Production Line Pump Cleaning Validation Method Question

PeterLe

Involved In Discussions
Hello everyone!

I'd like to get some feedback on cleaning validation protocol and one of the reviewers has some concerns. FYI, this a retrospective validation and was identified as a gap in our system.

Just to give a background: In our production line, we have diluent solution running through a pump. The current cleaning method is to flush the pump with solution X. Then flush the pump with water. Then flush the pump with diluent solution. Once a month we send out samples to an outside lab to test the diluent solution to see if it is "dirty."

The strategy to validate the cleaning method is as follows:

1) Do a production run and collect samples of diluent. Send those samples to the outside lab to test. The hope here is the test results show that the diluent samples are Clean.

2) Introduce bacteria into the system (We feel this is the worse case scenario). Do a production run and collect samples of diluent. Send those samples to the outside lab to test. The hope here is that the test results show that the diluent samples are "Dirty."

3) With the bacteria present in the pump, clean the pump with the method described above.

4) Do another production run and collect samples of diluent and send out to outside lab. The hope here is the test results will show the diluent samples as Clean and hence the cleaning method will be validated.

One of the reviewers concern is that this does not replicate what can potentially happen during manufacturing. They stated that they seen in one occasion in the past that bacteria incubated inside the pump and hence caused bad test results. The current validation strategy of the cleaning method does not address that and hence the strategy will not tell us anything.

My thoughts:
I feel like the validation strategy is pretty sound. We are purposely introducing bacteria into the system which in our opinion is the worst case. One way to address some of the reviewers concerns is to let the bacteria sit inside the pump for a certain amount of time (24 hours, 48 hours, etc). We did discuss that idea with the reviewer but they still stated current strategy to validate the cleaning method is not sound.

Am I missing something here? I would love to hear others thoughts on this matter. Thank you so much in advance! I appreciate the feedback!
 
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