There s more to clean environments than meets the eye. Our vision of a safer future: Air & Surface Monitoring Solutions.

Transcription

1 There s more to clean environments than meets the eye. Our vision of a safer future: Air & Surface Monitoring Solutions. EMD Millipore is a division of Merck KGaA, Darmstadt, Germany

2 2

3 Contents Environmental monitoring solutions 4 Particle counting solutions 6 APC SmartTouch products 7 APC ErgoTouch Pro 2 7 Active air monitoring solutions 8 MAS-100 series 9 MAS-100 NT and MAS-100 NT Ex 9 MAS-100 CG Ex 9 MAS-100 Iso NT 10 RCS Air Sampling Systems 10 RCS High Flow Touch 10 RCS Isolator 11 RCS Plus Ex 11 HYCON agar strips for RCS Air Samplers 12 M Air T Air Samplers 12 M Air T Isolator 12 Pre-filled agar cassettes for M Air T Systems 13 Pre-filled agar cassettes for isolators 13 Passive air monitoring solutions 14 ICR Settle Plates 15 LI Settle Plates 15 Personnel and surface monitoring solutions 16 ICR Contact Plates 17 ICR plus Contact Plates 17 ICR Swabs 18 Gamma-irradiated HYCON Contact Slides 18 HYCON Contact Slides 19 RT and RT plus Contact Plates 19 Ordering information 3

4 One portfolio, unlimited reliability: Complete safety with environmental monitoring solutions Safety is a big issue in today s industries. It s a time issue. A cost issue. And most important, it s a risk issue. What s required to cover all these issues is a vision. A vision for a safer future. That s why we offer you a complete solution to help you stay on the safe side: with high-quality products, with excellent service, and with professional expertise, EMD Millipore provides more safety than meets the eye. Let s take a closer look: most contaminants are invisible to the naked eye. Although single micro-organisms (as well as those carried on particles) are fairly small, they pose a severe threat to the safety of products and brands: every year, several hundred products have to be recalled, resulting in financial and image losses.

5 At EMD Millipore, we believe that the solution to this problem is not only simple but also cost-efficient: with our complete portfolio for environmental monitoring, covering particle counting, active and passive air monitoring as well as surface and personnel monitoring solutions. The relatively low costs of monitoring result in improved quality and increased safety and in the reduction of overall expenses. To keep expenses low in the long term, EMD Millipore offers a comprehensive range of high-quality monitoring and testing solutions that help you keep your facilities safe, from less critical to highly critical clean rooms and isolators. With our monitoring solutions you can conveniently check surfaces, equipment, and air quality for contaminants getting answers rapidly and reliably. Since our products have been developed in close cooperation with users and authorities, they are tailored to the customers needs and follow international guidelines for critical and controlled environments, such as EU cgmp, USP, or FDA Aseptic Guidance. What s more: as a one-stop supplier, we also offer a wide range of services, including IQ/OQ maintenance, calibration, product validation, and application. 5

6 Small details make the big safety picture: Particle counting solutions Particle counting is a critical component of clean room monitoring programs. Particle counter data are needed to detect contaminants in the air and to determine the cleanliness of air in controlled environments, such as those found in the pharmaceutical or sensitive food industries, which have to comply with ISO 14644, GMP and FS9E. Our APC instruments meet JIS B 9921:1997 and ISO standards for performance, counting efficiency, and calibration. They are available in either stainless steel or plastic with stainless steel components. The APC SmartTouch and the APC ErgoTouch Pro 2 are ideally suited for disinfection and fulfill the most stringent hygiene standards.

7 Award-winning safety: APC SmartTouch products (airborne particle counters) visual representation of sampling locations: minimizes risk of human errors ideally suited for disinfection: easy to clean equipped with high-capacity batteries: allows for continuous sampling follows strict hygiene standards large color touch screen with familiar icons and intuitive menu: easy to use all required actions start from main menu: increases operating efficiency and saves time complete system with many accessories: no need to invest in multiple instruments, reducing costs of associated routine calibration designed for dual flow rates: significantly reduces clean room certification and monitoring costs Transportable safety: APC ErgoTouch Pro 2 (handheld airborne particle counters) all the functionalities of portable airborne particle counter, 6 channels: high performance on small scale meets JIS standards lightweight device: practical use state-of-the-art design, large color touch screen: intuitive, easy handling low investment: for validation of ISO 7, 8 and GMP Gr. C, D compressed gas adaptor: available for high pressure wide range of accessories Take a closer look at the safe side: ordering information for our particle counting products can be found on pp

8 Solutions that spring into action so you can take action: Active air monitoring solutions As regulations and standards for pharmaceutical products are increasing, the need for effective air sampling methods is on the rise too. After all, the quality of production environments is directly linked to the finished products quality. That s why customers demand highly precise and reliable active air sampling solutions. With active air monitoring products by EMD Millipore you can be sure of getting the most accurate sample solutions available. Our easy to use monitoring systems fully comply with all international standards and regulations ensuring reproducible and reliable results.

