Pharma product sterility assurance: Making it easier to get to market

The quality and accreditation of culture media have a direct impact on the results and overall costs involved in operating a pharmaceutical microbiological quality control (QC) laboratory.

In this on-demand webinar, we're joined by Alycia Jayroe, Senior Manager of Quality, Microbiology, at Thermo Fisher Scientific, who shares how you can accelerate product release-to-market time, lower overhead costs and secure organizational revenue goals while meeting USP/EP/JP regulations with Thermo Fisher Scientific microbiology testing products. Get a closer look at how these products are improving laboratory workflows while meeting important regulations. Plus, Stephanie Spears, Global Brand Manager, Thermo Fisher Scientific, joins the Q&A session to share how to partner with Thermo Fisher Scientific for your culture media sterility and validation needs.

Read on for highlights from the live Q&A session or register to watch the webinar at a time that suits you.

Q: How do you mitigate the risk of sterility in a case of media fill failure?

SS: The way to mitigate the risk of sterility in the case of a media fill failure is a clear investigation procedure, which will speak to your in-house corrective actions. Once you have completed and made sure that standard operating procedure is according to the guidelines, then you have to follow all of the different investigative steps with your environmental monitoring.

You need to verify that what you may have seen in your media fill is not something that would either grow in your product or have the capability of getting past all of your cleaning validations, your testing process verifies that your facility is clean. With that investigation, you can justify a satisfactory sterility test of your product when you have a failed media fill.

Q: Which important factors should be taken into consideration for the investigation of sterility failure?

SS: The important factors are your cleaning validations, your product suitability testing, your ability to verify that your processes have their controls and that you have routine monitoring and sampling that indicate you're in control.

If you do have a sterility failure of your product, there are guidelines that allow you to retest with that investigation, but those are very stringent. Generally, if you have a sterility failure, it's going to be very difficult to justify the release of that product. That's why sterilities are so critical.

Q: Working as a QA in a reputed industry, what is the minimum years of experience required?

AJ: For a quality assurance position in this industry, you will typically need to have a four-year degree, a bachelor's degree or equivalent, and experience in the field over time. There are a few specific programs at universities, however, a lot of this content is learned through experience. For example, the Parenteral Drug Association has a good program for students to start getting involved while they're at a university and begin to learn specifics about the industry.

Q: What media did you use for yeast and mold sampling, TSA, SabDex, or another approved media, and why did you choose that media?

SS: You want to follow your regulatory guidelines. Depending on the way you're going to incubate your product and the way you're going to sample, you can use either one. Preferably SabDex as it’s in the regulations, but TSA can be used.

Generally, yeast and mold monitoring is not done as frequently as your standard monitoring, but when it's done, you need to verify that you can get the yeast and mold from your environment. Sometimes there's even an environmental isolate that you have gotten from your environment; if you've challenged those media and you indicate that either one works sufficiently, then you can use either.

AJ: I think that that's the key that you would need to qualify that. If you are not using SabDex Agar for yeast and mold, you would need to qualify and show that your TSA is able to recover those and just make sure that you have the documentation on file in case you're audited.

Q: How often should a media fill be performed?

AJ: For media fills, at least an annual requalification is required. This is assuming that there have not been any significant changes. If there are significant changes to your process, you will need to re-execute a media fill. The FDA Aseptic Guidance is a very good document for providing specifics on how to approach performing a media fill and what those requirements are.

Q: What constitutes a good investigation for sterility failure?

AJ: Just making sure that all aspects are considered. Sometimes it's easy to think there could be an issue in the laboratory, but there are a lot of risks in manufacturing as well. So, making sure that all aspects are evaluated, and especially having a focus on any risk-mitigating factors that are in place.

Q: What products do you have available for media fills?

SS: We have a Veggie Peptone and we sell that at Thermo Fisher Scientific. Thermo Scientific is the brand, we sell both BTSB and the Veggie Peptone because several organizations cannot have animal-containing products in their facility or in their equipment or kettles. We sell both of those in 1-liter, 10-liter, and 20-liter bags as well as those powders if they're going to make it in-house.

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