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: 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…