What’s the most common question leadership asks around microbiological testing in every industry, from drugs to household care products?
How about, “Is this the most accurate microbiological method we could use?”
Or maybe, “Is this method compliant with all applicable regulations?”
No.
The question is always: “Why does micro take so long, and how can we make it faster?”
The food industry has all but entirely switched to RMM. For many reasons that we won’t go into here, the market of non-sterile but low bioburden has been slower to make the transition to RMM. Those markets include many drugs, cosmetics, and household care products that we are addressing here.
The stark reality is that traditional, culture-based microbiological methods like those described in USP <60>/<61>/<62> require anywhere from 2-7 days of incubation. These incubation times are not arbitrary – they have been validated and are critical to providing confidence in the resulting data. In microbiology, we are dealing with living things – we need to give them time to acclimatize to their environment and grow sufficiently for us to (hopefully) be able to see them. So, while some companies have tried to simply shorten incubation times to achieve desired speed of data release, this approach is typically not well justified and is usually rejected by regulatory authorities like the FDA.
However, that doesn’t mean that we can’t find another way to get the results you need to support product release faster. We just need to use a different method. Many technology developers have come up with alternative, rapid microbiological methods (RMM) to do just that.
There are many options when it comes to RMM that are currently on the market. However, in general, they typically fall into two main categories:
- Quantitative Methods – tell us how many viable organisms are present
- Qualitative Methods – tell us whether any viable organisms are present above the Limit of Detection (LOD), but not how many
- Note: Of the Qualitative Methods marketed in the industry, some will say that they are “semi-quantitative”. There is a reasonable but nuanced discussion to that point that goes beyond the scope of this blog. Stay tuned for additional posts exploring this and other related points. Or in the meantime, please reach out to us if you’d like to discuss.
There are pros and cons to each category of RMM, and not all methods will be appropriate for every product. Additionally, there are many things to consider when exploring what rapid methods may be appropriate for you, including:
- What turnaround time would justify the investment in an RMM?
- How often do you tend to see microbiological recovery (whether within specification or not) in your products?
- What are your microbiological specifications (quantitative and qualitative)?
- Many rapid methods do not report Colony Forming Units (CFU). Are you ok with updating your specifications?
- What types of products do you make? A broad range? Would you be ok with having different methods for different product types?
The list goes on.
The good news is that there is almost certainly at least one RMM that is appropriate for your product. Even better news – Q Labs offers a wide range of rapid methods. We also have extensive experience helping companies find a rapid method that is not just scientifically defensible, with a validation package ready to be subject to regulatory scrutiny, but also finding one that truly fits their business needs. We are also happy to partner with you to discuss best practices for implementing a rapid method into your company (e.g., updating procedures and specifications, training of Quality and Operational personnel, etc.).
We are excited to discuss how an RMM can help you bring products to the market faster and better than ever before!
