Sterility Testing for Medical Devices and Pharmaceuticals

Inner hero image with the title of our webinar and presenter photo and name alongside it. The background image features one of our isolators from our sterility lab.

Download our webinar and ensure the safety and efficacy of your products with expert insights on sterility testing. Designed for professionals in the Medical device, Combination Device and Pharmaceutical industries, this is a valuable resource to enhance your knowledge in the industry.

This webinar session will cover the importance of sterility testing in ensuring the safety and efficacy of medical products. We will explore the critical aspects of maintaining a controlled environment necessary for accurate and reliable sterility testing, and delve into the various media used in these tests, discussing their specific applications.

Our expert, Bianca Ganea, will review the essential pharmacopoeia guidelines and standards that govern sterility testing procedures. You’ll discover different methods employed in sterility testing, including their advantages and limitations, and gain insights into validating the suitability of these methods for specific products.

Additionally, the webinar will address how to handle and investigate non-conformance and out-of-specification (OOS) results to ensure compliance and product safety. The session will conclude with an interactive Q&A segment, providing you the opportunity to engage with us and gain deeper knowledge.

Designed for professionals in the medical device and pharmaceutical industries, this webinar aims to enhance your understanding of sterility assurance in product development and manufacturing.

Cormica’s mission is to improve patients’ lives by providing comprehensive testing services, enabling clients to launch and release their products safely and rapidly across the world.

Sterility testing is a critical regulatory requirement for Pharmaceutical, Combination product and Medical Device manufacutres, ensuring the safety and compliance of products pre- and post-market.

 At Cormica, our Microbiology laboratory, includes a Grade D (ISO Class 7) compliant cleanrooms and advanced Millipore Steritest® systems, provide unparalleled assurance of test integrity. Our flexible film isolators, sanitised with hydrogen peroxide vapour, minimize contamination risks, setting us apart from standard laminar flow cabinets.

We cater to a wide range of sterile products, from fluids like vaccines and antibiotics to various medical devices including dressings and implant devices.

Trust Cormica to deliver the highest standards of sterility testing for your products, backed by our experienced microbiology team. Contact us today to discuss your specific needs. sales@cormica.com

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Bianca Genea

Senior Scientist in the Sterility department at Wickham Micro Ltd.

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Bianca graduated from university with a degree in Pharmacology with expertise in cellular and molecular drug development and clinical pharmacology. Bianca has been at Wickham Micro for several years and now specialises in Sterility testing, test result approval, investigating out of specification (OOS) results, whilst also ensuring the reliability and accuracy of our testing services.

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