Filter Validation

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.   Filter 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. Top

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

Filter Validation Package Details

To be suitable for use in the manufacture of a pharmaceutical drug product, a filter cartridge must be both chemically and physically resistant to the process stream and operating conditions. Laboratory tests can be used to establish chemical compatibility.

Filter Validation Test Requirements

• Full process information
• Full product composition
• Approximately 2000 mL of product

Evaluation of Filter Adsorptive Effects

It is critical that filters are selected to minimize adsorption and loss of product components. Laboratory scale filter tests can be used to generate adsorption profiles to help with filter selections and process qualification.

Filter Validation Test Requirements

• Full process information
• Full product composition
• Approximately 1000 mL of product
• Analytical test methods

Extractables Analysis

Both quantitative and qualitative information on extracted materials must be generated. Commonly, extractables cannot be evaluated directly in the actual product, but a 'Model Solvent' approach must be developed. The Pall Validation Laboratories use a filter cartridge tested with the appropriate 'Model Solvent' to reproduce a worst- case situation.

Filter Validation Test Requirements

• Full process information
• Full product composition

Generation of Product Wet Filter Integrity Test Parameters

Filter integrity tests performed on critical filters immediately before and after batch filtration confirm performance to specification. In order to optimize processing, it may be more convenient to integrity test the filter cartridge wet with the product. Pall Validation Services Groups can provide users with the filter integrity test data for these specific products.

Filter Validation Test Requirements

• Full product composition
• Approximately 1000 mL of product

Microbial Retention Filter Validation

This is to qualify the ability of the filter media to produce sterile filtrate in the process. A solution of the product or simulant will be inoculated with the challenge organism at a concentration > 1 x 10⁷ viable organisms/m² of filter membrane area. The challenge is carried out on three filter membranes from different production batches, with at least one being at minimum specification.

Filter Validation Test Requirements

• Full process information
• Full product composition
• Approximately 1000 mL of product

Product Viability Filter Validation

Many pharmaceutical products are bactericidal. This test verifies the survival capacity of the organism selected for microbial challenge testing, in the whole product or a suitable product simulant, for the process time.

Filter Validation Test Requirements

• Full process information
• Full product composition
• Approximately 200 mL of product

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.

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Filter Validation Ordering Information

Charges

Wherever possible, we provide a fixed price in advance for the project. Where this is not possible, we will give an estimate to assist you in budgeting and cost control. The final invoice gives details on items such as labor and materials.

What's the Next Step?

Contact your local Pall representative, or contact Pall at 800-717-7255 or biotech@pall.com. We will contact you to discuss your specific requirements and forward your enquiry to Pall Validation Services Teams. We recommend you do this well in advance of a regulatory audit to ensure there is adequate time to generate appropriate test data.

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