2025 Update from SfSAP
SfSAP is a non-profit professional association, formed as a collaborative initiative by organizations including International Irradiation Association (iia), AAMI, and PDA.
Its core aim is to support the sterility assurance community, which includes people and organisations involved in sterilising medical and pharmaceutical products, by building standardised competency and training frameworks.
SfSAP defines modules in the sterilization lifecycle and creates learning frameworks and outcomes so that individuals – from novices to experts – can develop and demonstrate competency based on knowledge, understanding, and experience.
Membership is free and open to professionals, manufacturers, regulators, training organisations and other stakeholders.
Recent Activities & Developments in 2025
Release and Update of Learning Materials
In 2024, SfSAP focused heavily on building and refining its Learning Frameworks to offer tier-based learning pathways for sterility assurance professionals (SAPs). This allows learners, training organisations, and regulators to follow a structured, domain-based approach.
The frameworks cover key sterilization modalities such as:
- Aseptic processing
- EtO (ethylene oxide) sterilization
- Radiation sterilization
- Moist-heat sterilization
- Packaging & sterile barrier systems
- Microbiology aspects of sterility assurance
In August 2025, SfSAP announced comprehensive updates to its publications, including new documents like Level Descriptions for Learners, as well as updated versions of the existing Learning Frameworks and Outcomes.
Expansion of Working Groups: New Focus on VHP Sterilization
On 23 September 2025, SfSAP launched a new Working Group dedicated to Vaporized Hydrogen Peroxide (VHP) sterilization. The group’s mission is to develop specific Learning Frameworks and Outcomes for this modality, outlining required knowledge, skills, and learning outcomes.
This shows SfSAP is extending its scope to newer/alternative sterilization methods, and responding to evolving technologies and industry needs.
Outreach, Engagement & Pilot Projects
SfSAP leadership participated in major international events: e.g., at the Medical Device Sterilization Workshop 2025 — Optimizing Radiation Sterilization (at Fermilab, Batavia IL) in September 2025. This demonstrates active engagement with global stakeholders.
SfSAP plans to launch a pilot project in early Q1 2026 involving Education Delivery Organisations (EDOs), contract sterilisers and healthcare manufacturers, to test and document competencies based on the new frameworks. Several organisations have already signalled interest.
On the administrative side, the SfSAP website has been revamped to host all resources (guides, learning frameworks, presentation materials) making access easier for members and stakeholders.
Recognition of Expertise & Career Path Structure
The tiered learning and competency levels (e.g., 100, 200, 300/EXP) provide a clear career pathway, from basic/novice up through expert, for people working in sterility assurance roles.
Why This Matters — Impact on Industry & Professionals
- By standardizing competency through internationally accepted frameworks and compliance with regulations (e.g., medical device regulations, ISO standards, GMP), SfSAP helps manufacturers, sterilizers, and regulators ensure sterilization practices are safe, consistent and audit-ready.
- For professionals, SfSAP provides a recognised path for career development (structured education, competence evaluation, and recognition for contributions) increasing the professionalism and visibility of “sterility assurance” as a discipline, which historically has been under-recognized.
- As sterilization technologies evolve (e.g., VHP, radiation, moist-heat, packaging systems) and regulatory demands increase, having a shared competence framework helps ensure quality and patient safety across industries and geographies.
- By piloting the frameworks and engaging with global organisations, SfSAP sets the stage for broader adoption — potentially influencing how sterilization training, certification, and quality assurance are delivered worldwide.