home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Meetings and Conferences  
 

How to Implement Parametric Release in EO Sterilization - A Practical Approach

 
  August 08, 2012  
     
 
ComplianceOnline, Online Event
2012-09-11


Why Should You Attend:

Even though many companies are utilizing the advantage of parametric released for theirEO sterilized products, there are some which still thinks is too complex or risky to be implemented. Latest EN/ISO 11135 and TIR 20 revisions clearly defines the validation requirements but since it does not provides guidance on how to establish the parameters many sterilization experts has doubts regarding this critical aspect.

We developed this training utilizing not only the ISO guidance's but the hands-on experience acquired while successfully establishing parametric release for severalmedical device manufacturing companies.  Learn the use of this practical approach which will allow for a simple, straight-forward implementation of parametric release which has been evaluated by the FDA and found in compliance in all of these companies. We will discuss the validation and other requirements along with monitoring methods.

Areas Covered in the Seminar:

  • Introduction.
  • Cycle Validation for parametric release.
    • Microbiology requirements.
      • Methods A or B
    • Equipment Requirements
      • Pre-conditioning
      • Sterilization
      • Aeration
    • Product considerations
      • Pallet configuration
      • Product density
    • Parameter Establishment for routine monitoring
      • Humidity
      • EO concentration
      • Product temperature
  • Routine EO cycle monitoring.
    • Equipment requirements
    • Processing requirements
  • References
Event Details:
 
Date:                    September 11, 2012
Time:                    10:00 AM-11:00 AM PDT
Cost:                    $249 per attendee per computer terminal
Registration:         SIgn-Up on-line now.  Add to your shopping cart.

 
 
Organized by: ComplianceOnline
Invited Speakers: Marisel Ortiz, is the founder and President of Sterilization Expert, a consulting company offering technical consultation services in microbiology and sterilization fields. With over twenty two (+23) years experience in management and the application of vanguard sterilization and microbiology technology in world-wide leader companies such as: Baxter, McGaw, Edwards Lifesciences, Cardinal Health and Teleflex Medical Marisel is now dedicated to share her knowledge and experience with the Industry.
 
Deadline for Abstracts: 2012-09-11
 
Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701452?channel=hummolgen
E-mail: referral@complianceonline.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.