there’s more to clean environments than meets the eye. our ......(dust-, water spray-,...
TRANSCRIPT
There’s more to clean environments than meets the eye. Our vision of a safer future: Air & Surface Monitoring Solutions.
Merck Millipore is a division of
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ContentsEnvironmental 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 ICRplus Contact Plates 17 ICR Swabs 18 Gamma-irradiated HYCON® Contact Slides 18 HYCON® Contact Slides 19 RT and RTplus Contact Plates 19
Ordering information 20
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, Merck Millipore provides more safety than meets the eye.
Let’s take a closer look: most contaminants are invisible to thenaked 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.
One portfolio, unlimited reliability:Complete safety with environmental monitoring solutions
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At Merck Millipore, we believe that the solution to this problem is not only simple but also cost-efficient: with our complete portfolio for environmental monitor-ing, covering particle counting, active and passive air monitoring as well as surface and personnel monitoring solutions. The relatively low costs of monitor-ing result in improved quality and increased safety – and in the reduction of overall expenses.
To keep expenses low in the long term, Merck 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.
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 FS209E.
Our APC instruments meet JIS B 9921:1997 and ISO 21501 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.
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Award-winning safety: APC SmartTouch products (airborne particle counters)
Secure and reliable:• 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
Convenient:• 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
Flexible:• 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)
Secure and reliable:• all the functionalities of portable airborne
particle counter, 6 channels: high performance on small scale
• meets JIS standards
Convenient:• lightweight device: practical use• state-of-the-art design, large color touch screen:
intuitive, easy handling
Flexible:• 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. 20–21.
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 Merck Millipore you can be sure of getting the most accurate sample solutions available. Our easy to use monitoring systems fully comply with all interna-tional standards and regulations – ensuring reproducible and reliable results.
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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)
Secure and reliable:• fully validated according to EN ISO 14698• state-of-the-art mass flow sensor: assures
constant flow rate of 100 L/min, automatically adjusts to differences in environment
Convenient:• automatic calibration function: reduces risk
of errors
Flexible:• controlled parameters: can be changed via
PC software or directly on unit
MAS-100 CG Ex® (for testing of compressed gases)
Secure and reliable:• fully validated according to EN ISO 14698• 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
Convenient:• automatic calibration function: reduces risk
of errors• unique mass flow sensor technology:
no need to calibrate for specific gases• automated collection process: saves time
Flexible:• pre-programmed for a range of different gases:
no further calculations needed• can store up to 10 gas protocols
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MAS-100 Iso NT® (for sterile production areas and isolators)
Secure and reliable:• unique security concept: permits installation of
sampling heads for standard 90-100 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
Convenient:• easy to use, easy customization: different fixing
options for both control unit and sample head• user-friendly programming
Flexible:• 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 world- wide for over 30 years
RCS® High Flow Touch (for monitoring of ambient air and compressed gases in sterile environments)
Secure and reliable:• validated according to ISO 14698-1:
complete system with standardized media• renowned technology with comprehensive
validation documentation• autoclavable sampling head: easy disinfection,
compatible with common disinfectant methods
Convenient:• 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
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RCS® Plus Ex (explosion-proof)
Secure and reliable:• validated according to ISO 14698-1: applies to
complete system with standardized media• meets GMP and FDA guidelines for hazardous
areas• built according to ignition protection class <ib>
(EN 60079)
Convenient:• 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
Flexible:• 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
Flexible:• 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: 0.1–7 bar)
RCS® Isolator (for confined spaces in sterile environments)
Secure and reliable:• validated according to ISO 14698-1:
complete system with standardized media• sterilizable by H2O2 gas and UV:
easy to clean• air ducting can be directed outside of
controlled area: minimizes air turbulence at sampling point, reliable results
Convenient:• 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-γ that neutralize residual disinfectants (even up to 500 ppm H2O2)
Flexible:• 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
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HYCON® agar strips for RCS® Air Samplers
