At October’s PDA/BioPhorum meeting in Berlin, it was agreed that the Pre-Use Post-Sterilization Integrity Testing (PUPSIT) consortium would be renamed Sterile Filtration Quality Risk Management (SFQRM). The new name recognizes an important change in emphasis, not just for the team but also the industry.

“The reality is that too often in the past regulators have gained the impression that risk assessments have been focused on PUPSIT as a technique, rather than dealing with their concerns about the possibility of sterile filtration failure,” says Tony White, Director of BioPhorum Fill Finish. “These assessments have increasingly been seen by European health authorities as ‘predetermined justifications’ and have caused a lot of the increase in observations in recent years.”

The consortium recognized this reality at its launch meeting in April, when it embarked upon the mapping of risk and controls for the entire lifecycle of different types of final sterilization filter, from manufacture to post-use testing. All the while, positioning PUPSIT in the context of the other controls in the process.

With the involvement of the big filter manufacturers, 16 users and a host of consultants, this work is progressing at a good pace and the authorities are aware of its intent. Related consortium workpackages support this QRM approach and will ensure that industry will be better armed to identify where PUPSIT reduces risk, and then use it in the most effective way.

These workpackages include:

• Completing blinding studies to understand the probability and conditions that could lead to filter defect masking across a wide sample of 10-inch sterilizing grade filters
• Producing a best practice guide to help industry with installation design and operation issues where PUPSIT is applicable
• Data mining Bacterial Challenge Test data on filter failures to further illuminate the type of products that might be prone to masking flawed filters
• Developing and completing a risk management approach (Fault Tree Analysis and Failure Mode and Effects Analysis) to help industry minimize concerns about flawed filters being masked in final post-filtration integrity tests.

With a tailwind, the group is hoping to publish its results and outputs in early 2019, with the goal of adding as much science as possible to the debate and helping us ensure we are all doing the right things, in the right way to ensure product sterility.