Sample, 1/16 in. (required for Vessel-Mount Probes; extra harnesses required for 3-bath system, return to vessel, and Auto-Probes) Tubing Harness, PTFE, 3 ft, 8-Sample, 1/16 in. (required for Vessel-Mount Probes; extra harnesses required for 3-bath system, return to vessel, and Auto-Probes) HANSONRESEARCH.COM

32 3 Vision Elite 8 Vision Elite 8-2 L AUTOMATED SAMPLING WITH MAGAZINES DISSOLUTION TESTING PHYSICAL TESTING DIFFUSION TESTING The AutoMag and SuperMag magazines for the Vision G2 Elite 8 both accommodate Auto-Probes for automatic sampling from each vessel with the Vision AutoPlus, and either Recirculating Auto-Probes for automatic return of rinse to the vessel or Digital Temperature Probes for individual temperature readings in each vessel. The AutoMag works solely with 1 L or 2 L testing, whereas the SuperMag accommodates 1 L, 150 ml, and 250 ml testing. Each magazine requires a Tubing Harness. Probes and Tubing Harnesses are factory installed only when ordered together with a magazine. MAGAZINES SuperMag Assembly, Small Volume & 1 L, Vision G2 Elite 8 (factory installed; includes probe fittings) SuperMag Assembly, Small Volume & 1 L, Vision G2 Elite 8 (field installed upgrade to existing Vision G2 Elite 8 systems) AutoMag Assembly, 1 L, Vision G2 Elite 8 (factory installed; includes probe fittings) AutoMag Assembly, 1 L, Vision G2 Elite 8 (field installed upgrade to existing Vision G2 Elite 8 systems) Conversion Kit, AutoMag 1 L to 2 L, Vision G Conversion Kit, AutoMag to SuperMag, Vision G2 Elite AutoMag Assembly, 2 L, Vision G2 Elite 8 (factory installed; includes probe fittings) AutoMag Assembly, 2 L, Vision G2 Elite 8 (field installed upgrade to existing Vision G2 Elite 8 systems) 32 HANSONRESEARCH.COM

33 MAGAZINE PROBES AUTO-PROBES Auto-Probes are mounted directly in the magazine and reduce hydrodynamic interference by automatically exiting the vessels after sampling. Auto-Probes require a Tubing Harness for use with a magazine Probe (1), Auto, 1 L & Small Volume, 1/8 in., PEEK, Vision G2 (order 6 or 8; requires AutoMag or SuperMag and 3 ft Tubing Harness p/n /708) TUBING FOR AUTO-PROBES Probe (1), Auto, 2 L, 1/8 in., PEEK, Vision G2 (order 6 or 8; requires AutoMag and 3 ft Tubing Harness /708) Uses PE Tip Filters. DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING Tubing Harness, PTFE, 3 ft, 6-Sample, 1/16 in. (required for Auto-Probes; extra harnesses required for 3-bath system, return to vessel, and Vessel-Mount Probes) Tubing Harness, PTFE, 3 ft, 8-Sample, 1/16 in. (required for Auto-Probes; extra harnesses required for 3-bath system, return to vessel, and Vessel-Mount Probes) HANSONRESEARCH.COM

34 DISSOLUTION TESTING MAGAZINE PROBES (CONTINUED) After selecting Auto-Probes for your magazine's first probe position, choose either Digital Temperature Probes for automatic vessel temperature measurement or Recirculating Auto-Probes to return rinse media back into the vessel. Only one probe type can be used in your magazine's second probe position. DIGITAL TEMPERATURE PROBES DIFFUSION TESTING Probes, Digital Temperature, Vision G2 AutoMag/SuperMag (set/6) (factory installed) Probes, Digital Temperature, Vision G2 AutoMag/SuperMag (set/6) (field upgrade) Probe, Digital Temperature, for all Vision Mags (1) (use for 7th and 8th position or as a replacement probe; circuit board not included) PHYSICAL TESTING OR RECIRCULATING AUTO-PROBES Probes, Auto, Recirculating with Tubing Harness, 6-Sample, 1 L, PEEK, Vision, Factory Installed (for return to vessel; requires Auto- Probes; cannot be used simultaneously with Digital Temperature Probes) Probes, Auto, Recirculating with Tubing Harness, 6-Sample, 1 L, PEEK, Vision G2, Field Installed (for return to vessel; requires Auto- Probes; cannot be used simultaneously with Digital Temperature Probes) Probes, Auto, Recirculating with Tubing Harness, 8-Sample, 1 L, PEEK, Vision G2, Factory Installed (for return to vessel; requires Auto-Probes; cannot be used simultaneously with Digital Temperature Probes) Probes, Auto, Recirculating with Tubing Harness, 8-Sample, 1 L, PEEK, Vision G2, Field Installed (for return to vessel; requires Auto- Probes; cannot be used simultaneously with Digital Temperature Probes) CONVERSION KITS - DIGITAL TEMPERATURE PROBES Conversion Kit, Digital Temperature Probe Board (upgrades a G1 to G2 DTP Board; no probes included) Board, AutoMag for DTP, Vision (upgrade ver to 2.10 or replacement) 34 HANSONRESEARCH.COM

35 a. b. SINKERS c. d. e. f. DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING a. b. c. d. e. f Sinker, Japanese Pharmacopoeia Cage Sinker, 3 Prong Sinkers (6/pk) (wt 1.3 g; 9.5 mm x 25 mm capacity) Sinkers (12/pk) (wt 1.3 g; 9.5 mm x 25 mm capacity) Sinker, Spiral Coated (100% inert epoxy;.84 in. (inside length) x.37 in. (i.d.)) Sinker, Spiral Coated (100% inert epoxy;.84 in. (inside length) x.37 in. (i.d.)) Sinker, Spiral Uncoated 316 SS (.84 in. (inside length) x.38 in. (i.d.)) Sinker, Spiral Uncoated, 316 SS (.84 in. (inside length) x.38 in. (i.d.)) Wire, 316 SS (50 ft roll) (wire to sink capsules) HANSONRESEARCH.COM

36 DISSOLUTION TESTING DIFFUSION TESTING TIP FILTER PHYSICAL TESTING FILTERS TIP FILTERS FOR 1/8 IN. PROBES (PE) Filters, Tip, 1 micron, PE, 1/8 in. (100/pk) Filters, Tip, 1 micron, PE, 1/8 in. (1,000/pk) Filters, Tip, 4 micron, PE, 1/8 in. (100/pk) Filters, Tip, 4 micron, PE, 1/8 in. (1,000/pk) Filters, Tip, 10 micron, PE, 1/8 in. (100/pk) Filters, Tip, 10 micron, PE, 1/8 in. (1,000/pk) Filters, Tip, 35 micron, PE, 1/8 in. (100/pk) Filters, Tip, 35 micron, PE, 1/8 in. (1,000/pk) Filters, Tip, 45 micron, PE, 1/8 in. (100/pk) Filters, Tip, 70 micron, PE, 1/8 in. (100/pk) Filters, Tip, 70 micron, PE, 1/8 in. (1,000/pk) TIP FILTER FOR 1/16 IN. PROBES (PE) Filters, Tip, 10 micron, PE, 1/16 in. (100/pk) Filters, Tip, 10 micron, PE, 1/16 in. (1,000/pk) Filters, Tip, 20 micron, PE, 1/16 in. (100/pk) (for Sample & Return Probes only) Filters, Tip, 35 micron, PE, 1/16 in. (100/pk) Filters, Tip, 35 micron, PE, 1/16 in. (1,000/pk) Filters, Tip, 45 micron, PE, 1/16 in. (100/pk) Filters, Tip, 70 micron, PE 1/16 in. (100/pk) Filters, Tip, 70 micron, PE, 1/16 in. (1,000/pk) Porous Polyethylene (PE) is 100% inert in all applications and meets all current US FDA and USP guidelines. 36 HANSONRESEARCH.COM

37 FILTER BLOCK KIT IN-LINE / SYRINGE FILTER IN-LINE / SYRINGE FILTER IN-LINE FILTER FITTING KIT CARTRIDGE FILTER SHOWN WITH VESSEL-MOUNT PROBE DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING CARTRIDGE FILTERS (PE) Filters, Cartridge, 10 micron, PE, Vision (100/pk) Filters, Cartridge, 10 micron, PE, Vision (1000/pk) Filters, Cartridge, 35 micron, PE, Vision (100/pk) Filters, Cartridge, 35 micron, PE, Vision (1000/pk) Filters, Cartridge, 70 micron, PE, Vision (100/pk) Filters, Cartridge, 70 micron, PE, Vision (1000/pk) IN-LINE / SYRINGE FILTERS Filters, In-Line, 5 micron (75/pk) (for Filter Block Kit p/n or In-Line Filter Fitting Kit p/n ) FILTER KITS Filter Block Kit for In-Line Filters (uses In-Line Filters p/n ; includes 8-Sample Tubing Harness) Filter Fitting Kit, In-Line, SR8-Plus/AutoPlus (8/pk) (for In-Line/Syringe Filters p/n ) HANSONRESEARCH.COM

38 DISSOLUTION TESTING DIFFUSION TESTING AUTOSAMPLERS The Vision AutoPlus is a modern upgrade of the popular Hanson legacy AutoPlus autosampler. The Vision AutoPlus comes with a choice of 6 or 8 sampling channels, and DissoScan (1-bath) or Maximizer (up to 3 baths) configurations. Precision syringe pump mechanics, all-inert tubing and valves, and color touchscreen programming with up to 100 protocols are standard on each instrument. PHYSICAL TESTING VISION AUTOPLUS MAXIMIZER (Shown with Vision AutoFill) DissoScan 6-Sample System, 115/230 V, Vision G DissoScan 8-Sample System, 115/230 V, Vision G Maximizer 6-Sample System, 115/230 V, Vision G Maximizer 8-Sample System, 115/230 V, Vision G Firmware Upgrade Kit, Vision G2 Sampler (free firmware upgrades) 38 HANSONRESEARCH.COM

