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This Standard Operating Procedure (SOP) outlines the operation and cleaning procedures for the PFS & CARTRIDGE Filling machine with Isolator at Sanzyme Biologics. It details the responsibilities of various personnel, safety requirements, and the specific steps involved in the filling process, ensuring aseptic integrity and compliance with regulatory standards. The document also includes definitions, materials required, and pre-operation checks necessary for safe and effective machine operation.

Author

Katakam Srikanth

Language

EN