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UPS(무정전 동력공급장치)
Parker Pharmacetical Filter
TETPOR HP Filter Cartridges
  • liquid filters
  • hydrophilic PTFE

  • TETPOR HP filter cartridges have been specially designed to
    minimize protein and preservative binding in the sterilization of
    pharmaceutical and multi-dose ophthalmic solutions.

    Adsorption of proteins or preservatives from a pharmaceutical
    preparation onto the filter membrane can complicate the
    manufacturing process and lead to costly product wastage.
    The unique hydrophilic PTFE membrane featured in the
    TETPOR HP exhibits lower levels of binding than other
    commonly used filtration membranes such as PES and PVDF
    which can prevent product loss during processing.

    The TETPOR HP exhibits low extractable levels and the sterilizing
    grade membrane has comparative flow rates to PES and PVDF
    products. Its hydrophilicity is stable to both chemicals and heat.
    The product also offers an exceptionally broad range of chemical
    compatibility making it well suited to the processing of
    aggressive aqueous liquids.

    Features and Benefits
  • Exceptionally low binding membrane to prevent costly product
        loss and process down time
  • Incorporates a fully validated and integrity testable 0.2 micron
        membrane for assurance of sterility
  • Fast flowing membrane for increased process efficiency

  • Performance Characteristics

    Materials of construction
    - Filtration Membrane :
    - Upstream Support :
    - Downstream Support :
    - Inner Support Core :
    - Outer Protection Cage :
    - End Caps :
    - Standard o-rings :
    Hydrophilic PTFE
    Recommended Operating Conditions
    Up to 70 °C (158 °F) continuous operating temperature and higher short-term temperatures during CIP to the following limits:
    Effective Filtration Area (EFA)
    10¨ (250 mm)
    20¨ (500 mm)
    30¨ (750 mm)
    0.88 m2 ( 9.47 ft2)
    1.76 m2 (18.94 ft2)
    2.64 m2 (28.42 ft2)
    TETPOR HP filter cartridges are validated to withstand 10 steam-in-place cycles at 135 °C (275 °F).

    TETPOR HP filter cartridges can be sanitized with hot water at up to 90 °C (194 °F) and are compatible with a wide range of chemicals.

    For detailed operational procedures and advice on cleaning and sterilization, please contact the Technical Support Group through your usual Parker domnick hunter contact.
    Food and Biological Safety
    Materials conform to the relevant requirements of 21CFR Part 177 and current USP Plastics Class VI - 121 °C and ISO10993 equivalents.
    Quality Standards
    Pharmaceutical grade products are manufactured in accordance with cGMP, 100 % flushed with pharmaceutical purified water and integrity tested prior to despatch. A sample of each lot is tested to demonstrate conformity to validated claims.
    TOC / Conductivity
    The filtrate quality from a 10¨ (250 mm) TETPOR HP conforms to the requirements of current USP <643> (TOC) and USP <645> (conductivity) within the first 200 ml flush of purified water.
    Aqueous extracts from the 10¨ (250 mm) TETPOR HP contain < 0.25 EU / ml when tested in accordance with the Limulus Amoebocyte Lysate test.
    Non-Volatile Extractables (NVE)
    The quantity of NVE’s obtained from a TETPOR HP cartridge during a 24 hour static soak was undetectable compared to a control sample.
    Oxidizable Substances
    TETPOR HP filter cartridges meet current USP and EP quality standards for sterile purified water for oxidizable substances following a <1 litre water flush.
    Integrity Test Data
    All filters are integrity testable to the following limits when wet with water and using air as the test gas (a minimum 20 minute purified water flush is recommended prior to integrity testing in water).

    *Note: It is also possible to integrity test the TETPOR HP in 60 / 40 IPA / Water (v / v). Maximum allowable diffusional flow for a 10¨ (250 mm) TETPOR HP in 60 / 40 IPA / Water is 16.8 ml / min.
    Retention Characteristics
    TETPOR HP 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.
    Pharmaceutical Validation
    A full validation guide is available upon request from Laboratory Services Group (LSG).

    Ordering Information