Secure and reliable:• manufactured under strictly controlled,
aseptic conditions• fully validated according to EN ISO 14698 in
combination with RCS® Air Samplers• also available as gamma-irradiated consumables
in sterile double packaging: for use in critical areas
Convenient:• 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
Flexible:• 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)
Secure and reliable:• 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
Convenient:• 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
Flexible:• small, lightweight system: ideally suited for use in
confined spaces
M Air T® Isolator (for isolators and barrier environments)
Secure and reliable:• fully programmable: replicable results and
operation
Convenient:• small, lightweight system: user-friendly handling
Flexible:• programmable pump remains outside of operation
area, independent sampling head: eliminates electrical or mechanical components in controlled area
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Pre-filled agar cassettes for M Air T® systems
Secure and reliable:• 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
Convenient:• wing on edge of cassette: easy positioning
in tester head• integrated grid: easier colony counting• laser-marked cassettes: enables efficient
record keeping and tracking
Flexible:• wide range of different media available
Pre-filled agar cassettes for isolators
Secure and reliable:• especially qualified for use in isolators• validated packaging: impermeable to
sanitizing agents• consistent filling level and flat surface:
reproducible results
Convenient:• easy to load, even when wearing isolator gloves:
user-friendly handling
Flexible:• available with media specifically formulated for
isolators containing large residuals of H2O2
Take a closer look at the safe side: ordering information for our
active air monitoring products can be found on pp. 22–27.
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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 Merck Millipore are perfectly tailored to the requirements of different applica-tions. 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>.
Keeping a vigilant eye on safety all the time:Passive air monitoring solutions
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Transparent safety: ICR Settle Plates (for isolators and critical clean rooms)
Secure and reliable: • data matrix barcode on each plate: paperless
and secure identification of single plates • transparent, H2O2-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
Convenient:• 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
Flexible:• 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)
Secure and reliable:• data matrix barcode on each plate: paperless
and secure identification of single plates • produced in clean room: low risk of
contamination
Convenient:• storage at room temperature: storable at
site of use• long shelf life: fewer incoming goods controls• high filling volume: allows prolonged exposition
and incubation
Flexible:• 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. 28.
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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 produc-tion 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.
Merck 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 ICRplus 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 RTplus Contact Plates and Slides. Since every country has its own stand-ards, our surface and personnel monitoring solutions meet them all – to keep your products safe worldwide.
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Versatile safety: ICR Contact Plates (for isolators and critical clean rooms)
Secure and reliable: • data matrix barcode on each plate: paperless
and secure identification of single plates • transparent, H2O2-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
Convenient:• storage at room temperature: storable at
site of use• long shelf life: fewer incoming goods controls• SDA in pink plates: minimizes risk of confusion
Flexible:• many different formulations for the monitoring
of sanitized, dry surfaces• supplemented by neutralizers for a wide range
of disinfectants
ICRplus Contact Plates (for isolators and critical clean rooms)
Secure and reliable:• CLOSED- and VENT-Closure: safe transport
and flexible incubation conditions• data matrix barcode on each plate: paperless
and secure identification of single plates • transparent, H2O2-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
Convenient:• storage at room temperature: storing on location• long shelf life: fewer incoming goods controls• SDA in pink plates: easily distinguishes between
TSA and SDA
Flexible:• many different formulations for the monitoring
of sanitized, dry surfaces• supplemented by neutralizers for a wide range of
disinfectants and β-lactam antibiotics• new formulation of non-animal origin available:
minimizing the risk of BSE contamination
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Handy safety: ICR Swabs (for isolators and critical clean rooms)
Secure and reliable: • 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
• H2O2-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 growth-promoting residues on surfaces
Convenient:• easy handling steps• storage at room temperature: storable at
site of use• integrated hanging device for use in isolators
Flexible:• suitable for monitoring of difficult-to-access
locations such as filling needles, tubes, etc.
