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Sterilization of Medical Devices In-house Training

A comprehensive introduction

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

★★★★★ "[Speaker] very experienced, knowledgeable and approachable. Webinar [was] prepared taking into accou... more"

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Overview

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations.

These requirements have been supported by a portfolio of standards on:

Designating products as sterile;
Validating and routinely controlling the sterilization process; and
Maintaining sterility over time with appropriate sterile barrier systems

This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

Please note that delegates will require access to copies of ISO 11135 and ISO 11137-1 in order to take part in the exercises. If you do not already have access to these through your organisation, please see below the ways to acquire them:

ISO 11135 - https://www.iso.org/standard/56137.html

ISO 11137-1 - https://www.iso.org/standard/33952.html and amendment at https://www.iso.org/standard/72106.html

These standards are also available from national standards organizations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of attending

Gain a comprehensive overview of medical device sterilization
Recognise the principles of the commonly applied methods of sterilization
Learn the regulatory requirements for sterilization and how to comply
Understand the portfolio of supporting standards and their interrelationships

Who should attend

Microbiologists and sterilization professionals
Quality Management System (QMS) specialists
Regulatory Compliance specialists
Internal Auditors
Regulatory and Quality professionals

This course will cover:

Day 1
Day 2

The use of standards and overview of standards for sterilization

Role of standards
Interaction of standards and regulations for medical devices
Portfolio of sterilization standards

General requirements

ISO 14937 - Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Structure of sterilization standards
Common features of validation and routine control

Microbiology quality

Introduction to microbiology
Sources of microbial contamination
Contamination control

Microbiology methods

Bioburden estimation – EN ISO 11737-1 Sterilization of medical devices – Microbiological methods - Part 1: Determination of a population of microorganisms on products
Test of sterility – EN ISO 11737-2 Sterilization of medical devices – Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Microbial inactivation

Inactivation kinetics
Sterility assurance
EN 556-1 Sterilization of medical devices – Requirements for a terminally-sterilized device to be labelled “Sterile”

Sterilization by irradiation

Nature of ionizing radiation
Sources of ionizing radiation
Measurement of radiation dose
Installation Qualification, Operational Qualification and Performance Qualification
EN ISO 11137-1 1 Sterilization of health care products - Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
EN ISO 11137-4 Sterilization of health care products — Radiation — Part 4: Guidance on process control

Introduction and recap of day one

Sterilization by irradiation (cont.)

Establishing the sterilization dose
EN ISO 11137-2 Sterilization of health care products - Radiation – Part 2: Establishing the sterilization dose
ISO/TS 13004 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD_max^SD

Biological indicators

EN ISO 11138 series - Sterilization of health care products — Biological indicators

Syndicate exercise - Radiation sterilization

Feedback and discussion

Ethylene oxide sterilization

EN ISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

Ethylene oxide sterilizaton (cont.)

EN ISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

Syndicate exercise - Ethylene oxide sterilization

Feedback and discussion

Moist heat sterilization

EN ISO 17665-1 Sterilization of health care products - Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

Wrap up and Q & A

Annette Callaghan
Sterile Management Systems

A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).

More details

Reviews of IPI's Sterilization of Medical Devices training course

[Speaker] very experienced, knowledgeable and approachable. Webinar [was] prepared taking into account all of the participants with the general information as well as with the direct individual requirements in mind. Questions answered at the time as well as within time given after the webinar. Thank you.

Oct 17 2024

Dorota Seweryn United Kingdom
Quality Engineer, First Water Ramsbury Limited

Jun 6 2024

The Speaker was very knowledgeable and the inside stories are great!

Priya Woodun United Kingdom
Senior QA Compliance Officer, Endomagnetics Ltd

Jun 1 2023

Very structured training at perfect pace, covering all important point. Very good interaction.

Marijana Jelecevic Kakouros France
RA Manager, Beckton Dickinson

Oct 19 2023

Training materials were detailed and easy to follow. Trainer was engaged and made sure that contents were delivered in a way that the Trainees could relate to.

Esther Okeudo United Kingdom
QA Specialist, JenaValve

Jun 1 2023

An excellent webinar that delivered above and beyond. Eamonn would be a great contact to keep for the future. His knowledge is top class.

Kerry Poole United Kingdom
Mercian Surgical Co Ltd

United Kingdom