Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization
Brand Name:Medpharm
Certification:ISO
Model Number:SQ-H series
Minimum Order Quantity:1 unit
Place of Origin:China
Supply Ability:50 units per month
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B631, HUAFANG INTERNATIONAL MANSION, No.178 CHENGBEI STR., ZHANGJIAGANG, JIANGSU, PRC, 215600
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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 |
Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization
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