This course is a part of our Master Class series. Seats are limited.
Sterilization by moist heat, most often saturated steam under pressure, is the most common and one of the most effective means to render products or product contact parts free from microbial contamination. For products, 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 moist heat, focusing on steam as the most convenient and effective means of delivering lethality. Both terminal (product) and parts sterilization will be covered.
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
- sterilizer design consideration
- sterilization validation
- parametric release
- myths and misconceptions
Who Should Attend
This course is intended for individuals with a basic understanding and experience with the 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 steam sterilization systems and cycles, as well as those who use them and oversee their performance (e.g., Quality Assurance, Regulatory Investigators).
Course Leader: Phil De Santis
Phil DeSantis is a pharmaceutical consultant, specializing in Pharmaceutical Engineering and Compliance. Phil retired in 2011 as Senior Director, 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 the New Jersey Institute of Technology. He has over fifty years of pharmaceutical 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 Chair of the PDA Science Advisory Board and is active in ISPE and a frequent lecturer for both organizations. Phil has published or contributed to numerous articles, technical reports, and books in the area of validation and pharmaceutical engineering. He is co-editor of the forthcoming fourth edition of Validation of Pharmaceutical Processes, the definitive text in the field. In addition, Phil has lectured on “Steam and Dry Heat Sterilization” as part of the FDA’s field investigator training program.
Registration Deadline: 4 Dec 2020
|Basic Member Regular:||$495.00||— On Sale||Until: 04/12/20 3:15 PM|
|Pro Ticket Regular:||$445.00||— On Sale||Until: 04/12/20 3:15 PM|