Location: Philadelphia, PA

This November we are attending the ISPE Annual Meeting & Expo! We’ll be joining the conversation on critical topics affecting the pharma industry today. Additionally, educational sessions will include supply chain, information systems, product development & production systems, facilities & equipment and cutting-edge innovations. 

Be sure to visit us at Booths 1035 & 1037 and check-out the poster displays by our team members in the Expo Hall on Day 2 and Day 3! 

Day 2 - Monday, November 5th
10:00am-4:00pm Professional Poster Display in the Expo Hall 

Key Elements for Sustainable Cleaning Processes in the GMP Industry
Elizabeth Rivera, Technical Services Manager

Cleaning procedures are required in cGMP industries for maintaining safe and optimally performing manufacturing equipment and facilities.  The use of cleaning products to effectively remove process residues, dust, allergens, and infectious agents may be crucial to prevent product contamination that could adversely affect patient safety.  But the use of cleaning products may also present health and environmental hazardous, containing ingredients that must undergo significant treatments (e.g. pH adjustment) before they can be safely discharged.  Since the use of some products creates potential handling, storage, and disposal issues for users, these use factors and increasingly becoming components of the selection criteria when new or current cleaning processes are being developed. 

This poster addresses common issues regarding cleaning products and cleaning processes used by GMP industry users, and focuses on the critical elements in the selection of cleaning chemistries to ease major environmental and health concerns.  The focus is given to relevant issues in minimizing pollution, reducing waste, managing personnel hazards, and complying with local regulations.

Day 3 - November 6th 
10:00am-4:00pm Professional Poster Display in the Expo Hall

Evaluating surface cleanliness using a risk-based approach
Paul Lopolito, Technical Services Senior Manager

Regulated companies that use automated cleaning applications have always struggled with correlating rinse sample quality or visual inspection to surface cleanliness. The process typically involves performing 100% spray coverage testing, rinse recovery testing, specific or non-specific analytical method qualification, surface sampling and recovery testing of the sampling technique, and visual inspection performed during the cleaning validation. Each element of the justification needs to be reviewed and evaluated during the cleaning process design stage to defend a lean approach in continuously monitoring the cleaning process. A risk-based approach, supplemented with laboratory studies and information from published literature can be leveraged in the justification to reduce testing during cleaning qualification and continuous monitoring stages without impacting quality. Laboratory results from total organic carbon (TOC) and conductivity rinse sample for an alkaline detergent along with determining visible residue limits using multiple concentrations, light intensity, viewing angles, inspectors, and distances have been used by multiple biopharmaceutical companies. This approach has helped correlate rinse sample quality or visual inspection and justify a lean approach to continuously monitoring surface cleanliness.
Cleanroom Contamination Control: Disinfection Best Practices and Pre-sterilized Tools
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 risks to critical surfaces and the final product. Using this pre-sterilized cleanroom tools greatly reduces the risk of contamination to the cleanroom environment and critical surfaces.  These tools are sterilized using validated ethylene oxide and gamma irradiation processes, minimizing the possibility of microorganism contamination upon introduction of these materials into the cleanroom.

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