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.
Furthermore, 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.
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.
- Methods of sterilization
- Why one method is used over another
- Validations of the sterilizations method Covered in the Session
Who Should Attend
- Manufacturing companies
- Quality system auditors
- Microbiology analysts and technician
- Regulatory and Compliance Management
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
- Auditing Professional
- Microbiology Professionals