Contamination Response Investigation
Boston Analytical has the capability to provide expert root-cause analysis and onsite consultation in the unfortunate event of cleanroom, process, or water system contamination. With extensive experience in pharmaceutical manufacturing and process line improvements, our Microbiology group can provide the expertise to identify the cause or source of contamination and provide the necessary knowledge to mitigate your situation. We have worked with clients to respond to biofilm formations, disinfectant neutralization and efficacy validation, cleanroom validation, and water system specification failures.
Root Cause Analysis
Through a combination of remote meetings and onsite consultation and sample collection, Boston Analytical’s microbiologists will work to identify the root cause of a contamination or specification failure event. Once this cause is assessed, we will determine the most direct and effective approach to mitigate the event while accounting for the unique combination of variables within your process and facility. A comprehensive and concrete test plan will be determined based on your needs and the potential root causes. The goal of Boston Analytical’s Contamination Investigation program is to quickly ascertain the absolute source of the microbial contamination and work with your team to develop a path forward.
Sample Collection and Testing
Qualified and trained Boston Analytical personnel will collect onsite samples as part of the contamination investigation including:
- Water Bioburden
- Swab Bioburden
- Air Samples (Both Viable and Non-Viable)
- Surface Viable
Once collected, the samples are brought back to our laboratory and analyzed according to regulatory and client protocols to promptly determine the source of the contamination. As part of the overall contamination response event, Boston Analytical will provide a comprehensive report and, when requested, a contamination control plan for future operations.