Microbiologists working in pharma cleanrooms may be horrified picturing this environment. Every product must be contaminated!
This set up is very normal for non-sterile consumer goods. It’s important to note - we did bioburden testing on three samples from every lot made in this warehouse. Our recovery rate - the percent of samples with any micro recovery at all – was less than 2%. That stat includes:
Microbes getting into the product from this open environment was extremely rare. (atleast, microbes that we were able to recover during testing). This knowledge heavily influenced my micro contamination investigations when I returned to pharma manufacturing. Investigators rushing to close their investigation record were quick to blame micro excursions on (heavily gowned) personnel in the area or imperfect cleaning around the time the sample was collected. My time at the soap warehouse taught me those factors aren’t as likely to contribute to an excursion as most microbiologists think. As an extra note- I was proud of the quality assurance at this soap factory. I was especially proud when we made the conservative decision to reject the lot associated with this P.glucanolyticus organism. It was an expensive decision to make. To show my pride, the soap we made was my christmas gift to my extended family the year I worked there. I gave the same gift in the wake of Covid in 2020. We were a contract manufacturer and didn’t own the products we made, so I had to pay full price for all of this. Let's get you back to the original post.
0 Comments
Leave a Reply. |