Dear all. Any one tell me how i reduce CIP time for ophthalmic filling Operation. If i minimize one cycle or stirring time in vessel its applicable to GMP.
Please clarify your question more precisely. What do you mean by “CIP time”. Is it referred to as “Clean In Place” of ophthalmic filling machine which is cleaning related? If it is yes, then you will have to perform Cleaning validation of revised cleaning procedure / minimizing stirring time or one cycle.
For any change in the system or procedure, you will have to go through Change Control, Risk Assessment, and re-validation of that process /operation. Only upon getting a satisfactory outcome, you can proceed with the implementation of that change for routine use.
Thank you sir for reply. CIP or Clean in place for ophthalmic manufacturing to filling area. Sir I’m sharing a cycle of CIP. At first we take WFI in manufacturing vessel then purging nitrogen a fixed time then stirring a fixed, some WFI take out by sampling port, some WFI drainage then remaining water transfer to storage vessel,after receive WFI in storage vessel then it drainage and again take WFI in storage vessel then transfer it to buffer tank, a fixed time stirring in buffer tank then drainage WFI. Its total Process for a CIP cycle. We do this work 6 times and take 50-58 minute for a cycle if it become 200 L vessel. I have curiosity to know why we do this work 6times if we reduce any cycle or minimize any step It’s go against GMP.
Yes, you may reduce the cycle time or the number of repeat cycles of CIP of ophthalmic mfg. equipment and filling machine. You must do cleaning validation to demonstrate that the revised cleaning procedure is equally effective to clean the equipment to get less than acceptable levels of residues of the previous product.