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Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization
Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization
Specifications
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
Description

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
Product tags

e o gas sterilizer

,

e.o.gas sterilizer

,

eo gas sterilization
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Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization

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Product Detail
Brand Name :
Medpharm
Model Number :
SQ-H series
Certification :
ISO
Place of Origin :
China
MOQ :
1 unit
Supply Ability :
50 units per month
Contact Supplier
Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization

ZHANGJIAGANG MEDPHARM MACHINERY LTD.

Verified Supplier
10 Years
jiangsu
Business Type :
Manufacturer, Trading Company
Main Products :
Autoclave Steam Sterilizer, Hospital Steam Sterilizer, Lab Autoclave Sterilizer
Certification Level :
Verified Supplier
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