Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach

Duration: 90 Minutes
Different microorganisms in different environments during sterilization have different resistance to the destructive principles that causes the organism or spore to die (lethality). Some extreme thermophile organisms have their optimal growth temperature at 110°C, whereas most vegetative cells are killed at 60°C.
Online Sterilization Course
Instructor: Jerry Dalfors
Product ID: 500858

Heat sterilization is a probability function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms. Current regulations expect the sterilization process to provide a level of assurance of at least 1 x 10-6 probability (fewer than one non-sterile unit per million units) of survival (non-sterility) for terminally sterilized parenterals and medical devices. Since regulations require that we generate in our sterilization processes a probability of a non-sterile unit (PNSU), how do we use D-values, Z-values and Fo to calculate the probability and determine that we have essentially zero risk in our products due to lack of sterility?

D-value is the term used to describe the amount of time required to kill or destroy a microorganism. Spores are much more difficult to kill than vegetative cells, which is why we use spores as our Biological Indicator for the effectiveness monitor of our sterilization process. D121 tells us how many minutes it takes to kill an organism at 121°C (or 250°F). The D-value is the time required to reduce a population of microorganisms by one log at the process temperature. From 1x106 to 1x105 – from 1,000,000 to 100,000 organisms. Z-value of a microorganism is a measure of how heat resistance changes with changes in temperature. Z is defined as the number of degrees temperature change to change the D-value by a factor of 10.

The Z-value allows integration of the lethal effect of heat as the temperature changes during the heating and cooling phases of a sterilization cycle. D121 tells us how many minutes it takes to kill an organism at 121°C (or 250°F). This webinar will also cover the different elements that affect D-value and z-value and how to calculate the probability that a defined cycle is going to give us the SAL and PNSU that is needed to ensure that only or less than 1 in a million patients might have a problem due to sterility issues as well as reviewing what has caused a number of FDA Warning Letter due to inappropriate sterilization development, validation and on-going assessment of the process.

Why Should you Attend:
Attend this webinar to understand the definition of sterile, what are the different sterilization methods, various approaches to be used for the validation of a sterilization process, and what are the requirements for routine monitoring and control of sterilization process.

Objectives of the Presentation:
The prime objectives of the presentation are to discuss the mathematical means of developing and proving that the sterilization process is effective and does not generate a problem for heat liable products. The speaker will also cover areas such as:
  • Linear Regression used to calculate the edge of failure
  • Survivor Curves to determine D-values and Z-values
  • Fraction Negative studies
  • Cold spot determination - product and chamber - TD and HP
  • Correction factors associated with heating and cooling
  • Calculation of process lethality
  • Laboratory Studies needed to support Sterilizer Studies
  • Biological Indicators to be used and how to make the selection
  • Identification of elements in the process that can affect D-value
Who can Benefit:
  • Manufacturing Operations
  • Formulation
  • Engineering
  • QA/QC
  • Product and Process Development
  • Regulatory Affairs
  • Research and Development
  • Sterility Assurance
  • Technical Operations and Validation Professionals
  • Inspectors and Auditors.
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.

He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.
View More