Accurate safety:Gamma-irradiated HYCON® Contact Slides (for flat and curved surfaces)
Secure and reliable: • transparent, H2O2-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 cm2)• strict quality control, including 100 % visual
inspection of each slide
Convenient:• individually sealed, H2O2-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
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Flexible safety: HYCON® Contact Slides (for flat and curved surfaces)
Secure and reliable: • produced in clean rooms: minimizes risk
of contamination• standardized contact area (25 cm2)• strict quality control, including 100 %
visual inspection of each slide
Convenient:• storage at room temperature: storable at
site of use• resealable sleeve: safe transport
Adjustable safety: RT and RTplus Contact Plates (for less critical clean rooms)
Secure and reliable: • CLOSED- and VENT-Closure for safe transport
and differentiated incubation conditions (RTplus only, see also ICRplus contact plates)
• produced in clean rooms: minimized risk of contamination
• data matrix barcode on each plate: safe, paperless identification of single plates
Convenient:• storage at room temperature: storable at
site of use
Take a closer look at the safe side: ordering information for
our personnel and surface monitoring products can be found
on pp. 29–31.
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APC SmartTouch products
Particle counting solutions
Products Ord. No.
APC SmartTouch APC SmartTouch, 1 CFM & 100 LPM, steel (flow rate 1 cubic foot per minute & 100 L/min) 1.44093.0001
APC SmartTouch, 1 CFM, steel (flow rate 1 cubic foot per minute) 1.44181.0001
APC SmartTouch, 50 LPM, steel (flow rate 50 L/min) 1.44182.0001
APC SmartTouch, 100 LPM, steel (flow rate 100 L/min) 1.44183.0001
APC SmartTouch, 1 CFM & 100 LPM, plastic (flow rate 1 cubic foot per minute & 100 L/min) 1.44089.0001
APC SmartTouch, 50 LPM, plastic (flow rate 50 L/min) 1.44092.0001
APC SmartTouch, 100 LPM, plastic (flow rate 100 L/min) 1.44091.0001
APC SmartTouch Accessories
Lithium-ion Battery (1 piece) 1.44144.0001
Carrying Case (with wheels and handle)for plastic instrumentsfor stainless steel instruments
1.44148.00011.44259.0001
Thermal Printer Paper (5 rolls) 1.44147.0001
Temperature / Relative Humidity Probe (only in conjunction with recalibration) 1.44088.0001
Air Velocity Probe (only in conjunction with recalibration) 1.44087.0001
Isokinetic Probe1 CFM50 L/min100 L/min
1.44084.00011.44121.00011.44119.0001
Filter Scanning Probe, 1 CFM (including tubing) 1.44083.0001
Sampling Tubing (per meter) 1.44104.0001
Purge Filter 1.44079.0001
APC Compressed Gas Adapter (select the right nozzle set below) 1.44179.0001
Nozzle Set Compressed Gas Adapter1 CFM50 L/min100 L/min
1.44170.00011.44168.00011.44166.0001
Power Supply (including country-specific power cord) 1.44145.0001
USB Connection Cable 1.44100.0001
Table-top Tripod (for isokinetic probe, including adapter) 1.44105.0001
APC SmartTouch Download Utility Software 1.44077.0001
APC SmartTouch Qualification Handbook(for performing complete IQ, OQ, and PQ of APC SmartTouch Airborne Particle Counters, English)
1.44076.0001
External Charger (including country-specific power cord) 1.44146.0001
Network Cable (1 meter) 1.44075.0001
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APC ErgoTouch Pro 2
Products Ord. No.
