Gamma Sterilization: Validation & Monitoring

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Gamma Radiation Sterilization

Gamma radiation is one of sterilizing agent used in sterilization process. It uses Cobalt 60 to kill microorganisms on medical devices. A dose is introduced to the samples for sterilization process. The unit for the dose is kiloGray, kGy.

 

Gamma Sterilization Validation

To achieve a sterile label claim product, an appropriate sterilization dose must be established. The sterilization dose shall be validated accordingly. 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

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

  • Product Sterility

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

 

Gamma Sterilization Routine Monitoring (Dose audit) & Revalidation

Medical devices require careful and regular monitoring to assure sterility is not compromised. For Gamma sterilization dose audit, is it recommended to conduct in every three months. As for revalidation of sterilization, it is recommended to perform annually.

 

Tests applicable:

  • Bioburden

  • Product Sterility

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

 

Reference Standards:

  1. ISO 11137

  2. ISO 11737

  3. USP <71>

  4. USP <61>

  5. USP <62>

Test Code
Test Method
No. of Samples
MB100 b
Sterility test by direct immersion (>100 mL media)
M
MB100 d
Sterility test by USP <71> method (2 media)
M
MB101 a
Bacteriostasis and fungistasis test (3 organism)
3
MB101 b
Bacteriostasis and fungistasis test (5 organism)
5
MB101 c
Bacteriostasis and fungistasis test (6 organism)
6
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
MB104a
Endotoxin (Kinetic Turbidimetric)
3
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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