MISSION STATEMENT ABOUT US DISTEK S MISSION DISTEK S VISION AND VALUES

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2 ABOUT US MISSION STATEMENT DISTEK S MISSION Distek, Inc. is a leading manufacturer of pharmaceutical laboratory instruments, specializing in dissolution testing products, as well as an experienced provider of validation and qualification services. In addition, Distek provides solutions for dissolution media degassing, dispensing and disposal, in-situ fiber optic UV, bathless tablet disintegration testing, physical tablet testing, and automated sampling. Founded in 1976, Distek has grown to offer innovation and support to companies worldwide. Our success is dependent upon Distek s employees, who bring their expertise, experience, and dedication to providing pharmaceutical laboratory instruments and services of the finest quality. The company s commitment to excellence extends to the community, as Distek actively supports educational and research activities with donations of equipment and assistance. For technological advancements that offer reliable and consistent performance, the pharmaceutical industry trusts Distek. Distek s mission is to design, manufacture, sell, and support state-of-the-art laboratory testing equipment that performs flawlessly and meets our customer s needs and expectations. DISTEK S VISION AND VALUES In order to accomplish our mission, we must incorporate quality into all that we do. Our philosophy is to continually strive for improvement in order to accomplish our mission. It is our belief that quality, innovation and support are essential to our current and future growth and continual improvement is crucial to ongoing success. We recognize that our customers expect, and deserve, our support in their validation and other regulatory compliance efforts for the equipment that we provide. To serve our customers, we understand that our efforts need to mesh with the current initiatives for the globalization of pharmaceutical standards led by the International Committee on Harmonization. To achieve our goals, accomplish our mission and be a global market leader, we are committed to providing equipment and support that will satisfy our customers and meet the expectation of all regulatory and standards setting agencies, including the United States Food and Drug Administration (US FDA) and the United States Pharmocopeia (USP). Distek s bottom line is that we are an international, market-driven company with a hard-earned reputation for providing innovative, highquality, reliable laboratory systems, accessories and support services that meet or exceed industry standards; and we want to continue in this positive direction. ISO : About Us Mission Statement 3

3 SYMPHONY 7100 BATHLESS DISSOLUTION INSTRUMENT The symphony 7100 Bathless Dissolution System is the most advanced dissolution design to date, bringing to market features never before available on a dissolution unit. Building upon Distek s first to market bathless technology, this third generation unit offers the fastest media heating in the industry while empowering the user to conduct up to three unique methods simultaneously. Patented Bathless Technology Eliminates the water bath and all associated maintenance while high watt heaters raise media temperatures from ambient to 37ºC in less than 15 minutes. In-Shaft Temperature Sensor Embedded temperature sensors ensure users compliance and allow continuous control and recording of individual vessel temperatures. Independent Modules Configurable for up to 8 positions, the symphony 7100 s self-contained modules allow users unprecedented ease and scalability. Color Touch Screen Display The icon driven user interface lowers overall cost by reducing training time and user errors while maximizing productivity and command of the dissolution test. Run Multiple Methods Simultaneously Up to three independent methods run simultaneously minimizing development time and increasing productivity. SYMPHONY 4 Bathless Dissolution Instrument Bathless Dissolution Instrument 5

4 MODEL 2500 WATER BATH DISSOLUTION INSTRUMENT Offering maximum flexibility and configurability, the Distek Model 2500 Dissolution System succeeds four generations of the user-friendly 2100 series. A brilliant touch screen and unparalleled command of the instrument with electronic manual, serial numbers, electronic qualification labels, and extensive reporting and method storage capabilities make this a robust and reliable system. Color Touch Screen Display The icon driven user interface lowers overall cost by reducing training time and user errors while maximizing productivity and command of the dissolution test. Quick Change Paddles and Baskets Interchangeable stirring elements coupled with the automatic height adjustment provide a fast transition between Apparatus 1 and 2 without having to remove the shaft. Self-Priming Thermocirculator The self-priming design and microprocessor control allow for improved temperature uniformity and heating time while the low profile design allows the circulator to be stowed behind the bath, requiring no additional linear bench space. Volume Flexibility Accommodates up to 8 vessels ranging in size from 100mL to 4L, allowing the user to run a diverse range of tests. Automatic Height Adjustment Setting the height is done through a one-time adjustment and utilization of the interchangeable paddles and baskets. MODEL MODEL Water Bath Dissolution Instrument Water Bath Dissolution Instrument 7

