Microbial Environmental Monitoring
in the Pharmaceutical Industry
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.
Learn more about our environmental monitoring portfolio and services for aseptic manufacturing within the brochure.
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.
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.
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.
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:
Contact our experts to request more information on environmental monitoring solutions for the pharmaceutical industry.
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.
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, 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.
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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