Rapid microbial methods (RMM) have become a prevalent topic in microbiology quality control (QC)—particularly among QC labs with lean or paperless initiatives. However, RMM is not necessarily a one-size-fits-all proposition for every facility or process. Furthermore, in highly regulated industries such as pharmaceutical manufacturing, it can be difficult to sway the industry away from the tried and true traditional method.
Rapid Micro Biosystems recently had the opportunity to speak with Dr. Tim Sandle, head of microbiology at Bio Products Laboratory, regarding his perspective on RMM and the pharmaceutical manufacturing industry in general.
Q: What is your take on RMM and what advantages do you think it has for QC labs?
Dr. Sandle: I think rapid methods are the future. I think the rate of implementation has been slower than, perhaps people saw five or 10 years ago. But I think it’s a conservative industry. However, rapid methods offer the advantage of time to result, which is increasingly important with modern manufacturing. Also with automation, rapid methods take out a degree of subjectivity in interpreting results, and also help avoid error in preparing samples.
Q: Why do you think the adoption of RMM is slower than people saw a few years back?
Dr. Sandle: I think one of the problems is some pharmaceutical peers list standard methods, which require validation because they are standard methods. Now, in recent years, both the European and the United States pharmaceutical peer chapters have said rapid methods can be used in lieu of the standard methods; however, they need to be validated. Then you have a group of people who say, "Well, timed results are only mildly important to us, so it's easier for us not to change methods.” That's one reason.
Then sometimes there are confused messages from regulatory authorities. Some support rapid methods, some don't. But that is changing and we are seeing greater support. Then, there is a naturally conservative industry where a rapid method will be shown to one company and their first question will be, "Who else is using this?" If a big pharmaceutical company is using it, then others might use it. But if no one else is using it, some may not want to be the first to adopt the technology.
Then there are the long lead times in terms of method validation. There are a lot of parameters and variables to cover.
Q: What do you think are some of the industry’s hot topics right now?
Dr. Sandle: The biggest thing at the moment is risk assessment—the move to building in quality by design. The need to build in as much real-time testing as possible is increasingly important. Tracking the quality through the process and taking readings and things whilst products are being manufactured, rather than waiting for the final result is important—particularly with something like a sterility test, which I think is the rapid method everyone wants to champion. Many want to be the first to get it into the market. With the compendial method, it takes 14 days to get sterility test results. With an RMM, the time to result is much quicker.
So if something goes wrong with the test, not only do you have to go through the process again, but it might take a week or so to fill it then run the sterility test. At this point, with the traditional method, three to four weeks may have gone by before anyone realizes there's a contamination. That's why there's a thrust to building quality into the process itself.
Q: You frequently publisher in your industry. Aside from the subjects you research, are there topics you find interesting as a thought leader in your industry?
Dr. Sandle: Aside from rapid methods, I think the trend at the moment is about non-sterile products and which microorganisms may or may not cause patient harm. There's a big debate around things that come under the label of objectionable microorganisms, and what is and what isn't objectionable.
There's also a lot of interest in fungal contamination, which has been neglected in relation to bacteria. However, it might be causing more patient risk than has previously been thought.
To learn more about the benefits of automated rapid detection and enumeration Dr. Sandle mentioned, download this free guide.