Sterile Packaging Validation & Batch Release Webinar
Ensuring the quality of incoming product material is critical for pharmaceutical manufacturers and their suppliers. This is especially important for sterile packaging suppliers to guarantee the products they provide to manufacturers do not delay or impede their ability to meet patient demand. Currently the traditional 14-day sterility test is one of the biggest roadblocks in preventing critical medication from reaching patients faster.
In this webinar, Stevanato Group, a leading manufacturer of sterile primary packaging containers presents a case study on how they successfully implemented a rapid microbial method for sterility assurance. Learn how they applied a nine-step framework using Celsis AMPiScreen® and ATP-bioluminescence technology to achieve success as well as actionable insights on how this can improve your production process and your entire supply chain.
Key takeaways you’ll receive:
- How lead time was reduced from 14 to 6 days
- The methodology for supplier qualification and validation
- How to apply this process to easily implement your own rapid microbiological method
“We are using Celsis for the sterility test on the final sterilized product since some years: the use of an ARMM method significantly reduced our time-to-result, mitigating the risk of subjective visual inspection of the media and improving our time to market. Additionally, we proceed transferring the method to other Sites, having in this way a global approach always compliant to the main Regulatory Standards.”
Greta Franzoso, Compliance Quality DCS Manager, Stevanato Group
Webinar Presenters
Greta Franzoso
Compliance Quality DCS Manager
Stevanato Group
Lucia Ceresa, PhD
Senior Technology and Market Development Manager
Charles River
Additional Information
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