Clean Room Microbial Load and Characterization of Microorganisms in the Clean Room Environment

Rudy Pina
Instructor Rudy Pina
Product Id 600590
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Clean Room Microbial Load and Characterization of Microorganisms in the Clean Room Environment

Overview:
A summary of test methods will be covered, and a review of types of microorganisms that can be present, will be discussed.

A general review of environmental niches where they may be present will be discussed. You will be introduced to the different methods available to conduct testing. Key areas discussed will be Compressed Air, Personnel Monitoring, Surface and Raw Material Monitoring. Recommended selection of sampling sites will be covered. An overview of different types of potential microorganisms that can be encountered will be discussed. A pattern of a Potential Historical Contamination Trend will be discussed.

Why you should attend: The attendee will be given a summary of test methods and, in addition, a brief overview of which methods to select based on scientific documentation. The attendee will be given information related to appropriate and relevant standards in order to assist in the development or update of current monitoring programs. Finally, the attendee will be given a glimpse into the types of microorganisms and their environmental source that can exist in a cleanroom and subsequently, on your product. You should attend in order to ensure your current system is adequate or learn how to develop a new monitoring system.

Areas Covered in the Session:
  • Definition of a Cleanroom, Clean Zone
    • Monitoring Systems
      • Air Sampling
        • Active
        • Passive
      • Surface Sampling
        • Contact Plates
        • Swabs
      • Personnel Monitoring
      • How to identify contamination sites
        • Gowns
        • Hands
        • Aerosol
      • Sampling Methods
        • Contact Plates
        • Bioburden Extraction 11737
        • Compressed Air
        • Slit to Agar
  • Establish sampling Plain Select Appropriate Sites
    • Parental - U.S.P. <1116>
      • Container
      • Path of opened container
      • Compressed Air (Impact on Product)
    • Device
      • Assembly Line
      • Packaging
      • Storage/ Warehouse
      • Compressed Air
  • Microbiological Characterization (Based on)
    • Unique Flora
    • Regional Finger Print
    • Equipment & Personnel
    • Water System
    • Seasonal Trends
    • Cleanroom Classification
  • Method of Analysis
    • DNA Sequences
    • Biochemical Analysis
    • Fatty Acid profiling
  • Microbiological Flora/ Seasonal Trend
Who Will Benefit:
  • Quality Manager
  • Sterility Assurance Manager
  • Quality Engineer
  • Sterilization Engineer
  • Regulatory Affairs Manager
  • Infection Control Specialist
Speaker Profile
Rudy Pina has over 30 years of experience in The Medical Device Industry. He has worked for American Hospital Supply, Baxter Healthcare. Rudy is President of Dynatec Scientific Laboratories Inc. Rudy is a member of the Association for the Advancement of Medical Instrumentation (AAMI) Sterilization Working Group. Member of FDA/Industry Coolition - Dallas District Office Member of NAFTA - Trilateral Negotiations - Medical Technology Sector.

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