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Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization

Good quality Hospital Steam Sterilizer for sales
Good quality Hospital Steam Sterilizer for sales
It is worthy to cooperate with Medpharm again. Also, prompt action on after sales service left me a deep impression.

—— Manusawee Wareesuwan

I like the sterilizer here running in our factory,it is wonderful.It is fully made to my requirement.Before that I contact many suppliers but they can

—— Marina.Stolyrova

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Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization

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

Large Image :  Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization

Product Details:

Place of Origin: China
Brand Name: Medpharm
Certification: ISO
Model Number: SQ-H series

Payment & Shipping Terms:

Minimum Order Quantity: 1 unit
Packaging Details: Plywood box
Supply Ability: 50 units per month
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Detailed Product Description
Media: EO Mixture Gas Door Type: Manual
Medical Appliances: Electronic Instruments, Optical Instruments Control System: Microcomputer
Air Filter: Incorporated Loading: With Trays

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

Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization

SHALLOW VACUUM CYCLE

Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization

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

Contact Details
ZHANGJIAGANG MEDPHARM MACHINERY LTD.

Contact Person: Ms. JULIET

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