Challenges In Sterile Manufacturing Of Multiple Product Lines

Author: Joseph Wojcik, Development Engineer

Summary: During technical transfer of two concentrations (high and low) of a polymeric bulk sterilized Blow Fill Seal (BFS) sterile product a common process was desired. Sterility Assurance Validation was executed and the low concentration product was validated successfully. However, the high concentration product clogged the clarifying filter at ~60% of complete bulk utilization.

Alternatives were considered but deemed inappropriate:
1 - waste (dumping unused formulation)
2 - time delays (filter replacement, re-sterilization)
3 – new process (potential to require new sterility assurance validation)

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