EO Sterilization: Validation & Monitoring

Medical-Steroid-Injections
Ethylene Oxide Sterilization

Ethylene Oxide (EO) gas is the most widely used sterilizing agent for medical device manufacturing. It is the preferred method because it can deeply penetrate most materials and does not require high temperatures to sterilize products.

 

EO Sterilization Validation

To meet the required Sterility Assurance Level (SAL), EO sterilization process needs to be validated. At SaniChem, we offer a wide range of tests to help you validate your sterilization process in accordance with national and international standards.

 

Tests applicable:

  • Bioburden

  • Biological Indicator (BI) Verification

  • BI Sterility

  • Bacteriostasis/Fungistasis Test (B/F) or Method Suitability Test

  • Product Sterility

  • EO Residual Test

 

*scroll to the bottom to see more details on the tests we offer and the number of samples required

 

EO Sterilization Routine Monitoring/Revalidation

Medical devices require careful and regular monitoring to assure sterility is not compromised. For EO sterilization is it recommended that you conduct routine monitoring every two months until a stable enumeration is achieved. Once that is achieved, routine monitoring can be performed quarterly. Revalidation of sterilization process is recommended at least every two years.

 

Tests applicable:

  • Bioburden

  • BI sterility

  • Product Sterility

  • EO Residual Test

 

Reference Standards:

  1. ISO 11135

  2. ISO 11737

  3. ISO 11138

  4. ISO 10993

  5. USP <71>

Test Code
Test Method
No of Samples
MB102 a
Determination of bioburden by membrane filtration (Aerobic bacteria+ Fungi)
10
MB102 b
Determination of bioburden by membrane filtration (Aerobic + Anaerobic bacteria)
10
MB102 c
Determination of bioburden by membrane filtration (Anaerobic bacteria)
10
MB102 d
Determination of bioburden by pour plate method (Liquid sample)
10
MB102 e
Determination of bioburden by pour plate method (Aerobic + Anaerobic bacteria)
10
MB102 f
Correction factor for bioburden -repetitive extraction
5
MB102 g
Correction factor for bioburden -inoculation method
5
MB103 a
Population determination of biological indicators (Etigam Method)
10
MB103 b
Population determination of biological indicators (3M Method)
4
MB101 c
Bacteriostasis and fungistasis test (6 organism)
6
MB101 b
Bacteriostasis and fungistasis test (5 organism)
5
MB101 a
Bacteriostasis and fungistasis test (3 organism)
3
MB100 f
Sterility of Biological Indicator by USP <71> method (2 media)
M
MB100 e
Sterility of Biological Indicator by direct immersion
M
MB100 d
Sterility test by USP <71> method (2 media)
M
MB100 b
Sterility test by direct immersion (>100 mL media)
M
MB100 a
Sterility test by direct immersion (<100 mL media)
M

*M - Number of samples are dependent on method of EO sterilization applied and product specifications.

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