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Environmental Monitoring | Alachua
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9/16/2016
When: 09/16/2016
8:30 AM - 12:30 PM
Where: Biotility at UF’s Center of Excellence for Regenerative Health Biotechnology
13706 Innovation Drive
Alachua, Florida  32615
United States
Contact: Tamara Mandell

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Please visit http://biotility.research.ufl.edu/biotility-calendar for more information.

 

Environmental monitoring of cleanrooms and adjacent areas is an extremely critical component of a pharmaceutical manufacturing facility’s contamination control strategy and mandated by law.  (Bio)pharmaceutical drugs must be free from contamination by adventitious agents such as bacteria, fungi, mycoplasma and viruses to ensure not only consumer safety but also good business.  Consequences of contamination may be grave and include patient fatalities and murder charges against manufacturers.  This was exemplified by the 2014 indictment of 14 New England Compounding Center (NECC) owners and employees who sold unsterile drugs that infected hundreds of patients with fungal meningitis.  The indictment included 25 murder charges against two lead pharmacists.  Less serious repercussions of contamination may involve lengthy investigations, shut-downs and costly recalls.

Participants in this course will be introduced to the principles of environmental monitoring through lectures and hands-on activities.  During the lectures students will learn about regulatory requirements, types and sources of contamination, cleanroom classifications, sampling methods and frequencies, interpretation of environmental testing results and types of cleanroom microorganisms.  Students will also develop a sampling plan, conduct environmental sampling, count surface and air sample plates and interpret the results.  REGISTER


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