Location: Las Vegas, Nevada
ISPE Annual Meeting & Expo
October 27 - 30, 2019
Our STERIS team is excited to attend the ISPE Annual Meeting & Expo in Las Vegas! With technical sessions, education tracks, and exhibiting - this meeting and expo has it all. Stop by booth 414 to chat with our experts about pharma manufacturing and contamination control questions.
Day 2 | October 28
10:00 -11:00 - Poster Presentation in Milan Foyer
How a Contamination Control Program Impacts Product Sterility
Presented by: Aaron Mertens, Technical Services Manager
Maintaining microbial control in the pharmaceutical, medical device and biotech cleanroom environment is not only a regulatory requirement and expectation, but is absolutely critical to prevent contamination of the finished product. An effective cleaning and disinfection program alone is not sufficient to ensure product sterility. Adding layers of protection throughout the manufacturing process greatly reduces risk to the final product. However, in order to maximize efficiencies in production, organizations must streamline pre and post sterilization cycle productivity while minimizing risk to the finished product.
Selecting the most effective decontamination products against environmental isolates, rotating these products, and maintaining surfaces free from residue build-up are essential pieces of a contamination control program. Case study examples demonstrate how adding protection over critical surfaces greatly improves product sterility assurance.
Day 3 | October 29
10:00 - 11:00 - Poster Presentation in Milan Foyer
Bridging the Gap Between Rinse Water Analysis and Surface Cleanliness
Presented by: Elizabeth Rivera, Technical Services Manager
Regulated companies which use automated cleaning applications have always struggled with demonstrating final rinse water quality or visually clean to surface cleanliness. The justification typically involves 100% spray coverage testing, rinse recovery testing, specific and non-specific analytical method qualification, surface sampling and recovery testing of the sampling technique, and visual inspection testing performed during the cleaning validation. Each element needs to be reviewed and evaluated during the cleaning process design stage. A risk-based approach, supplemented with laboratory studies and information from published literature can be leveraged to reduce testing during cleaning qualification and continuous verification without impacting quality. Laboratory results from total organic carbon (TOC) and conductivity rinse water recovery for an alkaline detergent as well as determining visible residue limits using multiple concentrations, light intensity, viewing angles, inspectors and distances were used by multiple biopharmaceutical companies in additional to existing technical literature to help bridge the gap between final rinse water quality to surface cleanliness.