Designing Environmental Monitoring Programs for Non-Sterile Manufacturing
image via Pharmaceutical International
Non-Sterile environments present a completely different set of issues to monitor compared to the average sterile environment. This is commonly found in Oral Solid Dosage (OSD) form facilities. These facilities require monitoring equipment and high room cleaning standards to prevent microbial problems. Not only do personnel pose a contamination potential but the materials being used also pose a threat.
Nancy Tomoney will be presenting a case study on this issue at INTERPHEX as a part of the specialty forums. Her skills as Senior Validation Manager at West-Ward Pharmaceuticals have led her to her conclusions on non-sterile environment control. This program will greatly benefit those who work within OSD manufacturing. Attendees can expect to gain an understanding of the differences in the monitoring programs for sterile and non-sterile environments, as well as how to effectively evaluate bioburden data for cleaning, sanitation and monitoring, and how to effectively use sun static and dynamic HVAC PQs in an oral solids manufacturing facility.
View this presentation on Wednesday, March 19th at 10 am.
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