9 Precise safety: MAS-100 series (microbial air monitoring systems) most accurate sample solutions available for reliable, exact results MAS-100 NT and MAS-100 NT Ex (for clean rooms and sterile environments) fully validated according to EN ISO state-of-the-art mass flow sensor: assures constant flow rate of 100 L/min, automatically adjusts to differences in environment automatic calibration function: reduces risk of errors controlled parameters: can be changed via PC software or directly on unit MAS-100 CG Ex (for testing of compressed gases) fully validated according to EN ISO collects samples under gas pressure; after sampling, gradual decompression occurs, avoiding possible damage to microorganisms sampling at two different flow rates: suitable for low flow applications only compressed gas microbial air sampler approved for use in Zone 2 explosion hazard areas automatic calibration function: reduces risk of errors unique mass flow sensor technology: no need to calibrate for specific gases automated collection process: saves time pre-programmed for a range of different gases: no further calculations needed can store up to 10 gas protocols 9

10 MAS-100 Iso NT (for sterile production areas and isolators) unique security concept: permits installation of sampling heads for standard mm Petri dishes at critical control points all electronic and moving parts are outside of critical zone internal pump with flow control: automatic sterilization of sampling head and aspiration tube easy to use, easy customization: different fixing options for both control unit and sample head user-friendly programming multiple communication options can be adapted for all types of environments (dust-, water spray-, explosion-proof) Proven safety: RCS Air Sampling Systems employed by pharmaceutical companies worldwide for over 30 years RCS High Flow Touch (for monitoring of ambient air and compressed gases in sterile environments) validated according to ISO : complete system with standardized media renowned technology with comprehensive validation documentation autoclavable sampling head: easy disinfection, compatible with common disinfectant methods high-resolution color touch screen, intuitive software: easy to operate innovative battery concept with advanced control options short sampling time: from preparation to start of measurement within a minute 10

11 RCS Plus Ex (explosion-proof) portable, battery-driven and lightweight 7 preset sampling volumes and 3 user-defined volumes from 1 to 2,000 liters: adapts to user-specific needs user-defined sampling options: adjust individual volumes, time delay, interval sampling fully compatible with wide range of standardized agar media adapter for compressed gas measurements (pressure range: bar) RCS Isolator (for confined spaces in sterile environments) validated according to ISO : complete system with standardized media sterilizable by H 2 O 2 gas and UV: easy to clean air ducting can be directed outside of controlled area: minimizes air turbulence at sampling point, reliable results validated according to ISO : applies to complete system with standardized media meets GMP and FDA guidelines for hazardous areas built according to ignition protection class <ib> (EN 60079) multiple sample volumes of up to 1,999 liters with flow rate of 50 L/min autoclavable sampling head: easy disinfection self-explanatory keypad: user-friendly battery-driven, lightweight: easy to operate 7 preset sampling volumes and 3 user-defined volumes from 1 to 1,999 liters: adapts to user-specific needs fully compatible with wide range of standardized agar media allows for operation outside of restricted access areas: safe handling user-friendly keypad and integrated battery with charge indicator display best used with gamma-irradiated agar strips TCI- that neutralize residual disinfectants (even up to 500 ppm H 2 O 2 ) two-component system separation of sampling head and operating unit: flexible use in confined spaces accessories for variable installation options available: adapts to users needs fully compatible with wide range of standardized agar media 11

12 HYCON agar strips for RCS Air Samplers manufactured under strictly controlled, aseptic conditions fully validated according to EN ISO in combination with RCS Air Samplers also available as gamma-irradiated consumables in sterile double packaging: for use in critical areas individually packed and at 100% visually controlled allows storage at room temperature: reduces preparation time extended shelf life of up to six months: reduces costs available as total count media and selective media: adapts to user-specific needs Rapid safety: M Air T Air Samplers (for clean rooms, barrier environments, and critical areas) saves air flow parameters in tester s memory: reduces risk of human errors, reduces set-up time delay timer: allows operator to leave area before testing begins powerful device: able to sample up to 1,000 liters in 7 minutes programmable electronics, ready-to-use agar cassettes: easy to use runs up to 7 hours on single charge: less frequent need to change batteries small, lightweight system: ideally suited for use in confined spaces M Air T Isolator (for isolators and barrier environments) fully programmable: replicable results and operation small, lightweight system: user-friendly handling programmable pump remains outside of operation area, independent sampling head: eliminates electrical or mechanical components in controlled area 12

