In this episode, Anne Klees and Adele Gisselmann (Global Product Managers with Merck KGaA Darmstadt, Germany) unravel the New GMP Annex I (Draft 2020) and explain what effect its changes and new sections will have on environmental microbial monitoring.
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With the publication of the new EU GMP Annex 1, delegates attending the PHSS Annual Conference will have an opportunity to ask Cherwell experts for practical advice and solutions on environmental monitoring and process validation for aseptic processing of Biological and ATMPs.
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The recent draft of Annex 1 mentions contamination control strategies many times. It states that they should be in place across all sterile manufacturing sites. But what is a contamination control strategy and why are they important? Find out here.
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Cherwell’s range of environmental monitoring accessories are designed to protect samples and support EU GMP Annex 1 compliance ensuring maximum protection of environmental monitoring samples, for manufacture of sterile medicinal products.
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SAS Daily Heads are a viable way to help reduce risk and ensure compliance to the new stringent risk management and contamination control strategy within the revised EU GMP Annex 1. These certified sterile disposable air sampler heads provide an alternative to reduce the risk of false positives.
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Results from a study investigating the potential microbial contamination risk to a product from manufacturing processes are available. Researchers modified the most frequently used active air sampling method in a non-controlled environment to enhance knowledge of risks involved. 
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In cell culture-based vaccine manufacturing processes, microbial contamination control and impurity testing are crucial quality control components. Smart and rapid solutions streamline the daily routine and accelerate time to result.
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The ImpactAir-ISO-90 and ImpactAir-90 ranges helps users address continuous monitoring challenges presented by the new Annex 1. The modular design provides differing formats to suit specific deployment needs and challenges within your facilities.
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In this episode, Adele Gisselmann (Global Product Manager with Merck KGaA Darmstadt, Germany) describes the challenges of performing environmental monitoring in isolators, like manipulation with thick gloves and the effect of VHP, and explains how smart product design overcomes these challenges.
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Peter Penn, Sales Director at NaughtonPenn Consultants discusses products that are designed to help laboratories ensure they achieve the correct CFU of reference organisms required to carry out the various testing procedures that they perform, whether it be the GPT or other tests.
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Lonza’s MODA® Solution can overcome the challenges of paper-based data capture methods by offering comprehensive analysis, and trend reporting tools, including dashboards and heat maps, enabling companies to make decisions in real time.
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