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

Live Webinar on

Clean Room Microbial Load and Characterization of Microorganisms in
the Clean Room Environment
Date & Time:


Thursday, October 27, 2011
10:00 AM PDT | 01:00 PM EDT

Register Now

Duration: 60 Minutes
Instructor: Rudy Pina
Location: Online
Price : $245.00 (for one participant)

Instructor Profile:
Overview:
Rudy Pina
A summary of test methods will be covered, and a review of types of
Lab Director, Dynatec
microorganisms that can be present, will be discussed.
Scientific Labs

A general review of environmental niches where they may be
Rudy Pina has over 30 years of
present will be discussed. You will be introduced to the different
experience in The Medical Device
methods available to conduct testing. Key areas discussed will be
Industry. He has worked for
Compressed Air, Personnel Monitoring, Surface and Raw Material
American Hospital Supply, Baxter
Healthcare. Rudy is President of
Monitoring. Recommended selection of sampling sites will be covered.
Dynatec Scientific Laboratories Inc.
An overview of different types of potential microorganisms that can
Rudy is a member of the Association
be encountered will be discussed. A pattern of a Potential Historical
for the Advancement of Medical
Contamination Trend will be discussed.
Instrumentation (AAMI) Sterilization

Working Group. Member of
FDA/Industry Coolition - Dallas
Why you should attend:
District Office Member of NAFTA -

Trilateral Negotiations - Medical
The attendee will be given a summary of test methods and, in
Technology Sector....more
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
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the development or update of current monitoring programs. Finally,
the attendee will be given a glimpse into the types of
Your Necessity is our Priority
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:
l
Definition of a Cleanroom, Clean Zone

Monitoring Systems
n
Air Sampling
n
Active
n
Passive
n
Surface Sampling
n
Contact Plates

n
Swabs

n
Personnel Monitoring
n
How to identify contamination sites
n
Gowns
n
Hands
n
Aerosol
n
Sampling Methods
n
Contact Plates
n
Bioburden Extraction 11737
n
Compressed Air
n
Slit to Agar
l
Establish sampling Plain Select Appropriate Sites

Parental - U.S.P. <1116>
n
Container
n
Path of opened container
n
Compressed Air (Impact on Product)

Device
n
Assembly Line
n
Packaging
n
Storage/ Warehouse
n
Compressed Air
l
Microbiological Characterization (Based on)

Unique Flora

Regional Finger Print

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Equipment & Personnel

Water System

Seasonal Trends

Cleanroom Classification
l
Method of Analysis

DNA Sequences

Biochemical Analysis

Fatty Acid profiling
l
Microbiological Flora/ Seasonal Trend
Click here to register for this webinar
Who Will Benefit:
l
Quality Manager
l
Sterility Assurance Manager
l
Quality Engineer
l
Sterilization Engineer
l
Regulatory Affairs Manager
l
Infection Control Specialist
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator
GlobalCompliancePanel
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