13 Pre-filled agar cassettes for M Air T systems USP and EP compliance certificate distance between sieve and surface of agar cassette remains constant: reproducible results double-sleeve packaging, gamma-irradiated: safe for barrier environments wing on edge of cassette: easy positioning in tester head integrated grid: easier colony counting laser-marked cassettes: enables efficient record keeping and tracking wide range of different media available Pre-filled agar cassettes for isolators especially qualified for use in isolators validated packaging: impermeable to sanitizing agents consistent filling level and flat surface: reproducible results easy to load, even when wearing isolator gloves: user-friendly handling available with media specifically formulated for isolators containing large residuals of H 2 O 2 Take a closer look at the safe side: ordering information for our active air monitoring products can be found on pp

14 Keeping a vigilant eye on safety all the time: Passive air monitoring solutions Passive viable air monitoring with the help of settle plates is a useful complement to active air sampling methods. Settle plates allow for a semi-quantitative determination of microbial contaminations in the air. They are also suitable for personnel monitoring (e.g., gloves). And that s not all: settle plates are easy to use, efficient, and enable continuous monitoring during production processes. Since they are fairly small, they can also be used conveniently in confined spaces. Passive air sampling solutions by EMD Millipore are perfectly tailored to the requirements of different applications. Our triple-bagged and gamma-irradiated ICR Settle Plates are designed for the use in critical clean rooms and isolators. For less critical clean rooms and other controlled environments, we offer single-bagged LI Settle Plates. All of our products have one thing in common: they meet all international standards and regulations, including EU cgmp, FDA Aseptic Guide, and USP 34 <1116>. 14

15 Transparent safety: ICR Settle Plates (for isolators and critical clean rooms) data matrix barcode on each plate: paperless and secure identification of single plates transparent, H 2 O 2 -impermeable triple-sleeve packaging: safe transportation in clean rooms (ISO 5) and isolators produced in clean rooms, gamma-irradiated in final packaging: minimizes risk of contamination storage at room temperature: storable at site of use long shelf life: fewer incoming goods controls high filling volume: allows prolonged exposition and incubation SDA in pink plates: easily distinguishes between TSA and SDA usable for personnel monitoring or as disposables for active air monitoring with MAS Air Samplers Practical safety: LI Settle Plates (for less critical clean rooms) data matrix barcode on each plate: paperless and secure identification of single plates produced in clean room: low risk of contamination storage at room temperature: storable at site of use long shelf life: fewer incoming goods controls high filling volume: allows prolonged exposition and incubation usable for personnel monitoring or as disposables for active air monitoring with MAS Air Samplers Take a closer look at the safe side: ordering information for our passive air monitoring products can be found on p

16 On the surface of safety, but not superficial: Personnel and surface monitoring solutions The health and pharmaceutical industry takes a lot of measures to keep production plants clean and minimize the risk of contamination. A crucial tool to monitor the efficiency of these measures is the sampling of surfaces and personnel with proven methods like easy to use contact plates, contact slides, or swabs. EMD Millipore offers a wide range of swabs and contact plates adapted to clean room requirements and different surface types. For highly critical areas such as clean rooms (ISO 5) or isolators, we provide triple-bagged, gamma-irradiated ICR and ICR plus Contact Plates and Contact Slides. They are ideally complemented by our ICR Swabs for difficult-to-access locations like tubing or filling needles. The safe choice for less critical environments are our single-bagged, non-irradiated RT and RT plus Contact Plates and Slides. Since every country has its own standards, our surface and personnel monitoring solutions meet them all to keep your products safe worldwide. 16

17 Versatile safety: ICR Contact Plates (for isolators and critical clean rooms) data matrix barcode on each plate: paperless and secure identification of single plates transparent, H 2 O 2 -impermeable triple-sleeve packaging: safe transportation in clean rooms (ISO 5) and isolators produced in clean rooms, gamma-irradiated in final packaging: minimizes risk of contamination storage at room temperature: storable at site of use long shelf life: fewer incoming goods controls SDA in pink plates: minimizes risk of confusion many different formulations for the monitoring of sanitized, dry surfaces supplemented by neutralizers for a wide range of disinfectants ICR plus Contact Plates (for isolators and critical clean rooms) CLOSED- and VENT-Closure: safe transport and flexible incubation conditions data matrix barcode on each plate: paperless and secure identification of single plates transparent, H 2 O 2 -impermeable triple-sleeve packaging: safe transportation in clean rooms (ISO 5) and isolators produced in clean rooms, gamma-irradiated in final packaging: minimizes risk of contamination storage at room temperature: storing on location long shelf life: fewer incoming goods controls SDA in pink plates: easily distinguishes between TSA and SDA many different formulations for the monitoring of sanitized, dry surfaces supplemented by neutralizers for a wide range of disinfectants and -lactam antibiotics new formulation of non-animal origin available: minimizing the risk of BSE contamination 17