APC ErgoTouch Pro 2 APC ErgoTouch Pro 2 – Airborne Particle CounterHandheld 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)
1.44302.0001
APC ErgoTouch Pro 2 accessories
Power Supply with universal plugs 1.44306.0001
Battery Pack 1.44132.0001
Computer Cable (2 m), USB A to B 1.44100.0001
HEPA Zero Filter Assembly 1.44157.0001
External Battery Charger with AC adapter and power cord 1.44134.0001
External Printer 1.44305.0001
Carry Case 1.44303.0001
Temperature / Humidity Probe 1.44304.0001
Stainless steel isokinetic inlet 1.44159.0001
Isokinetic Probe (used with tubing) 1.44160.0001
0.1 CFM Barb Inlet Fitting 1.44143.0001
Tubing, Superthane 1/8-inch ID x 1/4-inch OD, clear 100 ft 1.44142.0001
APC Compressed Gas Adapter 1.44179.0001
APC Compressed Gas Adapter Nozzle Set 1.44180.0001
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).
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MAS-100 series
Active air monitoring solutions
Products Ord. No.
Instruments MAS-100 NT® Air Sampler 1.09191.0001
MAS-100 Eco® Air Sampler 1.09227.0001
MAS-100 NT® Ex Air Sampler, explosion-proof 1.09194.0001
MAS-100 CG Ex® 1.09327.0001
DA-100 NT Digital Anemometer 1.09192.0001
Spare parts and accessories
MAS-100 NT® Extra Dust Cover* 1.09084.0001
Perforated lid for MAS-100 NT® (300 x 0.6 mm)** 1.09195.0001
Main Charger for MAS-100 NT® ** 1.09200.0001
Battery Pack Li-Ion for MAS-100 NT® ** 1.09208.0001
MAS-100 Main Charger 1.09085.0001
MAS-100 NiMH Battery Pack 1.09229.0001
MAS-100 NiCd Battery Pack (for version 2.62 or lower) 1.09087.0001
MAS-100 Extra Perforated Lid, Aluminum* 1.09088.0001
MAS-100 Tripod 1.09326.0001
MAS-100 Tripod Adapter - Quick Connect 1.09223.0001
MAS-100 Tube Adapter 1.09224.0001
MAS-100 PC Interface Cable for Nova-LIMS® 1.09226.0001
MAS-100 Contact Plate Holder 1.09214.0001
MAS-100 Perforated Lid for Contact Plates 1.09213.0001
MAS-100 CG Ex® Extra Sampling Head, Low Flow 50 L/min and 100 L /min 1.09237.0001
MAS-100 Eco® Main Charger 1.09128.0001
MAS-100 Eco® Tripod Adapter 1.09127.0001
MAS-100 Ex NiCd Battery Pack 1.09087.0001
MAS-100 Ex Extra Dust Cover* 1.09123.0001
MAS-100 Ex Extra Perforated Lid, Aluminum* 1.09124.0001
* 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.
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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
1.44194.0001
RCS® High Flow Touch accessories
Docking Station For recharging the integrated lithium-ion battery 1.44256.0001
RCS® Compressed Gas Adapter Touch Autoclavable adapter for microbial monitoring of compressed gases; designed for a pressure of 1 bar
1.44257.0001
Nozzle Set for RCS® Compressed Gas Adapter Set of five nozzles to extend the air inlet pressurefrom 1 bar to 0.1-7.0 bar
1.44235.0001
Sterile Sleeves 10 pieces; for covering non-autoclavable housing parts 1.44199.0010
Tripod For use at heights up to three meters 1.44209.0001
Table-top Tripod For horizontal operation 1.44210.0001
RCS® High Flow Touch Validation HandbookGerman versionEnglish 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
1.44176.00011.44189.0001
RCS® High Flow Touch Qualification HandbookGerman versionEnglish version
Plan for instrument qualification of the RCS® High Flow Touch in controlled areas, contains IQ, OQ & PQ 1.44178.0001
1.44192.0001
CalibSo Calibration Software for automated, computer-aided calibration and data storage
1.44206.0001
Anemometer Portable device for measuring the air flow rate during calibration of RCS® Microbial Air Samplers
1.44205.0001
Adhesive Tapes 60 pieces, adhesive ring foils to seal the air inlet holes of the rotor during calibration
1.44208.0001
Rotor Spare part, autoclavable, each combination of sampler and rotor must be calibrated separately
1.44196.0001
Protection Cap Spare part (stainless steel), autoclavableFor protection of the rotor during air sampling
1.44225.0001
Air Outlet Ring Spare part, autoclavable 1.44198.0001