39 VISION AUTOPLUS FEATURES Precision syringe pump autosampling system All-inert syringes, valves, tubing, and fluidics Choice of 6 or 8 sampling syringes (for 6 or 8 vessels) Volume accuracy and repeatability ±1% Seamless integration with G2 Classic 6 and Elite 8 Automatic media replace standard with Maximizer Convenient Auto Start feature Automatic addition of dilutions or stabilizers Handles problem drugs, surfactants, and buffers Trouble-free maintenance, no peri-pumps or check valves Small, stacked footprint leaves open bench space in front for waste beaker and other tools Optional in-line filter block kit (easy tubing and filter connections) Customizable end of test auto-wash feature automatically prepares the system for the next test Full color touchscreen with intuitive menus and programming Up to 100 protocols (create, manage, and save routines) Upload and download programs with flash drive Electronics and firmware include 32-bit digital technology Print to both serial and network (PostScript) printers Alarms for sampling, maintenance, and calibration Compatible with non-hanson dissolution testers USP / US FDA / ASTM / EP / JP / CE / CSA / RoHS compliant Security: 25 users 21 CFR Part 11 security compliant DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING HANSONRESEARCH.COM

40 DISSOLUTION TESTING VISION AUTOPLUS AUTOSAMPLING SYSTEMS DIFFUSION TESTING 1 1-BATH BASIC SYSTEM: DISSOSCAN & MAXIMIZER SAMPLE 1 BATH DETECT COLLECT TO WASTE PHYSICAL TESTING RETURN TO VESSEL OR RETRIEVAL 2 1-BATH WITH MEDIA REPLACE: MAXIMIZER SAMPLE 1 BATH DETECT COLLECT TO WASTE MEDIA REPLACE OR RETRIEVAL 40 HANSONRESEARCH.COM

41 3 Vision G2 dissolution test Instruments are designed for seamless integration, intuitive programming and operation, flexibility to handle a wide range of applications, with maximum throughput and productivity. Design your lab system to handle everything from basic 1-bath routines to extensive multi-bath testing. Collect samples for off-line analysis in UV-Vis, HPLC, or UPLC detectors. Connect to a spectrophotometer multi-cell transport for on-line UV analysis. 2-BATH WTH MEDIA REPLACE: MAXIMIZER SAMPLE 2 BATHS MEDIA REPLACE DETECT COLLECT TO WASTE OR RETRIEVAL DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING 4 3-BATH SYSTEM: MAXIMIZER SAMPLE 3 BATHS DETECT COLLECT TO WASTE OR RETRIEVAL HANSONRESEARCH.COM

42 DISSOLUTION TESTING DIFFUSION TESTING SAMPLE COLLECTION The Vision AutoFill is a sample collector designed for seamless integration with the Vision AutoPlus. Vision AutoFill accessories include choice of collection racks with 13 x 100 or 16 x 100 mm test tubes for UV-Vis, 12 x 32 mm vials for HPLC, sample trays with 12 x 32 mm vials for UPLC, and more. VISION AUTOFILL PHYSICAL TESTING AutoFill Collector, 115/230 V, Vision G2 42 HANSONRESEARCH.COM

43 VISION AUTOFILL FEATURES Precision fraction collector built for the Vision platform Seamless integration with AutoPlus Choice of easy install collection racks with rack detection sensors Collect in test tubes for UV or vials for HPLC & UPLC Compatible with 13 x 100 and 16 x 100 mm test tubes and 12 x 32 mm vials New wash port with automatic end-of-test wash routine Sample retrieval return to vessel accessory CE / CSA / RoHS compliant DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING HANSONRESEARCH.COM

44 DIFFUSION TESTING PHYSICAL TESTING DISSOLUTION TESTING RACKS TUBES VIALS Collection Racks for the Vision AutoFill accommodate 13 x 100 or 16 x 100 mm test tubes for UV-Vis and 12 x 32 mm vials for HPLC. Vial trays for 12 x 32 mm Shimadzu/ Agilent HPLC vials and Waters Acquity UPLC vials are also available. Collection Racks that use vial trays require a Needle Block Kit to accurately align with the Vision AutoFill needles. 44 HANSONRESEARCH.COM

45 COLLECTION RACKS Collection Rack for 16 mm x 100 mm Test Tubes, AutoFill (18 rows) Collection Rack for 12 mm x 32 mm HPLC Vials, AutoFill (21 rows) DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING Collection Rack for 13 mm x 100 mm Test Tubes, AutoFill (18 rows) (Special Order) HANSONRESEARCH.COM

46 DISSOLUTION TESTING COLLECTION RACKS (CONTINUED) b. a. c. DIFFUSION TESTING a b. Collection Rack for 12 mm x 32 mm Shimadzu/Agilent HPLC Vials, AutoFill Vial Trays, 54 Wells, 12 mm x 32 mm, HPLC, Shimadzu/ Agilent Rack (3/pk) (each tray = 9 x 6 rows) PHYSICAL TESTING REQUIRED (Vial Trays + Needle Block Kit) c Needle Block Kit for Shimadzu/Agilent HPLC Rack (factory installed) Needle Block Kit for Shimadzu/Agilent HPLC Rack (field installed) d. e. f. d e. Collection Rack for 12 mm x 32 mm Waters Acquity UPLC Vials, AutoFill REQUIRED (Vial Trays + Needle Block Kit) f Vial Tray, 48 Well for 2 ml UPLC Vials, AutoFill (each tray = 8 x 6 rows; requires 3 trays per UPLC Rack p/n ) Needle Block Kit for Waters UPLC Rack (factory installed) Needle Block Kit for Waters UPLC Rack (field installed) 46 HANSONRESEARCH.COM

47 TEST TUBES AND VIALS Test Tubes, 13 mm x 100 mm (250/pk) Test Tubes, 16 mm x 100 mm (250/pk) Vials w/ Pre-Cut Septum, HPLC, UPLC, 12 mm x 32 mm (100/pk) Caps, Evaporation, 16 mm, Reusable, Short Style (100/pk) DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING RETRIEVAL RESERVOIR The AutoFill Retrieval Reservoir is an accessory add-on to the Vision AutoFill that eliminates sampling waste volume. The retrieval accessory returns rinse media back to the vessel after UV analysis and/or collection. Easy field retrofit Retrieval Reservoir, AutoFill SAMPLER TRAY A Sampler Tray is required for the Vision AutoPlus if Vision AutoFill is not purchased, or if the AutoFill will not sit on top of the Vision AutoPlus as recommended Sampler Tray, Vision G2, AutoPlus, Vision Microette HANSONRESEARCH.COM

48 DISSOLUTION TESTING DIFFUSION TESTING HANSON ON-LINE UV-VIS In conjunction with worldwide partners Shimadzu and Solvias, Hanson Research presents four On-Line UV-Vis system configurations for your Vision G2 Classic 6 or G2 Elite 8 dissolution tester. Each system configuration incorporates the Shimadzu UV-1800, the spectrophotometer with the highest resolution in its class, as well as cutting-edge ARGUS/Dissolution application software from Solvias for pharmaceutical dissolution testing. PHYSICAL TESTING SHIMADZU UV-1800 The Shimadzu UV-1800 is a compact, double-beam UV-Vis spectrophotometer wrapped in a sleek form. The UV-1800 uses the Czerny-Turner mounting for its monochromator, and boasts the highest resolution in its class, a bright optical system, and a compact design. Like Vision instruments, the UV-1800 is USB-memory ready, which enables you to save measurement data to highly versatile USB memory, and perform data analysis printing using a PC. 48 HANSONRESEARCH.COM

49 DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING ARGUS/DISSOLUTION ARGUS/Dissolution is a revolutionary scientific dissolution data management software tool for instrument control and advanced data acquisition, management, processing and reporting. Whether you perform dissolution tests occasionally or several times each day, ARGUS/Dissolution will make you more productive in running tests and analyzing results. Developed according to regulations set forth in 21 CFR Part 11, ARGUS/Dissolution automatically creates detailed audit trails to record changes of methods, analyses, system configurations, and other relevant data. The client-server architecture of the ARGUS platform perfectly fits into your corporate network to control your dissolution tester hardware, retrieve and store methods from a documents database, and more. ARGUS/Dissolution simplifies how you collect and report dissolution test results by letting you choose the analysis template that matches the way you work. Minimum PC Requirements for ARGUS/Dissolution Windows 7, or higher (32 and 64 bit). 1 GB RAM minimum 1280 x 1024 screen CD drive 1 GHz CPU 200 free disk space HANSONRESEARCH.COM

50 DISSOLUTION TESTING HANSON S ON-LINE UV-VIS SYSTEM CONFIGURATIONS DIFFUSION TESTING PHYSICAL TESTING 1 Vision G2 Classic 6 or Elite 8 Shimadzu UV-1800 Ismatec Peri-Pump PC with ARGUS CLOSED LOOP WITH PERI-PUMP The Closed Loop with Peri-Pump system is ideal for those who only want their samples analyzed and returned right back into the dissolution vessels. This configuration utilizes an Ismatec Peri-Pump that pulls samples directly from your Vision dissolution tester. Samples pass through the Shimadzu UV-1800 that is connected to a standard PC operating ARGUS/Dissolution software, where they are measured and analyzed. After samples are measured, they are returned right back into their original vessels, thus closing the entire system loop On-Line UV - Closed Loop w/ Peri-Pump (The Closed Loop with Peri-Pump system includes everything you need to connect your Vision dissolution tester and PC including: Ismatec Peri-Pump, tubing, connectors, Ethernet switch, software drivers, and validation documents. 21 CFR Part 11 Compliant.) Vision G2 Classic 6 or Elite 8 Vision AutoPlus with AutoFill Shimadzu UV-1800 PC with ARGUS 2 DETECT & COLLECT 1-BATH The Detect & Collect 1-Bath system allows for the collection of samples in a sample collector after they have been measured and analyzed by the Shimadzu UV This configuration utilizes a Vision G2 Classic 6, or the G2 Elite 8 paired with the AutoMag or SuperMag magazine. Precision sample aliquots are withdrawn by the Vision AutoPlus autosampler from the dissolution tester and pushed through the Shimadzu UV-1800 connected to a standard PC operating ARGUS/Dissolution software. After samples are measured and analyzed, they are collected in the Vision AutoFill On-Line UV Detect & Collect 1-Bath (The On-Line UV Detect & Collect 1-Bath system includes everything you need to connect your Vision dissolution tester, autosampler, and PC including: tubing, connectors, Ethernet switch, software drivers, and validation documents. 21 CFR Part 11 Compliant.) 50 HANSONRESEARCH.COM

