Investigating Microbial Contamination seminars announced

Feb 16-17 2006 — Crowne Plaza, Foster City, San Francisco Area

March 23-24 2006– Caribe Hilton, San Juan, Puerto Rico

January 18, 2006 — /MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM)/ — RAMSEY, N.J. — Microrite Inc released today its schedule of upcoming microbial contamination seminars.


Investigation Strategies & Investigating Media Fill Failures

<>Discussion on critical systems where microbial contamination may affect product quality
<>Confirming the validity of contamination
<>Identifying risks & liabilities
<>Administrative controls for investigating microbial contaminations

<>Systems to investigate when microbial contamination occurs
— Establishing an investigation plan
— Identifying areas to investigate
— Data review
— Interviews
— Summarizing findings

<>Determine the assignable cause: systems to inspect for tracking contamination to the source
<>Developing corrective action plan recommendations
<>Points to consider while compiling the investigation report
<>Discussion on aseptic media fills & sterility testing
— Similarities & differences between the 2

<>Discussion on validation of aseptic processing guidance for industry
<>Elements of investigation for failed media fill runs
— Facility
— Equipment
— Personnel
— Training
<>Addressing unusual events during media fills
<>Consequences of contamination during media fills


<>Investigating environmental monitoring excursions & equipment cleaning & sterilization
— What is an environmental monitoring excursion?
— What do you do when you find an EM excursion? (step-by-step)
— What safety issues need to be addressed when you find an excursion?
— How is an investigation for an EM excursion conducted?
— What type of information do you need to collect during your investigation?
— How people misuse of information from microbiology text books.
— How much information do you need to make decisions with?
— What are corrective actions & how do you know that they worked for sure?
— When is it appropriate to use EM data as a product release criterion?
— What type of investigational approach is used for media fill failures?
— What type of investigational approach is used for sterile batch failures?
— What expectations do FDA officials have regarding failure investigations for sterile products?

<>Discussion on cleaning kinetics issues during investigations of equipment contamination
— What is going on during the cleaning process
— Is the equipment getting cleaned to remove all prior product or contamination
— Investigating equipment design flaws that can lead to contamination

<>Discussion on what to look in equipment design when investigating product contamination
— Points to consider while choosing equipment & parts from a contamination control perspective
— Definition of a CIP Cycle – What is each step for?
— Understanding & developing CIP cycles to avoid contamination
— Investigating appropriateness of CIP Cycles as a part of a contamination investigation
— CIP skid components – what to look for in the plant
— Step by step investigating components of the CIP skid to ensure that CIP cycles are effective

<>Types of bioburden reduction:
<>Sanitary vs sterile
<>Steam-In-Place (SIP)
<>Saturated steam conditions
— Temperature/pressure relationship
— Function of steam traps

<>Autoclaves, Vessels, Filters & Transfer Lines
— Autoclaves (Vacuum vs Nonvacuum)
— Empty vessel SIP
— Full vessel SIP
— Sterile envelope boundary

<>Proper Use of Tempilstik
<>Post-Contamination Procedure
— Be prepared
— Immediate actions following a contamination investigation
— Step by step investigation

— What to conclude from your findings
— False positive?

<>Contamination Prevention
— Preventive Steps
— Good equipment design
— Design flaws (Avoid at all cost)


Limited sleeping rooms are available at reduced rates for both hotels.


Ziva Abraham
Microrite Inc
5019 New Trier Ave
San Jose CA USA 95136
408-445-0507 phone
408-445-1236 fax
[email protected]


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