Validation Services & Support
Filters are used for bacteria removal in a wide range of industries from food & beverage processing to instrument reprocessing in hospitals to pharmaceutical manufacturing. However, in pharmaceutical manufacturing, the validation of filter performance is required by the US Food & Drug Administration (FDA), the European Medicines Agency (EMA), International Standards Organization (ISO), the US Pharmacopeia (USP) and the European Pharmacopeia (EP) among other national regulatory bodies.
Pre-Qualification of Filters
Critical Process Filtration filters are proven to remove bacteria according to the standard test from ASTM International (ASTM F838-05). We can provide a detailed validation guide showing product specifications and the results of bacteria retention and other tests used to pre-qualify filters for consideration in pharmaceutical applications.
Testing for Specific Applications
Regulatory bodies require that filter performance be tested in conditions that closely resemble the actual application. That is because some pharmaceutical intermediates and ingredients may affect the performance of the filter. Liquids such as solvents and oils can affect flow rates and may affect the retention characteristics of the filters. Some materials may also cause high levels of leachables. To document that the filter will perform under actual operating conditions, critical Process Filtration will jointly conduct testing with customers in actual process fluids. Tests are conducted to determine if the filters will perform as required under the "worst case" operating conditions of the application. Those tests include:
- Material Compatibility
- Filter performance is not adversely affected by the fluid
- The fluid is not adversely affected by the filter
- Leachable Identification and Quantification
- Prove Bacteria Retention in Customer Fluid (ASTM F838-05)
- Establish Integrity Test Specifications for the Filter in the Fluid
We work with our customers to perform additional tests, if warranted by individual user operating conditions or the specific regulations of their location.
This practice closely follows the recommendations of the Parenteral Drug Association’s Technical Report 26 - "Sterilizing Filtration of Liquids". The guidelines in TR26 are followed by most manufacturers of pharmaceutical products as a means to validate their sterile filtration processes and assure compliance with FDA guidelines.
Critical Process Filtration coordinates all testing and offers these services with no additional cost to the user. Our goal is to provide the user with the most cost-effective filtration systems and services possible with the most efficient support possible.
Click here for a brochure outlining our Validation Services.
Our validation guides include:
- Performance and Safety Data
- Bacteria Retention (ASTM F838-05)
- Sensitization (ISO 10993-10)
- Hemocompatibility (ISO 10993-4)
- Biocompatibility "USP Class VI" (USP ‹88› - exceeds ISO 10993-10, 10993-11)
- Cytotoxicity (ISO 10993-5)
- Gravimetric Extractables (USP<661› NVR)
- Extractables Identification and Quantification (testing based on ISO 10993-18, FDA and EMEA guidelines, the PQRI Leachables and Extractables Working Group, and other information)
- TOC (USP ‹643›)
- Conductivity (USP ‹645› )
- USP Oxidizable Substances
- Bacterial Endotoxins (USP ‹85›)
- Non-Fiber Release (USP ‹788›)
- Particle Release (USP ‹788›)
- Filter Specifications
- Water and Air Flow Rates
- Integrity Test Specification (Water Bubble Point and Diffusive Flow)
- Operating Limits –
- Differential Pressure
- Operating Pressure
- Operating Temperature
- Heat Sanitization Tolerance –
- Hot Water
- Inline Steam
- Chemical Compatibility (sanitization and disinfection chemicals, common solvents)
- Certification of Compliance with 21 CFR (FDA Food Contact)
- Silicone Free Materials Statement
- No Animal Products Statement