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Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization

    Buy cheap Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization from wholesalers
     
    Buy cheap Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization from wholesalers
    • Buy cheap Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization from wholesalers

    Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization

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    Brand Name : Medpharm
    Model Number : SQ-H series
    Certification : ISO
    Supply Ability : 50 units per month
    • Product Details
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    Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization

    EO PROCESSING STEPS

    • Preconditioning/conditioning
      • Exposure to RH and temperature
      • Ensure uniformity of these conditions
    • Sterilization cycle
      • Exposure to EO gas
    • Aeration
      • Dissipation of remaining gases

    DECISIVE PROCESS PARAMETERS

    • Gas concentration >400mg/L
    • Temperature ~100 – 140ºC
    • Relative humidity ~35 – 80%
    • Exposure (dwell) time 2 – 10 hours

    DEEP VACUUM CYCLE

    SHALLOW VACUUM CYCLE

    FACTORS AFFECTING CYCLE SUCCESS

    • Bioburden
    • Product/package properties
    • Loading configuration
    • Cycle parameters

    DETERMINE THE STANDARD

    • AMI/ISO 11135-01 4ed

    “Sterilization of health care products – Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices”

    • Europe – EN 550

    EO VALIDATION OVERVIEW

    • Process development
    • Product compatibility
    • Commissioning
    • PQ – Physical
    • PQ – Microbiological
    • Certification
    • Revalidation

    PROCESS CONTROL

    • Must assure that validated process parameters are met
      • Temperature
      • RH
      • Gas concentration
    • Biological indicators are used to demonstrate lethality
    • Microprocessors are used to control process

    RELEASE MECHANISMS

    • Documentation showing that processing specification are met
    • Successful results of tests
      • Sterility of BI
      • EO residues
      • Packaging
      • Pyrogens

    PARAMETRIC RELEASE

    • BIs not used in release
    • Validation more involved
    • Routine control more rigorous
    • AAMI TIR20:2001 “Parametric release for ethylene oxide sterilization”

    PRODUCT COMPATIBILITY

    • Post sterilization testing for
      • Device functionality
      • Package integrity and strength
      • Residue dissipation rates
      • Impact of re-sterilization

    COMMISSIONING

    • Equipment specifications/diagram
    • Calibration records
    • Profiles for
      • Preconditioning (temp. and RH)
      • Aeration rooms (temp.)
      • Empty chamber temperature distribution

    ModelChamber size(L*W*H)cmOverall size(L*W*H)cm
    SQ-H8055×27×3874×47×92
    SQ-H12060×40×5077×61×106
    SQ-H22074×50×6092×68×115
    SQ-H36080×65×7097×84×131
    SQ-H46080×72×8098×92×148
    SQ-H60088×80×86116×100×155
    SQ-H80095×90×95115×110×166
    Quality Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization for sale
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