Method & System Validation Protocol Pack

7 editable protocols: disinfectant efficacy, preservative efficacy (AET), MLT method suitability, purified water method suitability, HVAC (AHU) PQ, compressed air PQ and sterile accessories hold time.

What's inside

7 protocols with result formats and summary report annexures
Acceptance criteria written to USP, Ph. Eur., ISO 14644 and EU GMP Annex 1 (2022)
Generated as Word (DOCX) with your company details

7 protocols in this pack

Validation of Disinfectant Efficacy by Use-Dilution and Surface Challenge Tests · 8 formats
Antimicrobial Effectiveness Test (Preservative Efficacy) Protocol · 7 formats
Method Suitability (Validation) of Microbial Enumeration Test and Tests for Specified Micro-organisms · 7 formats
Method Suitability for Microbial Testing of Purified Water (Membrane Filtration on R2A Agar) · 6 formats
Performance Qualification of HVAC System (Air Handling Unit) for Classified Areas · 8 formats
Performance Qualification of Compressed Air System (Generation and Points of Use) · 6 formats
Hold Time Study of Sterilised Glassware and Microbiological Accessories · 5 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.