Eliminating Blind Spots
You can never be too cautious when it comes to monitoring your manufacturing lines
GMP compliant solutions for process monitoring in pharmaceutical manufacturing
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. The risk-based implementation of sampling plans, as well as the subsequent trend analysis of monitoring results, helps to detect deviations from qualified status, prepare root cause analysis, and follow up with appropriate corrective action and preventive action (CAPA).
Microbial monitoring of cleanrooms, isolators and RABS
We offer a broad portfolio of products and instruments for microbial monitoring of aseptic pharmaceutical manufacturing, including:
- Convenient, ready-to-use (RTU) 55 mm and 90 mm agar plates, also in rapid transfer bags
- All-in-One ICR Swabs minimizing cross-contamination risks
- Viable air samplers for ambient air and compressed gas testing
Furthermore, to ease your workflows, we provide specific concepts for monitoring of isolators and restricted access barrier systems (RABS). In addition to solutions for classical environmental monitoring, we have irradiated granulated as well as ready-prepared culture media for aseptic process simulations.
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 offer, performed by certified service engineers, that covers:
- Validation protocols and on-site IQ/OQ service
- Training
- Maintenance and service plans
- Traceability and calibration accuracy
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.
- IsoBag™ ease the environmental monitoring workflow in aseptic production isolator
- Settle plates for isolators and critical cleanrooms
- Contact Plates and Swabs for Personnel and Surface Monitoring in Cleanrooms and Isolators
- High quality granulated and ready-to-use culture media irradiated for accurate and reliable aseptic process simulations.
- In this study we investigated the influence of a 5-hour exposure of two different settle plates, TSA w. LTHThio sedi. - ICR and TSA - ICR+ on their growth promoting properties.
- Microbial monitoring; environmental monitoring; interim storage; ICR contact plates; contact plates; TSA w. LTHThio Contact ICR+
- MAS-100 NT; cleanrooms; cleanroom cross contamination; viable air sampling;
Highlights
In this webinar, our media fill experts give an overview of what to consider when selecting media for aseptic process simulations.
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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