Merck
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Microbial Environmental Monitoring

in the Pharmaceutical Industry

GMP Compliant Environmental Monitoring Solutions in Pharmaceutical Manufacturing

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Because patient safety matters, the manufacture of pharmaceutical products is performed under strictly controlled conditions. Microbial monitoring is an important part of GMP regulatory compliance, used to prove that the manufacturing process is under control, especially in aseptic production.

Explore our broad portfolio of GMP-compliant solutions for microbial monitoring of aseptic pharmaceutical manufacturing including surface and personnel monitoring and microbial air monitoring. We also provide specific concepts for monitoring isolators and RABS to ease your workflows.

In addition to solutions for classical environmental monitoring, we have granulated as well as ready-to-use culture media for media fills/aseptic process simulations.

Learn more about our environmental monitoring portfolio and services for aseptic manufacturing within the brochure.

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Surface and Personnel Monitoring

To ensure that your environmental monitoring is comprehensive, air sampling is often not enough. Thanks to our ready-to-use contact plates, slides and swabs, surface and personnel monitoring is now made simple.

Stay on the safe side

Surface and personnel monitoring with ready-to-use contact plates, slides, and swabs

 

  • ICR Swabs for surface and personnel monitoring in isolators and cleanrooms are designed for absence-presence testing on dry surfaces that are difficult to access.
  • ICR Contact plates are designed to minimize the risk of contamination as they are produced in clean rooms. The ICRplus/RTplus versions are lockable and can be safely transported for incubation under aerobic, microaerophilic or anaerobic conditions.
  • Hycon® Contact Slides are designed for monitoring flat and curved surfaces as well as personnel. The contact plates are available in standard single packaging or a double-bagged, gamma-irradiated format.

 

Microbial Air Monitoring

We offer a variety of easy-to-use solutions helping you ensure the highest standards in critical environments while meeting international standards and regulations.

Comprehensive monitoring solutions

MAS-100 NT® microbial air sampler for environmental monitoring
  • The MAS-100 NT® and MAS-100 NT Ex® portable microbial air samplers are the industry standard for use in critical environments. These air samplers are available with a HEPA exhaust filter or can be upgraded with a filter mounting kit to reduce any risk of cross-contamination between low to high-grade cleanroom areas.
  • The MAS-100 VF® active air sampler is specially developed for controlled environments. It is compact, easy to handle and ideal for monitoring the quality of your environment.
  • Detect microbial contamination in gases with a few easy and automated steps. The MAS-100 Atmos® compressed gas sampler is simple and safe to use, and compliant with 21 CFR Part 11.
  • ICR and ICRplus settle plates come with a high filling volume of 30 mL in 90 mm plates in order to reduce water loss during air monitoring. The plates are available in animal-free formulations to minimize the risk of BSE/TSE contamination.

Isolators and RABS

To further ease your workflows, we provide specific concepts for monitoring isolators and restricted access barrier systems (RABS).

Clever solutions for isolators and RABS

IsoBag® rapid transfer bag for remote microbial air sampling

Isolators and RABS are designed to prevent any human contact during controlled manufacturing. The MAS-100 Iso NT® & MAS-100 Iso MH® instruments in combination with the IsoBag® rapid transfer bag – allow a safe remote microbial air sampling for rapid culture media transfer into isolators.

Environmental monitoring in aseptic production isolators is made quicker by the IsoBag® as it provides ready-to-use gamma-irradiated contact or settle plates for immediate use. There is no need for decontamination cycles before introducing settle or contact plates, freeing up time for your actual production processes and thus saving costs.

Media Fills/Aseptic Process Simulation

Every aseptic process should be validated with at least 3 successful aseptic process simulations, or media fill tests. The aseptic process simulation should then be repeated regularly and the choice of the media for aseptic process simulation is crucial.

Granulated and ready-to-use culture media for secure media fill tests

Gamma irradiated, triple-wrapped granulated media and ready-to-use culture media for media fill testing

With our irradiated, triple-wrapped granulated media or ready-to-use media you need not worry about compromising your validated process while performing media fill trials.

  • Granulated culture media has been carefully formulated to ensure pharmaceutical manufacturers can perform efficient media fill trials with minimal risks.
  • Ready-to-use culture media include Tryptic Soy Broth (TSB) and Vegetable Peptone Broth (VPB). These liquid broths are first sterilized by autoclave and then undergo a two-step pre-filtration process.

