This course is a part of our Master Class series. Seats are limited.
Terminal sterilization, the sterilization of an item in its final package, is the safest way to ensure the sterility of an injectable drug or sterile device. This program will discuss sterilization by heat, focusing on steam as the most convenient and effective means of delivering lethality. Terminal sterilization of devices (and infrequently, drugs) by radiation will be included in less detail.
A full day interactive seminar will include:
- – The meaning of sterility
- – Terminal sterilization vs. aseptic processing
- – Kinetics of microbial death
- – The thermal death-time curve: D-values
- – The thermal resistance curve: z-values
- – Cycle development: overkill, bioburden, “combination” cycles
- – Bioindicators
- – Sterilizer design consideration
- – Sterilization validation
- – Radiation
- – Myths and misconceptions
This course is intended for individuals with a basic understanding and experience with manufacture of sterile drugs and devices. It will present a balance of engineering and microbiological content so that it will be valuable for those who are required to specify, design and maintain terminal sterilization systems and cycles, as well as those who use them and oversee their performance (e.g., Quality Assurance, Regulatory Investigators).
SPEAKER: Mr. Phil DeSantis
Phil DeSantis is a pharmaceutical consultant, specializing in Pharmaceutical Engineering and Compliance. Phil retired in 2011 as Senior Director, Pharmaceutical Engineering Compliance for Global Engineering Service at Merck (formerly Schering-Plough) located in Whitehouse Station, NJ. His responsibilities included development, implementation and support of standards and practices for all facility and equipment-related capital projects and site operations. He served as Global Subject Matter Expert for Facilities and Equipment and on the Global Validation Review Board and Quality Systems and Standards Committee.
Phil is a chemical engineer, having received a BSChE from the University of Pennsylvania and an MSChE from New Jersey Institute of Technology. He has over forty-four years of pharmaceutical engineering industry experience. Prior to Schering-Plough, Phil held executive positions for Fluor Corporation and Raytheon Engineers & Constructors, where he led groups providing validation and compliance consulting services to pharmaceutical and biotech clients. Prior to that, he served in technical positions in several major pharmaceutical firms, including Squibb, Ortho Pharmaceutical Corporation and an earlier period at Merck. He is on the PDA Scientific Advisory Board and is active in the International Society for Pharmaceutical Engineering (ISPE). He has been as a frequent lecturer for both organizations. He has published or contributed to several articles and books in the area of validation and pharmaceutical engineering. In addition, Phil has lectured on “Steam and Dry Heat Sterilization” as part of the FDA’s field investigator training program.
|Basic Member Ticket:||$795.00||— Sold Out|
|Pro/Pro Plus Member Ticket:||$745.00||— Sold Out|