Clean Facility Roundtable Part 2: Upgrading Microbial Monitoring

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.

If a pharmaceutical company is looking to upgrade its microbial monitoring and testing processes the first thing they should do is move to an automated alert system. Too many facilities receive 483s because they didn’t act on results that exceeded their own action and alert specifications. Companies can automate the review of their data by installing an environmental monitoring software package to facilitate rapid and frequent review. Inclusion of automated microbial detection systems and direct communication to the software facilitates better data security as well as better control.

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.

Regular reviews of SOPs related to microbial monitoring should be performed and revised as necessary based on trends and internal audits to assess risk. It is also important to visit the production floor on a regular basis to uncover any changes that have been implemented through discussions with production managers to ensure no changes are missed by the EM team. (For example: new people in the production facility including cleaning personnel, change in suppliers for gloves, HEPA filters, gowning, raw materials.)