51 3 Vision G2 Classic 6 or Elite 8 Vision AutoPlus with AutoFill Vision G2 Classic 6 or Elite 8 DETECT & COLLECT 2-BATH The Detect & Collect 2-Bath system expands on the Detect & Collect 1-Bath system by adding the ability to sample from two Vision dissolution testers during the same test. The Detect & Collect 2-Bath system employs two Vision G2 Classic 6 dissolution testers, or two Vision G2 Elite 8 dissolution testers paired with AutoMag or SuperMag magazines. Precision sample aliquots are withdrawn by the Vision AutoPlus autosampler from the dissolution tester and pushed Shimadzu UV-1800 PC with ARGUS through the Shimadzu UV-1800 connected to a standard PC operating ARGUS/Dissolution software. After samples are measured and analyzed, they are collected in the Vision AutoFill On-Line UV Detect & Collect 2-Bath (The On-Line UV Detect & Collect 2-Bath system includes everything you need to connect your Vision dissolution tester, autosampler, and PC including: tubing, connectors, Ethernet switch, software drivers, and validation documents. 21 CFR Part 11 Compliant.) DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING Vision G2 Classic 6 or Elite 8 Vision G2 Classic 6 or Elite 8 Vision AutoPlus with AutoFill Vision G2 Classic 6 or Elite 8 Shimadzu UV-1800 PC with ARGUS 4 DETECT & COLLECT 3-BATH The Detect & Collect 3-Bath system gives you the capability to analyze and measure samples from three Vision G2 Classic 6 dissolution testers, or three Vision G2 Elite 8 dissolution testers paired with AutoMag or SuperMag magazines. Samples are pulled, analyzed, and collected in the same manner as the Detect & Collect 1-Bath and 2-Bath systems On-Line UV Detect & Collect 3-Bath (The On-Line UV Detect & Collect 3-Bath system includes everything you need to connect your Vision dissolution tester, autosampler, and PC including: tubing, connectors, Ethernet switch, software drivers and validation documents. 21 CFR Part 11 Compliant.) FLOW CELL OPTIONS FOR ALL CONFIGURATIONS UV Flow Cell, 1 mm UV Flow Cell, 2 mm UV Flow Cell, 5 mm UV Flow Cell, 10 mm HANSONRESEARCH.COM

52 DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING SAMPLE FILTRATION The Vision AutoFilter Changer automatically introduces 25 mm syringe filters into the fluidic path of your dissolution samples. Designed as a seamless addition to Hanson s Vision family of quality test instruments, the Vision AutoFilter Changer brings a new approach to automated filtration by giving you the power to determine the life of your filters. Rather than discard filters after one-time use, the Vision AutoFilter Changer enables you to automatically introduce filters to the fluidic path, remove them if desired, return them back into position, or completely discard them, all of which is programmable. There are almost no limitations to the Vision AutoFilter Changer you decide what works best for your method. VISION AUTOFILTER CHANGER AutoFilter Changer, Vision 115/230 V VISION AUTOFILTER CHANGER FEATURES Filters 6, 7, or 8 samples simultaneously Automatic insertion and removal of filters from fluidic path Compatible with a variety of 25 mm syringe filters Supports automation-compatible filters Comes standard with both 18-filter and 25-filter stack tubes Customizable filter capacity (the ceiling is the limit!) Pull-through or push-through system configuration capability User can create, manage, and save up to 100 protocols Upload and download programs with flash drive User-defined alarms for sampling, maintenance, and calibration Ability to temporarily remove filters from the fluidic path for complete system rinse between samples Full color touchscreen with intuitive menus and programming Electronics and firmware include 32-bit digital technology Print to both serial and network (PostScript) printers Front-facing filter positioning for easy visual verification of filters Catch bin drawer conveniently stores discarded filters Elegant, ergonomic design with workhorse performance 21 CFR Part 11 security compliant USP / US FDA / ASTM / JP / EP / CE / CSA / WEEE / RoHS compliant 52 HANSONRESEARCH.COM

53 DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING Collector PUSH-THROUGH CONFIGURATION (Recommended) Up to 3 Dissolution Testers Autosampler Vision AutoFilter Changer Collector PULL-THROUGH CONFIGURATION 1 Dissolution Tester Vision AutoFilter Changer Autosampler HANSONRESEARCH.COM

54 DISSOLUTION TESTING MEDIA PREP SYSTEM DIFFUSION TESTING MEDIA-MATE PLUS PHYSICAL TESTING Media-Mate Plus, L, 115 V Media-Mate Plus, L, 230 V The Media-Mate Plus is the perfect media-prep system for a busy dissolution lab that demands both speed and accuracy. It delivers pre-heated, filtered, deaerated, and volumetrically dispensed media to 6 or 7 dissolution vessels simultaneously in less than five minutes. Built on a unique ergonomic cart, the Media-Mate Plus offers maximum portability for easy servicing of many dissolution test stations. The Media-Mate Plus exceeds USP / US FDA recommended media deaeration specifications making it one of the most effective tools in ensuring successful Performance Verification Tests (PVT). By significantly reducing dissolved oxygen levels and dispensing media simultaneously into 6 or 7 vessels, the Media-Mate Plus eliminates the variable caused by Prednisone tablets that are highly sensitive to dissolved oxygen levels, thus facilitating successful passage of PVT tests. 54 HANSONRESEARCH.COM

55 DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING MEDIA-MATE PLUS FEATURES: Preheats, filters, deaerates, and volumetrically dispenses media in less than 5 minutes Delivers media to 6 or 7 vessels simultaneously Easy adjustments for precise volumetric dispensing with ±1% accuracy Mobile, ergonomic cart for easy use around the lab Convenient retractable power cord Measuring vessels made with corrosion-resistant parts Compatible with nearly all dissolution testers Interchangeable pre-heat tanks (10-40 L) can be conveniently dedicated to different media and buffers USP <711> and <1092> compliant Full compliance to USP Toolkit (dissolved oxygen below 6 ppm) The most important tool for ensuring successful PVT tests HANSONRESEARCH.COM

56 DISSOLUTION TESTING Operational panel provides easy-to-use controls. One simple button initiates complete media measurement/deaeration/ dispense cycle. Fills dissolution vessels in less than 5 minutes. Volume change adjustments provide quick and easy volume settings from 250 ml to 1,000 ml in 50 ml increments. Fill 6 or 7 vessels in Hanson, Agilent, VanKel, Distek, Erweka, or other dissolution testers. DIFFUSION TESTING PHYSICAL TESTING Interchangeable pre-heat tanks (10-40 L) can be conveniently dedicated to different media and buffers. Order an extra Tank, Heater, and Temperature Control for this purpose. 56 HANSONRESEARCH.COM

57 DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING MEDIA-MATE PLUS ACCESSORIES Tank, Heater, and Temperature Control, 115 V, Media-Mate Plus Tank, Heater, and Temperature Control, 230 V, Media-Mate Plus Temperature Control only, 115 V, Media-Mate Plus Temperature Control only, 230 V, Media-Mate Plus Heater Assembly only, 115 V, Media-Mate Plus Heater Assembly only, 230 V, Media-Mate Plus Vessel Filler, Single, Media-Mate Plus Media Filler Hose Extension w/ Filter, Media-Mate Plus (draws media from other source) Filter Cartridge for Tank, Polypropylene, 5 micron, Media-Mate Plus (5/pk) Low Volume Tank Assembly, Media-Mate Plus Tank, Low Volume, Upgrade Kit, Media-Mate Plus Fill Tube Upgrade Kit, Media-Mate Plus Dispense Bar Assembly, (Sotax AT7), Media-Mate Plus Calibration Gauge Set, Media-Mate Plus (required for fine volume adjustment) Calibration Kit, Media-Mate Plus (includes 8 Plastic Vessels (1 L), 8-Position Vessel Carrier, and Calibration Gauge Set) HANSONRESEARCH.COM

58 LEGACY ACCESSORIES (MACHINES NO LONGER SOLD) PHYSICAL TESTING DISSOLUTION TESTING DIFFUSION TESTING LEGACY SR8-PLUS Our SR8-Plus dissolution tester has been discontinued since April Although these products will no longer be sold, we still support a wide range of common accessories and consumables for the SR8-Plus. Additional Service parts and accessories may be available. 58 HANSONRESEARCH.COM

59 VESSELS A Vessel Centering Ring is required for each 1 L and 2 L vessel used with the SR8-Plus, except for Peak Vessels. 1 L VESSELS a. b. 1 L VESSELS ACCUCENTER SYSTEM All vessels have volumetric graduation marks and serial numbers except Plastic Vessel p/n a. b Ring, Vessel Centering, SR8-Plus (fits into base plate for 1 L and 2 L vessels) Ring, Vessel Centering, SR8-Plus (included w/ Peak Vessels; required for Super Precision Vessels if AccuCenter Centering Bracket is not used) Vessel, USP, Precision, 1 L, Glass, SR8-Plus (serialized) Vessel, USP, Precision, 1 L, Glass, Amber, SR8-Plus (Special Order-min order 6) (serialized) Vessel, Peak, 1 L, Glass, SR8-Plus (serialized w/ vol markings; includes Vessel Centering Ring p/n ) Vessel, Peak, 1 L, Amber, SR8-Plus (serialized w/ vol markings; includes Vessel Centering Ring p/n ) Vessel, USP, 1 L, Plastic (not serialized; no volume markings) DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING The AccuCenter system provides ultimate dimensional accuracy, making it ideal for ASTM and USP mechanical calibration requirements. The system consists of a vessel centering bracket designed for the SR8-Plus base plate* and a Super Precision vessel that is held in place by the bracket. *AccuCenter brackets are also available for Agilent VK 7000 and Distek 2100 A, B, and C base plates. SUPER PRECISION VESSELS Vessel, USP, Super Precision, 1 L, Glass, SR8-Plus (serialized; requires Vessel Centering Ring p/n or AccuCenter Centering Bracket p/n ) Vessel, USP, Super Precision, 1 L, Glass, Amber, SR8-Plus (Special Order-min order 6) (serialized; requires Vessel Centering Ring p/n or AccuCenter Centering Bracket p/n ) VESSEL CENTERING BRACKET Vessel Centering Bracket, AccuCenter, SR8-Plus Vessel Centering Bracket, AccuCenter, Distek Vessel Centering Bracket, AccuCenter, Vankel HANSONRESEARCH.COM