18 Handy safety: ICR Swabs (for isolators and critical clean rooms) all-in-one swab: open only once for sampling minimizes the risk of secondary contaminations due to handling triple-sleeve packaging: safe transport in clean rooms (ISO 5) and isolators H 2 O 2 -impermeable inner packaging: protects medium from VHP vapor during decontamination of isolator gamma-irradiated (25 to 35 kgy): minimizes risk of contamination pre-moistened swab tip: leaves no growthpromoting residues on surfaces easy handling steps storage at room temperature: storable at site of use integrated hanging device for use in isolators Accurate safety: Gamma-irradiated HYCON Contact Slides (for flat and curved surfaces) transparent, H 2 O 2 -impermeable double-sleeve packaging: safe transportation in clean rooms (ISO 5) and isolators produced in clean rooms, gamma-irradiated in final packaging: minimizes risk of contamination standardized contact area (25 cm 2 ) strict quality control, including 100% visual inspection of each slide individually sealed, H 2 O 2 -impermeable primary packaging: storage of single slides in clean rooms and in isolators during contamination resealable sleeve: safe transport storage at room temperature: storable at site of use long shelf life: fewer incoming goods controls suitable for monitoring of difficult-to-access locations such as filling needles, tubes, etc. 18

19 Adjustable safety: RT and RT plus Contact Plates (for less critical clean rooms) CLOSED- and VENT-Closure for safe transport and differentiated incubation conditions (RT plus only, see also ICR plus contact plates) produced in clean rooms: minimized risk of contamination data matrix barcode on each plate: safe, paperless identification of single plates storage at room temperature: storable at site of use Flexible safety: HYCON Contact Slides (for flat and curved surfaces) Take a closer look at the safe side: ordering information for our personnel and surface monitoring products can be found on pp produced in clean rooms: minimizes risk of contamination standardized contact area (25 cm 2 ) strict quality control, including 100% visual inspection of each slide storage at room temperature: storable at site of use resealable sleeve: safe transport 19

20 Particle counting solutions APC SmartTouch products Products Ord. No. APC SmartTouch APC SmartTouch, 1 CFM & 100 LPM, steel (flow rate 1 cubic foot per minute & 100 L/min) APC SmartTouch, 1 CFM, steel (flow rate 1 cubic foot per minute) APC SmartTouch, 50 LPM, steel (flow rate 50 L/min) APC SmartTouch, 100 LPM, steel (flow rate 100 L/min) APC SmartTouch, 1 CFM & 100 LPM, plastic (flow rate 1 cubic foot per minute & 100 L/min) APC SmartTouch, 50 LPM, plastic (flow rate 50 L/min) APC SmartTouch, 100 LPM, plastic (flow rate 100 L/min) APC SmartTouch Accessories Lithium-ion Battery (1 piece) Carrying Case (with wheels and handle) for plastic instruments for stainless steel instruments Thermal Printer Paper (5 rolls) Temperature / Relative Humidity Probe (only in conjunction with recalibration) Air Velocity Probe (only in conjunction with recalibration) Isokinetic Probe 1 CFM 50 L/min 100 L/min Filter Scanning Probe, 1 CFM (including tubing) Sampling Tubing (per meter) Purge Filter APC Compressed Gas Adapter (select the right nozzle set below) Nozzle Set Compressed Gas Adapter 1 CFM 50 L/min 100 L/min Power Supply (including country-specific power cord) USB Connection Cable Table-top Tripod (for isokinetic probe, including adapter) APC SmartTouch Download Utility Software APC SmartTouch Qualification Handbook (for performing complete IQ, OQ, and PQ of APC SmartTouch Airborne Particle Counters, English) External Charger (including country-specific power cord) Network Cable (1 meter)

21 APC ErgoTouch Pro 2 APC ErgoTouch Pro 2 Products APC ErgoTouch Pro 2 Airborne Particle Counter Handheld particle counter with a flow rate of 2.83 L/min and six channels, calibrated to 0.3/0.5/ 1.0/3.0/5.0/10.0 μm, user-configurable in 0.1 μm increments (0.3 to 10.0 μm) Ord. No APC ErgoTouch Pro 2 accessories Power Supply with universal plugs Battery Pack Computer Cable (2 m), USB A to B HEPA Zero Filter Assembly External Battery Charger with AC adapter and power cord External Printer Carry Case Temperature / Humidity Probe Stainless steel isokinetic inlet Isokinetic Probe (used with tubing) CFM Barb Inlet Fitting Tubing, Superthane 1/8-inch ID x 1/4-inch OD, clear 100 ft APC Compressed Gas Adapter APC Compressed Gas Adapter Nozzle Set Including power supply, power cord, battery, isokinetic inlet, stylus, purge filter, ErgoTrak Lite Data Download Utility Software (CD), operational manual (CD), computer cable, calibration certificate, and Quick Start Guide (CD). 21

