Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization processing in a medical device manufacturing environment. Developed by medical device manufacturers, the U.S. Food and Drug Administration (FDA), and industry consultants, the course addresses sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.

Course Objectives:

Course participants will learn how to:

• Apply the principles of sterilization
• Address sterilization requirements during product design
• Select and implement an appropriate sterilization process
• Identify the elements of successful sterilization validation
• Describe the critical parameters of a chosen sterilization process
• Participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes
• Compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods
• Correlate appropriate standards with sterilization processes and identify requirements pertinent to validation, packaging, and routine process control
• Describe the critical factors in making product release decisions
• Identify resources for complying with FDA requirements

Format
This highly interactive program combines classroom lecture with situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. In addition, participants will work through a series of case studies illustrating problematic situations. Case studies will cover various aspects and phases of sterilization processes...from design, to cycle development, to validation, to process control, to product release.

Program At-A-Glance

Course Materials
Participants will receive the following:

• ANSI/AAMI/ISO 17665-1:2006 Sterilization of health products – Moist heat – Part 1: Requirements for development, validation, and routine control of a sterilization process for medical device;
• ANSI/AAMI/ISO 11137-1:2006 Sterilization of health products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
• ANSI/AAMI/ISO 11137-2:2006 Sterilization of health products – Radiation – Part 2: Establishing the sterilization dose;
• ANSI/AAMI/ISO 11137-3:2006 Sterilization of health products – Radiation – Part 3: Guidance on dosimetric aspects;
• ANSI/AAMI/ISO 11135-1:2007 -- Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
• ANSI/AAMI/ISO 11607-1:2006 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems, and packaging, 3ed
• ANSI/AAMI/ISO 11607-2:2006 11607-2 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing, and assembly processes
• AAMI TIR22:2007 Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2:2006
• Pertinent FDA documents; additional references; and a participant's guide for easy note-taking.

Who Should Attend?
To maximize the peer-learning opportunity, this course is recommended for those who are relatively new to the sterilization process environment and need information to help them better understand the principles and science of industrial sterilization. This course is designed for professionals such as design and process engineers, operations managers and technicians, corporate quality assurance and regulatory compliance personnel, or others directly involved in sterilization processes and responsible for meeting industry standards and FDA requirements.

Faculty
In consultation with industry and government leaders, this course was developed to meet the medical device industry's need for a better understanding of sterilization principles, standards, and regulations. The mix of industry leaders, independent experts, and FDA personnel helps to ensure a balanced presentation of many aspects of industrial sterilization as described in the objectives.

Registration Fees
Fee includes course materials and continental breakfast, lunch, and refreshment breaks for all four days.

Join AAMI and Save!! Link to Membership

RETURN TO TOP