Pall fully appreciates the stringent regulatory demands for filter validation documentation in the BioPharmaceutical industry and maintains a comprehensive global filter validation service to help meet these demands.
Many of Pall’s Validation Laboratories are stand-alone facilities where specialists working to GLP principles perform specific customer tests. To date, in excess of 2000 customer validation studies have been completed in these facilities.
First-time regulatory approval of the filtration validation package is our mission. Pall’s close links with industry and regulatory agencies ensure we can adhere to current good manufacturing processes and respond to the most recent regulatory guidelines.

Validation Objectives

To prove the suitability of the filter for a process, the following questions must be answered:
• Does the product affect the filter?
• Does the filter affect the product?
• Does the product affect microbial retention by the filter?
To achieve these objectives, Pall uses a Parametric Approach to ensure that filter validation is performed taking into account all critical product attributes and process parameters. This is in line with regulatory expectations and the recommendations of PDA Technical Report 26.

The Filter Validation Package

The filter validation package will be tailored to meet your specific needs and may include some or all of the following:
• Compatibility assessment
• Challenge viability study
• Bacterial, mycoplasma, or bacteriophage retention study
• Extractables analysis
• Evaluation of adsorptive effects
• Generation of product wet integrity test data We can also develop customized microbiological procedures using your specific process isolates. Prior to the start of any test, a protocol detailing the test methodology and acceptance criteria will be issued for approval.
At the conclusion of testing, a comprehensive report including all experimental data is provided.