22 Active air monitoring solutions MAS-100 series Products Ord. No. Instruments MAS-100 NT Air Sampler MAS-100 NT with 400 hole lid MAS-100 Eco Air Sampler MAS-100 NT Ex Air Sampler, Explosion Proof MAS-100 Iso NT Air Sampler MAS-100 Iso NT Air Sampler IP66 Model MAS-100 CG Ex DA-100 NT Digital Anemometer Spare parts and accessories MAS-100 NT Extra Dust Cover* Perforated lid for MAS-100 NT (300 x 0.6 mm)** Main charger for MAS-100 NT ** Battery pack Li-Ion for MAS-100 NT ** MAS-100 Mains Charger MAS-100 NiMH Battery Pack MAS-100 NiCd Battery Pack (For Version 2.62 or lower) MAS-100 NT Extra Perforated Lid, Aluminum* MAS-100 NT Extra Perforated Lid, Stainless Steel, 400 x 0.7 mm MAS-100 Tripod MAS-100 Tripod Adapter - Quick Connect MAS-100 Tube Adapter MAS-100 PC Interface Cable for Nova-LIMS MAS-100 Contact Plate Holder MAS-100 Perforated Lid for Contact Plates MAS-100 CG Ex Extra Sampling Head, Low Flow 50 L/min and 100 L /min MAS-100 Eco Mains Charger MAS-100 Eco Tripod Adapter MAS-100 Ex NiCd Battery Pack MAS-100 Ex Extra Dust Cover* MAS-100 Ex Extra Perforated Lid, Aluminum* Validation Protocols MAS-100 NT MAS-100 ISO MAS-100 CG EX MAS-100 ECO * Lids and dust covers are all interchangeable among MAS-100, MAS-100 Eco, MAS-100 Ex. ** Products are also suitable for MAS-100 NT Ex. 22

23 RCS High Flow Touch and accessories Products Description Ord. No. RCS High Flow Touch Including power supply, serial RS232 cable, USB adapter, RCS management software, rotor, protection cap, carrying case, calibration certificate, quick start guide, and user manual RCS High Flow Touch accessories Docking Station For recharging the integrated lithium-ion battery RCS Compressed Gas Adapter Touch Autoclavable adapter for microbial monitoring of compressed gases; designed for a pressure of 1 bar Nozzle Set for RCS Compressed Gas Adapter Set of five nozzles to extend the air inlet pressure from 1 bar to bar Sterile Sleeves 10 pieces; for covering non-autoclavable housing parts Tripod For use at heights up to three meters Table-top Tripod For horizontal operation RCS High Flow Touch Validation Handbook German version English version Comprehensive compendium of validation data for RCS Microbial Air Samplers (RCS High Flow, RCS Isolator, RCS Plus) and Agar Strips; contains RCS Qualification Handbook for RCS High Flow Touch RCS High Flow Touch Qualification Handbook German version English version Plan for instrument qualification of the RCS High Flow Touch in controlled areas, contains IQ, OQ & PQ CalibSo Anemometer Adhesive Tapes Rotor Protection Cap Calibration Software for automated, computer-aided calibration and data storage Portable device for measuring the air flow rate during calibration of RCS Microbial Air Samplers 60 pieces, adhesive ring foils to seal the air inlet holes of the rotor during calibration Spare part, autoclavable, each combination of sampler and rotor must be calibrated separately Spare part (stainless steel), autoclavable For protection of the rotor during air sampling Air Outlet Ring Spare part, autoclavable Carrying Case Power Supply Serial Cable Spare part, aluminum carrying case with sections for the RCS High Flow Touch Microbial Air Sampler, two rotors, power supply, serial cable, USB adapter, documentation and Agar Strips Spare part, for recharging the integrated battery, including country-specific power cord Spare part, for connecting with a PC via the serial RS232 interface USB Adapter Spare part, for connecting with a PC via the USB interface Spare Part Set Bag containing spare protection caps (electrical sockets for the docking station and power supply, the serial interface, and the tripod) and housing feet

24 RCS Isolator and accessories Products Description Ord. No. RCS Isolator Including sampling unit, operating unit, connection cable with a secured plug, infrared remote control, rotor, protection cap, carrying case, and user manual RCS Isolator accessories Universal Battery Charger For charging the integrated 12 V NiMH batteries of the operation unit RCS Compressed Gas Adapter Autoclavable adapter for microbial monitoring of compressed gases; designed for a pressure of 1 bar Nozzle Set for RCS Compressed Gas Adapter Set of five nozzles to extend the air inlet pressure from 1 bar to bar Support Stand for Sampling Unit Stainless steel tripod for vertical mounting of sampling unit Tripod For use at heights up to three meters; an adapter for connection with the tripod is required Tripod Adapter For mounting to tripods or other installations Table-top Tripod For horizontal operation Air Outlet Tubing Tri-Clamp Cable Transfer RCS Validation Handbook German version English version CalibSo Anemometer Adhesive Tapes PVC outlet air tube to redirect the exhausted air to non-critical areas For use in isolators; connects the operating unit with the sampling unit through the isolator wall Comprehensive compendium of validation data for RCS Microbial Air Samplers (RCS High Flow, RCS Isolator, RCS Plus) and Agar Strips Calibration Software for automated, computer-aided calibration and data storage Portable device for measuring the air flow rate during calibration of RCS Microbial Air Samplers 60 pieces, adhesive ring foils to seal the air inlet holes of the rotor during calibration Sampling Unit Replacement unit at an existing installation Rotor Protection Cap Spare part, autoclavable, each combination of sampler and rotor must be calibrated separately Spare part (stainless steel), autoclavable For protection of the rotor during air sampling Infrared Remote Control

