8 replies to this topic

[PrplomSolved]

I currently ran into an issue where in a formulation trial I had 1 of 4 products fail an already validated hold time. The issue I am having is that the product was extremely near a 5 log reduction, but simply did not meet. Additionally, it was only one lot of the same formulation that went rogue (ran in duplo). 

 

It would appear that it was a formulation issue (products have yet to hit market, still hand preparing product) imho. What would be the proper decision on moving forward? Would you re-test?

Customer has put an extremely tight time constraint on this as well but we all know you can't rush good science...

Edited by PrplomSolved, 18 September 2023 - 07:27 PM.

[Scampi]

Re-test because people's lives depend on it

 

Essentially, you had a fail rate of 25%--------imagine if that was the failure rate of brakes?

 

Since you've said that this product has not been batched up, odds are this was human error which is better caught now than after scale up

[G M]

You mention that the unacceptable one was just under your 5-log reduction target, how much did the good one pass by?  

[PrplomSolved]

You mention that the unacceptable one was just under your 5-log reduction target, how much did the good one pass by?  

 

Out of the other 3, 1 was relatively close to 5.5-log, the other 2 were closer to a 5.8-log reduction. 

[PrplomSolved]

Re-test because people's lives depend on it

 

Essentially, you had a fail rate of 25%--------imagine if that was the failure rate of brakes?

 

Since you've said that this product has not been batched up, odds are this was human error which is better caught now than after scale up

 

 

So the product that failed is one of the first formulations this company had testing completed on, which led to much better results. This is where I am at a loss because it SHOULD have passed. Absolutely agree, I think re-testing would be their best option but getting a customer on board with that is much harder in practice xD

[Scampi]

Explain what a recall or withdrawal costs-------they might then be on board

 

You're absolutely sure everything was identical? same jar manufacturer, same lids same exact recipe?? Same fill temp etc etc etc

[PrplomSolved]

Explain what a recall or withdrawal costs-------they might then be on board

 

You're absolutely sure everything was identical? same jar manufacturer, same lids same exact recipe?? Same fill temp etc etc etc

 

Although I was not on-site for them to make the batches I am confident the consumables they used for packaging were the same. The only possible thing I could have seen happening is that one batch was prepared slightly different. 

[Charles.C]

It may also relate to the degree of accuracy in the measurement of "log reduction".

[AndrewTG]

If the product has failed to meet the critical limit of the control, I agree that retesting would be the best option with the batch preparation being absolutely water tight. 

 

One other comment, presumably the validation is taking account of all the worst case conditions that come about due to process variations? It seems that this process is pretty sensitive to variation.

 

The previous commentors point about accuracy of the measurement method is also pertinent, depending on what the method is, which hasn't been specified. If it's based on temperature measurement then I would be more confident than, for example, a microbiological surrogate method.