Evaluating Competency through Collaboration

Enabling Manufactures of healthcare products, Standards Development Organizations, Industry Associations, Contract Sterilizers, and Interest Groups to collaborate in order to establish a standard approach and standard criteria for the evaluation of the competency of sterility assurance professionals.

Creating and maintaining a career pathway for sterility assurance professionals to demonstrate competency and a continuing professional development program to maintain the desired level of competency once achieved.

What is the SfSAP?

The Society for Sterility Assurance Professionals has been established as a collaborative not-for-profit initiative by the iia, AAMI and ASTM. It aims to enable the medical device and pharmaceutical industries to formulate a standard approach to meeting the requirements of MDR, ISO 13485:2016. The Society has a formal constitution and has been created as a legal entity in the United Kingdom. A board of directors will provide oversight of strategic matters. A steering committee will co-ordinate all collaborative initiatives and the formation of working groups. Members of the working groups will collaborate to develop the required output and guidance in their area of expertise. A driving force behind the initiative continues to be Arthur Dumba who can be contacted via the following email: [email protected]

SfSAP Founding Principles

The Society for Sterility Assurance Professionals (SfSAP) is a professional association that is dedicated to the advancement of sterility assurance for medical and pharmaceutical products. The founding principles of the SfSAP are:


To establish the required level of knowledge, understanding and experience to demonstrate competency based on the individuals’ role in the sterilization lifecycle.


To encourage better coordination in the training, testing and development of Sterility Assurance professionals through a competency framework.


To support individuals in achieving their development goals and the needs of the healthcare community in the field of Sterility Assurance.


To enable members of the community to build networks in order to achieve their career development goals and the needs of the wider healthcare community.


To create a career pathway for those involved in the sterility assurance and the sterilisation lifecycle of medical and pharmaceutical products.

Membership is Free

Join the SfSAP →