Society for Sterility Assurance Professionals (SfSAP) 2024 Update
The Society for Sterility Assurance Professionals (SfSAP), one of the iia’s industry initiatives, has had a busy 2024. SfSAP was established with aims to enable the medical device and pharmaceutical industries to meet regulatory requirements by formulating a standard approach to defining and evaluating the competency of sterility assurance professionals.
In 2024, the SfSAP has focused on building Learning Frameworks for defining and providing learning pathways for sterility assurance professionals (SAP) to advance their knowledge and careers. This year, learning frameworks have been updated to allow: learners to have a tier-based learning approach to their development; Education Delivery Organisations (EDOs) to structure their training to follow the domain-based approach to learning (see image below); and Health Authorities/Regulators and Auditors to have tools to establish a harmonised approach to competency, skills, and knowledge.
Learning Frameworks with the Domain Based Learning that will be available in Q1 of 2025 will be:
- Aseptic Processing Sterilization Professional Learning Framework and Outcomes (Revision 2 with Domains)
- Healthcare Products ETO Professional Learning Framework and Outcomes (Revision 2 with Domains)
- Healthcare Products Radiation Sterilization Professional Learning Framework and Outcomes (Revision 2 with Domains)
- Microbiological aspects of sterility assurance for healthcare products Learning Framework and Outcomes (Revision 2 with Domains)
- Moist Heat Sterilization Learning Framework and Outcomes (Revision 1 with Domains)
- Packaging & Sterile Barrier Systems Learning Framework and Outcomes (Revision 1 with Domains)
Industry Recognised Contributions
In 2025, SfSAP plans to introduce “Industry Recognized Contributions” badges for professionals actively contributing as conference speakers, report or guideline contributors, authors, or professional award recipients. Applicants will submit evidence via the SfSAP website, and badges may include SfSAP and partner organization logos. Work continues to find a platform for “portable resume” capabilities.
Educational Delivery Organisations (EDOs)
SfSAP is engaging with EDOs to align their courses with the learning frameworks, either by developing new content or adapting existing offerings.
SfSAP Website Updates
The revamped SfSAP website, set to launch in January 2025, will host resources like learning frameworks, guides, and presentation materials to support members and stakeholders.
Global Presentations
In 2024, various team members presented the SfSAP’s work at international conferences and meetings, including:
- GMPs by the Sea (August 2024) – Jim Vesper
- PDA/FDA (September 2024) – Arthur Dumba
- Fermilab regulators meeting (Sept 2024) – Arthur Dumba and Jim Vesper
- IMRP 2024 (Kim Patton, Jim Vesper)
At IMRP 2024, several posters showcased the use of SfSAP Frameworks, including two by Steris (led by Ginger Zappa and Niamh Pardy) and one by BD (led by Nicola Bench), highlighting their practical application.
Upcoming abstracts have been submitted for the 2025 Kilmer Conference and PDA Annual Meeting, with a structured “message arc” being developed to enhance future presentations.
Pilot Project Launch
The SfSAP plans to launch a pilot project in early Q2 2025 with EDOs, contract sterilisers, and healthcare manufacturers to test learning frameworks and document competencies. Several organisations have shown interest; details and evaluation criteria are in development.
Learning Framework Finalisation
Workstream leads are finalising frameworks, including module names, supporting references, required knowledge/skills, and prioritised learning outcomes. Outcomes are categorised by levels (100, 200, 300/EXP) to guide professionals through development stages, from novice to expert.