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Solutions for addressing fungal and bacterial spore contamination in pharmaceutical and biotech operations

The workshop will cover the most common causes of contamination: operators, items brought into the cleanroom, and degradation of the cleanroom over time. Case studies in operator borne contamination will be discussed as well as preventative long term solutions. Specific examples of aerobic and anaerobic vegetative bacteria will be highlighted and analyzed. Items brought into cleanrooms that can harbor fungal and bacterial spores will be discussed as well as specific case studies highlighting examples where sources were items brought into the cleanroom or in some cases other common causes. Fungal and bacterial spore structures as well as efficacy testing and specific test conditions will be briefly discussed. Solutions will be presented to prevent efficacy testing failures due to test method, recovery, and coupon porosity issues. Targeted long term solutions will be discussed regarding the spore case studies in a concerted effort to limit reoccurrences. The overall objective and scope of this seminar will be to discuss specifi c cases studies that have occurred in my years of experience in the industry. Specific and precision long term solutions will be conveyed to prevent reoccurrences and yield higher levels of control in the cleanroom operations.

Veranstaltungsort: Holiday Inn Kensington Forum
Sprache: Englisch
Veranstalter: SMi Group
  • Degradation
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