5 EVOLUTION 6300 WATER BATH DISSOLUTION INSTRUMENT The Evolution 6300, providing independent through the shaft temperature monitoring of each vessel, has set the benchmark by which all dissolution water bath systems are measured. In-Shaft Temperature Sensor Embedded temperature sensors ensure users compliance and allow continuous control and recording of individual vessel temperatures. Tolerance Checking Monitored and reported test parameters confirm compliance with stated industry guidelines for temperature and RPM. Security and Password Protection Setting of user and manager privileges increases control over key parameters and reduces human error. Method Storage with Audit Trail Records, stores and sorts up to 100 methods, including the previous 50 modifications made to each method, noting name, creation and change dates. Built in NIST Temperature Probe Improves temperature accuracy and ease of calibration by offering an easily accessible calibrated temperature probe on the unit. EVOLUTION EVOLUTION Water Bath Dissolution Instrument Water Bath Dissolution Instrument 9

6 EVOLUTION 4300 AUTOMATED DISSOLUTION SAMPLER The Evolution 4300 is equipped with state-of-the-art electronics and utilizes highly reliable and accurate syringe pumps for sample collection. Accommodating up to two independent syringe pumps, both dual sampling and simultaneous dissolution methods make the Evolution 4300 the premier dissolution sampler option. Positive Displacement Syringe Pumps The single or dual syringe pump configuration allows for accurate, high volume sample collection. Independent Method Programming The dual bath configuration allows two different and independent dissolution methods to be run. Simple Yet Detailed Interface User Logins set access limits, sampling is logged for audit purposes and the printer provides during and after testing result reports. Media Recycling and Replacement Media Recycling and Replacement offer the advantage of returning unused media and replacing the collected sample volume for ease of dissolution calculations. Five Minute Sampling The EVO 4300 is ideally suited for immediate release profiling when a sampling time of five minutes between time points is required.* (*Sampler parameters will affect minimum time intervals) EVOLUTION EVOLUTION Automated Dissolution Sampler Automated Dissolution Sampler 11

7 EZFILL 4500 VIP 4400 DISSOLUTION MEDIA HEATING, DEGASSING, AND DISPENSING Transportable, easy-to-use and compact, the ezfill 4500 s unique integration and control of critical functions like heating and vacuum degassing allow the unit to prepare and accurately dispense media in approximately 90 seconds* while offering tight controls over key volume and temperature parameters for fast and effective de-aeration and media dispensing. Compact Design Fits easily on the bench or used with the optional mobile cart or autofill. In-Line Heating Ready to prepare media immediately upon power up eliminates the time delays and wasted energy associated with immersion heaters used in bulk media tanks. (Maximum 20 C rise) Precision Vacuum Chamber Piston controlled vacuum chamber creates a high vacuum for effective de-aeration and delivers precise media volumes accurate to within 1% of the set volume. Variable Dispense Volumes Selectable volume settings from 250mL to 1000mL allow for quick and easy volume changes without the need for system recalibration. DISSOLUTION VESSEL WASHER The VIP 4400 addresses one of the most time consuming and least productive aspects of the dissolution test: dissolution vessel clean-up. Customers employing the VIP 4400 are guaranteed to save time, reduce cost and increase the output of the dissolution laboratory by eliminating the tedious process of removing, draining and cleaning dissolution vessels. Patented Cyclone Wash The Cyclone wash nozzle and drain have been integrated into one assembly offering a 360º wash that provides a more thorough cleaning of the entire vessel that takes only seconds. Self-Adjusting Drain The spring loaded, self-adjusting drain automatically compensates for vessel height variations, minimizing residual wash water remaining in the vessel after cleaning. Universal Wash Module Securely fits into any 1L USP conforming dissolution vessel regardless of the manufacturer. Cleans up to 4 Baths Cleans up to 28, 1L vessels in under 15 minutes. Rapid Drain & Wash Cycles Throughput is greatly increased as the VIP 4400 can drain and wash a 1L vessel in approximately 30 seconds. Variable Temperature Optional temperatures from ambient to 45 C. * Cycle time is volume and temperature dependent 12 Dissolution Media Preparation Dissolution Vessel Washer 13

8 OPT-DISS 405 IN-SITU FIBER OPTIC UV TESTING Improved precision and accuracy of test measurements, the elimination for the need of sampling and the near real time results are just three of the benefits of the Opt-Diss 405 Fiber Optic In-Situ UV for dissolution testing. This latest advancement in dissolution sample analysis reduces setup times while offering the flexibility to increase and vary the number of data points taken along a dissolution profile :05:00 00:07:30 00:10:00 00:12:30 00:15:00 00:17:30 00:20:00 00:22:30 In-Situ UV Measurements Moves the analytical measurement into the vessel, eliminating sampling errors and media loss calculations. Horizontal Pathlength Transmits light across a horizontal pathlength without the need for mirrors or prisms and minimizes the potential for trapping air bubbles and build up of particles found with dip type probes with vertical pathlengths. Rapid Spectra Collection Increased dissolution accuracy and improved quality of profile analysis through simultaneous data collection from 6-12 vessels in as fast as every 5 seconds. Universal Interface Allows the Opt-Diss 405 to be used on most dissolution systems without the need for additional hardware. Resident Stationary ARCH Probes Eliminates the need for a raising and lowering sampling manifold. OPT-DISS 14 In-situ Fiber Optic UV Testing In-situ Fiber Optic UV Testing 15

