MAS-100 Iso MH®

Flexible microbial air sampling in isolators and RABS with up to four sampling points

The MAS-100 Iso MH® is designed for the microbiological monitoring of isolators and Restricted Access Barrier Systems (RABS) with more than one sampling point.

The air sampler combines maximum product protection with high flexibility in isolator layouts, making it ideal for complex production lines with multiple critical zones.

A base unit located outside the clean area controls up to four sampling heads inside the isolator via tubing with lengths of up to 50 meters. The MAS-100 Iso MH was developed in accordance with GAMP 5 and is fully validated to ISO 14698 and EN 17141.

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One system. Total freedom.

A single, compact base unit can be equipped with up to four sampling heads at various critical positions in the isolator. Three methods for controlling the sampling heads allow for flexible sampling strategies. In addition, tested cable lengths of up to 50 m give integrators and plant engineers considerable freedom in designing the isolator architecture. Numerous interfaces allow the MAS-100 Iso MH to be seamlessly integrated into SCADA and LIMS environments. 

Each collection head operates at an air flow rate of 100 SLPM and achieves a collection efficiency of d50 = 1.1 µm with an accuracy of ±2.5%. The integrated mass flow sensor with temperature and pressure compensation guarantees sampling that is independent of the environment. This ensures that the air flow remains within the specified range even with different pipe lengths and layouts. Air flow calibration is performed separately for each collection position using the MAS-100 Regulus® digital anemometer.  

As with the MAS-100 Iso NT®, the collection head and air-conducting components in the isolated area are completely separated from the base unit. A sequential double valve system prevents the ingress of contaminants. The electropolished stainless steel surfaces in the enclosure can be sterilized automatically with gaseous or vaporized hydrogen peroxide. This ensures that the product and the environment are protected—even with highly active substances, thanks to the optional environmental protection filter. 

Like the MAS-100 Iso NT, the MAS-100 Iso MH is also fully compliant with the requirements of EU GMP Annex 1 when used as part of a comprehensive environmental monitoring concept. In combination with passive air measurement using MAS-100 Libra® via sedimentation plates and real-time solutions such as Rapid-C+, operators can establish a comprehensive contamination control strategy. 

Key features of the MAS-100 Iso MH

High sampling efficiency with up to 4 sampling heads

Sampling at up to four critical locations with a single base unit

Reliable contamination protection

Suitable for toxic filling, dual-valve systems, and optional HEPA filter; automated in-line decontamination

Optimal isolator integration

Up to 50 m tubing length between sampling head and control unit

MBV

Customized sampling programs

Flexible adaptation to different production workflows: standard, sequential, consecutive

Reproducible sampling

Mass flow sensor with temperature and pressure compensation for consistent airflow

Versatile plate formats

90 mm or 100 mm agar plates and GrowthDirect® cassettes

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Easy integration and low-maintenance operation

The MAS-100 Iso air samplers are manufactured to the highest Swiss quality standards using premium, particle-free components. Careful production and assembly of all parts ensure long-lasting, trouble-free operation.

Since all moving parts are located outside the critical zone, maintenance is simple and contamination-free. Sequential valve control ensures that at least one valve remains closed during operation, allowing the base unit to be replaced without fully opening the isolator system.

Comprehensive documentation, CAD drawings, and fully automated control functions significantly simplify integration planning.

Precision perforated lids for maximum sampling efficiency

The precision and material design of the perforated lid have a decisive impact on sampling efficiency and the long-term stability of measurement results. That is why we place the highest importance on uniform hole sizes, perfectly fitting lid-to-instrument contact surfaces, and easy handling with gloves.

To ensure uninterrupted workflows, the lids can be exchanged between air samplers and autoclaved. The precision seal between the perforated lid and the sampling head, made of electropolished pharmaceutical-grade stainless steel, does not require an O-ring, significantly simplifying cleaning and disinfection.

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EU GMP Annex 1

The MAS-100 Iso NT and MAS-100 Iso MH air samplers fully comply with the requirements of EU GMP Annex 1. When combined with settle plates for passive monitoring, they also cover all specifications for environmental monitoring and a comprehensive Contamination Control Strategy (CCS), as described in Chapter 9, “Environmental and Process Monitoring.”

Companies using MBV products in their isolators or RABS can reliably meet the regulatory requirements of Annex 1.


