ISO 11137 Gamma sterilization validation, dose setting, dose audit

[rmyjq]

ISO 11137 Gamma sterilization validation, dose setting, dose audit:
1. Section 7.2, Dose setting Method 1, bioburden no less than 1.0, multiple production batch
2. Section 9.2, Dose setting Method VDmax25 for multiple production batches
3. Section 10.2, Dose auditing, Method 1
4. Section 10.3, Dose auditing, Method VDmax25
Use flow chart to easy understand.

 

[humoor]

Hello Guys,
I will appreciate if you can provide me with SOP for gamma sterilization validation and monitoring. we are using VDMAX 25.
Thanks

 

[humoor]

ISO 11137 Gamma sterilization validation, dose setting, dose audit:
1. Section 7.2, Dose setting Method 1, bioburden no less than 1.0, multiple production batch
2. Section 9.2, Dose setting Method VDmax25 for multiple production batches
3. Section 10.2, Dose auditing, Method 1
4. Section 10.3, Dose auditing, Method VDmax25
Use flow chart to easy understand.

Thank you, Just saw it