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Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization

Categories ETO Sterilization Machine
Brand Name: Medpharm
Model Number: SQ-H series
Certification: ISO
Place of Origin: China
MOQ: 1 unit
Supply Ability: 50 units per month
Packaging Details: Plywood box
Media: EO mixture gas
Door type: Manual
Medical Appliances: Electronic instruments, optical instruments
Control system: Microcomputer
Air filter: Incorporated
Loading: With trays
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    • Product Details
    • Company Profile

    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
    Buy Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization at wholesale prices
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