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Course Description

The sterilization course covers the entire range of sterilization processes utilized in the pharmaceutical, biotechnology and medical device industries. Sterilization methods, validation practices and related subjects to be covered include: Prerequisites for Sterilization; Microbiology of Sterilization; Use of Biological Indicators; Steam sterilization for porous loads; Terminal Sterilization using Steam; Steam sterilization-in-place; Dry heat sterilization and depyrogenation; Gas, Liquid and Vapor sterilization (including isolator decontamination); Radiation sterilization; Filtration sterilization; Emerging sterilization methods; US and EU Compendia and Regulatory Considerations.

The aseptic course will provide comprehensive coverage of aseptic processing reviewing basic principles, technology choices, process design, environmental monitoring, and process simulation. The last sessions in this course will address aseptic processing risk management, contemporary regulatory expectations and future technologies process. The course will draw upon FDA’s 2004 Guideline on Sterile Drug Products Produced by Aseptic Processing and EMA’s – Annex 1 on Sterile Medicinal Products.

There will be ample time for interactive discussion among the students and instructors on the topics being presented.

Who Should Attend

These courses are intended for individuals working with sterile products where sterilization and aseptic processing knowledge is critical for their continued success. Those experienced with these technologies will refine their knowledge of the subjects through interaction with industry experts. Those without a strong background will learn the basics and develop an understanding of the more advanced considerations. The course is appropriate for personnel working in QA/QC, regulatory affairs, R&D, production, engineering, validation, and microbiology.

Your Instructor

James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 100 health care firms in a wide range of validation, automation and compliance areas. Jim has over 35 years of industry experience and has worked in organic synthesis, pharmaceutical formulation, pharmaceutical production, project and process engineering, validation and process automation during his career at Merck, Pfizer, Squibb and Bristol-Myers Squibb. He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He is a member of USP's Microbiology and Sterility Assurance Expert Committee for 2005-2010. He is a frequent author and lecturer on the subject of sterilization, aseptic processing and process validation.

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