60 DISSOLUTION TESTING 2 L VESSELS Vessel, USP, 2 L, Glass, SR8-Plus (serialized) Vessel, USP, 2 L, Glass, Amber, SR8-Plus (Special Order-min order 6) (serialized) 150 ML VESSELS DIFFUSION TESTING PHYSICAL TESTING Vessel, Round Bottom, 150 ml, Glass, SR8-Plus (serialized) Vessel, Round Bottom, 150 ml, Glass, Amber, SR8-Plus (Special Order min order 6) (serialized) Vessel, Flat Bottom, 150 ml, Glass, SR8-Plus (serialized; for Immersion Cell p/n ) CIRCULATING WATER PUMP Pump, Circulating Water, Non-Reverse Plug, SR8-Plus ( ) Pump, Circulating Water, Reverse Plug, SR8-Plus (since 1997) Air Stone for Soft-Flo, SR8-Plus (10/pk) VESSEL COVERS FOR 1 L & 2 L VESSELS Vessel Cover, Low Evaporation, Rotary, SR8-Plus Vessel Cover, Rotary-X, SR8-Plus (for Super Precision Vessels) Vessel Cover, ADD, SR8-Plus ("Auto-Dosage Delivery") FOR 150 ML VESSELS Vessel Cover, 150 ml, Small Volume, SR8-Plus 60 HANSONRESEARCH.COM

61 VESSEL CARRIERS Universal Vessel Carriers hold all brands of 1 L and 2 L dissolution vessels. Made of all non-corrosive rigid ABS plastic construction with sturdy non-ski rubber legs, these vessel carriers transport filled vessels to and from media prep stations and dissolution baths. Space-saving stackable design when empty Vessel Carrier, Universal, 6 Position, SR8-Plus Vessel Carrier, Universal, 8 Position, SR8-Plus USP APP. 1 BASKETS AND SHAFTS FOR 1 L AND 2 L Basket Assembly Basket Assembly w/ 15 in. shaft, USP, SR8-Plus (serialized) Basket Assembly w/ 21 in. shaft, USP, SR8-Plus (serialized) Baskets Basket, USP, Precision, 40 Mesh, 316 SS, SR8-Plus/Vision (serialized) Basket, 10 Mesh, 316 SS, SR8-Plus/Vision (Special Order min order 6) Basket, 20 Mesh, 316 SS, SR8-Plus/Vision (Special Order min order 6) Basket, Suppository, SR8-Plus/Vision (not serialized) Shafts Basket Shaft, USP, 15 in., 1 L, SR8-Plus (serialized) Basket Shaft, USP, 21 in., 2 L SR8-Plus (serialized) DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING Stationary Basket Basket, Stationary, USP, 8 Mesh, 316 SS (uses Stationary Basket Vessel Cover p/n ) Vessel Cover, Stationary Basket, SR8-Plus (for Stationary Basket p/n ) FOR 150 ML Basket Basket, Mini, 40-Mesh, 316 SS, Vision (Special Order min order 6) (serialized; for Small Volume, requires Basket Shaft p/n ) Basket Shaft Spin-Basket Shaft, Mini, 316 SS,Vision (Special Order min order 6) (serialized; for Small Volume; requires Mini Basket p/n ) HANSONRESEARCH.COM

62 USP APP. 2 PADDLES DISSOLUTION TESTING DIFFUSION TESTING FOR 1 L PHYSICAL TESTING Paddle w/ 15 in. shaft, USP, PVDF, SR8-Plus (serialized) Paddle w/ 15 in. shaft, USP, 316 SS, SR8-Plus (serialized) Paddle w/ 18 in. shaft, Long, PTFE, SR8-Plus (serialized) FOR 2 L Paddle w/ 21 in. shaft, Extra Long, USP, 2 L, PVDF, SR8-Plus (serialized) Paddle w/ 21 in. shaft, Extra-Long, USP, 2 L, 316 SS, SR8-Plus (serialized) FOR 150 ML Mini-Paddle, PTFE Coated, for 150 ml vessels, SR8-Plus (serialized) BASKET AND PADDLE HEIGHT SPACERS Spacer, Basket Height Adjustment, SR8-Plus (serialized) Spacer, Paddle Height Adjustment, SR8-Plus (serialized) APPARATUS TRAYS Apparatus Tray - Vision 2, Stackable, Vision (holds paddles, baskets shafts, and baskets for Vision 2 L or SR8-Plus ) 62 HANSONRESEARCH.COM

63 SMALL VOLUME KITS Hanson small volume accessories are used for low concentration drug formulations and other special applications when small volume dissolution media is required. Small Volume Kits for the SR8-Plus include a Mini-Paddle, 150 ml vessel (choice of Round Bottom or Flat Bottom vessel), and a Vessel Adapter Kit for use on the SR8-Plus base plate. Extras may be ordered separately. SMALL VOLUME DISSOLUTION KITS Small Volume Dissolution Kit (1), Round Bottom, 150 ml, SR8-Plus Small Volume Dissolution Kit, Round Bottom, 150 ml, SR8-Plus (set/6) Small Volume Dissolution Kit (1), Flat Bottom, 150 ml, SR8-Plus Small Volume Dissolution Kit, Flat Bottom, 150 ml, SR8-Plus (set/6) DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING VESSEL ADAPTER KIT Vessel Adapter Kit, Small Volume, SR8-Plus (1 per vessel) SMALL VOLUME PROBE RETROFIT KIT Small Volume Probe Retrofit Kit, SR8-Plus (1 per vessel) USP APP. 5 - PADDLE OVER DISK Transdermal Sandwich for Patch (1), App Transdermal Sandwich, App. 5 (set/6) USP APP. 6 - ROTATING CYLINDER Apparatus 6 Rotating Cylinder, SR8-Plus (max patch area = 5.5 in. x 2 in.) Apparatus 6 Rotating Cylinder with Extension, SR8-Plus (max area patch w/ extension = 5.5 in. x 5.69 in.) HANSONRESEARCH.COM

64 DISSOLUTION TESTING SINKERS IMMERSION CELL DIFFUSION TESTING For Sinkers See page 35. For Immersion Cell See page 27. For convenient installation and removal of the basket and cover assembly, Extra-Long Paddle Shafts are recommended. PHYSICAL TESTING TEMPERATURE PROBES Hanson Digital Temperature Probes (DTPs) are rugged and robust digital devices, intelligent in design, and virtually imperious to analog noise. Our exclusive "digital-sensor" technology ensures precision temperature resolution, reporting, and validation, and provides extensive data on multiple vessel temperatures, including maximum/ minimum/average statistical data. Each DTP carries an individual and unique electronic signature, serial number, and calibration log ideal for USP/US FDA/21 CFR Part 11 compliancy. Easy retrofit on all Hanson SR8-PLus dissolution testers. DTPs are normally attached to a sampling probe. DIGITAL TEMPERATURE PROBES Probe, Digital Temperature, SR8-Plus (single probe) Probes, Digital Temperature, SR8-Plus (set/6) (factory installed) Probes, Digital Temperature, SR8-Plus (set/6) (field upgrade kit) DIGITAL TEMPERATURE PROBES Probe, Analog Temperature, for SR8-Plus/SR6 ValiData 64 HANSONRESEARCH.COM

65 MANUAL SAMPLING CANNULAS CANNULA KIT Manual Sampling Cannula Kit, SR8-Plus (set/8) (includes probes and syringes for obsolete Slide-Open Vessel Cover p/n ) DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING CANNULAS 316 STAINLESS STEEL 316 SS cannulas come with an inert Tefzel female luer, have a 1/8 in. o.d., low hold-up volume, and are compatible with In-Line/Syringe Filters and Tip Tilters Cannula, Manual Sampling, 500 ml, 7.75 in., 316 SS Cannula, Manual Sampling, 900 ml, 4.75 in., 316 SS Cannula, Manual Sampling, Head Mount, 15 in., 316 SS CANNULAS PEEK PEEK cannulas come with an inert Tefzel female luer, have a 1/8 in. o.d., and are compatible with In-Line/Syringe Filters and Tip Filters. PEEK and Tefzel are biocompatible, chemically inert, and non-corrosive Cannula, Manual Sampling, 900 ml, 4.75 in., PEEK Cannula, Manual Sampling, Head Mount, 15 in., PEEK Stopper for 15 in. cannula SYRINGE Syringe, Disposable, Luer Type, 10 ml HANSONRESEARCH.COM

66 DISSOLUTION TESTING MANUAL SAMPLING PROBES Easi-Probe Kits are used for manual sampling with the SR8-Plus. Easi-Probes are mounted to the SR8-Plus head and use 1/8 in. filters or In-Line/Syringe Filters. EASI-PROBES FOR 1 L Probes, Easi-Probe Kit, 1 L, 6-Sample, 1/8 in., SR8-Plus Probes, Easi-Probe Kit, 1 L, 8-Sample, 1/8 in., SR8-Plus DIFFUSION TESTING EASI-PROBES FOR 2 L Probes, Easi-Probe Kit, 2 L, 6-Sample, 1/8 in., SR8-Plus Probes, Easi-Probe Kit, 2 L, 8-Sample, 1/8 in., SR8-Plus AUTOMATED SAMPLING PROBES PHYSICAL TESTING Fixed Vessel Sample Probe Kits include vessel covers with stainless sample probes and return probes, tubing connectors, and a wash station (Tubing Harness not included). Order 1 kit for each bath. Use of standard tip filters or 5 micron in-line/syringe filters are required f0r sample filtration into the AutoPlus. FIXED VESSEL PROBES FOR 1 L Probes, Fixed Vessel Sample Probe Kit, 1 L, 6-Sample, 1/16 in., SR8-Plus (w/ covers) Probes, Fixed Vessel Sample Probe Kit, 1 L, 8-Sample, 1/16 in., SR8-Plus (w/ covers) Probes, Fixed Vessel Sample Probe Kit, 1 L, 6-Sample, 1/8 in., SR8-Plus (w/ covers) Probes, Fixed Vessel Sample Probe Kit, 1 L, 8-Sample, 1/8 in., SR8-Plus (w/ covers) EASI-PROBES FOR 1 L E-Probes (Electronic Probes) use 1/8 in. filters. E-Probes are for use with E-Probe Actuator Kits. If an E-Probe Actuator Kit is not used with E-Probes, order a Head Kit p/n to mount E-Probes to SR8-Plus head. Contact your local Hanson representative for more information on E-Probe Actuator Kits Probes, Sample Probe Kit, 1 L, 6-Sample, 1/8 in., Head Mount, E-Probes Probes, Sample Probe Kit, 1 L, 8-Sample, 1/8 in., Head Mount, E-Probes EASI-PROBES FOR 2 L Probes, Sample Probe Kit, 2 L, 6-Sample, 1/8 in., Head Mount, E-Probes Probes, Sample Probe Kit, 2 L, 8-Sample, 1/8 in., Head Mount, E-Probes HEAD KIT Head Kit (set/8), SR8-Plus (use for Head Mount Probes w/o E-Probe Actuators) 66 HANSONRESEARCH.COM

