Mastering Sterilisation by Steam: The Importance of EN ISO 17665-1 Training for Medical Device Professionals

In medical device manufacturing, sterilisation is one of the most important processes. The expectation for manufacturers is that products presented for surgical procedures are free of viable microorganisms. Not only is this an expectation of regulations, but also a fundamental responsibility to safety for patients. Steam sterilisation remains one of the most dependable and frequently used sterilisation methods. Understanding steam sterilisation from principles to validation requirements to documentation requirements involves much more than just knowledge of the technical aspects of sterilisation procedures. This is where the MDSSPRO Sterilisation by Steam Course is vitally important.

Understanding EN ISO 17665-1: The Cornerstone of Steam Sterilisation

The standard, EN ISO 17665-1, scope provides the requirements for the development, validation and routine control of steam sterilisation processes for medical devices. The standard offers a structure to provide consistent sterilisation outcomes while maintaining device integrity.

For manufacturers and the quality department, EN ISO 17665-1 is the required standard for demonstrating compliance with both the Medical Device Regulation (MDR) and Medical Device Directive (MDD). The MDSSPRO Sterilisation by Steam Course supports participants in practice, clearly demonstrating how to apply the standard in their own operations.

Overview of the Course

This unique training course walks participants through every key step of steam sterilisation, starting with the design of the process and ending with performance qualification. Typical subjects include:

• The principles and mechanisms of moist heat sterilisation studies 
• The qualification and validation requirements of the equipment
• Biological and chemical indicators of process verification
• Documentation and record-keeping to meet regulatory expectations 
• Risk management and process improvement to stay compliant

Each module is intended to provide an insight into real life, ensuring participants know the theoretical basis for the methods and know how to apply them at their facilities. 

Why Is It Important?

In the medical device industry, non-compliance can have serious implications – product recalls, loss of certification, and potentially injured end-users. When steam sterilisation procedures are validated, confidence is present that each device reaches the end-user compliant with the strictest safety and quality controls. 

MDSSPRO’s Sterilisation by Steam Course is intended to bridge the gap between the regulatory text and a potential implementation. It incorporates unique strategies to assist engineers, validation specialists, and quality managers in interpreting EN ISO 17665-1 text appropriately and refrain from costly errors that commonly arise from misapplying an intent that was established in the validation process.

Who Should Attend?

The course is beneficial for professionals involved in:

• Quality assurance and regulatory compliance
• Designing and validating sterilisation processes
• Manufacturing and production of sterile medical devices
• Research, development, and technical support roles

If you are new to sterilisation or would like to enhance your knowledge, this course represents an opportunity to enhance your understanding and compliance credentials.

Learning by Experts with Practical Application

At MDSSPRO, each training program is run by experienced regulatory and technical experts who have supported numerous manufacturers successfully through audits and inspections. The Sterilisation by Steam Course blends interactive learning with practical examples, which means that delegates will be immediately ready to put into practice the knowledge gained.

The course generally covers instructions for interpreting process data, managing deviations, and monitoring validated states throughout the manufacturing cycle. At the conclusion of the course, delegates will be able to walk away with a clear framework to ensure that their sterilisation processes are effective and compliant.

Confidence with Compliance

What truly stands out about the course is MDSSPRO’s larger commitment to client success. Each training session is ultimately not simply about delivering information, but about building confidence through competence in each participant. This representation of participant ability is why it is so important to MDSSPRO to support medical device companies in obtaining up-to-date and sustainable regulatory compliance.

Final Thoughts

The Sterilisation by Steam Course goes beyond a simple compliance training. It is a commitment to quality, safety, and professional development. With patient health on the line, every organisation engaged in the manufacture of sterile medical devices must understand and effectively apply EN ISO 17665-1. 

By utilising MDSSPRO, our team has the expertise and know-how to ensure that your team has the skills, understanding and confidence to comply with global regulatory requirements. Steam sterilisation may be a traditional method for sterilising medical devices, but it is the understanding and capability to successfully validate and control steam sterilisation that reflects the excellence of medical device production in a modern world.