Tetpor Plus
TETPOR PLUS filters are manufactured entirely from fluoropolymers, making them extremely resistant to a wide range of aggressive chemicals. These filters have been specifically designed for the filtration of liquids and gases in the bulk pharmaceutical, chemical, and biopharmaceutical industries, where particulate removal, bioburden reduction, and guaranteed sterility are required.
The increasing use of ozonation for the treatment of WFI systems has highlighted compatibility issues with vent filters based on standard polypropylene components. The introduction of a fully validated 0.2 micron sterilising grade TETPOR PLUS filter cartridge provides guaranteed long-term performance in these applications. Additionally, the filter’s integrity can be validated by the water intrusion test method.
The high voids volume single layer PTFE membrane ensures an excellent combination of flow rate and retention.
Technical Specifications
Materials of Construction
- Filtration Membrane: Polytetrafluoroethylene
- Upstream Support: Polytetrafluoroethylene
- Downstream Support: Polytetrafluoroethylene
- Inner Support Core: PFA
- Outer Protection Cage: PFA
- End Caps: PFA
- Standard o-rings: FEP Encapsulated Silicone
Food and Biological Safety
Materials conform to the relevant requirements of 21CFR Part 177, EC1935 / 2004 and current USP Plastics Class VI – 121 °C and ISO10993 equivalents.
Recommended Operating Conditions
Up to 125 °C (257 °F) continuous operating temperature and higher short-term temperatures during CIP to the following limits:
Effective Filtration Area (EFA)
- 10” (250 mm): 0.63 m² (6.78 ft²)
- K Size (125 mm): 0.32 m² (3.44 ft²)
Cleaning and Sterilisation
TETPOR PLUS cartridges can be repeatedly steam sterilised in situ or autoclaved at up to 142 °C (287.6 °F) for a maximum of 30 cycles. For detailed operational procedures and advice on cleaning and sterilisation, please contact the Technical Support Group through your usual Parker domnick hunter contact.
Retention Characteristics
TETPOR PLUS filter cartridges are validated by bacterial challenge testing with Brevundimonas diminuta to current ASTM F838-05 methodology (107 organisms / cm² EFA minimum) with typical in-house challenge levels being 10¹¹ organisms per 10” (250 mm) module.
Integrity Test Data
The following is the integrity test information for the micron ratings available within the TETPOR PLUS product range. Diffusional flow and bubble point values are given for cartridges wetted in 60:40 v/v IPA:Water solution.
Pharmaceutical Validation
A full validation guide is available upon request from Laboratory Services Group (LSG).
Features and Benefits
- Sterile filtration of oxygen/oxygen-enriched feeds in cell culture
- Exceptional resistance to solvents and oxidative environments
- Ideal for sterile venting on ozonated water systems
- Fully validated to ASTM F838-83 for sterilising grade filters
- PTFE membrane
- Available in a wide range of micron ratings to suit all applications
