: In order to stay within regulatory guidelines, what are some must-have technologies that a pharmaceutical company should implement to meet microbial monitoring requirements?
PB: There are certain technologies and methods for microbial monitoring which are very well-established. Testing should be done at regular intervals. Viable sampling, air and surface bacterial and fungi counts, is a must to observe general trending and determine if cleaning regiments are sufficient. Methods will vary depending on the areas of interest but examples include: air samples, fallout plates, contacts and swabs.
These tools are efficient and cost-effective, and will serve a pharmaceutical company well in meeting microbial monitoring requirements. Looking to the future, we are seeing increasing interest in rapid bioburden and sterility.
There are situations when clients will need to implement continuous monitoring process, for example manufacturers and when validating a clean room.
Many of our clients, looking to establish a more robust microbial monitoring program, are requesting that we add microbial identification to their testing package.
: If a pharmaceutical company is looking to upgrade its microbial monitoring and testing processes, are there some relatively easy, first steps to take? What do you recommend and why?
PB: Within regular sampling events, clients should consider getting more from their environmental monitoring samples. Characterization of the isolates is a start. Depending on how specific a client needs to be, biochemical testing and genetic ID work can be an important part of making sure their areas are clean and safe.
The type of organism identified might suggest the origin of contamination (human, water, process), the level of risk, and how a client may need to modify their cleaning protocol.
: Do you foresee pharmaceutical companies implementing the strict microbial monitoring strategies used for sterile product production on other types of products – such as solid dosage?
PB: We are seeing some clients in non-sterile environments stepping up their microbial monitoring strategies. Specifically, clients concerned about B. cepacia. They are adding HEPA curtains around their non-sterile rooms, either as a preventative measure or in response to FDA findings.
: What are some best practices a pharmaceutical company should put in place to collect, store and analyze microbial monitoring data?
PB: As an independent contract laboratory, our clients are interested in receiving the reports and raw data. In certain cases, SGS also provides trending reports for clients on request.
When clients provide us with specifications, our team can alert them to any OOS so they can take the appropriate action. Then SGS can retest once they’ve resampled.
: In the near future do you see pharmaceutical companies moving away from large cleanrooms to processing sterile products in isolators, gloveboxes or RABS? If so, why?
PB: We are not seeing a huge shift right now. There are certainly situations where clients have specific requests for isolators. However, there are situations where that’s not appropriate or possible, for example with medical devices – the samples are large and wouldn’t fit in an isolator, and must be tested in a cleanroom environment.