9 LABEYE DIGITAL VIDEO SYSTEM Designed specifically for laboratory use, the LabEye is a ready-to-implement multi-camera system performing visual process monitoring, chronicling research in HD clarity and providing automation troubleshooting. Engineered by Two Square Science this collaborative effort between Distek, Two Square Science and Industry leaders offers a welcome and needed addition to any laboratory that looks to streamline pharmaceutical testing in both research and development and quality environments. Lab Ready Cameras Capturing images in true HD, the LabEye cameras record 30 fps at 1080p resolution. Direct to Digital, HD Resolution Take snapshots at a high frame rate with HD resolution and watch live or save video for later playback. Standard Mounting System Equipped with a standard mount system for popular dissolution systems and other analytical devices. Scalable Scalable from 1-8 cameras. Scheduling Timed snapshot and video recorded events can be scheduled and created in the control software then sent to the command center which will start processing the schedule immediately. 16 Digital Video System Digital Video System 17

10 SENSIR 3200 BATHLESS DISINTEGRATION INSTRUMENT Distek s sensir 3200 uses proven bathless heating to offer a disintegrator without the hassle and inconveniences associated with conventional water bath-based instruments. By eliminating the water bath and utilizing a sleek modular unit, Distek s sensir 3200 offers two, four or six disintegration test stations in the smallest footprint of any comparably equipped model. Auto Endpoint Detection Auto Endpoint Detection using Patent Pending Near Infrared eliminates the need for modified fluted disks. Unattended endpoint detection saves time and increases throughput. Bathless Heating Heating media from ambient to 37 C in approximately 8 minutes significantly increases throughput. Eliminates common problems associated with standard water baths such as slow heating rates and algae growth. Advanced User Interface Includes robust features such as: storing of 100 reports and records, running of three unique methods simultaneously, managing 25 users, setting qualification reminders and much more. Integrated Temperature Sensor Enables the monitoring and documenting of the individual breaker temperatures for improved regulatory compliance while eliminating the need for manually verifying temperature equilibration prior to tablet introduction. Scalability SENSIR Available in 2, 4, or 6 standard positions to meet your productivity needs while being upgradeable in the field as capacity demands. 18 Bathless Disintegration Instrument Bathless Disintegration Instrument 19

11 VALIDATION SERVICES DEDICATED TO MEETING YOUR VALIDATION NEEDS Distek is committed to providing its customers with the most consistent, traceable results needed to satisfy regulatory requirements. Much like our philosophy for designing quality instruments, Distek s Validation Service Group utilizes highly skilled chemists and technicians that undergo comprehensive training and certification in all aspects of validation services. Our product is our people, each of which has an unparalleled commitment to both customer service and assuring that your instrument is performing according to industry specifications. Installation Qualification (IQ) Assuring that your system is received in good condition, IQ will verify the system meets specifications as well as certifies the system is set up and installed correctly, in the right environment and ready for operational qualifications and performance qualifications. Mechanical Qualification (MQ) Certification that the mechanical performance of the system is satisfactory and that the system is available for further performance qualification. Performance Verification Test (PVT) Ensures the system is working properly and both verifies and certifies the instrument meets system suitability test requirements per USP <711> guidelines using USP calibrator tablets and reference standards. Multi-Vendor Services Provides expertise and qualification services for Distek and non-distek equipment. Contact Distek for specific instrument services. Preventative Maintenance (PM) Servicing of equipment to confirm continued proper operation per the manufacturer s specifications including the replacement of parts, inspection and replacement of electronic components, connections, switches, motors and more. Operational Qualification / Performance Verification (OQ / PV) Verifies the system is functioning and that all critical operational parameters are within specifications while supplying the evidence needed to meet the requirements of regulatory agencies and makes certain your laboratory equipment performs within specified guidelines. SOP Writing Saving valuable time and money, the validation services team will write your SOP s to qualify your instruments as well as train your staff to execute them. Validation Contracts Eliminate worry while keeping costs down. 22 Validation Services Validation Services 23

12 Distek products are available in Canada exclusively from: Betatek Inc. 654 Petrolia Road, Toronto, ON M3J 2W4 Tel: (416) Toll Free: (800) Fax: (416) Visit distekinc.com/contact/sales_regions.asp for a complete list of International Distributors Rev. A DISTEK distekinc.com info@distekinc.com 121 North Center Drive North Brunswick, NJ 08902