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    Biopharm 32887

    Uploaded by

    Martin Šimurda
    biopharm_32887 (1)

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    © All Rights Reserved
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    Biopharm 32887

    Uploaded by

    Martin Šimurda
    125 views3 pages
    biopharm_32887 (1)

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    biopharm_32887 (1)

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    Copyright:

    © All Rights Reserved
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    Download as pdf or txt
    125 views3 pages

    Biopharm 32887

    Uploaded by

    Martin Šimurda
    biopharm_32887 (1)

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 3

    Novasip™ Capsules with Emflon® PFR Membrane

    Description

    The unique Novasip™ capsule filter combines Pall cartridge technology with the latest engineered polymers in
    an all-plastic filter assembly that can provide all of the benefits of a capsule filter with SIP (steam-in-place)
    capability. Novasip filters, therefore, provide an alternative to stainless steel housings in many applications.
    This enables filter users to reduce capital and labor costs and to minimize maintenance costs. Novasip filters
    consist of a standard design filter cartridge permanently sealed in a clear polyetherimide housing.

    Polyetherimide is an advanced plastic selected for its high-strength at elevated temperatures and pressures.
    This ensures that Novasip filters can be used under a wide range of operating conditions including multiple
    steam-in-place cycles. Novasip filters are supplied with inlet/outlet connections compatible with sanitary flange
    fittings. Vents and drains are available with integral valves.

    Novasip filters with Emflon® PFR filter membranes are purpose-designed for use in critical air and vent
    applications.

    Comprehensive Validation Documentation

    Novasip filters with Emflon PFR filter membrane have been extensively tested to ensure consistent and reliable
    performance under a range of process conditions.
    A full validation guide is available on request.
    Installation and operating instructions, including information on steam-sterilization, are available from Pall.

    Features and Benefits

    Low installation cost — up to 80 % less than a comparable stainless steel system


    Integrity testable in situ using the water intrusion test (WIT)
    Integral Stäubli-compatible vent valve enables direct in-line connection to electronic test equipment
    Repeatedly steam-sterilizable for long service life and low operating costs
    Suitable for use in high pressure air systems up to 6.5 barg (94 psig) at temperatures
    up to 40 °C
    Supplied with a numbered disc which can be fitted easily to the capsule and used to help record the
    number of times the filter is sterilized

    High Quality Standards

    Validated in liquids with Brevundimonas diminuta (ATCC 19146) at a challenge level of


    107 organisms/cm2 of filter area
    100 % integrity tested during manufacturing
    Identified by a lot number with a unique serial number for complete traceability of manufacturing history
    and for user traceability systems
    Each filter supplied with a Certificate of Test
    Comprehensive validation guide available
    Manufactured under a Quality Management System certified to ISO 9000
    Meets USP Biological Reactivity Tests in vivo, in accordance with USP Class VI plastics
    at 121 °C

    Specifications

    Materials of Construction

    Membrane Hydrophobic PTFE


    Membrane Support and Drainage Layer Assembly Polypropylene
    Endcaps Polypropylene
    Core and Cage Polypropylene
    Housing Bowl Polyetherimide
    Housing Head Polyetherimide with TiO2
    O-rings Silicone elastomer

    Maximum Accumulated Steam Life1

    Temperature 125 °C 135 °C 142 °C


    Maximum Steam Exposure2 100 cycles 50 cycles 5 cycles

    1 Validated using 30 minute cycles.


    2 Maximum values determined in laboratory tests. Actual steam life may vary with conditions of use.

    Operating Conditions3

    Maximum Operating Pressure 6.5 barg (94 psig) at 40 °C


    Maximum Differential Pressure 5.2 barg (75 psig) at 40 °C

    Note: Maximum differential pressure during steam sterilization at up to 142 °C is 300 mbar (4.3 psid).
    3 With fully compatible fluids that do not soften, swell or adversely affect the filter or its materials of construction.

    Typical Air Flow Rates4


    4 Typical initial clean P, air at 20 °C. Contact your local Pall representative for assistance.

    Nominal Dimensions

    Maximum Diameter (Including Valves) 123 mm (4.84 in.)


    Length 157 mm (6.18 in.)

    Ordering Information

    Contact Information

    © Copyright Pall Corporation

    Visit us on the Web at www.pall.com

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