There’s more to clean environments than meets the eye. Our ......(dust-, water spray-,...

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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

Transcript of There’s more to clean environments than meets the eye. Our ......(dust-, water spray-,...

Page 1: There’s more to clean environments than meets the eye. Our ......(dust-, water spray-, explosion-proof) Proven safety: RCS® Air Sampling Systems • employed by pharmaceutical companies

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

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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.

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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.

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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

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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

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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

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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

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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

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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

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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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We provide information and advice to our customers on application technologies and regulatory matters to the best of our knowledgeand 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: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.