MAS-100 Iso NT®

Safe and efficient microbial air monitoring in isolators and RABS

The MAS-100 Iso NT® is designed for microbial air monitoring in isolators and restricted access barrier systems (RABS).

The sampling head is located inside the isolated environment, while the control unit with electronics and all moving parts is installed outside the clean zone. The system is designed for maximum product and operator protection and can be operated either manually via the integrated display or fully automatically via a process control system.

The MAS-100 Iso NT was developed in accordance with GAMP 4 and is fully validated to ISO 14698 and EN 17141.

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Maximum microbial collection efficiency. With confidence.

The sequential double-valve system reliably protects the interior from contamination originating in the surrounding environment.

Thanks to the clear separation between the sampling head and the control unit, maintenance can be performed without any intervention in the aseptic zone.

All air-contacting surfaces within the isolated area are made exclusively of electropolished stainless steel and can be automatically sterilized using gaseous or vaporized hydrogen peroxide. This makes the MAS-100 Iso NT a fully enclosed concept designed for maximum product and environmental protection. For systems handling highly active substances, an optional environmental protection filter can be integrated.

The MAS-100 Iso NT detects even the smallest microbial particles with an accuracy of ±2.5%. An integrated mass flow sensor with temperature and pressure compensation ensures a constant airflow regardless of ambient conditions. Precision-manufactured stainless steel perforated lids – also available with a handle for hard-to-reach locations – guarantee reproducible measurement results and long-term stability. Airflow calibration can be performed independently by maintenance personnel using the MAS-100 Regulus®. 

For applications without system integration, the integrated touch display allows convenient operation directly on the instrument. In addition, the MAS-100 Iso NT can be seamlessly integrated into SCADA and LIMS environments via numerous interfaces such as Ethernet and USB, protocols like Profibus and Profinet, as well as digital inputs and outputs. This enables sampling programs to be directly incorporated into existing process controls – ideal for modern isolator lines with clearly defined SOPs and audit requirements.

The MAS-100 Iso NT can be used in ISO 14644 Class 5 (GMP Grade A) environments and fully complies with the requirements of EU GMP Annex 1. When the air sampler is additionally combined with the MAS-100 Libra® for passive monitoring using settle plates, all requirements for a Contamination Control Strategy (CCS), as outlined in Chapter 9 “Environmental and Process Monitoring,” can be fulfilled.

Feature highlights of MAS-100 Iso NT

High collection efficiency with a single sampling head

Cut-off diameter d₅₀ = 1.1 µm at 100 SLPM, accuracy ±2.5%

Reliable contamination protection

Double-valve system, optional HEPA filter, automated in-line decontamination

Optimal isolator integration

Up to 10 m tubing length between sampling head and control unit

MBV

Integrated touch display

Direct instrument operation

Reproducible sampling

Mass flow sensor with temperature and pressure compensation for consistent airflow

Versatile plate formats

90 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 long-term stability of measurement results. That is why we place the highest importance on uniform hole sizes, precisely 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 283 mm, width 230 mm, height 160 mm

Weight:
Approx. 7.5 kg (without sampling head)

Plate compatibility:
90–100 mm agar dishes

Airflow rate & accuracy:
100 SLPM, ±2.5%

Sample volume:
Individually configurable

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

Calibration:
Fully automatic with MAS-100 Regulus

Special features:
In-line decontamination of the sampling head and air channel
Max. hose/pipe length: 10 m

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

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

Interfaces:
Ethernet
Profibus
Profinet adapter
USB
9 digital inputs/outputs

Programs:
Two sampling programs: Standard and Sequential

Documentation:
Detailed description of data interfaces available

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

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

Depending on individual configuration:
Stainless steel perforated lid (standard: 300 × 0.6)
Stainless steel Petri dish holder (EasyClean or standard)
Network module (Ethernet, Profinet, Profibus)
IP54 kit
Tri-clamp
Silicone gasket with or without protective mesh
External power supply with power 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 NT, a total tubing length of 10 m is specified. The recommended internal tubing diameter should be 22–27 mm, and other restrictions such as bends and twists in the tubing should be minimized.

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

2. In the service menu, go to the section “Decontamination Settings” and set the pump speed to 50% or higher. The decontamination flow displayed on the left side must be higher than 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 functional test by blocking the suction of the decontamination line and start a decontamination by pressing the “Start decontamination” button in the “All devices” menu. After some time, Error 95 (Decontamination flow too low!) must occur.

5. Acknowledge the alarm. The alarm signal will stop, and the decontamination pump will then be successfully set.

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 is fully compatible with the decontamination gas. All MAS-100 Iso instruments from MBV (except RABS) feature a dedicated decontamination gas pathway inside the instrument, which is automatically activated during decontamination and enables the decontamination of the sampling head, tubing/lines, and valves. The separate decontamination gas pathway prevents sensitive components (mainly the airflow sensor) from being damaged by the decontamination gas.

Do you have more questions? You can find additional questions and answers here.

FAQs

Downloads

Vorschaubild PDF:
Brochure


All you need to know about the MAS-100 Iso air samplers

Vorschaubild PDF:
Factsheet


Technical Data and Facts: MAS-100 Iso NT

Vorschaubild PDF:
Application Note


How MAS-100 instruments sample air isokinetically without disturbing the surrounding airflow.

Vorschaubild PDF:
Article


The crucial role of active air sampling in compliance with EU GMP Annex 1.

Vorschaubild PDF:
Article


Loss prevention for aseptic manufacturers: How you can save millions.

Vorschaubild PDF:
Installation


Your installation checklist for the MAS-100 Iso in RABS.

Vorschaubild PDF:
Brochure


Everything about the MAS-100 Regulus digital anemometer for the independent calibration of MAS-100 air samplers.

Präzises Luftmonitoring für pharmazeutische Reinräume
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MAS-100 – Your solution for reliable monitoring

Quality You Can Count On

For 40 years, MBV has been developing and producing premium air samplers – precise, reliable, and built to last.

Swiss Excellence

MAS-100 instruments are designed and manufactured in Switzerland. “Swiss Made” is not just a label; it’s our promise turned into reality.

Everything from a Single Source

Fast, flexible, and customer-focused: We provide end-to-end solutions from one hand, enabling you to respond quickly to every challenge.

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Working hand in hand with our clients, we create tailored solutions that meet real-world requirements.

Regulatory Compliance

Our documentation meets international standards, ensuring smooth audits, validations, and maximum safety.

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Andy Zingre is happy to find your perfect monitoring match.
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