Sterile Products Testing SOP Pack

19 editable SOPs: sterility test, media fill (APS), BET gel clot, bioburden, CCIT, personnel and particle monitoring, compressed gases, sterility pumps, depyrogenation, garments and OOS.

What's inside

19 SOPs with all record formats (annexures)
Written for sterile injectable QC micro labs
Generated as Word (DOCX) with your company details

SOPs in this pack

Sterility Test by Membrane Filtration and Direct Inoculation · 6 formats
Bacterial Endotoxin Test by Gel Clot Method · 7 formats
Bioburden Test of Bulk Solutions for Parenteral Products · 1 formats
Container Closure Integrity Test by Microbial Ingress · 1 formats
Personnel Monitoring in the Sterility Testing Area · 5 formats
Operation of Sterility Test Pump (Closed Canister System)
Operation of Membrane Filtration Pump for Microbial Testing
Operation of Leak Test Apparatus · 1 formats
Operation and Cleaning of Depyrogenation Oven · 2 formats
Operation and Verification of Visual Inspection Booth · 1 formats
Operation of Capsule Filtration System
Handling of Cleanroom Garments · 1 formats
Operation and Cleaning of Garment Cabinet and Mobile Cart
Material Movement in the Microbiology Laboratory · 1 formats
Handling of Out of Specification Results in Microbiology · 5 formats
Environmental Monitoring Programme for Clean Rooms · 3 formats
Non-viable Particle Monitoring in Clean Rooms · 1 formats
Microbial Monitoring of Compressed Air, Nitrogen and Other Gases · 4 formats
Aseptic Process Simulation (Media Fill) · 3 formats

Downloaded from the SOP Builder as Word files with your company name, logo, SOP numbers and sign-off.

How to use these templates

Replace the bracketed fields such as [Company Name] and [SOP No.], check every limit against your product and market, and approve through your own change control before use.