Carrying Case 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
1.44150.0001
Power Supply Spare part, for recharging the integrated battery, including country-specific power cord
1.44145.0001
Serial Cable Spare part, for connecting with a PC via the serial RS232 interface
1.44207.0001
USB Adapter Spare part, for connecting with a PC via the USB interface 1.44152.0001
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
1.44200.0001
RCS® High Flow Touch and accessories
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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
1.44236.0001
RCS® Isolator accessories
Universal Battery Charger For charging the integrated 12 V NiMH batteriesof the operation unit
1.44216.0001
RCS® Compressed Gas Adapter Autoclavable adapter for microbial monitoring of compressed gases; designed for a pressure of 1 bar
1.44233.0001
Nozzle Set for RCS® Compressed Gas Adapter
Set of five nozzles to extend the air inlet pressurefrom 1 bar to 0.1-7.0 bar
1.44235.0001
Support Stand for Sampling Unit Stainless steel tripod for vertical mounting ofsampling unit
1.44247.0001
Tripod For use at heights up to three meters;an adapter for connection with the tripod is required
1.44169.0001
Tripod Adapter For mounting to tripods or other installations 1.44248.0001
Table-top Tripod For horizontal operation 1.44210.0001
Air Outlet Tubing PVC outlet air tube to redirect the exhausted air to non-critical areas
1.44239.0001
Tri-Clamp Cable Transfer For use in isolators; connects the operating unit with the sampling unit through the isolator wall
1.44246.0001
RCS® Validation HandbookGerman versionEnglish version
Comprehensive compendium of validation data forRCS® Microbial Air Samplers (RCS® High Flow, RCS® Isolator, RCS® Plus) and Agar Strips
1.44175.00011.44185.0001
CalibSo Calibration Software for automated, computer-aided calibration and data storage
1.44206.0001
Anemometer Portable device for measuring the air flow rateduring calibration of RCS® Microbial Air Samplers
1.44205.0001
Adhesive Tapes 60 pieces, adhesive ring foils to seal the air inlet holes of the rotor during calibration
1.44208.0001
Sampling Unit Replacement unit at an existing installation 1.44238.0001
Rotor Spare part, autoclavable, each combination of sampler and rotor must be calibrated separately
1.44196.0001
Protection Cap Spare part (stainless steel), autoclavableFor protection of the rotor during air sampling
1.44225.0001
Infrared Remote Control 1.44197.0001
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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
1.44204.0001
RCS® Plus Ex accessories
Universal Rapid Battery Charger230 / 240 V (EU)120 V (US)
For charging of 9.6 V and 7.2 V Ni-Cd batteries1.44241.00011.44251.0001
Battery Discharger For discharging of the residual capacity of 9.6 V and 7.2 V batteries; prevents battery memory effects
1.44221.0001
Sterile Sleeves 10 pieces; for covering non-autoclavable housing parts 1.44199.0010
Tripod For use at heights up to three meters 1.44209.0001
Table-top Tripod For horizontal operation 1.44210.0001
RCS® Validation HandbookGerman versionEnglish version
Comprehensive compendium of validation data forRCS® Microbial Air Samplers (RCS® High Flow, RCS® Isolator, RCS® Plus) and Agar Strips
1.44175.00011.44185.0001
Anemometer Portable device for measuring the air flow rateduring calibration of RCS® Microbial Air Samplers
1.44205.0001
Adhesive Tapes 60 pieces, adhesive ring foils to seal the air inlet holes of the rotor during calibration
1.44208.0001
7.2 V Ni-Cd Replacement Battery Spare part 1.44252.0001
Rotor Spare part, autoclavable, each combination of sampler and rotor must be calibrated separately
1.44223.0001
Protection Cap Spare part (stainless steel), autoclavableFor protection of the rotor during air sampling
1.44225.0001
Infrared Remote Control Spare part 1.44212.0001
RCS® Plus Ex and accessories
26
Products Pack Size Ord. No.
