Sterilization of Pharmaceutical Products and Medical Devices
Duration : 60 Minutes
Carl Patterson, MS, SSGB, SSBB,
Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However Read more
This topic will discuss the methods of sterilization to be used on medical devices and pharmaceutical products. Understanding the regulations pertaining to sterilization of products will help to decide with method to use for your product. The advantages and disadvantages of each will be discussed. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.
Pharmaceutical products and medical devices are required to be sterile to be used in patients. Sterilization of these crucial products can be done in several ways depending on the characteristics of the product being sterilized. There are four typical ways a product can be sterilized. These are sterilization by Ethylene Oxide, Gamma irradiation, Steam and Pressure, and filtration. Knowing the characteristics of your product will determine what method will be used. This webinar will go over the four methods of sterilization and why one method would be chosen over the other.
Course Objective:
• Types of sterilization methods
• Predominant uses of sterilization within the Medical Device and Pharmaceutical/Biotech industries
• Product interactions with Various Modes of Sterilization
• When to Use one Sterilization Mode vs. Another
• Parametric Release - What is it?
• How to Use Parametric Methods
• Development of the Techniques - Issues and Answers
• Considerations of cost of sterilization
• Use of contract sterilization vs. in-house
Course Outline:
• Regulations relating to sterilization of products
• Methods of sterilization
• Why one method is used over another Validations of the sterilizations method
What You Get:
• Training Materials
• Live Q&A Session with the Speaker
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Manufacturing companies
• Quality system auditors
• Microbiology analysts and technicians
• Consultants
• Regulatory and Compliance Management
• Quality Assurance personnel
• Quality Control personnel
• Research & Development
• Regulatory Affairs Professionals
• Validation
• Auditing Professionals
• Microbiology Professionals
• Auditors
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
