Sterilization of Medical Devices

If you are auditing, assessing or setting up a sterilization process for medical devices, this is the training you need!  This well-established 5-day course was first held in the late 1990’s, as part of a university course. More than 20 years ago it was turned into an open course; since then, over 100 people have participated and passed their degree. 

Course description

You will learn how to select and implement an appropriate sterilization method, identify the elements of a successful sterilization validation, and how to demonstrate the continued effectiveness of the chosen method.  Participants will be able to compare sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods. By taking this training you will get the necessary knowledge to audit the sterilization processes covered.

After the training you have the opportunity to undergo an exam to verify your learning (read more about the course content and the exam in the “Course outline”, see link below).

Learning objectives

At the end of this course, participants should have an in-depth understanding of  

• The main sterilization methods for medical devices and the necessary manufacturing environment 
• Principles and requirements of sterilization ISO standards and guidance documents 
• General microbiology for achieving sterility 
• Sterility assurance – Sterility Testing, Cleanrooms, and Aseptic processing 
• Quality Management System requirements supporting medical device sterilization processes 
• How and what to audit, for medical device sterilization compliance 

Course outline

• Introduction, overview of standards for sterilization  
• Microbiology and contamination control 
• General considerations, sterilization standards and their relationship with ISO 13485:2016  
• General Requirements for Sterilization of Medical Devices (ISO 14937:2009) 
• Microbiological methods- Part 1. Determination of population of microorganisms (ISO 11737-1:2018)  
• Microbial inactivation kinetics – Requirements for terminally sterilized device to be designated “STERILE” (EN 556-1)  
• General considerations; Sterility testing (Pharmacopoeia ‘Test for sterility’ vs’ Test of sterility’ 
• Biological indicators (ISO 11138-1:2017) 
• Clean rooms (ISO 14644, Part 1–5) 
• Tests of sterility performed in the definition, validation and maintenance of a sterilization process. (EN ISO 11737-2:2019) 
• Packaging for terminally sterilized medical devices – Requirements on materials, sterile barrier system and packaging systems (ISO 11607-1:2019) 
• Radiation sterilization (ISO 11137-1, -2, -3) 
  • Requirements for development, validation and routine control of a sterilization process  
  • Dosimetry, Establishing the sterilization dose  
  • Installation Qualification, Performance Qualification & Routine Control 

• Ethylene oxide – Validation and routine control of the sterilization process (ISO 11135:2014)  
• Moist heat – Validation and routine control of the sterilization process  (ISO 17665-1:2006) 
• Dry heat — Validation and routine control of the sterilization process (ISO 20857:2013) 
• Aseptic processing.  Part 1: General requirements ISO 13408-1 (and to some extent, Part 2-5) 

Download full Course Outline (PDF) >

Important information:

1. Before the course: The course literature is distributed as e-book (or printed if you prefer so) 3 weeks before the training. To get the most out of the training is highly recommended that you read this book and get well familiarized with the content. The amount of preparation needed depends on your previous experience with the various sterilization methods. 
2. During the course: The course includes exercises during daytime, but also two exercises done as homework (Tuesday and Thursday evening).
3. After the course, you can choose to undergo an examination to verify your knowledge. The exam consists of eight questions that shall be answered with free text (there are no alternatives to choose from). It is an open exam, so you can make use of the e-book, the training material and any other information while preparing the answers, but please note that it is an individual test, meaning that no co-operation with other attendees should occur when preparing and submitting the answer

Who should attend

The course is suitable for people working in the field of medical devices who are responsible for either audit, assess or set up a sterilization process for medical devices. 

Need of prior knowledge/experiences

• Academic education in engineering or life sciences. 
• Basic knowledge in medical device regulations and the role of standards
• 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry), alternatively from working at an authority or Notified Body. 

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