Tuesday June 19, 2018
1:30 pm – 3:00 pm EDT
Instructor: Barry A. Friedman, Ph.D. (more about the instructor)
Within the medical industry a number of sterilization methods are available to assure that products are produced that are devoid of any microorganisms. All of these methods render a product sterile; however, some of these methods provide a Sterility Assurance Level (SAL) or Probability of Non-Sterility (PNS) that are greater than others, i.e., provide a greater confidence level that no viable microorganisms remain viable within the final sterile product.
Terminally sterilized products represent the lowest risk category of sterile pharmaceutical and medical device products. Unlike products aseptically manufactured in a microbiologically controlled environment, terminally sterilized products are subjected to a sterilization process that imparts a measurable minimum SAL.
Because aseptic processing relies on exclusion of microbiological contamination and is not based upon lethality imparted on the product in its sealed container, it is not possible to accurately estimate the SAL.
With aseptic processing, SAL can only be estimated from media fill contamination rates or other forms of risk assessment.
The strategies used to validate a terminal sterilization process development fall into three categories:
- Bioburden-based process
- Biological indicator/bioburden combined process
- Overkill process
The Bioburden-Based Process requires extensive knowledge of product bioburden. Several radiation dose-setting procedures involve establishing radiation processes on the basis of bioburden count and radiation resistance. This method requires that at least a 10–6 PNS be attained for bioburden by the sterilization process.
The objective of this Executive Conference Corporation (ECC) webinar is to provide a broad based understanding of various modes of aseptic and terminal sterilization, and to provide an understanding of when each mode of sterilization is applicable to the product(s) under consideration for sterilization. Please plan to attend this webinar with your entire Project Team to learn how to move forward with your various sterilization programs.
By attending you will learn:
- Description of sterilization methods
- Predominant uses of sterilization within the Medical Device and Pharmaceutical/Biotechnology industries
- What “fits” best for my sterilization application
- Product interactions with various modes of sterilization
- Issues within each sterilization mode
- Contract vs. on-site sterilization
- Observe selected Warning Letters on this topic
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-035