Moist-heat sterilization is a commonly used and widely accepted process in pharmaceutical manufacturing. Given its critical role, it is essential that this process is carried out correctly to ensure product safety and efficacy. In this webinar, we will explore real-world observations related to moist-heat sterilization processes, delve into the underlying science behind these observations, and present practical solutions to achieve a successful validation outcome.
The discussion will begin with an in-depth examination of the principles of moist-heat sterilization, highlighting the importance of precise control over process parameters to ensure effective microbial inactivation. Participants will learn about common challenges and pitfalls encountered during the sterilization process, and how to address these issues to maintain optimal performance.
A key aspect of the webinar will be the role of a contamination-control program in ensuring microbiologically acceptable products, typically with a sterile claim. The ability to demonstrate sterility is paramount, and although this is often achieved through sterility testing via USP<71>, it is important to recognize that this test only provides a snapshot within the broader context of contamination control. Therefore, a comprehensive perspective on sterility verification will be discussed, considering various factors and methodologies beyond the standard sterility test.
The webinar will provide insights into integrating a holistic approach to sterility assurance, incorporating strategies for robust process validation, ongoing monitoring, and continuous improvement. By understanding the complete picture of contamination control, participants will be better equipped to implement effective sterility assurance programs in their own facilities.
This webinar is essential for professionals involved in pharmaceutical manufacturing, quality assurance, and regulatory compliance who are looking to enhance their understanding of moist-heat sterilization and ensure the highest standards of product sterility. Join us to gain valuable knowledge and practical solutions for achieving successful validation and maintaining sterility in pharmaceutical processes.