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: [external URL]
ISO 11137-1: [external URL] and amendment at [external URL]
These standards are also available from national standards organizations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.
CPD Hours: 12
Course Content
- Day 1
- The use of standards and overview of standards for sterilization
- General requirements
- Microbiology quality
- Microbiology methods
- Microbial inactivation
- Sterilization by irradiation
- Q & A
- Day 2
- Introduction and recap of day one
- Sterilization by irradiation (cont.)
- Biological indicators
- Syndicate exercise - Radiation sterilization
- Ethylene oxide sterilization
- Ethylene oxide sterilizaton (cont.)
- Syndicate exercise - Ethylene oxide sterilization
- Moist heat sterilization
- Wrap up and Q & A
Speakers
Annette Callaghan
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).
