Industrial Sterilization for Medical Devices

Industrial Sterilization for Medical Devices is a comprehensive 4 day course covering essential information on 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.

Who Should Attend?

This program is recommended for professionals relatively new to the sterilization process environment who need information to help them better understand the principles and science of sterilization. This course is designed for 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.

Dates & Hotels

2015LocationPhone & RatesOnline Registration
May 18–21
Hotel Monaco Alexandria
480 King Street
Alexandria, VA 22314
Website
+1-703-549-6080
Single/double rate: $239
Rate through: May 11, 2015

Online Registration

NOTE: Reservation requests should be made as soon as possible, but no later than the 'rate through' date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline.

Additional Info

Program At-A-Glance

Day One:  8:00 a.m. – 5:00 p.m.Introduction

  • Key Concepts / Definitions
  • Microbes and Sterilization
  • Test Method Validation
  • Inactivation of Microorganisms

Day Two:  8:00 a.m. – 5:00 p.m.

  • Sterile Packaging
  • Radiation Sterilization — Introduction
  • Radiation Sterilization — Process Definition and Dose Establishment
  • Radiation Exercise 1
  • Radiation Exercise 2
  • Radiation Sterilization—Product Definition & Routine Processing

Day Three:  8:00 a.m. – 5:00 p.m.

  • Moist Heat and Ethylene Oxide Product Definition
  • Moist Heat Sterilization — Introduction
  • Moist Heat Sterilization — Process Definition
  • Moist Heat Sterilization — Routine Processing
  • Ethylene Oxide Sterilization — Introduction

Day Four:  8:00 a.m. – 5:00 p.m.
  • Ethylene Oxide Sterilization — Process Definition
  • Ethylene Oxide Sterilization — Routine Processing
  • Contract Sterilizers & Laboratories
  • FDA Perspectives

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.


Fees & Registration

Fees include:  PowerPoint presentations and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments.

As part of the course materials, attendees receive copies of standards on the validation and routine control for industrial moist heat sterilization, ethylene oxide sterilization, and radiation sterilization as well as standards and a technical information report on packaging for terminally sterilized devices.

  • AAMI members:  $2435
  • Nonmembers:  $2735
  • Government employees:  $835

Registration options include: 

  • Online at the online registration links in the hotel chart
  • Phone  +1-800-373-3174, to order with credit card
  • Fax the registration form (PDF) to +1-240-396-5781