Millipore® MAS-100 CG Ex Compressed Gas Microbial Sampler

Overview

The Millipore® MAS-100 CG Ex is an intrinsically safe, portable compressed gas microbial sampler engineered for quantitative viable particle monitoring in pressurized industrial gas systems operating within classified hazardous environments. It employs a calibrated, high-precision impaction principle: compressed gas is directed at controlled velocity through a precisely machined perforated impactor plate onto standard 90 mm or 100 mm contact agar plates or membrane filters. This physical separation mechanism ensures reproducible deposition of microorganisms—bacteria, yeasts, and molds—onto the growth medium without thermal or chemical stress, preserving viability for subsequent colony enumeration and identification. Designed specifically for ISO 14698-1 and EU GMP Annex 1-compliant environmental monitoring programs, the MAS-100 CG Ex enables routine bioburden assessment of nitrogen, compressed air, carbon dioxide, argon, and other process gases used in pharmaceutical aseptic manufacturing, biotech fill-finish lines, and sterile medical device production.

Key Features

• Intrinsically safe design certified to ATEX Directive 2014/34/EU: II 2G Ex db IIB T4 Gb (gas atmospheres, Zone 1) and II 2D Ex tb IIIC T135°C Db (dust atmospheres, Zone 21), enabling deployment directly adjacent to compressors, dryers, and distribution manifolds.
• Dual fixed-flow operation: factory-calibrated 50 L/min (optimized for low-concentration or high-pressure applications) and 100 L/min (standard for rapid sampling in high-bioburden risk zones), both maintained with active flow regulation across the full 1.5–10 bar_abs operating pressure range.
• Integrated pressure-compensated mass flow sensor with traceable calibration; accuracy specified as –0% to +10% deviation at setpoints of 50 or 100 L/min under varying backpressure conditions—critical for maintaining consistent volumetric sampling across dynamic plant pressure profiles.
• Robust stainless steel housing (IP65-rated) with explosion-proof electronics enclosure; operational continuity assured across ambient temperatures from 0°C to 40°C and humidity up to 80% RH (derated linearly to 50% RH at 40°C).
• Battery-powered autonomy: approx. 3.5 hours of continuous operation per charge, supporting multiple sampling events per shift without external power dependency—essential for mobile QA/QC audits and validation protocols.

Sample Compatibility & Compliance

The MAS-100 CG Ex accommodates industry-standard microbiological media formats: 90 mm Petri dishes (with or without pre-poured agar), 100 mm contact plates, and 47 mm or 50 mm sterile membrane filters mounted on compatible holders. Its impaction geometry conforms to ISO 14698-2 requirements for sampler performance verification and is validated per USP , EP 2.6.12, and PDA Technical Report No. 13 (Revised 2022) for compressed gas monitoring. The system supports full audit trail generation when integrated with compliant laboratory information management systems (LIMS) and satisfies data integrity expectations under FDA 21 CFR Part 11 and EU Annex 11 when paired with appropriate electronic record controls.

Software & Data Management

While the MAS-100 CG Ex operates as a standalone hardware platform with intuitive front-panel interface (LED status indicators, tactile push-button controls, real-time flow and pressure readouts), it interfaces seamlessly with Millipore’s optional SamplerLink™ Data Manager software suite. This Windows-based application enables centralized configuration, batch-level sampling protocol definition (including user-defined start/stop triggers, pressure thresholds, and alarm limits), automated export of time-stamped sampling logs (flow, pressure, duration, operator ID), and direct integration into enterprise quality management systems (QMS). All electronic records include immutable timestamps, operator authentication, and change history—fully aligned with ALCOA+ principles and GLP/GMP documentation standards.

Applications

• Pharmaceutical Grade Compressed Air Monitoring: Routine surveillance of point-of-use locations in cleanrooms, isolators, and lyophilizers per EU GMP Annex 1 §8.42.
• Viable Particle Risk Assessment in Bioprocess Gases: Quantitative microbial load testing of CO₂, N₂, and O₂ supply lines feeding bioreactors and cell culture incubators.
• Validation Support for Compressed Gas Systems: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) studies requiring documented, repeatable sampling in hazardous zones.
• Medical Device Sterilization Gas Verification: Monitoring of ethylene oxide (EtO) carrier gas purity prior to sterilization chamber loading.
• Food & Beverage Process Gas Hygiene Audits: Assessing microbial contamination in packaging gas mixtures (e.g., MAP blends) where explosive atmospheres may be present.

FAQ

Is the MAS-100 CG Ex suitable for sampling non-sterile compressed air in Zone 1 classified areas?

Yes. Its ATEX certification (II 2G Ex db IIB T4 Gb) explicitly permits operation in Zone 1 gas hazardous locations, provided installation complies with IEC 60079-14 wiring and grounding requirements.
Can the flow rate be adjusted continuously between 50 and 100 L/min?

No. The MAS-100 CG Ex offers only two factory-set, fixed flow rates: 50 L/min and 100 L/min. These are selected via hardware switch; no variable-speed control is implemented to preserve calibration integrity and intrinsic safety compliance.
Does the instrument require annual recalibration?

Per Millipore’s maintenance recommendation and ISO/IEC 17025-aligned practice, the integrated mass flow sensor should undergo traceable recalibration every 12 months—or after any event affecting mechanical integrity (e.g., impact, exposure to condensate, or pressure surge exceeding 10 bar_abs).
What validation documentation is supplied with the system?

Each unit ships with a Factory Calibration Certificate (traceable to NIST or PTB standards), ATEX Certificate of Conformity, EC Declaration of Conformity, and IQ/OQ protocol templates compliant with ASTM E2500 and ISPE GAMP 5 guidelines.