“Last month, I attended my first PDA Northern CA Chapter meeting for a presentation on Contamination Control Basics. My Delta PM lead recommended it since my current project is supporting Environmental Monitoring for a local company.
The Wells Fargo's Market Street venue was excellent along with the good food (make-your-own tacos), beer, and great turnout of at least 50-60 people. Overall, this event was a great time to meet other industry professionals and learn something new.
Ziva Abraham, President and Founder of Microrite, Inc and a California-based technical consultant, presented at the event. She is a witty speaker, has a diverse set of experiences, and clearly knows her business. She began by stating that "Contamination Control is not a Paper Exercise." It has to be an organizational mindset. All the risk assessments in the world won't help if they are not based on data, facts, and good observations. As with any technical project, you have to Get Out, Look, and See what is going on. (Just like a validation project!)
Watch people gown, inspect the facility, and understand your EM sampling & data.
Ziva cautioned us about a common drawback — gowning selected by purchasing and not necessarily by microbiologists. A gown supplier audit should be standard practice. When you gown, check for tears, holes, and bad seams. Learn and follow the procedure carefully, and maintain good gown and glove integrity in the suite. Remember that any organism is an Objectionable Organism!
Like me, you may have used a lot of dry ice/WFI vapor for air-flow visualization. While dry ice may have its place, you must use a buoyant fog or smoke for good visualization. You can learn a lot from good smoke studies, so pay close attention to them and don't assume that all will pass.
Finally, EM and Sterility Assurance need to pay close attention to all isolated organisms. New, seriously problematic bugs come along all the time. Both aerobes and anaerobes are problems, and EM techniques must be robust for both types of organisms. For a robust program, make sure any simulated studies (e.g. plate exposure times) are conducted under truly representative conditions.
A big thank you to Ziva, PDA, and all the sponsors for a great session and event!”
- Lee Anderson, Sr. Quality Engineer at Delta PM