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Environmental Monitoring and Aseptic Process Simulation

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Three MAS-100® portable microbial air samplers displayed on a white surface. MAS-100® Sirius to the left, MAS-100 VF® in the middle, and MAS-100 Eco® to the right.
The portable MAS-100 Atmos® compressed gas sampler for microbial detection in compressed gas from pharmaceutical, cosmetic, food & beverage industry.
MAS-100 Iso NT® and MAS-100 Iso MH® microbial air samplers for microbial monitoring in isolators and RABS
Non-lockable ICR and lockable ICRplus Contact and Settle Plates suitable for environmental monitoring in isolators and critical cleanrooms.
The IsoBag® solution, a sterile polyurethane DPTE Beta Bag designed for safe and convenient transfer of materials into isolators or RABS.
Gamma irradiated, triple-wrapped granulated media and ready-to-use culture media for aseptic process simulation

Patient safety is crucial, thus pharmaceutical products are manufactured under stringent controls. Microbial monitoring plays a vital role in GMP regulatory compliance, demonstrating that manufacturing processes, particularly in aseptic production, are well-managed.

Explore our comprehensive range of GMP-compliant solutions for microbial monitoring in aseptic pharmaceutical manufacturing, which includes monitoring of surfaces, personnel, and air. We also offer tailored solutions for isolators and RABS to enhance your workflow.

Additionally, we provide both granulated and ready-to-use culture media for media fills and aseptic process simulations, supporting classical environmental monitoring.

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Microbial Air & Gas SamplersCulture Media for Environmental MonitoringCulture Media for Aseptic Process SimulationPortable Air SamplersHandheld Air SamplerMicrobial Air SamplingMaterial Transfer

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Microbial Air Samplers

Our air samplers are based on different principles, enabling technological selection to suit your environmental monitoring needs. We offer products specifically designed for explosion hazard areas, cleanrooms and isolators, and compressed gas monitoring. Our easy-to-use monitoring systems are designed for many environmental monitoring needs.

  • The new MAS-100 Sirius® portable microbial air sampler enhances active air monitoring in high-grade cleanrooms, making it more reliable and convenient than ever. Designed for a digital environment, this air sampler supports data integrity and full traceability to ensure compliance.
  • The MAS-100 VF® active air sampler is specifically tailored for controlled environments. Its compact design and ease of handling features make it ideal for monitoring environment quality.
  • The MAS-100 Atmos® compressed gas sampler is simple, safe, and compliant with 21 CFR Part 11, allowing for easy and automatic detection of microbial contamination in gases.  
  • ICR and ICRplus settle plates features a high filling volume of 30 mL in 90 mm plates. They are gamma-irradiated and triple bagged, making them ideal for both active air monitoring with MAS-100® Air Samplers and passive microbial air sampling in isolators and clean rooms.

Surface and Personnel Monitoring

We provide a wide selection of plates tailored for environmental monitoring in isolators and critical cleanrooms, including the non-lockable ICR and lockable ICRplus Contact Plates with TSA + LTHTh.

  • ICR Contact plates are designed to minimize the risk of contamination as they are produced in clean rooms. The lockable ICRplus/RTplus versions can be safely transported for incubation under aerobic, microaerophilic, or anaerobic conditions.
  • ICR Swabs are designed for absence-presence testing on dry surfaces in isolators and cleanrooms that are challenging to access for surface and personnel monitoring. Key features include:

Isolator and RABS solutions

Isolators and RABS are designed to eliminate human contact during controlled manufacturing.

  • The MAS-100 Iso MH® microbial air sampler is engineered for the highest collection efficiency and safety in isolators. For only a single sampling point in your Grade A area, we offer the MAS-100 Iso NT® air sampler.
  • IsoBag® rapid transfer solution enables safe and rapid culture media transfer into isolators and critical areas. The IsoBag® solution expedites environmental monitoring in aseptic production isolators by providing ready-to-use gamma-irradiated contact or settle plates for immediate use.

Culture Media for Aseptic Process Simulation

Our irradiated, triple-wrapped granulated media or ready-to-use media alleviate concerns about compromising validated processes during media fill trials.

  • Granulated culture media, carefully formulated, enables pharmaceutical manufacturers to conduct efficient media fill trials with minimal risks.
  • Ready-to-use culture media, such as Tryptic Soy Broth (TSB) and Vegetable Peptone Broth (VPB), undergo sterilization by autoclave and a two-step pre-filtration process, ensuring their quality.

Related Resources

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An advanced laboratory device is displayed, featuring a digital interface and a cylindrical chamber at the top. Next to it are several petri dishes containing orange media, along with sealed packages of additional laboratory supplies.

Navigating Cleanroom Compliance for Safe Material Transfer

The safe transfer of materials into a controlled area is one of the greatest challenges of managing cleanrooms and isolators. Learn more about regulations and solutions to nagivate safe material transfer.

A person in a cleanroom suit and gloves is holding a metallic container with a blue lid. The background is a blurred laboratory setting, emphasizing a sterile and controlled environment.

Get your Aseptic Facility Ready for EU GMP Annex 1

The European Commission's revision of Annex 1 introduces Quality Risk Management to enhance sterile product manufacturing, focusing on risk-based and effective contamination control strategy.

A series of petri dishes filled with a yellowish medium are visible inside a sterile enclosure. A gloved hand is reaching through a sealed access point, holding another petri dish. The setup suggests a controlled environment for microbiological work, emphasizing cleanliness and precision in handling samples.

Aseptic Isolator Manufacturing: Introduction to Innovative Technology Solutions

Environmental Monitoring in aseptic production, especially in barrier environments like Isolators and RABS, is crucial. This presentation will discuss regulatory standards, risk-based sampling strategies, and advanced technologies to enhance monitoring efforts.

Two petri dishes filled with a yellowish agar medium are stacked slightly on top of each other.

How Crucial is Culture Media Selection in Environmental Monitoring?

Culture media selection is critical for environmental monitoring in aseptic manufacturing. Learn how its requirements and design influence practices, focusing on regulatory compliance, media handling, and reducing false results.

Related Applications
Viable Air Monitoring
Microbial air monitoring ensures aseptic environments, vital in food, beverage, and cannabis manufacturing.
Surface & Personnel Testing
Surface monitoring and personnel monitoring measure the levels of microbial contamination in production areas to control the measures of disinfection routines.
Aseptic Process Simulation (APS)
Aseptic Process Simulation (APS), also known as Media Fill test, evaluates the aseptic manufacturing process by using a sterile microbiological culture medium. It ensures that aseptic techniques are effective in preventing contamination during production.
Small Molecules Analysis & QC
Small molecules analysis ensures compliance with pharmacopoeia specifications in drug development.
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Maintenance & Service Plans
Browse our maintenance and service plans for Milli-Q water purification systems and our microbiology testing systems.
System and Equipment Installation for Microbiology Testing Systems
Installation of your lab system is an important step before commissioning your equipment or prior to any qualification and it could be critical for system integrated in isolator.
Pharma Microbiology Method Development & Validation
When a microbial test method (S.O.P.) needs to be set up for a new product or improved for a product that demonstrates antimicrobial effects and/or filtration issues, our applications laboratory can develop a method that is compliant with applicable regulations (Pharmacopoeias). As a company, we are known for the quality of our products. We apply these same high standards to our methods development assignments and keep the same strict attention to regulatory compliance.
Training & Education
Pharmaceutical and biopharmaceutical manufacturers can enhance their skill sets with practical, hands-on training courses in-person or streamed live from our M Lab™ Collaboration Centers.
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