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

Instructor: Marisel Ortiz
Product ID: 701452
Training Level: Advanced
  • Duration: 60 Min
This webinar will present a practical approach for implementing parametric release in EO sterilization. We will discuss the cycle validation and other requirements for implementation of parametric release in EO sterilization as per EN/ISO 11135.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2012

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Course "How to Implement Parametric Release in EO Sterilization - A Practical Approach" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

Even though many companies are utilizing the advantage of parametric released for their EO 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 several medical 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

Who Will Benefit:

This seminar is designed for professionals with responsibility for validating or making decisions related to the EO sterilization process.

  • Sterilization/Quality Managers
  • Directors and VP of manufacturing/ quality
  • Quality or laboratory personnel
  • Product Managers
  • Regulatory Affairs
  • Quality or laboratory personnel

Instructor Profile:

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. She has been recognized to be the sterilization expert driving competitive advantage through innovative solutions thus creating greater value while maintaining full regulatory compliance. Was renowned for uncompromisable ethics and integrity and for always honoring commitments.

Marisel has three Bachelor degrees in Science: Pre-medicine, Industrial Microbiology and Biology. She graduated with Cum Laude honors from the prestigious University of Puerto Rico, Mayaguez campus.

She is founder member of the Industrial Microbiology Society of Puerto Rico University.

Follow us :
Analytical Method Validation
Laboratory Inspection and Auditing

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

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