Sterilization of Medical Devices Training Course

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.

Benefits in 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

Introduction and welcome

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

Q & A

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