Sterilizing Grade Membrane Filtration Validation Study Report|Filter Validation Report|0.22 Micron Filter Validation Report

1.0 OBJECTIVE:

The objective of this study is to validate the sterilizing-grade filter (0.22 µm Nylon-66 Membrane) used for XXXXXX Injection filtration to ensure it meets regulatory and performance criteria. This report summarizes the observations and conclusions based on the executed protocol.

2.0 SCOPE:

This validation study applies to the sterile filtration process in Injection Manufacturing area using a 0.22 µm Nylon-66 membrane filter for XXXXX Injection.

3.0 RESPONSIBILITY

Responsibilities of different department/ personnel involved in different activities related to the Filter Validation of the equipment are defined below:

4.0 FILTER VALIDATION TESTS & OBSERVATIONS

The following tests were conducted as per the validation protocol, and the observations are recorded below.

4.1 Integrity Testing (Pre- & Post-Filtration)

4.1.1 Objective:

To confirm the filter integrity before and after filtration using the Bubble Point Test and Diffusive Flow Test.

5.2 Filter Throughput Study

5.2.1 Objective:

To determine whether the filter can process the required batch volume efficiently.