Jake_Jasuke
Registered
Hello everyone,
Initially, I have completed Process Qualification (PQ) for the sterilization process using the previous EO gas supplier, which covered two batches:
Batch A: plastic + fabric products, with a sterilization duration of 240 minutes
Batch B: fabric products, with a sterilization duration of 180 minutes
Currently, there is a plan to change the EO gas supplier, while maintaining the same gas concentration and without any changes to other process parameters. Therefore, my intention is to conduct requalification only for Batch A.
If the requalification results for Batch A demonstrate that the process remains effective and compliant, would it be acceptable from a regulatory and scientific perspective to apply the new EO gas supplier to routine processing of Batch B without performing a separate requalification for Batch B?
Initially, I have completed Process Qualification (PQ) for the sterilization process using the previous EO gas supplier, which covered two batches:
Batch A: plastic + fabric products, with a sterilization duration of 240 minutes
Batch B: fabric products, with a sterilization duration of 180 minutes
Currently, there is a plan to change the EO gas supplier, while maintaining the same gas concentration and without any changes to other process parameters. Therefore, my intention is to conduct requalification only for Batch A.
If the requalification results for Batch A demonstrate that the process remains effective and compliant, would it be acceptable from a regulatory and scientific perspective to apply the new EO gas supplier to routine processing of Batch B without performing a separate requalification for Batch B?