25 RCS Plus Ex and accessories Products Description Ord. No. RCS Plus Ex Including two rechargeable 7.2 V Ni-Cd batteries, infrared remote control, battery compartment key, rotor, protection cap, carrying case, and user manual RCS Plus Ex accessories Universal Rapid Battery Charger 230 / 240 V (EU) 1 V (US) For charging of 9.6 V and 7.2 V Ni-Cd batteries Battery Discharger For discharging of the residual capacity of 9.6 V and 7.2 V batteries; prevents battery memory effects Sterile Sleeves 10 pieces; for covering non-autoclavable housing parts Tripod For use at heights up to three meters Table-top Tripod For horizontal operation RCS Validation Handbook German version English version Anemometer Adhesive Tapes Comprehensive compendium of validation data for RCS Microbial Air Samplers (RCS High Flow, RCS Isolator, RCS Plus) and Agar Strips Portable device for measuring the air flow rate during calibration of RCS Microbial Air Samplers 60 pieces, adhesive ring foils to seal the air inlet holes of the rotor during calibration V Ni-Cd Replacement Battery Spare part Rotor Protection Cap Spare part, autoclavable, each combination of sampler and rotor must be calibrated separately Spare part (stainless steel), autoclavable For protection of the rotor during air sampling Infrared Remote Control Spare part

26 Disposables for RCS High Flow Touch, RCS Isolator, RCS Plus Ex, HYCON Agar Strips Products Pack Size Ord. No. Total count media Selective media Agar strip accessories TC Tryptic Soy Agar for determination of the total count. Store at 2 25 C TSM Modified Tryptic Soy Agar with neutralizers against disinfectants and growth supplements; for identification of the total count of fastidious and sublethally damaged microorganisms. Store at 2 25 C TC- Gamma-irradiated Tryptic Soy Agar, double-wrapped; for determination of total count in aseptic environments. Store at 2 25 C TCI- Gamma-irradiated Tryptic Soy Agar with neutralizers, double-wrapped; for determination of total count in aseptic environments and in peroxide-containing air. Store at 2 25 C PEN- Gamma-irradiated Tryptic Soy Agar with Penase; for determination of total count in penicillin-containing air in aseptic environments. Store at 2 25 C LAC- Gamma-irradiated Tryptic Soy Agar with broad-spectrum cephalosporinase; for determination of total count in aseptic environments containing antibiotics. Store at 2 25 C YM Rose Bengal Agar with streptomycin; for determination of yeasts and molds. Store at 2 25 C SDX Sabouraud Dextrose Agar with modified pharmacopoeia formulation; for determination of yeasts and molds. Store at 2 25 C SDX- Sabouraud Dextrose Agar with modified pharmacopeia formulation; for determination of yeasts and molds in aseptic environments. Store at 2 25 C DG-18 Dichloran Glycerine Agar; for determination of yeasts and molds. Store at 2 25 C S Mannitol Salt Agar; for determination of staphylococci. Store at 2 15 C C MacConkey Agar; for determination of coliform bacteria. Store at 2 15 C HYCON Blank Strip Kit Empty strips for manual production of culture media for special applications HYCON Cover Slides Cover slides for Agar Strips to prevent desiccation during incubation Incubation Rack for HYCON Agar Strips Stainless steel; with indicator for incubation time 50 strips strips strips strips strips strips strips strips strips strips strips strips strips slides pc

27 M Air T Air Sampler Products Pack Size Ord. No. M Air T Portable Tester Kit 1 ATAS05060 M Air T Portable Tester Validation Protocol (A4 format) 1 ATASA4VP1 M Air T Portable Tester Validation Protocol (US letterhead) 1 ATASLTVP1 M Air T Isolator Kit 1 ATIS0KIT1 M Air T Isolator Validation Protocol 1 ATBP0VG01 M Air T Isolator Printer Expendables (5 thermal paper rolls, 2 ink cartridges) 1 ATBPRNT22 M Air T Cassette prefilled with TSA Media 60 ATSMTTD60 M Air T Cassette prefilled with Sabouraud Dextrose Agar Media 60 ATSMSDD60 M Air T Cassette prefilled with TSA and beta-lactamase 60 ATSMPND60 M Air T Empty Cassette 114 ATSMC0114 M Air T Isolator Cassette prefilled with TSA Media 24 ATSMTTB24 M Air T Isolator Cassette prefilled with TSA Media (with pyruvate for VHP-sanitized environments) 24 ATSMTPB24 27

