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Manuf. QC microbial hit…how to salvage the batch
So it’s an anhydrous powder product with 0 water activity and I manufactured a large batch of product only to get a microbial hit during manufacturing QC…after the whole production run was completed. Pretty sure my raw material was contaminated..and it was sourced from a “reputable supplier” too so I am extra upset.
How do I salvage these 3,000 units? Can I send them off for gamma radiation? If so, what does the turnaround time on that usually look like?
Any help is greatly appreciated…kicking myself in the leg for working with this factory. They never asked me for any COA or SDS, and I didn’t have the experience to know that I needed to get the COA from supplier prior to production.
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2 Replies
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I am very sorry, you do not salvage the batch. If it failed to meet (micro) spec., it is adulterated. You could do an investigation to determine if somehow the micro hit is not legit. Failing that there is nothing you can do.
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Unfortunately, you will have to discard the entire batch. There is no magic bullet.
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