: In order to stay within regulatory guidelines, what are some must-have technologies that a pharmaceutical company should implement to meet microbial monitoring requirements?
CB: A robust environmental monitoring program is essential in demonstrating that your aseptic processes are in control. Even though it has been around for decades, active air sampling remains one of the best tools for EM. However in order for air samplers to generate the best data, they need to be in calibration. Is calibrating once or twice a year enough? Having the ability to calibrate your fleet of air samplers on a routine basis is the best way to show regulatory inspectors that your data is the best that can be. Also, incorporating integrated active air samplers into isolators is a must-have. These systems are calibrated in place and can be automatically decontaminated. Lastly media plates are now packaged in gamma irradiated beta bags for isolator applications in which plates are brought in only when you need them.
: 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?
CB: Microbial testing can be very labor intensive and there have been some changes to existing product platforms to improve workflow. For example, the latest upgrade to our Milliflex bioburden testing platform includes hardware that doesn’t require autoclaving and very easy no membrane handling directly to the media plate. When there are improvements to workflow, the risk of both false positives and false negatives is reduced.
: 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?
CB: Non-sterile products that contain a high percentage of water pose a significant risk of gram-negative bacterial contamination; thus, this will continue to be a regulatory focus and will require strict microbial monitoring.
: What are some best practices a pharmaceutical company should put in place to collect, store and analyze microbial monitoring data?
CB: Many companies have implemented LIMS and electronic notebooks into their facilities. Regulatory inspectors are trained and now expect to see these systems. If you do not have a LIMS, you should be planning to have one very soon. Inspections are so much more efficient if data is easily accessed.
: 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?
CB: FDA has stated several times that all new aseptic processing lines should be in an isolator or RABS. If you construct a conventional clean room instead, your facility will be scrutinized on every inspection.