Sterilization of Pharmaceutical Products and Medical Devices
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, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.
To date, Carl has now
garnered over two decades’ worth of extensive hands-on expertise.
Currently, he is the Chief Consultant of his very own consultant
business called aseptic-process.net, where he specializes in the aseptic
processing of pharmaceutical products in the pharmaceutical
manufacturing sector. Recently, he is in the process of creating
webinars so he can share pertinent information about pharmaceutical
manufacturing from a microbiological perspective.
Carl holds various degrees and certifications, including an M.S. in
Biomedical Quality Systems from San Diego State University, a B.S. in
Microbiology from the University of Texas, and Specialized Certificates
in QA/QC & Biotechnology from UCSD.
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.
- 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 Level - Intermediate
Who Should Attend
This webinar will provide valuable assistance to the following personnel in pharmaceutical and medical device manufacturing companies:
- Manufacturing companies
- Quality system auditors
- Microbiology analysts and technicians
- Regulatory and Compliance Management
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
- Auditing Professionals
- Microbiology Professionals