67 AUTO PILL DROPPERS Auto Pill Droppers, 6-Sample, SR8-Plus (requires E-Probes) Auto Pill Droppers, 8-Sample, SR8-Plus (requires E-Probes) FILTERS TIP FILTERS See page 36. Use Tip Filters for 1/16 in. probes. IN-LINE / SYRINGE FILTERS See page 37. FILTER KITS Filter Fitting Kit, In-Line, SR8-Plus/AutoPlus (8/pk) (for In-Line/Syringe Filters p/n ) VOLUMETRIC FLASKS DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING Flask, Volumetric, 1000 ml, Class A/20 C Flask, Volumetric, 500 ml, Class A/20 C Flask, Volumetric, 500 ml, Class A/37 C Flask, Volumetric, 900 ml, Class A/20 C Flask, Volumetric, 900 ml, Class A/37 C FIRMWARE UPGRADE KITS Firmware Upgrade Kit ver for SR8-Plus (compatible with Vision G2 AutoPlus) Q-PAK SELF-VALIDATION GUIDELINES Q-Pak IQ/OQ/PQ Validation Guideline, SR8-Plus USP Q-Pak IQ/OQ Validation Guideline, SR8-Plus ASTM PRINTERS AND SUPPLIES See page 94. SPARE PARTS KITS Spare Parts Kit, 2 Year, 115 V, SR8-Plus Spare Parts Kit, 2 Year, 230 V, SR8-Plus HANSONRESEARCH.COM

68 DISSOLUTION TESTING LEGACY ACCESSORIES (MACHINES NO LONGER SOLD) DIFFUSION TESTING LEGACY AUTOPLUS The AutoPlus with MultiFill has been discontinued since April Although these products will no longer be sold, we still support a wide range of common accessories and consumables for the legacy AutoPlus and MultiFill. PHYSICAL TESTING COLLECTION RACKS Collection Rack for 12 mm x 32 mm HPLC Vials, MultiFill (uses Pre-Cut Septum Vials p/n ) Collection Rack for 13 x 100 mm Test Tubes, MultiFill Collection Rack for 16 mm x 100 mm Test Tubes, MultiFill TUBING Tubing Harness, PTFE, 3 ft, 6-Sample, 1/16 in., AutoPlus/AutoMag/SuperMag Tubing Harness, PTFE, 3 ft, 8-Sample, 1/16 in., AutoPlus/AutoMag/SuperMag RETRIEVAL RESERVOIR Retrieval Reservoir & Bench Mount Base Assembly - Complete, AutoPlus/Vision-Enabled AutoPlus NEEDLE OPTIONS Needles, PEEK, Option, MultiFill (set/8) (field retrofit replaces SS needles) FIRMWARE UPGRADE KITS Firmware Upgrade Kit ver. 3.20, AutoPlus Firmware Upgrade Kit ver. 4.0, Vision-Enabled AutoPlus (field installed) SOFTWARE DRIVER FOR AGILENT Driver for Hanson/Agilent Dissolution Systems, Current Version, SR8-Plus/Vision G2 AutoPlus (provided on CD; not compatible with Vision-Enabled AutoPlus) PRINTERS AND SUPPLIES See page 94. Q-PAK SELF-VALIDATION GUIDELINES Q-Pak IQ/OQ/PQ Validation Guideline, AutoPlus Q-Pak IQ/OQ/PQ Validation Guideline, Vision-Enabled AutoPlus SPARE PARTS KITS Spare Parts Kit, 2 Year, 115/230 V, AutoPlus 68 HANSONRESEARCH.COM

69 DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING HANSONRESEARCH.COM

70 DISSOLUTION TESTING DIFFUSION TESTING DIFFUSION TESTING PHYSICAL TESTING Diffusion testing is a release rate test of an active pharmaceutical ingredient in semisolid form as it permeates through a skin-like membrane into solution. Diffusion replicates the process of skin-applied medicine as it permeates the skin into the body for local or systemic action. It is ideal for the quality control of topical preparations. PAGE 72 AUTOMATED DIFFUSION TEST SYSTEM PAGE 73 MANUAL DIFFUSION TEST SYSTEM PAGE 74 SYSTEM ACCESSORIES PAGE 76 VERTICAL DIFFUSION CELLS PAGE 78 CELL ACCESSORIES 70 HANSONRESEARCH.COM

71 HANSONRESEARCH.COM DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING

72 DISSOLUTION TESTING DIFFUSION TESTING DIFFUSION TEST SYSTEMS The Vision Microette system automates sampling from groups of six Hanson Vertical Diffusion Cells (VDCs) for extensive unattended tests and handles surfactants, saline, and hydroalcoholic receptor solutions. The Vision Microette is an ideal research and quality control tool for the study of topical and transdermal drug delivery formulations, as well as ophthalmics, cosmetics, skin care products, and pesticides. VISION MICROETTE AUTOMATED TEST SYSTEM 1. Programmable Circulating Waterbath 2. Vision Mircoette 3. 6-Cell Drive System 4. Vision AutoFill PHYSICAL TESTING HANSONRESEARCH.COM

73 MANUAL DIFFUSION TESTING The Hanson 6-Cell Manual Diffusion Test System is a startup vertical diffusion cell test system ideal for manual use and sampling. It is adaptable for later addition of the Vision Microette autosampler. The Manual Diffusion Test System includes: 6-Cell Drive System 6 Vertical Diffusion Cells Jacketed Beaker for Media Replacement Supply Kit with Manual Sampling Syringe AUTOMATED DIFFUSION TESTING The Vision Microette Automated Test System requires: Vision Mircoette Vision AutoFill 6-Cell Drive System 6 Vertical Diffusion Cells Programmable Circulating Waterbath Cell Manual Diffusion Test System w/ 4 ml Cells, Clear Cell Manual Diffusion Test System w/ 4 ml Cells, Amber Cell Manual Diffusion Test System w/ 7 ml Cells, Clear Cell Manual Diffusion Test System w/ 7 ml Cells, Amber Cell Manual Diffusion Test System w/ 12 ml Cells, Clear Cell Manual Diffusion Test System w/ 12 ml Cells, Amber Vision Microette Autosampler, Single-Group Vision Microette Autosampler, Multi-Group AutoFill Collector Cell Drive System, MicroettePlus/Vision Microette Waterbath, Programmable Circulating, 115 V, Vision Microette (requires firmware ver. 2.11) Waterbath, Programmable Circulating, 230 V, Vision Microette (requires firmware ver. 2.11) DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING HANSONRESEARCH.COM

74 DISSOLUTION TESTING SINGLE-GROUP VS. MULTI-GROUP The Vision Microette includes two models: a versatile Multi-Group system that can automate up to 3 groups of VDCs, and a lower cost Single-Group system that automates 1 group of VDCs. To expand the Multi-Group system from 1 group of VDCs to more, an additional 6-Cell Drive System, 6 VDCs, and Vision AutoFill is required. US Patents; CE / CSA / RoHS compliant DIFFUSION TESTING 6 CELLS SINGLE-GROUP SETUP Vision Microette Single-Group setup automates sampling from 1 group of 6 VDCs (6 cells total). 12 CELLS MULTI-GROUP SETUP Vision Microette Multi-Group setup automates sampling from 2 groups of 6 VDCs (12 cells total). 18 CELLS MULTI-GROUP SETUP Vision Microette Multi-Group setup automates sampling from 3 groups of 6 VDCs (18 cells total). PHYSICAL TESTING MULTI-GROUP EXPANSION KIT Expansion Kit, Multi-Group (order 1 per additional 6-cell group) SYSTEM ACCESSORIES The Startup Tool Kit provides all the tools needed to prepare vertical diffusion cells for a diffusion test. It includes an applicator to apply dosages to the cell top and cleaning tools that conveniently extract media from the cells without the need to remove the cells from the stand Startup Tool Kit, 115 V Startup Tool Kit, 230 V Cell Cleaning Adapter Kit Needle Cleaning Adapter Kit (6/pk) Check Valves for Manual Diffusion Cell System (100/pk) Syringe, Manual Sampling, 1 ml, Manual Diffusion Vials w/ Pre-Cut Septum, HPLC, UPLC, 12 mm x 32 mm (100/pk) Membrane for Cells, 25 mm diam x 0.45 micron (100/pk) (filter media: hydrophilic polysulfone) 74 HANSONRESEARCH.COM

75 HOW THE AUTOMATED SYSTEM WORKS 1. The system is set up by filling each 3. A selected aliquot of fresh Hanson Vertical Diffusion Cell (VDC) replacement media is injected from a with heated deaerated receptor precision syringe pump in the Vision solution from the Jacketed Beaker. Microette through the VDC s media The dosage wafer with membrane is replace port into its receptor chamber. filled with the formulation and placed This forces an exact equal amount from on top of the VDC to start the test. the VDC to be extracted through the sampling port to the Vision AutoFill. 2. A given protocol is activated to initiate the start. On program 4. A rinse cycle just before each command, the Helix stirrer stops. sampling cycle ejects contents of the The Vision Microette saves up to sample tube to waste. This cleans the 25 protocols for sampling volumes, sample lines prior to sampling and and time points, including advanced collection. routines for cell dilution and other requirements. 5. Sample aliquots are collected and archived in pre-cut septum HPLC vials in the Vision AutoFill. When each sampling point is complete, the Helix stirrer starts again to restore homogeneity. 6. This sampling and collection sequence continues for each programmed time point until the end of the test. The serial or network (PostScript) printer provides an ongoing status report of all test operating conditions. 7. Throughout the test, the Programmable Circulating Waterbath maintains controlled temperature in the Jacketed Beaker and each VDC (typically 32 C for skin permeation studies). DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING HANSONRESEARCH.COM

76 DISSOLUTION TESTING VERTICAL DIFFUSION CELL (VDC) The Hanson Vertical Diffusion Cell (VDC) is an ideal tool for the study, development, and quality control of topical preparations. Made of inert borosilicate glass, the VDC is designed for accuracy and ease of use with over thirty years of rigorous industry, university, and regulatory application and collaboration. Hanson VDCs are compatible with a number of membrane types including synthetic, animal skin, cadaver skin, and Strat-M membranes. Hanson VDCs include individualized serial numbers and are readily available in three convenient sizes. DIFFUSION TESTING PHYSICAL TESTING 76 HANSONRESEARCH.COM