Total count media TCTryptic Soy Agar for determination of the total count. Store at 2–25 °C
50 strips 1.44253.0050
TSMModified 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
50 strips 1.44240.0050
TC-γGamma-irradiated Tryptic Soy Agar, double-wrapped; for determination of total count in aseptic environments. Store at 2–25 °C
40 strips 1.44226.0040
TCI-γGamma-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
40 strips 1.44228.0040
PEN-γGamma-irradiated Tryptic Soy Agar with Penase; for determination of total count in penicillin-containing air in aseptic environments. Store at 2–25 °C
40 strips 1.44109.0040
LAC-γGamma-irradiated Tryptic Soy Agar with broad-spectrum cephalosporinase; for determination of total count in aseptic environments containing antibiotics. Store at 2–25 °C
40 strips 1.44108.0040
Selective media YMRose Bengal Agar with streptomycin; for determination of yeasts and molds. Store at 2–25 °C
50 strips 1.44242.0050
SDXSabouraud Dextrose Agar with modified pharmacopoeia formulation; for determination of yeasts and molds. Store at 2–25 °C
50 strips 1.44243.0050
SDX-γSabouraud Dextrose Agar with modified pharmacopeia formulation; for determination of yeasts and molds in aseptic environments. Store at 2–25 °C
40 strips 1.44244.0040
DG-18Dichloran Glycerine Agar; for determination of yeasts and molds. Store at 2–25 °C
25 strips 1.44245.0025
SMannitol Salt Agar; for determination of staphylococci. Store at 2–15 °C
25 strips 1.44102.0025
CMacConkey Agar; for determination of coliform bacteria. Store at 2–15 °C
25 strips 1.44099.0025
Agar strip accessories HYCON® Blank Strip KitEmpty strips for manual production of culture media for special applications
50 strips 1.44107.0050
HYCON® Cover SlidesCover slides for Agar Strips to prevent desiccation during incubation
100 slides 1.44111.0100
Incubation Rack for HYCON® Agar StripsStainless steel; with indicator for incubation time
1 pc. 1.44249.0001
Disposables for RCS® High Flow Touch, RCS® Isolator, RCS® Plus Ex, HYCON® Agar Strips
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
28
Gamma-irradiated, triple-bagged ICR Settle Plates (90 mm and 150 mm) for critical clean rooms and isolators
LI Settle Plates (90 mm) for less critical clean rooms
Passive air monitoring solutions
Products Pack Size Ord. No.
90 mm Plates SDA + LT - ICR 30 ml (heipha ref. 03542e – with neutralizers lecithin, Tween 80, filled in pink plates)
20 1.46081.0020
SDA + LTHTh - ICR 30 ml (heipha ref. 03544e – with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate; filled in pink plates)
20120
1.46005.00201.46005.0120
SDA selective + LTHTh - 30 ml ICR (heipha ref. 03545e – with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate, antibiotics against bacteria, filled in pink plates)
20120
1.46016.00201.46016.0120
TSA - ICR 30 ml (heipha ref. 03075e) 20120
1.46001.00201.46001.0120
TSA + LT - ICR 30 ml (heipha ref. 030828e – with neutralizers lecithin, Tween 80) 20120
1.46050.00201.46050.0120
TSA + LTHTh - ICR 30 ml (heipha ref. 030826e – with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate)
20120
1.46069.00201.46069.0120
TSA + LT + Cephase – ICR (heipha ref. 03085e – with neutralizers lecithin, Tween 80, β-lacatamases for inactivation of penicillins, all generations of cephalosporins and carbapenems)
20120
1.46076.00201.46076.0120
TSA + LTHTh + Penase - ICR 30ml (heipha ref. 03086e – with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate, penase for inactivation of penicillins)
120 1.46013.0120
150 mm Plates TSA + LTHTh - ICR 15 cm (heipha ref. 020829a3- 3 plates, each triple-packed – with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate)
18 1.46051.0018
Accessories Plate Rack for settle plates (heipha ref. 63141 – stainless steel rack for 10 x 90 mm plates) 1 1.46519.0001
Products Pack Size Ord. No.
