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Adding preservative to pseudomonas + product
Another manufacturer friend of mine asked me if adding additional preservative to a cream that has tested positive for Pseudomonas would do any good? Does anyone know?
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14 Replies
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Pseudo Monas have come to party, have they?
*gives you a funny look * -
Apparently they have. I told him to check his water supply, change hoses etc but he was wondering if there is a way to save the batch of product by adding more preservative. I tend to think not but that is not based on anything, just my thoughts.
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Pseudomonas: “Infections range from mild external ones (affecting the ear or hair follicles) to serious internal infections (affecting the lungs, bloodstream …”
The batch should be junked immediately. That’s my opinion. -
1. Verdict from a legal standpoint = Unknown
2. Ethical standpoint = gray zone. Pathogenicity unknown.
3. Loss $$ to him if he dumps it.a. What is the preservative system?
b. Had that been tested prior by whomever ordered the batch?
c. If it comes back a fail for that organism…could be due to preservative fail prior to the order, not a colony partying in the machines.I’d dump it. And find the source, and if fault lies with the preservation system, the cost goes to the buyer.
Them Psuedo Monas are a wiley bunch!
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I think the thing that he should be concerned about in the first place is that his preservative did not resolve the issue on its own. Regardless of where in his process the contamination occurred, if he were using the proper preservative to begin with, batch would not have tested positive.
Interesting that dumping the batch is even a question.
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Regardless of where in his process the contamination occurred, if he were using the proper preservative to begin with, batch would not have tested positive.
Irrelevant. It Did test positive.
So, the solution, in your opinion is what?
#1. Toss more preservative at the batch and hope it solves the problem?
or
#2. ….? -
All Academics aside, the proper answer is to discard the batch;
1. Should he add more preservative, there is a chance that he could be exceeding the Regulatory limits for that particular preservative.
2. This is inferring that the preservative possesses a disinfectant property, I am sure that a Micro expert can weigh-in, but I believe this is an erroneous assumption.
3. Lastly and most important. If you are properly documenting your batch records, you would have to document the out-of-standards results for micro. Should your last ditch remedy of simply retreating does not work (say it exceeds standards once it is with the consumer), the FDA would see that you violated good practices. Under credible cGMP standards, tossing the batch is the most conservative and safest approach. -
You’re missing the point … The preservative failed. Without knowing if the manufacturer did a PCT on this formulation, you don’t know the cause of the failure. Perhaps the issue is adding more of the same preservative, perhaps the issue is that this particular preservative does not work in this formulation, perhaps the overall preservation strategy for this formulation is ineffective and needs to be thought through again.
There are various factors that need to be considered. The first approach would be to completely sterilize all equipment and run a batch of another formulation and see if it is a process source of contamination or if the contamination is specific to this particular formulation.
The batch failed the test. Tossing the batch is the only option.
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Just think about how this plays out in a courtroom if someone sues. What will the plaintiff’s lawyer ask you and how will you defend yourself?
Potential risk = very high -
Is there a chance to know what preservative was it? For the sake of learning experience, it would be nice to understand if it had bacteriostatic or bacteriocidal properties with regards to the bug.
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if the batch is truly irreplaceable, it could be sterilised by irradiaton
how the price of irradiation weighs up against the cost of disposing of the batch altogether and starting again, I don’t know
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Ok we are chemists but who wants to sell a cream that has failed QC, then irradiated or post-preserved? At least I wouldn’t.
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Anything short of discarding the batch is taking a very high risk. What I would be really, really worried about is this … If this batch failed and I have some sort of systemic source of contamination, will this happen to subsequent batches of other products and I end up having to discard lots of batches.
I would expeditiously try to sort out if this is a preservative failure in one product or do I have a much bigger problem.
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This was a batch that was made by another manufacturer and sent to him in bulk for filling into tubes. We would assume the original manufacturer tested the product but who knows. I did suggest the best action is to tell the customer to dump it but he had asked if adding more preservative would do anything. So, I asked. It’s out of my hands.
Thank you all for weighing in on this. Oh, and I don’t know what preservative was used or anything else in the product.
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