Tag: Microbial limits testing

SOP for Sterility Assurance Level (SAL) Testing

1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide guidance for Sterility Assurance Level (SAL) testing of sterile medical devices and products. 2. Scope: This SOP covers the procedures for conducting SAL testing of sterile medical devices and products. The testing is carried out to ensure that the product is free…

Microbiology Testing

Microbiology Testing: SOP for Media Fill Testing

SOP for Media Fill Testing: 1.0 Purpose: The purpose of this SOP is to outline the procedure for conducting Media Fill Tests in Pharmaceutical Manufacturing. 2.0 Scope: This SOP applies to all personnel involved in Media Fill Testing in Pharmaceutical Manufacturing. 3.0 Responsibility: 3.1 Quality Assurance – Responsible for reviewing the SOP and ensuring adherence…

Microbiology Testing