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China factory - ZHANGJIAGANG MEDPHARM MACHINERY LTD.

ZHANGJIAGANG MEDPHARM MACHINERY LTD.

  • China ,Jiangsu
  • Verified Supplier

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China Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas
China Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas

  1. China Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas

Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas

  1. MOQ: 1 unit
  2. Price:
  3. Get Latest Price
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
Brand Name Medpharm
Model Number SQ-H series
Certification ISO
Place of Origin China

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  1. Product Details
  2. Company Details

Product Specification

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
Brand Name Medpharm Model Number SQ-H series
Certification ISO Place of Origin China
High Light ethylene oxide sterilization equipmentethylene oxide sterilizers

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

     

Model Chamber size(L*W*H)cm Overall size(L*W*H)cm
SQ-H80 55×27×38 74×47×92
SQ-H120 60×40×50 77×61×106
SQ-H220 74×50×60 92×68×115
SQ-H360 80×65×70 97×84×131
SQ-H460 80×72×80 98×92×148
SQ-H600 88×80×86 116×100×155
SQ-H800 95×90×95 115×110×166

Company Details

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 from Quality China Factory
  • Business Type:

    Manufacturer,Trading Company

  • Ecer Certification:

    Verified Supplier

MEDPHARM Company team is committed to providing quality sterilization products, service, parts and maintenance training at significant savings. From customized parts packages to turnkey&n... MEDPHARM Company team is committed to providing quality sterilization products, service, parts and maintenance training at significant savings. From customized parts packages to turnkey&n...

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Get in touch with us

  • Reach Us
  • ZHANGJIAGANG MEDPHARM MACHINERY LTD.
  • B631, HUAFANG INTERNATIONAL MANSION, No.178 CHENGBEI STR., ZHANGJIAGANG, JIANGSU, PRC, 215600
  • https://www.steamsterilizerautoclave.com/

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