77 FEATURES: Donor Chamber (membrane not shown) Circulator Ports Ideal for topical and transdermal drug delivery formulations, ophthalmics, cosmetics, skin care products, and pesticides Occluded design seals the donor from air to minimize any back-diffusion from sampling Water jacket covers entire receptor chamber for temperature consistency Bubble Trap catches bubbles before they enter VDC and affect the diffusion rate Circulator ports provide connections to ensure A Standard Cell Top Receptor Chamber Sampling Port Water Jacket Media Replace Port Bubble Trap Helix Stirrer cell-to-cell temperature uniformity Shorter sampling port reduces dead volume Clamp Assembly holds the cell top in place while providing even cell-top pressure Purchase of a Hanson VDC includes Standard Cell Top and Clamp Assembly Automated sampling capability with the Vision Microette diffusion test system USP <1724> compliant Cell Type DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING B 4 ml 7 ml 12 ml C A 38 mm 38 mm 38 mm E B 9 mm 15 mm 15 mm C 9 mm 9 mm 15 mm D 30 mm 30 mm 30 mm D E 61 mm 61 mm 61 mm Hanson VDCs are available in the three standard sizes in amber or clear glass, or in custom sizes upon request. The 7 ml Standard VDC is recommended by the US FDA for topicals. HANSONRESEARCH.COM

78 DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING VERTICAL DIFFUSION CELLS COMPLETE (includes Standard Cell Top, Helix Kit, and Clamp Assembly) 4 ML "SMALL" Vertical Diffusion Cell, 9 mm orifice, 4 ml vol, Small (serialized) Vertical Diffusion Cell, 9 mm orifice, 4 ml vol, Amber, Small (serialized) 7 ML "STANDARD" Recommended by US FDA for topicals Vertical Diffusion Cell, 15 mm orifice, 7 ml vol, Standard (serialized) Vertical Diffusion Cell, 15 mm orifice, 7 ml vol, Amber, Standard (serialized) 12 ML "LARGE" Vertical Diffusion Cell, 15 mm orifice, 12 ml vol, Large (serialized) Vertical Diffusion Cell, 15 mm orifice, 12 ml vol, Amber, Large (serialized) VERTICAL DIFFUSION CELLS SPARE PARTS Helix Kit (for 4 ml and 7 ml VDCs) Helix Kit (for 12 ml VDCs) Vertical Diffusion Cell, 4 ml, Clear (cell only) Vertical Diffusion Cell, 4 ml, Amber (cell only) Vertical Diffusion Cell, 7 ml, Clear (cell only) Vertical Diffusion Cell, 7 ml, Amber (cell only) Vertical Diffusion Cell, 12 ml, Clear (cell only) Vertical Diffusion Cell, 12 ml, Amber (cell only) 78 HANSONRESEARCH.COM

79 STANDARD CELL TOP The Standard Cell Top is included with a Hanson VDC. It is occluded to minimize back diffusion during the sampling process. A membrane is applied to one side of the dosage wafer, and the dosage is applied to the opposite side in the donor chamber. This cell top is best used for viscous materials such as creams, ointments, and gels. Cell Type 4 ml 7 ml 12 ml A 38 mm 38 mm 38 mm B 9 mm 15 mm 15 mm C 4 mm 4 mm 4 mm D 1.5 mm 1.5 mm 1.5 mm STANDARD CELL TOP COMPONENTS Glass Cell Disk Cell Ring Dosage Wafer Cell Ring C Glass Cell Disk A D Dosage Wafer B Membrane (not included) Vertical Diffusion Cell DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING STANDARD CELL TOPS INDIVIDUAL COMPONENTS Cell Ring Glass Cell Disk Dosage Wafer, 9 mm (for 4 ml VDCs) Dosage Wafer, 15 mm (for 7 ml and 12 ml VDCs) Clamp Assembly HANSONRESEARCH.COM

80 DISSOLUTION TESTING DIFFUSION TESTING STANDARD CELL TOPS DOUBLE THICK DOSAGE WAFERS VERTICAL DIFFUSION CELL TESTING WITH THE STRAT-M MEMBRANE PHYSICAL TESTING Hanson Research has worked with EMD Millipore to develop a special dosage wafer for the Hanson Vertical Diffusion Cell (VDC) to accommodate the EMD Millipore Strat-M membrane. This synthetic, non-animal based model for transdermal diffusion testing is predictive of diffusion in human skin without lot-to-lot variability, safety, and storage requirements. DOUBLE THICK DOSAGE WAFER, STRAT-M The Hanson VDC dosage wafer for the Strat-M membrane is specifically designed to readily accommodate the EMD Millipore 25 mm Strat-M membrane. The wafer is double thick, with a 3 mm deep dosage area, and also includes a unique and proprietary Hanson O-ring design to effectively secure the Strat-M membrane in the VDC device without any leakage problem. DOUBLE THICK DOSAGE WAFER, NO LEAK Hanson Research has also developed a similar double thick dosage wafer for use with other synthetic membrane types. The No-Leak dosage wafer includes a similar O-ring seal to minimize any leakage problems that analysts have experienced when working with the VDC. The double thick dosage area (3 mm deep) accommodates the infinite dose requirement for semisolid diffusion testing of creams, ointments, and gels. 80 HANSONRESEARCH.COM

81 Cell Ring Glass Cell Disk Dosage Wafer Hanson Vertical Diffusion Cell VDC with Clamp Assembly In most cases, Strat-M membrane correlates more closely to human skin than do animal skin models commonly used for in vitro screening of transdermal formulations. And because it is a synthetic test model with low variability and no special storage or hydration requirements, Strat-M membrane simplifies experimental design and data analysis. Diffusion through Strat-M membrane is predictive of diffusion through human skin for a wide range of substances: Active pharmaceutical ingredients (API) Cosmetic actives Formulations Personal care products Pesticides Chemicals Membranes such as the Strat-M membrane are applied to the bottom side of the Hanson VDC dosage wafer to act as a screen between the donor and receptor chambers. Double Thick Dosage Wafers are designed to work with the 58-Series Hanson Vertical Diffusion Cell (VDC) consult your local Hanson representative for full details on diffusion cell testing Dosage Wafer, Strat-M, Double Thick w/ O-Ring, 9 mm x 3 mm (for 4 ml VDCs) Dosage Wafer, Strat-M, Double Thick w/ O-Ring, 15 mm x 3 mm (for 7 ml and 12 ml VDCs) Dosage Wafer, No-Leak, Double Thick w/ O-Ring, 9 mm x 3 mm (for 4 ml VDCs) Dosage Wafer, No-Leak, Double Thick w/ O-Ring, 15 mm x 3 mm (for 7 ml and 12 ml VDCs) Required for Double Thick Dosage Wafers: Clamp Assembly for Double Thick Dosage Wafer EMD Millipore and Strat-M are registered trademarks of Merck KGaA, Darmstadt, Germany. DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING HANSONRESEARCH.COM

82 DISSOLUTION TESTING DIFFUSION TESTING OPEN CELL TOP WITH CAP The Open Cell Top with Cap is easily adaptable to the Hanson VDC. The cap can be removed between sampling time points to add or remove material. It is best used for less viscous materials because the cell top can be assembled prior to applying the dose. The larger donor chamber also allows more donor material to be used. OPEN CELL TOP WITH CAP COMPONENTS Threaded Cell Top Cap Seal PHYSICAL TESTING Cell Type Cap A 4 ml 38 mm 7 ml 38 mm 12 ml 38 mm D Seal B C D E F 9 mm 9 mm 12 mm 6 mm 30 mm 15 mm 18 mm 22 mm 6 mm 30 mm 15 mm 18 mm 22 mm 6 mm 30 mm Membrane (not included) E F B C A Threaded Cell Top 15 mm Vertical Diffusion Cell OPEN CELL TOPS Open Cell Top w/ Cap, 9 mm, Glass (2 ml capacity; for 4 ml VDCs) Open Cell Top w/ Cap, 9 mm, Glass, Amber (2 ml capacity; for 4 ml VDCs) Open Cell Top w/ Cap, 15 mm, Glass (6 ml capacity; for 7 ml and 12 ml VDCs) Open Cell Top w/ Cap, 15 mm, Glass, Amber (6 ml capacity: for 7 ml and 12 ml VDCs) 82 HANSONRESEARCH.COM

83 CUSTOM APPLICATIONS Novel dosage forms are being researched everyday throughout various scientific industries. Hanson Research s team of development engineers can design special cells and cell tops to accommodate custom applications such as in-situ fiber optics, non-viscous dosage forms, permeation through fingernails and toenails, iontophoresis and much more. Hanson can support your unique application. DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING SPECIAL APPLICATION CELLS & CELL TOPS Cell, Fiber Optic Diffusion, 15 mm (Special Order min order 6) (Fiber Optic Probe not included) Cell, Fiber Optic Diffusion, 15 mm, Amber (Special Order min order 6) (Fiber Optic Probe not included) Cell Top, Finger/Toe Nail Holder, 10 mm, PEEK (Special Order min order 6) (cell not included) Cell Top Kit, Iontophoresis, 9 mm (set/6) (Special Order min order 6) (for 4 ml VDCs) Cell Top Kit, Iontophoresis, 15 mm (set/6) (Special Order min order 6) (for 7 ml and 12 ml VDCs) Patch Support (replaces Glass Cell Disk and Dosage Wafer to allow for air circulation at top of patch) HANSONRESEARCH.COM

84 DIFFUSION TESTING DISSOLUTION TESTING PHYSICAL TESTING PHYSICAL TESTING Physical testing refers to the monitoring of physical characteristics of a drug product, typically oral dosage forms such as tablets and capsules. Physical testing examines the physical attributes of the drug form, such as disintegration and powder flowability. PAGE 86 POWDER FLOWABILITY PAGE 88 QC-21 ACCESSORIES 84 HANSONRESEARCH.COM

85 DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING HANSONRESEARCH.COM

86 DISSOLUTION TESTING POWDER FLOWABILITY DIFFUSION TESTING PHYSICAL TESTING The Flodex is a simple-to-use tool that helps you determine a reliable and repeatable flowability index over an arbitrary scale of 4 to 40 to use as a specification for your raw materials. This one simple test takes in account the numerous parameters that affect powder flowability such as: Particle size and shape Fines Unit surface Actual and bulk density Porosity Settling Electrostatic charge The Flodex determination of intrinsic flowability is based upon the ability of powder to fall freely through a hole in a disk. The Flodex comes complete with a full set of disks with different sized holes to use in determining this index and is fully compliant with USP <1174>. FLODEX Flodex Test System Complete Flodex Index Disk Kit (includes disks #1 through #19; all Flow Disks are 304 SS) 86 HANSONRESEARCH.COM