Watch Our Environmental Monitoring Webinars

  1. Get your Aseptic Facility Ready for EU GMP Annex 1

    The upcoming Annex 1 revision will include guidance specifically on designing a risk-based and effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles.
    Watch Webinar

  2. Aseptic Isolator Manufacturing: Introduction to Innovative Technology Solutions

    Environmental monitoring within an isolator should be based on a formal risk assessment concerning the product, process and routes of entry. Watch the webinar to learn about regulatory requirements for environmental monitoring. Also, you will be introduced to innovative and effective technology solutions available to enhance your environmental monitoring program.
    Watch Webinar

  3. How Crucial is Culture Media Selection in Environmental Monitoring? A Roundtable Discussion

    The choice of culture media plays a crucial role in quality control strategy in aseptic manufacturing for environmental monitoring in cleanrooms and isolators. Watch the webinar if you have faced challenges in your environmental monitoring practices and are interested to learn the impact of manufacturer requirements and design specifications of culture media in your current practices.
    Watch Webinar

Environmental Monitoring Services

All our portfolios are supported by a broad range of services, embodying our ambition to remain one step ahead of customer demands and expectations. Benefit from our all-around services offers, performed by certified service engineers, that cover:

  • Validation protocols and on-site IQ/OQ service
  • Training
  • Maintenance and service plans
  • Traceability and calibration accuracy
Explore Related Services

Discover our Environmental Monitoring Solution

Contact our experts to request more information on environmental monitoring solutions for the pharmaceutical industry. 

Related Articles

We have extensive knowledge about the workflow of environmental monitoring in pharmaceutical manufacturing areas. We fulfil all requirements requested for microbiological methods in the various GMP guidance’s as well as related in norms such as ISO 14698, EN 17141 and ISO 14644 by proven documentation. 

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Viable Air Monitoring
Microbial air monitoring is a critical step in maintaining aseptic environments, cleanrooms and production areas to ensure the quality of raw materials and finished products.
Surface & Personnel Testing
Surface monitoring and personnel monitoring measure the levels of microbial contamination in production areas to control the measures of disinfection routines.
Media Fills
Media fill is a critical microbiological test carried out to assess the performance of an aseptic manufacturing process by replacing the pharmaceutical or beverage product with a sterile culture medium.
Classical Pharmaceutical Formulation & Manufacturing
Manufacturing the final dosage form of a small molecule drug requires robust quality and design in development of the formulation and production of the final product. Explore solutions and best practices to advance and accelerate small molecule pharmaceuticals, from development to commercialization.
Related Services
Calibration and Verification for Microbiology Testing Systems
Microbiological testing services such as calibration and verification are critical to enhance performance and ensure the reliability of test results. Learn more about our proposed calibration and verification services and ensure that your equipment complies with specifications to keep confidence in your test results.
Maintenance and Service Plans for Microbiology Testing Systems
Conformity of systems used to perform QC tests and sampling is critical to ensure reliability of test results. Discover our maintenance testing services plan offering portfolio to assure your equipment is with compliance and reliability.
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 QC Systems Qualification
We understand the need for quality, cost containment, and regulatory compliance when it comes to the validation of your microbiology methods. With our validation protocols, we provide you the correct documentation to be used for audits and in front of the regulatory authorities. When on-site with a customer, our validation engineers ask the right questions as well as understand your application and the validation requirements of your equipment.
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.
Related Product Categories
Microbial Culture Media
A microbial culture medium promotes and supports the growth and the survival of microorganisms. It can be prepared as a liquid broth, solid agar plate or as semi-solid deeps. We offer a broad range of dehydrated and ready-to-use culture media that fulfils the highest industry standards and regulatory requirements.
Viable Air Samplers
Active air samplers impact microorganisms of a known volume of air onto an agar medium for detection of colony-forming units. Our MAS-100® and RCS® air sampler series provide accurate results with good repeatability and regulatory compliance.

Highlights

Media Selection Made Easy
Media Selection Made Easy

In this webinar, our media fill experts give an overview of what to consider when selecting media for aseptic process simulations.

EU GMP Annex 1 (Draft 2020) and How It Affects Aseptic Manufacturing
EU GMP Annex 1 (Draft 2020) and How It Affects Aseptic Manufacturing

This webinar outlines a holistic approach to ensure continued compliance, taking into account the expected changes with EU GMP Annex 1 (Draft 2020), including the need for EM programs and procedures based on risk analysis.

EN 17141 & Active Air Sampling
EN 17141 & Active Air Sampling

EN 17141, a new European standard for biocontamination control, has recently come into effect. In Europe, it will replace ISO 14698 Parts 1 and 2 from 2003, the previous standard for biocontamination control in cleanrooms and associated controlled environments.

Key Challenges when Selecting Media for Media Fill Tests
Key Challenges when Selecting Media for Media Fill Tests

In this 10-minute quick learning tutorial our expert Adèle Gisselmann will guide you through the requirements for aseptic manufacturers when selecting media for media fill tests or aseptic process simulations.

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