Description:
Radiation Sterilization Validation as per ISO 11137 involves determining the appropriate sterilization dose for the medical device. The range of services offered by Charles River Singapore for Radiation Sterilization Validation include the following:
- Bioburden Validation
- 3-lot Bioburden Determination
- Dose Verification via Method 1 or VDmax
- Sterilization dose establishment
- Quarterly bioburden enumeration and dose audits.
Our ISO 11137 Certificate of Compliance effectively summarizes your quarterly Radiation Sterilization bioburden and dose verification data to support your audit programmes.
| Test Code | Description | Sample requirement |
| BIO-I | Bioburden Validation – Inoculation recovery method | Sterile samples |
| BIO-R | Bioburden Validation – Repetitive recovery method | Non-sterile samples |
| BIO-002 | Bioburden Validation | 3-lot analysis:30 non-sterile samples Quarterly bioburden audits:10 samples |
| STRD-002 | Method 1 dose audits | 100 sterile samples |
| STRD-002 | VDMax dose audits | 10 sterile samples |