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Article l Best Practices for Sterility Assurance in Fill/Finish Operations

Article l Best Practices for Sterility Assurance in Fill/Finish Operations

Medium: BioPharm International

Achieving acceptable sterility assurance levels for aseptically filled drug products requires certain tools, technologies, and standard operating procedures to ensure sterility across settings. Because many biologics cannot be terminally sterilized, isolators and RABS are the most commonly utilized technologies to achieve product sterility. But are these technologies the best means of achieving sterility of processes? 

Today, there are two distinct technologies dominating the fill/finish process; isolators and restricted access barrier systems (RABS). Of the two technologies, each has its advantages in certain criterias. Why are these technologies the best means of achieving sterility of processes? What are some of the challenges associated with fill/finish operations and how have they been overcome? The answers to these questions and more insight regarding best practices in sterility assurance are provided by two leading industry experts in an informative article from BioPharm International.

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Best Practices for Sterility Assurance in Fill/Finish Operations

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