87 FLODEX FEATURES: USP <1174> compliant Allows for a simple repeatable index of flowability of powders Easily operated by non-technically trained personnel Enables flowability testing before the setup and filling of manufacturing equipment Comes complete with a full set of disks for use with a variety of powder types Stainless steel loading funnel discharges electrostatic potential that builds up between particles of powder Ideal for purchasing and quality assurance specifications Avoids a high coefficient of variation in product uniformity Accommodates a variety of powder types for use in manufacturing oral pharmaceutical dosage forms, coffee, and more! DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING INTRINSIC FLOWABILITY For complete technical details, please see "Intrinsic Flowability: A New Technology for Powder-Flowability Classification" by Dr. Gioia in Pharmaceutical Technology Magazine. Reprints are available from Hanson Research. HANSONRESEARCH.COM

88 DISSOLUTION TESTING LEGACY ACCESSORIES (MACHINES NO LONGER SOLD) PHYSICAL TESTING DIFFUSION TESTING LEGACY - QC-21 Our QC-21 disintegration test system has been discontinued since September Although this product will no longer be sold, we still continue to support a wide range of common accessories and consumables for the QC-21. Additional service parts and accessories may be available Basket Assembly, USP Standard Disintegration, 6 Tube, 10 Mesh, QC-21 (App. A) Basket Top Plate Assembly, w/ 10-Mesh Screen, QC-21 (App. A) (Special Order) Disc, Fluted Plastic for Standard Baskets, QC-21 (set/6) (App. A) Tubes, Glass for Standard Baskets, QC-21 (set/6) Basket, Veterinary Bolus Disintegration, 3 Tube, QC-21 (App. B) Disc, Plastic for Veterinary Basket, QC-21 (set/3) (App. B) Tubes, Glass for Veterinary Basket, QC-21 (set/3) (App. B) Beaker, 1 L, Flat Bottom, QC-21 QUALIFICATION PROTOCOL Qualification Protocol, IQ/OQ, QC-21 SPARE PARTS KIT Spare Parts Kit, 2 Year, 115 V, QC Spare Parts Kit, 2 Year, 230 V, QC HANSONRESEARCH.COM

89 HRCARE HRCARE SERVICE At Hanson Research, we care about quality! We build our equipment to last ten years and longer, and we want our customers to earn return after return on their investment. Hanson HRCare support programs maintain your dissolution test systems in tiptop shape for years of service, performance, and laboratory throughput. HRCare service, maintenance, installation, and validation programs are designed to bring you the confidence of audit-proof dissolution lab validation. We support every maintenance, calibration, and validation protocol with ISO 9001:2008 quality documentation. HRCare programs are available to all U.S. customers. Similar programs are available in select countries worldwide please consult Hanson for details. HRCare service technicians are factory trained and updated on the latest product technology, software/firmware, and regulatory developments. DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING HANSONRESEARCH.COM

90 Material... Grey CPVC & Borosilicate Glass A. Vessel Height mm B. Vessel Inside Diameter mm C. Hemispherical Bottom mm 9810 Variel Avenue Chatsworth, CA USA Fax Rev DISSOLUTION TESTING HRCARE PHYSICAL TESTING DIFFUSION TESTING ASTM PROGRAM Hanson HRCare provides ASTM E mechanical qualification, in addition to comprehensive IQ/OQ/PQ, service, and extended warranty programs. HRCare ASTM mechanical qualification is available for Hanson SR8-Plus and Vision dissolution testers, including older units already installed and in use. A suitable PM program is recommended for all older equipment. The Hanson HRCare team is factory-trained and certified on all aspects of instrument qualification, service, and preventive maintenance. Hanson Research Corp. hereby certifies that this product was designed, evaluated, validated, inspected, and tested to approved specified quality requirements of Hanson Research Corp. in conformance with current USP <711>, EP (2.9.3), JP (6.10), and ASTM E specifications. The following standards regarding quality assurance requirements were used for this quality analysis: 1. ISO 9001:2008 clause Monitoring and Measurement of Product 2. ANSI Z1.9 Sampling Procedures and Tables for Inspection by Variables 3. ANSI Z540-1 part 2 Quality Assurance Requirements for Measuring and Test Equipment Easi-Lock Precision Vessel, Product Name 1 Liter, Glass, Clear Part Number Serial Number(s): December 16, 2013 Hanson ASTM Certificates of Conformity (COCs) are available for USP accessories (vessels, paddles, baskets, and shafts), detailing all relevant ASTM dimensions and tolerances. These quality accessories, with corresponding COCs, are required for ASTM. Certificates of Analysis (COAs), recording actual dimensional measurements, are available for USP accessories on special order (minimum order 6). Please note that a COA is not required for ASTM when a COC is available. A convenient pre-scan to evaluate previously installed equipment is available prior to full ASTM mechanical qualification. ASTM Certificate of Conformance (COC) COCs for individual accessories are available on special order. "Range" COCs are available at: 90 HANSONRESEARCH.COM

91 SERVICE AND VALIDATION PLANS SERVICE & MAINTENANCE Basic Service & Repair P/N EMERGENCY ON- CALL SERVICE SCHEDULE VISITS (PER UNIT) TELEPHONE & SUPPORT HRCARE DOCUMENTATION Service Docs INCLUDES PHYSICAL CALIBRATION SERVICE PARTS DISCOUNT LABOR DISCOUNT SERVICE REPAIR WARRANTY 3 Mos. PM /Yr PM Certs 10% 3 Mos. 50% Q-PAK DISCOUNT PM /Yr PM Certs 20% 10% 3 Mos. 50% PM /Yr PM+ Certs PM /Yr PM+ Certs INSTALLATION & VALIDATION Installation & Familiarization IQ/OQ (excluding baths) Installation & Operation Qualification IQ (baths only) Installation Qualification Training Docs As Found & As Left As Found & As Left IQ/OQ Certs As Left IQ Certs OQ /Yr OQ Certs As Left OQ /Yr OQ Certs As Left 10% PQ /Yr PQ Certs PQ /Yr PQ Certs ASTM /Yr ASTM Certs ASTM /Yr ASTM Certs Chemical Calibration Chemical Calibration ASTM As Left ASTM As Left MVPQ /Yr MVPQ Certs As Left 10% 3 Mos. 50% 20% 10% 3 Mos. 50% 10% 10% 50% DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING MVPQ /Yr MVPQ Certs As Left 10% EXTENDED WARRANTY Extended Warranty 1 Year Parts & Labor EW Certs 100% 100% Yr 50% PM = Preventative Maintenance PM+ = Preventative Maintenance Plus OQ = Operation Qualification (baths only) PQ = Performance Qualification ASTM = ASTM Mechanical Calibration MVPQ = Mechanical Verification & PQ See page 96 for Certificates and Replacement Parts HANSONRESEARCH.COM

92 DIFFUSION TESTING VALIDATION CALIBRATION REFERENCE PHYSICAL TESTING DISSOLUTION TESTING 92 HANSONRESEARCH.COM

93 Q-PAK SELF-INSTALLATION GUIDELINES The Hanson Q-Pak addresses manufacturers' and USP / US FDA recommendations for dissolution instrument IQ, OQ, and PQ (Installation, Operation, and Performance Qualifications). This unique guideline directs the user through instrument qualification and documentation of key elements of functional validation. Combined with our easy-touse calibration tools, the Q-Pak can ensure optimum dissolution performance and maximum regulatory compliance. Q-Paks are ideal guidelines to help develop document system qualification for audit trail. VISION Q-Pak IQ/OQ/PQ Validation Guideline, Vision USP Q-Pak IQ/OQ Validation Guideline, Vision ASTM Q-Pak IQ/OQ/PQ Validation Guideline, Vision G2 AutoPlus Q-Pak IQ/OQ Validation Guidelines, AutoFilter Changer Q-Pak IQ/OQ/PQ Validation Guideline for Media-Mate Plus Q-Pak IQ/OQ/PQ Validation Guideline, Vision Microette Q-Pak IQ/OQ/PQ Validation Guideline, Manual Diffusion Cell System Q-Pak, On-Line UV Systems (for Closed Loop w/ Peri-Pump) DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING LEGACY Q-Pak IQ/OQ/PQ Validation Guideline, SR8-Plus USP Q-Pak IQ/OQ Validation Guideline, SR8-Plus ASTM Q-Pak IQ/OQ/PQ Validation Guideline, AutoPlus Q-Pak IQ/OQ/PQ Validation Guideline, Vision-Enabled AutoPlus Q-Pak IQ/OQ/PQ Validation Guideline, MicroettePlus Qualification Protocol, IQ/OQ, QC-21 HANSONRESEARCH.COM

94 DISSOLUTION TESTING VISION HEATER Heater Assembly, 115/230 V, Vision G2 PRINTERS AND SUPPLIES Order one printer per Vision instrument. DIFFUSION TESTING Printer, Validation, 115 V, Vision Printer, Validation, 230 V, Vision Printer, Validation, 115 V, AutoPlus/ MicroettePlus/Vision Microette Printer, Validation, 230 V, AutoPlus/ MicroettePlus/Vision Microette Printer, Validation, Reverse Plug Style, CE, 115/230 V, SR8-Plus Paper, Validation Printer (5/pk) Ribbon, Validation Printer (2/pk) PHYSICAL TESTING CALIBRATION ACCESSORIES Calibration Standard, USP, Prednisone Calibration Tablets, USP, Prednisone (30 tabs) (disintegrating) TOOLS a. Used by HRCare specialists when performing service and validation on Hanson instruments. Recommended for in-house validation programs Validation Tool Kit (for Vision dissolution testers and ASTM validation on SR8-Plus) Digital Level Kit (required for Vision dissolution testers and all ASTM waterbath validation) Height Set & Check Tool Kit, Vision (set tool for Go/No Go Depth Gauge) O-Ring Tool Kit, Vision (service tool only) Certified Calibrated Digital Thermometer, SR8-Plus/Vision Certified Calibrated Digital Tachometer, SR8-Plus/Vision a Certified Vibration Meter Kit, SR8-Plus/Vision (typically measures displacement, but may also be used to measure acceleration and velocity) Certified Alignment Kit, SR8-Plus (includes Alignment Gauge, Shaft Wobble Meter, Level, Depth Gauge, and Height Ball Gauge) Shaft Straightening Kit w/ Dial Indicator, SR8-Plus Analog Temperature Probe for SR8-Plus/SR6 ValiData 94 HANSONRESEARCH.COM