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Product Specifications

Material:
Stainless steel EN 1.4435, electropolished pharmaceutical grade, RA < 0.8 µm

Dimensions:
Length 380 mm, Width 230 mm, Height 120 mm

Weight:
Approx. 7.5 kg (without sampling heads)

Plate compatibility:
90–100 mm Petri dishes

Airflow rate & accuracy:
100 SLPM, ±2.5%

Sampling volume:
Individually configurable per sampling head

Physical cut-off diameter:
d₅₀ = 1.1 µm @ 100 SLPM

Calibration:
Fully automated with MAS-100 Regulus

Special features:

  • 1–4 sampling heads per base unit, sequentially controllable
  • In-line decontamination of sampling head and airflow channel
  • IP65 protection
  • Specified hose/tubing length: 10 m, tested up to 50 m

Function:
Computer-based software for configuration, qualification, and calibration
Integration into SCADA systems or comparable LIMS control systems

Limit settings:
Adjustable “out-of-specification” limit for airflow: selectable between 2.5% and 25%

Interfaces:
Ethernet
Profi-Bus
ProfiNet adapter
USB
9 digital inputs/outputs

Programs:
Three sampling programs: Standard, Sequential, Consecutive

Documentation:
Description of data interfaces available

Calibration management:
Calibration reminder
Option to lock the instrument when the calibration interval has expired

Depending on the individual order:

MAS-100 Iso MH base unit
Adapters and seals for data cable connections
Calibration certificates for the air sampler and digital anemometer (issued by our in-house ISO 17025-accredited calibration laboratory)


  • Optionally, depending on the individual configuration:

    • 1–4 external valves with control cables
    • Valve block for instruments with 2–4 sampling heads
    • Mounting plate for base unit and valve block
    • Stainless steel perforated lid (standard: 300 × 0.6 mm)
    • Stainless steel Petri dish holder (Easyclean or standard)
    • Network module (Ethernet, ProfiNet, Profibus)
    • Tri-Clamp
    • Silicone seal with or without protective mesh
    • External power supply with cable and country-specific adapters
    • Stainless steel dust cover

    Impaction principle in microbial air sampling


    For active microbial air sampling based on the impaction principle, a predefined volume of air is drawn through a perforated sieve. The air and the particles in it are accelerated and directed onto an agar plate positioned below the sieve.

    Due to inertia, particles above a certain size are impacted onto the agar medium. After appropriate incubation, microbe-bearing particles become visible as colony forming units (CFU), can be counted and reported as CFU/m3. The particle size at which 50% of the particles impact and the other half remain in the air stream is called the cut off diameter d50 (um). 

    Great emphasis is placed on precision in the manufacture of MBV perforated sieves. This ensures that the cut off diameter is identical in all holes and that microbial air sampling is repeatable.

    FAQ

    For the MAS-100 Iso MH, a total tubing length of 10 m is specified. The recommended inner diameter of the tubing is 22–27 mm, and other restrictions, such as bends and curves, should be minimized.

    Due to the stronger blower of the MAS-100 Iso MH compared to the MAS-100 Iso NT, longer tubing lengths may be possible, but they should be tested in advance.

    1. Open the MAS-100 Iso NT/MH Communication & Calibration (C&C) PC software and log in to the Service menu.

    2. Navigate to the Decontamination Settings section in the Service menu and set the pump speed to 50% or higher. The decontamination flow displayed on the left side must be above 600 mV.

    3. Disable the option “Enable digital flow monitor signal” and set the flow monitor alarm threshold to approximately 200 mV below the ADC flow value.

    4. Perform a function test by blocking the exhaust of the decontamination path, then start a decontamination using the “Start Decontamination” button in the All Devices menu. After a short time, Error 95 (Decontamination flow too low!) should appear.

    5. Confirm the alarm. The alarm signal will stop, indicating that the decontamination pump has been successfully configured.

    No. The base units of the MAS-100 Iso are installed outside the isolator. Only the sampling head is located within the exposed area. The sampling head is made of stainless steel and fully compatible with the decontamination gas.

    All MAS-100 Iso instruments from MBV (except RABS models) feature a dedicated decontamination gas flow path inside the instrument. This is automatically activated during decontamination and ensures the decontamination of the sampling head, tubing, and valves. The separate gas flow path prevents sensitive components—primarily the airflow sensor—from being damaged by the decontamination gas.

    Want to dive deeper? Our full FAQ section covers many more questions about the MAS-100 Iso instruments. Take a look — the answer you’re looking for might already be there!

    Dive deeper

    Downloads

    Vorschaubild PDF:
    Brochure


    Overview of the MAS-100 Iso Air Sampler Series

    Vorschaubild PDF:
    Application Note


    Isokinetic microbial air sampling with MAS-100 air samplers

    Vorschaubild PDF:
    Application Note


    Safe remote microbial air sampling with the MAS-100 Iso MH

    Vorschaubild PDF:
    Brochure


    Self-calibration – the MAS-100 Regulus digital anemometer

    Vorschaubild PDF:
    Technical article


    Loss prevention for aseptic manufacturers: How to save millions.

    Vorschaubild PDF:
    Technical article


    EU GMP Annex 1 Compliance through Active Air Sampling

    Vorschaubild PDF:
    Installation


    MAS-100 Iso MH : Installation Checkliste

    Precise air monitoring for pharmaceutical cleanrooms
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