A VHP validation approach to a multi chamber and complex flexible filling line with Q&A скачать в хорошем качестве

A VHP validation approach to a multi chamber and complex flexible filling line with Q&A

Isolator technology is now the expectation in fill finish. The sterility assurance this technology offers greatly reduces contamination risk and offers clients a much higher quality product. But, how do you validate a multi-chamber filling line with multiple pieces of complex equipment? How do you ensure that a sufficient sanitization level is met? In this one hour webinar, Berkshire Sterile Manufacturing and Steriline will discuss their validation approach for BSM's new filling line that will begin operations in 2022. This new line will be validated to a 6-log reduction in geobacillus spores, which is far greater than any SAL that could be reached with a closed RABs system. Contents of this Video: 00:00 - Intro 01:29 - Why are we discussing VHP validation? 02:28 - What is VHP sanitization and how is it performed? 11:28 - How do you validate a VHP cycle for a new line? 21:11 - Closing Remarks 23:15 - Q&A