28 Passive air monitoring solutions Gamma-irradiated, triple-bagged ICR Settle Plates (90 mm and 150 mm) for critical clean rooms and isolators Products Pack Size Ord. No. 90 mm Plates SDA + LT - ICR 30 ml (heipha ref e with neutralizers lecithin, Tween 80, filled in pink plates) SDA + LTHTh - ICR 30 ml (heipha ref e with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate; filled in pink plates) SDA selective + LTHTh - 30 ml ICR (heipha ref e with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate, antibiotics against bacteria, filled in pink plates) TSA - ICR 30 ml (heipha ref e) 1 TSA + LT - ICR 30 ml (heipha ref e with neutralizers lecithin, Tween 80) TSA + LTHTh - ICR 30 ml (heipha ref e with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate) TSA + LT + Cephase - ICR (heipha ref e with neutralizers lecithin, Tween 80, -lacatamases for inactivation of penicillins, all generations of cephalosporins and carbapenems) TSA + LTHTh + Penase - ICR 30ml (heipha ref e with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate, penase for inactivation of penicillins) 150 mm Plates TSA + LTHTh - ICR 15 cm (heipha ref. 0829a3 3 plates, each triple-packed with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate) Accessories Plate Rack for settle plates (heipha ref stainless steel rack for 10 x 90 mm plates) Abbreviations: SDA = Sabouraud Dextrose Agar, TSA = Tryptic Soy Agar LI Settle Plates (90 mm) for less critical clean rooms Products Pack Size Ord. No. 90 mm Plates SDA - LI n. EP (heipha ref e) 1 SDA + Chloramphenicol - LI 30 ml (heipha ref e) SDA + LTHTh - LI 30 ml (heipha ref e with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate) TSA - LI 30 ml EP+USP (heipha ref e) TSA + LTHTh - LI 30 ml (heipha ref. 0308e with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate) Accessories Plate Rack for settle plates (heipha ref stainless steel rack for 10 x 90 mm plates) Abbreviations: SDA = Sabouraud Dextrose Agar, TSA = Tryptic Soy Agar 28

29 Personnel and surface monitoring solutions Gamma-irradiated, triple-bagged ICR Contact Plates (55 mm) for critical clean rooms and isolators Products Pack Size Ord. No. 55 mm Plates SDA Contact + LTHTh - ICR (heipha ref e with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate, filled in pink plates) TSA Contact + LT - ICR (heipha ref. 2284e with neutralizers lecithin, Tween 80) TSA Contact + LTHTh - ICR (heipha ref. 2283e with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate) TSA Contact + Penase + LTHTh - ICR (heipha ref. 2280e with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate, penase for inactivation of penicillins) Accessories Plate Rack for contact plates (heipha ref stainless steel rack for 10 x 55 mm plates) Abbreviations: SDA = Sabouraud Dextrose Agar, TSA = Tryptic Soy Agar Lockable, gamma-irradiated, triple-bagged ICR Contact Plates (55 mm) for critical clean rooms and isolators Products Pack Size Ord. No. 55 mm Plates Chocolate Contact Agar + LTH - ICR+ (heipha ref. 835 with neutralizers lecithin, Tween 80, histidine, supports growth of fastidious aerobic and anaerobic microorganisms) SDA Contact + LTHTh - ICR+ (heipha ref. 850 with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate; filled in pink plates) SDA Contact + LTHTh selective - ICR+ (heipha ref. 851 with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate, irradiation-resistant antibiotics against bacteria, filled in pink plates) TSA Contact + LT - ICR+ (heipha ref. 821 with neutralizers lecithin, Tween 80) TSA Contact + LTHTh - ICR+ (heipha ref. 8 with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate) TSA Contact + LT + Cephase - ICR+ (heipha ref. 823 with neutralizers lecithin, Tween 80, -lacatamses for inactivation of penicillins, all generations of cephalosporins and carbapenems) TSA Contact + LTHTh + Penase - ICR+ (heipha ref. 824 with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate, penase for inactivation of penicillins) Vegetable Contact Agar + LTHTh - ICR+ (heipha ref. 840 with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate) TSA Contact + Neutralizer A - ICR+ (heipha ref. 822 neutralizers for increased spectrum of disinfectants, short shelf life, storage at 25 C) Accessories Plate Rack for contact plates (heipha ref stainless steel rack for 10 x 55 mm plates) Abbreviations: SDA = Sabouraud Dextrose Agar, TSA = Tryptic Soy Agar 29