90 mm Plates SDA - LI n. EP (heipha ref. 03300e) 20120
1.46028.00201.46028.0120
SDA + Chloramphenicol - LI 30 ml (heipha ref. 03350e) 20120
1.46003.00201.46003.0120
SDA + LTHTh - LI 30 ml (heipha ref. 03540e – with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate)
20120
1.46015.00201.46015.0120
TSA - LI 30 ml EP+USP (heipha ref. 03074e) 20120
1.46004.00201.46004.0120
TSA + LTHTh - LI 30 ml (heipha ref. 030820e - with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate)
20120
1.46002.00201.46002.0120
Accessories Plate Rack for settle plates (heipha ref. 63141 – stainless steel rack for 10 x 90 mm plates) 1 1.46519.0001
Abbreviations: SDA = Sabouraud Dextrose Agar, TSA = Tryptic Soy Agar
Abbreviations: SDA = Sabouraud Dextrose Agar, TSA = Tryptic Soy Agar
29
Lockable, gamma-irradiated, triple-bagged ICR Contact Plates (55 mm) for critical clean rooms and isolators
Gamma-irradiated, triple-bagged ICR Contact Plates (55 mm) for critical clean rooms and isolators
Personnel and surface monitoring solutions
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)
20 1.46555.0020
SDA Contact + LTHTh - ICR+ (heipha ref. 850 - with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate; filled in pink plates)
20200
1.46501.00201.46501.0200
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)
20200
1.46538.00201.46538.0200
TSA Contact + LT - ICR+ (heipha ref. 821 – with neutralizers lecithin, Tween 80) 20200
1.46552.00201.46552.0200
TSA Contact + LTHTh - ICR+ (heipha ref. 820 – with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate)
20200
1.46527.00201.46527.0200
TSA Contact + LT + Cephase - ICR+ (heipha ref. 823 - with neutralizers lecithin, Tween 80, β-lacatamses for inactivation of penicillins, all generations of cephalosporins and carbapenems)
20200
1.46539.00201.46539.0200
TSA Contact + LTHTh + Penase - ICR+ (heipha ref. 824 - with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate, penase for inactivation of penicillins)
20200
1.46553.00201.46553.0200
Vegetable Contact Agar + LTHTh -ICR+ (heipha ref. 840 – with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate)
20200
1.46601.00201.41601.0200
TSA Contact + Neutralizer A - ICR+ (heipha ref. 822 – neutralizers for increased spectrum of disinfectants, short shelf life, storage at 20–25 °C)
20200
1.46548.00201.46548.0200
Accessories Plate Rack for contact plates (heipha ref. 63140 – stainless steel rack for 10 x 55 mm plates) 1 1.46502.0001
Products Pack Size Ord. No.
