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Filter Integrity Tester

  • Filter integrity tester Integtest V8.0

    Filter integrity tester Integtest V8.0

    Filter Integrity Tester —— Integtest series
    Dongguan Puno Filter Integrity Tester Integtest series are special instruments of integrity
    testing for sterile filtration membrane and filter system, where the testing method and instrument
    design fully meet the requirements for relevant laws and regulations in GMP, EP, FDA and USP.
    ◎ Regulatory requirements
    1. Chinese GMP and EU EP have made specific provision for the integrity testing of sterile
    filter on the test method, where the commonly used methods include bubble point test, diffusion
    flow test or pressure holding test. GMP regulates that the test is required after the use of sterile
    filtration. EP regulates that the test is required before and after the use, and at the same time EP
    regulates that the critical gas and air filter must be confirmed after use, while other filters must be
    tested on a regular basis.
    2. According to Drug Manufacturing Quality Management Standard (revised in 2010) Article
    310, two appendices of Computerized System and Confirmation and Validation are now issued,
    as the supportive documents for Drug Manufacturing Quality Management Standard (revised in
    2010), effective as of December 1, 2015.
    3. The requirements for electronic records and electronic signatures as specified in 21 CFR
    Part 11.
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  • Filter integrity tester Integtest V6.5

    Filter integrity tester Integtest V6.5

    Filter Integrity Tester —— Integtest series
    Dongguan Puno Filter Integrity Tester Integtest series are special instruments of integrity
    testing for sterile filtration membrane and filter system, where the testing method and instrument
    design fully meet the requirements for relevant laws and regulations in GMP, EP, FDA and USP.
    ◎ Regulatory requirements
    1. Chinese GMP and EU EP have made specific provision for the integrity testing of sterile
    filter on the test method, where the commonly used methods include bubble point test, diffusion
    flow test or pressure holding test. GMP regulates that the test is required after the use of sterile
    filtration. EP regulates that the test is required before and after the use, and at the same time EP
    regulates that the critical gas and air filter must be confirmed after use, while other filters must be
    tested on a regular basis.
    2. According to Drug Manufacturing Quality Management Standard (revised in 2010) Article
    310, two appendices of Computerized System and Confirmation and Validation are now issued,
    as the supportive documents for Drug Manufacturing Quality Management Standard (revised in
    2010), effective as of December 1, 2015.
    3. The requirements for electronic records and electronic signatures as specified in 21 CFR
    Part 11.
    inquirydetail
  • filter integrity tester

    filter integrity tester

    Integtest ®  Serials Integrity Tester are designed for testing integrity of filters and filter systems . The test meet to verify the sterilizing filter in the FDA, the State Pharmacopoeia and GMP specification requirements. The V4.0 Integrity Tester is compact, handy to use, and fully automated integrity test instrument, which performs bubble point, diffusion flow, enhanced bubble point, and water-based test for hydrophobic filters.The first domestic launch of integrity test for waterbased test for hydrophobic filters to meet different customer needs.

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