Wednesday May 8, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
Terminal moist heat sterilization is presently considered the method of choice to ensure sterility. All aqueous-based sterile products are subject to terminal moist heat sterilization unless the sterilization, itself, will degrade the product. This interactive, live Executive Conference Corp. (ECC) webinar is intended to provide manufacturers of pharmaceutical dosage forms as well as components (vials and stoppers) with guidance to establish the scientific effectiveness of moist heat sterilization processes. It has been developed as an overview of the elements of moist heat sterilization processes requiring evaluation and describes approaches to effectively accomplish this. This guideline, derived from Health Canada guidances, specifies the minimum documentation required to certify that moist heat sterilization processes have been thoroughly evaluated and are adequately controlled and validated.
It applies only to moist heat sterilization processes. While the principles outlined in this webinar are shared with other methods of sterilization, those processes require control and assessment of different parameters, e.g., ethylene oxide, cobalt irradiation, etc. It must be recognized that, regardless of the sterilization process, the control of manufacturing environments and good manufacturing practices, which provide barriers to microbial contamination, remain of utmost importance.
The objective of this live and interactive ECC webinar is to explore the validation of steam sterilization and learn how it may be used within your current manufacturing operation to provide both sterile components and final product. Please plan to attend as a cross-functional team to gain the most from this webinar.
By attending, you will learn:
-Definitions.
-IQ/OQ/PQ Requirements for Autoclave Validation.
-Determination of Autoclave Cycles.
-Equipment Qualification.
-Equipment Qualification – Biological Challenges.
-Sterilization Cycle Development.
-Autoclave Monitoring Tests.
-Consideration of Cycle Time in the Overall Autoclave Utilization Plan.
-Determination of “Cold Spots” using Thermistors.
-Biological Indicators – How and When to Use.
-Number of Required Replicate Cycles as a Component of Validation.
-Verification vs. Revalidation.
-European Test Requirements.
Personnel who may wish to attend include:
- Microbiologists
- Quality Control
- Quality Assurance
- Regulatory Compliance
- Metrology
- Validation
- Research and Development
- Manufacturing
- Project Management
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-598