Who should attend
This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:
- Members of the Senior Management Team
- Regulatory Affairs Managers
- Regulatory Affairs Officers
- Quality Assurance Professionals
- Quality Assurance Officers
- Design Engineers
- Development Engineers
- Operations Managers
- Packaging Engineers
Book onto this course
- 27th March 2012 - Full
- 23rd October 2012 – SSTE01/10/12
Course Outline
This informative and engaging course is designed for individuals who are seeking to understand Sterilization by steam in more depth. Covering the uses of steam, how is sterilizes, and how to validate steam sterilization processes, this course also gives insights into the standards for steam sterilization, ISO 17665, ISO 11138, EN 285 & EN 556, that must be met.
Steam sterilization of medical devices is one of the principal methods of sterilization in the healthcare industry. It requires that the product is exposed to steam at a controlled temperature and pressure for a defined period of time. This course will examine the whole process from product design to production and packaging and the considerations that are required if you choose to or already do sterilize by steam. The microbiology of steam sterilization will also be covered in this course together with process validation and making sure your products are sterile.
The increased regulatory demands have led to the steam sterilization process becoming increasingly sophisticated demanding manufacturers be diligent in ensuring that staff are aware of the process parameters and how to validate the process. Diligence can only begin once staff have an understanding of the methodology involved and what the requirements are.
This course is lead by our own experienced microbiologists and steam sterilization experts.
Topics covered include
- Background to single-us and reusable medical devices
- Overview of the steam process including the requirements for clean steam
- Over view of the microbiology of steam sterilisation
- Insights into ISO 17665, ISO 11138, EN 285 & EN 556
- Process validation – how the process is validated including physical properties and the use of biological indicator
- Product validation – how the product is validated
- The regulatory framework within which the process operates
- Possible issues with the use of steam
Outcomes
At the end of the seminar, delegates will gain an insight into:
- The steam sterilisation process
- The impacts of steam sterilization process on the device
- The various regulatory requirements for steam sterilization
- Process validation
- Release criteria for the process
Venue
- Holiday Inn, Birmingham, UK
- Close to Birmingham Internation Airport & International train station (with free shuttle bus)
- 1 minute from junction6 of the M42
