Contamination Control

Posted on July 30, 2020 by P Yeatman

Having worked in sterile production environments where contamination control was vital, there were zero exceptions to following the established procedures. Exceptions would invariably lead to unacceptable outcomes. With regards to lock-down and quarantine in relation to SARS-COV-2, there are many exceptions and deviations from the requirements. That will only lead to….you guessed it, an unacceptable outcome. With this in mind, I present to you a brief article on contamination control in sterile production environments. Continue reading →

Questions About What To Do With Lids When Air Sampling

Posted on July 19, 2020 by P Yeatman

The Question posed directly:

“Hi. I have a cleanroom question. When collecting an air sample with an air sampler device can you put the impactor head down when changing the plate. Can you put the lid of the plate down when you change the plate. What do you do with the two lids when changing the plate as I thought you could not put them down.

Thanks“

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Questions on Depyrogenation and Viable Environmental Monitoring

Posted on July 3, 2020 by P Yeatman

The Question posed on LinkedIn:

“Hi all, I need your support to find the answers of the following questions:
1. Using manual cleaning of glass vial before sterilization in dry oven in aseptic process for lyophilized product which means no depyrogenation , is it acceptable? and if yes, what is the requirement that should be provided to the inspector as evidence of no contamination (as documents / studies/ gown).
2. Is it mandatory to conduct viable and non-viable monitoring in the ascetic process during the capping and crimping?
Thanks in advance…“

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Question on Microbiological Testing of Finished Goods

Posted on June 7, 2020 by P Yeatman

The Question posed on LinkedIn:

“I have a question on microbiological testing of finished goods. We normally do TCP and Yest and Mold, however some customers are saying that pathogenic bacteria test is required after an enrichment is done. Is this really necessary if the PET passes and the TCP and Yest and Mold are less than 10 cfu?”

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About 20% of (FDA) Recalls are Due to Microbial Contamination.

Posted on March 4, 2020 by P Yeatman

As of March 4 2020, 16 of the last 50 recalls by the FDA for pharmaceutical products were due to microbial contamination or a lack of sterility assurance. Another 27 were due to impurities with 5 more due to mislabeling. Looking at TGA recalls for 2019, around half of the medicine recalls due to contamination were the result of microbial contamination. Continue reading →