30 ICR Swabs for critical clean rooms and isolators Products Pack Size Ord. No. ICR Swab (heipha ref ) Accessories Swab Rack (heipha ref stainless steel) HYCON Gamma-irradiated Contact Slides Products Pack Size Ord. No. Contact Slides TC- Gamma-irradiated Tryptic Soy Agar, double-wrapped; for determination of total count in aseptic environments; with neutralizers (lecithin, sorbitol monooleate complex, Tween 80) and growth supplements. Store at 2 25 C Accessories Contact Slides DE- Gamma-irradiated, modified Dey Engley Agar (D/E Agar), double-wrapped; for determination of total count in aseptic environments; with neutralizers (lecithin, sorbitol monooleate complex, sodium thioglycolate, sodium bisulfite) and growth supplements. Store at 2 15 C Contact Slides PEN- Gamma-irradiated Tryptic Soy Agar with Penase, double-wrapped; for determination of total count in penicillin-containing air; with neutralizers (lecithin, L-histidine, sorbitol monooleate complex, Tween 80) and growth supplements. Store at 2 25 C Contact Slides LAC- Gamma-irradiated Tryptic Soy Agar with penase and a broad-spectrum cephalosporinase, double-wrapped; for determination of total count in environments with antibiotics containing air; with neutralizers (lecithin, L-histidine, sorbitol monooleate complex, Tween 80) and growth supplements. Store at C Contact Slides SDX- Gamma-irradiated Sabouraud Dextrose Agar with modified pharmacopoeia formulation, double-wrapped; for determination of yeasts and molds in aseptic environments; with neutralizers (Tween 80, L- -phosphatidylcholine) and growth supplements. Store at 2 25 C Incubation Rack for HYCON Contact Slides Stainless steel; with indicator for incubation time

31 RT and RT plus Contact Plates (55 mm) for less critical clean rooms Products Pack Size Ord. No. 55 mm Plates DG 18 Agar + Chloramphenicol Contact RT (heipha ref. 248e) Malt Extract Agar Contact RT (heipha ref. 250e) Plate Count Agar Contact RT (heipha ref. 238e) SDA Contact + Chloramphenicol - RT+ (heipha ref. 862 lockable plate) TSA Contact RT (heipha ref. 235e) TSA Contact + LTH - RT (heipha ref. 234e with neutralizers lecithin, Tween 80, histidine) TSA Contact + LTH - RT+ (heipha ref. 860 with neutralizers lecithin, Tween 80, histidine, lockable plate) Accessories Rack for contact plates (heipha ref stainless steel rack for 10 x 55 mm plates) Abbreviations: SDA = Sabouraud Dextrose Agar, TSA = Tryptic Soy Agar Single-wrapped HYCON Contact Slides Products Pack Size Ord. No. Contact Slides TC Tryptic Soy Agar; for determination of the total count; with neutralizers (lecithin, L-histidine, sorbitol monooleate complex, Tween 80) and growth supplements. Store at 2 25 C Accessories Contact Slides YM Rose Bengal Agar with streptomycin and chloramphenicol; for determination of yeasts and molds; with growth supplements. Store at 2 25 C Contact Slides SDX Sabouraud Dextrose Agar with modified pharmacopoeia formulation; for determination of yeasts and molds; with neutralizers (Tween 80, L- -Phosphatidylcholine) and growth supplements. Store at 2 25 C Contact Slides B Sheep Blood Agar; for determination of total count of fastidious and pathogenic microorganisms. Store at 2 15 C Contact Slides C MacConkey Agar; for determination of coliform bacteria; with growth supplements. Store at 2 25 C Blank Strip Kit Empty slides for manual production of culture media for special applications Incubation Rack for HYCON Contact Slides Stainless steel; with indicator for incubation time

32 We provide information and advice to our customers on application technologies and regulatory matters to the best of our knowledge and ability, but without obligation or liability. Existing laws and regulations are to be observed in all cases by our customers. This also applies in respect to any rights of third parties. Our information and advice do not relieve our customers of their own responsibility for checking the suitability of our products for the envisaged purpose. For more information: EMD Millipore Corporation 290 Concord Rd. Billerica, MA 01821, USA Merck KGaA Frankfurter Str Darmstadt, Germany The M mark is a trademark of Merck KGaA, Darmstadt, Germany. HYCON, RCS and M Air T are registered trademarks of Merck KGaA, Darmstadt, Germany. MAS-100 NT, MAS-100 NT Ex, MAS-100 Eco, MAS-100 CG Ex, MAS-100 Iso NT are registered trademarks of MBV AG. w PB3774ENUS 07/12 12 EMD Millipore Corporation, Billerica, MA, USA. All rights reserved.