95 HANDBOOK OF DISSOLUTION TESTING DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING FEATURES: The latest on current standards, specifications, and requirements for dissolution testing New information on USP, FDA, FIP, and international harmonization All new information on special dosage forms The latest on method development and method validation New updates on controlling variables, the use of calibrator tablets, and solving practical problems New diagrams, tables, and checklists in an easy-to-use format New updates on automation, validation, 21 CFR 11 and IQ/OQ/PQ requirements Handbook of Dissolution Testing, 3rd Edition HANSONRESEARCH.COM

96 RECALIBRATION SERVICE 7-920* Recalibration Service (for Certified Calibration Kits) SPARE PARTS KITS Spare Parts Kit, 2-year, 115/230 V, Vision Elite Spare Parts Kit, 2-year, 115/230 V, Vision Classic Spare Parts Kit, 2-year, 115/230 V, Vision AutoPlus Spare Parts Kit, 2-year, 115/230 V, Vision AutoFill Spare Parts Kit, 2 Year, 115/230 V, AutoFilter Changer Spare Parts Kit, 2 Year, 115/230 V, Media-Mate Plus CERTIFICATES & REPLACEMENT SERVICES 7-930* Certificate of Analysis (COA) for USP Vessel (min order 6) 7-931* Certificate of Analysis (COA) for USP Paddle (min order 6) 7-932* Certificate of Analysis (COA) for USP Basket (min order 6) 7-933* Certificate of Analysis (COA) for USP Basket Shaft (min order 6) 7-909* Individual Certificate of Conformity (COC) for USP accessory (Special Order) 7-910* Documentation Replacement Service for Certificate of Conformity (COC) (Special Order) 7-911* Documentation Replacement Service for Blank IQ/OQ Protocols (U.S. customers only with proof of HRCare service purchase) 7-912* Documentation Replacement Service for Blank PQ Protocols (U.S. customers only with proof of HRCare service purchase) * No discounts apply to p/n 7-XXX. Please supply serial numbers at time of order, if applicable. DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING 96 HANSONRESEARCH.COM

97 HANSON RESEARCH CORPORATION ( HRC ) TERMS, CONDITIONS, AND WARRANTY Payment Terms: All banking charges are for buyer s account. Those charges should be accounted for prior to payment so that Hanson receives the full amount shown on invoice. Banking charges for letters or credit are buyer s responsibility. Domestic: Prepayment or Net 30 days for established accounts subject to approved credit limit (unless otherwise specified on quotation). Prepayment is required for new accounts, until credit is granted. International: Prepayment or irrevocable Letter of Credit, payable at sight in U.S. dollars (unless otherwise specified on quotation). Hanson Research Corporation s (HRC s) banking information will be provided at time of order confirmation. Any other payment arrangements may Cancellations & Returned Goods: Cancellations and return of goods are accepted only at the sole discretion of HRC. In the event that buyer cancels delivery of any product purchased hereby prior to the date of shipment, buyer agrees to pay HRC, in addition to any costs and expenses incurred by us in connection with this order, a 10 % (ten percent) cancellation charge. After shipment, buyer agrees to obtain written authorization from HRC for any return. If return of goods is authorized, buyer agrees to pay HRC, in addition to any costs and expenses incurred by us in connection with this order, all transportation charges and a restocking charge not to exceed 25% (twenty-five percent.) The return of custom or special items will not be permitted. only be made with approval by CEO or CFO. Payment terms may not be changed after order confirmation is accepted without approval by CEO or CFO. General Warranty: HRC products are warranted for one full year including parts and labor. Service contracts and Preventive Maintenance contracts are available for post-warranty support. International By providing Hanson with a P.O., this will constitute acceptance and understanding of terms and payment requirements as stated on Hanson s quote. dealer warranties may vary. HRC makes no warranty, expressed or implied, for glassware, consumables, or products not manufactured by HRC, as evidenced by nameplate on the item or other designation. 1. Payments may be made via wire transfer, credit card or check. HRC will give responsible assistance to buyer in obtaining from the 2. For wire transfers, HRC s banking information is available upon request. respective manufacturer whatever adjustment is reasonable in light of manufacturer s own warranty. HRC shall be released from any 3. For credit cards, HRC accepts Visa, MasterCard, or American Express. Please provide the account number, expiration date, security code and complete cardholder name as shown on card account. Cardholder s billing address must also be provided. and all obligations under any warranty, either expressed or implied, if the product covered is repaired or modified by other than its own personnel, or made without written authorization from HRC. There are no other warranties, expressed or implied, and HRC shall not be liable 4. For checks, make all checks payable to: Hanson Research Corporation, 9810 Variel Avenue, Chatsworth, CA 91311, payable in U.S. dollars only. under any circumstances for consequential damages. Force Majeure: The parties to this agreement shall not be held liable in damages or have the right to terminate this agreement for failure or Shipment Terms: Domestic: Orders will be invoiced as Prepay and Add shipments via an HRC contracted carrier, unless otherwise specified on purchase order. International: Orders will be shipped on an Ex-Works, Chatsworth, CAdelay in the performance of any of its terms as a result of conditions beyond their control, such as but not limited to war, strikes, fires, floods, acts of God, governmental restrictions, power failures, or damage or destruction of any network facilities or servers. Freight Collect basis, unless otherwise agreed upon. All shipping terms & carrier selection will be confirmed by a written HRC confirmation, based on an accepted purchase order. When carrier is not specified on Applicable Law: This agreement is made and entered into in the State of California, U.S.A., and shall be governed by its laws. purchase order or prior to shipment, HRC reserves the right to use a contracted carrier. Shipments: HRC assumes no responsibility for delay or damage of goods after delivery to carrier for all Ex-Works and Collect shipments. For Prepay and Add or CIP shipments, all damage claims must be Entire Terms, Conditions & Warranty: These terms, conditions and warranty constitute the entire terms, conditions and warranty as to their subject matter and supersede all prior and contemporaneous oral and written agreements. reported within 5 calendar days of receipt to both HRC and the carrier. All damage claims not reported within the 5 calendar day period will HRC / Effective February 23, 2015 not be reviewed or accepted. HRC will render all possible assistance in securing satisfactory adjustment for claims accepted by carrier. Delivery: The estimated delivery date quoted is our best approximation of order shipment. HRC assumes no liability for loss, general damages, or special or consequential damages due to delays. DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING HANSONRESEARCH.COM

98 DISSOLUTION TESTING PACKAGING INFORMATION SYSTEM PIECES WEIGHT (LB) WEIGHT (KG) BOX/PALLET DIMENSIONS (IN.) BOX/PALLET DIMENSIONS (CM) Vision Classic x 37 x x 94 x 99 DIFFUSION TESTING Vision Elite x 37 x x 94 x 115 Vision Elite 8-2 L "High Stand" 2 Box # x 37 x x 94 x 115 Box # x 22 x x 56 x 51 Vision AutoPlus & AutoFill x 41 x x 104 x 76 Vision AutoFilter Changer x 37 x x 94 x 115 Vision Microette & AutoFill x 41 x x 104 x 120 Manual Diffusion Test System x 20 x x 51 x 84 PHYSICAL TESTING Media-Mate Plus x 37 x x 94 x 150 Flodex x 10 x x 25 x 25 Alignment Kit x 12 x x 31 x 25 Validation Tool Kit x 16 x x 41 x 31 Certified Vibration Meter Kit x 12 x x 31 x 25 Vessels, 1 L, Glass, SR8-Plus (6 pc.) Vessels, Easi-Lock, 1 L, Glass, Vision (6 pc.) x 16 x x 41 x x 16 x x 41 x 31 Printer x 12 x x 31 x 26 Extra Tank, Heater, and Control for Media-Mate Plus x 22 x x 56 x 51 lb x.4536 = kilograms cm x.3937 = inches EIN # Sched. B. # for Systems: Sched. B. # for Accessories: Harmonized Tariff #: Courier shipment rates are calculated based on volumetric weight or actual weight, whichever is greater. U.S. Post Office will not accept packages larger than 79 in. total (length x girth). Order Cancellation Fee: 10% of order. Restocking Fee: Up to 25% on returned goods. No returns accepted on custom or special orders. Damage Claims must be made within 5 days of receipt of goods. Claims made after 5th day will not be accepted unless carrier agrees to claim. 98 HANSONRESEARCH.COM

99 TRADEMARKS HANSON TRADEMARKS HEREIN Registered Trademarks ( ) Vision Trademarks ( ) ADD Auto-Archive AutoFill AutoFilter AutoMag AutoPlus Auto-Probe Technology for Humanity Bill DDS Dissolution Data System Classic 6 Data-Pak Dissoette DissoScan Easi-Lift Easi-Lock Easy-Icon E-Probe Easi-Probe Elite 8 E-Probe Flodex OTHER TRADEMARKS HEREIN Empower, Alliance, and UPLC are registered trademarks of Waters Corporation. Merck Millipore and Strat-M are registered trademarks of Merck KGaA, Darmstadt, Germany. MultiFill is a trademark of SOTAX. Kynar is a registered trademark of Arkema, Inc. Teflon and Tefzel are registered trademarks of E. I. du Pont de Nemours and Company. Helix HRCare Legacy DDS Maestro Maximizer Media-Mate Media-Mate Plus Microette MicroettePlus QC-21 QC-72 Q-Pak Quality Technology Science Soft-Flo SR2 SR6 SR8 SR8-Plus SuperMag Transdermal Sandwich Technology for Humanity ValiData Vision G2 NOTICES Subject to Change: The products and services in this Buyer s Guide are periodically updated, and Hanson Research reserves the right to make additions or refinements at any time. Images: Some images may not be to scale, and some colors may vary from actual products. Materials: Hanson Research uses the highest quality materials and components in its design and manufacture of laboratory instruments. Critical wetted surfaces are typically borosilicate glass, quality 316 stainless steel, Teflon (or equivalent PTFE), Kynar (or equivalent PVDF), Tefzel (or equivalent ETFE), and/ or PEEK. See instrument user guides or visit our website (www. hansonresearch.com) for complete specifications. Special Orders are not stock items. Lead time varies. Minimum order quantities apply. No refunds, returns, or exchanges. Printed in the USA I Rev DISSOLUTION TESTING DIFFUSION TESTING PHYSICAL TESTING HANSONRESEARCH.COM

100 SETTING THE STANDARD SINCE 1951 HANSON RESEARCH CORP. ALL RIGHTS RESERVED. HANSONRESEARCH.COM