55 mm Plates SDA Contact + LTHTh – ICR (heipha ref. 25130e – with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate, filled in pink plates)
200 1.46201.0200
TSA Contact + LT – ICR (heipha ref. 2284e – with neutralizers lecithin, Tween 80) 20200
1.46195.00201.46195.0200
TSA Contact + LTHTh – ICR (heipha ref. 2283e - with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate)
20200
1.46231.00201.46231.0200
TSA Contact + Penase + LTHTh - ICR (heipha ref. 2280e – with neutralizers lecithin, Tween 80, histidine, sodium thiosulfate, penase for inactivation of penicillins)
20200
1.46153.00201.46153.0200
Accessories Plate Rack for contact plates (heipha ref. 63140 – stainless steel rack for 10 x 55 mm plates) 1 1.46502.0001
Abbreviations: SDA = Sabouraud Dextrose Agar, TSA = Tryptic Soy Agar
Abbreviations: SDA = Sabouraud Dextrose Agar, TSA = Tryptic Soy Agar
30
ICR Swabs for critical clean rooms and isolators
HYCON® Gamma-irradiated Contact Slides
Products Pack Size Ord. No.
ICR Swab (heipha ref. 60515) 100 1.46529.0100
Accessories Swab Rack (heipha ref. 63142 – stainless steel) 1 1.46530.0001
Products Pack Size Ord. No.
Contact Slides TC-γGamma-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
20100
1.44022.00201.44022.0100
Contact Slides DE-γ 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
20 1.44021.0020
Contact Slides PEN-γGamma-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
100 1.44014.0100
Contact Slides LAC-γGamma-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 15–25 °C
100 1.44015.0100
Contact Slides SDX-γ 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 -α-phosphatidylcholine) and growth supplements. Store at 2–25 °C
20 1.44016.0020
Accessories Incubation Rack for HYCON® Contact SlidesStainless steel; with indicator for incubation time
1 1.44249.0001
31
RT and RTplus 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) 20 1.46266.0020
Malt Extract Agar Contact – RT (heipha ref. 250e) 20 1.46191.0020
Plate Count Agar Contact – RT (heipha ref. 238e) 20 1.46154.0020
SDA Contact + Chloramphenicol - RT+ (heipha ref. 862 – lockable plate) 20 1.46549.0020
TSA Contact – RT (heipha ref. 235e) 20 1.46240.0020
TSA Contact + LTH – RT (heipha ref. 234e – with neutralizers lecithin, Tween 80, histidine) 20 1.46200.0020
TSA Contact + LTH - RT+ (heipha ref. 860 – with neutralizers lecithin, Tween 80, histidine, lockable plate)
20 1.46554.0020
Accessories Rack for contact plates (heipha ref. 63140 – stainless steel rack for 10 x 55 mm plates) 1 1.46502.0001
Abbreviations: SDA = Sabouraud Dextrose Agar, TSA = Tryptic Soy Agar
Single-wrapped HYCON® Contact Slides
Products Pack Size Ord. No.
Contact Slides TCTryptic 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
20100
1.44023.00201.44023.0100
Contact Slides YMRose Bengal Agar with streptomycin and chloramphenicol; for determination of yeasts and molds; with growth supplements. Store at 2–25 °C
20 1.44018.0020
Contact Slides SDXSabouraud Dextrose Agar with modified pharmacopoeia formulation; for determination of yeasts and molds; with neutralizers (Tween 80, L-α-Phosphatidylcholine) and growth supplements. Store at 2–25 °C
20 1.44017.0020
Contact Slides BSheep Blood Agar; for determination of total count of fastidious and pathogenic microorganisms. Store at 2–15 °C
20 1.44020.0020
Contact Slides CMacConkey Agar; for determination of coliform bacteria; with growth supplements. Store at 2–25 °C
20 1.44019.0020
Accessories Blank Strip KitEmpty slides for manual production of culture media for special applications
20 1.44024.0020
Incubation Rack for HYCON® Contact SlidesStainless steel; with indicator for incubation time
1 1.44249.0001
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For more information:www.merckmillipore.com/environmental-monitoring
Merck KGaA Frankfurter Str. 250 64293 Darmstadt, Germanywww.merckmillipore.com
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.w286159 PB3774EN00 07/12© 2012 Merck KGaA, Darmstadt, Germany. All rights reserved.