Sterile Barrier Association

What Sterile Barrier Association does

The Sterile Barrier Association (SBA) is a European non-profit trade association founded in 1992 that represents manufacturers, material suppliers, converters, and users of sterile barrier systems (SBS) used in medical packaging. It states that its members represent approximately 80% of the European SBS market. In 2026 the association re-domiciled from the United Kingdom to Ireland, registering as a Company Limited by Guarantee (CLG) and transferring all members automatically into the new entity, citing the UK's departure from the EU and the euro-area concentration of members as drivers.

SBA does not produce commercial products. Its core "products" are an information portal at sterilebarrier.org, a library of guidance documents (sterilization compatibility, validation processes, seal strength, SBS symbols, labelling), educational materials and training resources, and a calendar of bi-annual conferences plus participation in international trade shows such as Medica, Medical Japan, WHX Dubai, MD&M West, and Medical Fair Asia. It also runs industry research instruments such as the multilingual Hospital Survey on Sterile Packaging Waste under its Data & Statistics Committee.

The association operates a subscription-style membership model, charging recurring membership fees to manufacturers and suppliers in exchange for access to conferences, guidance documents, regulatory support, and networking. Distribution is primarily direct member engagement, the website portal, and physical events, complemented by partnerships with ASTM International, SPMC, HPRC, MedTech Europe, EORNA, WFHSS, ISE, and dialogue with the European Commission on EU medical device and packaging regulation. SBA is led by Director General Nina Tillaeus (since August 2023) and Board Chair Thibaut Hyvernat, supported by a 12-person staff.

Name

Sterile Barrier Association

Legal name

Sterile Barrier Association

Website

https://sterilebarrier.org

Company type

Private

Founded year

1992

Operating status

Operating

Headcount range

11–50 employees

Short description

The Sterile Barrier Association is a European trade association founded in 1992 representing manufacturers, suppliers, and users of sterile barrier systems for medical packaging. Recently re-domiciled to Ireland, its members account for approximately 80% of the European SBS market.

Ownership category

akta.pro rank

Headquarters

HQ city

Dublin

HQ country

Ireland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Membership fees: The SBA generates revenue through membership fees from manufacturers, suppliers, and users of sterile barrier systems. Membership provides access to conferences, guidance documents, regulatory support, and industry networking.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

The Sterile Barrier Association (SBA) is the European trade association representing approximately 80% of the European market for manufacturers, suppliers, and responsible users of sterile barrier systems (SBS), medical packaging materials, and related services. SBA delivers industry representation, regulatory support, technical guidance, and educational resources to advance best practices, patient safety, and sustainability in healthcare packaging. Core activities include publishing guidance documents, organising bi-annual conferences, and engaging with EU regulatory bodies on sterile barrier standards.

Product overview

The Sterile Barrier Association (SBA) is the European trade association for manufacturers and suppliers of sterile barrier systems (SBS), medical packaging materials, and related services. Rather than manufacturing products, SBA provides an industry platform that offers guidance documents, technical resources, educational materials, regulatory information, and networking opportunities. The organization supports approximately 80% of the European sterile barrier systems market through member companies that produce sterile barrier materials, pouches, wraps, films, and related accessories. SBA's core offerings include its website and information portal, downloadable guidance documents on sterilization compatibility and validation processes, educational materials including validated SBS symbols, and industry collaboration through conferences and partnerships with organizations like ASTM, HPRC, and MedTech Europe.

Differentiator

Problem solved

Functional benefit

Products and services

• Industry Membership Program
• Bi-annual Industry Conferences (Spring and Autumn)
• Hospital Survey on Sterile Packaging Waste

Quantifiable outcome

• The association represents approximately 80% of the European sterile barrier systems market

Segments3 records

Ideal customer profiles3 records

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Eight partnerships are on record, tiered core, major and minor.

• SPMC (Sterilization Packaging Manufacturers Council)coreStrategic or Co-development Partner · 1 January 2026The SPMC is the US sister organization of SBA, focusing on protecting patients through sterile barrier packaging for medical devices. SBA collaborates with SPMC on regulatory affairs, standards development, and shares information about developments in European regulatory landscape. SPMC presents updates at SBA conferences.
• HPRC (Healthcare Plastics Recycling Council)coreStrategic or Co-development Partner · 1 January 2026HPRC is an industry organization working across the entire supply chain to advance recycling solutions for plastic products and packaging in healthcare. SBA collaborates with HPRC on sustainability initiatives, sharing information about European regulatory developments, and projects including the Design Guidelines on Recycling.
• ASTM InternationalcoreStrategic or Co-development Partner · 1 January 2026ASTM International is a consensus standards organization. SBA collaborates with ASTM Committee F02 on Primary Barrier Packaging, sharing information about new standards and collaborating on usability guidance documents and aseptic presentation documents.
• MedTech EuropecoreStrategic or Co-development Partner · 1 January 2026MedTech Europe is a healthcare organization representing the medical technology industry. SBA collaborates on EU sustainability and environment policy, sharing insights on how medical technology manufacturers can work together for human and planetary health and navigating EU regulatory landscape.
• EORNA (European Operating Room Nurses Association)majorStrategic or Co-development Partner · 1 January 2026EORNA is the European Operating Room Nurses Association. SBA is a proud sponsor of EORNA congresses, presenting on sustainability topics and hospital survey insights related to sterile packaging waste management.
• WFHSS (World Federation of Hospital Sterilization Services)majorStrategic or Co-development Partner · 1 January 2026WFHSS is the World Federation of Hospital Sterilization Services. SBA collaborates on sustainability strategies, LCA frameworks, and professional education. SBA members are invited to participate in WFHSS World Congress events.
• European CommissioncoreOthers · 1 January 2026SBA works with the European Commission on healthcare policy, regulatory development, and sustainability initiatives. The association actively engages with EU regulators on packaging and medical device regulations.
• ISEminorStrategic or Co-development PartnerSBA collaborates with ISE on industry initiatives and shares information about European regulatory landscape developments.

Scale indicators4 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Sterilization Packaging Manufacturers Council (SPMC): SPMC is the US-based sister association of SBA, focused on protecting patients through sterile barrier packaging for medical devices. The two organizations explicitly collaborate on regulatory affairs and standards development, making SPMC the closest direct peer in mission, membership type and scope.
• World Federation of Hospital Sterilization Services (WFHSS): WFHSS is the global federation for hospital sterilization professionals and is an active SBA partner on sustainability, LCA frameworks, and professional education. It operates as an international association for end-users of sterile barrier systems, directly aligned with SBA's user-facing constituency.
• Healthcare Plastics Recycling Council (HPRC): HPRC is an industry organization advancing recycling solutions for healthcare plastics and packaging. SBA partners with HPRC on the Design Guidelines on Recycling and sustainability initiatives, making HPRC a closely aligned peer in healthcare packaging sustainability.

Broad incumbents

• ISO (International Organization for Standardization): ISO is the global consensus standards body whose TC 198 (Sterilization of health care products) and related committees set foundational standards for sterile barrier systems. SBA's Director General actively participates in ISO committees, making ISO the apex broad-incumbent peer in this space.
• Association for the Advancement of Medical Instrumentation (AAMI): AAMI is a US-based standards organization and membership association for medical instrumentation and device sterilization. It develops standards (e.g., ST79 for sterilization) that directly intersect with SBA's domain, making it a broad-incumbent peer in healthcare standards.
• European Committee for Standardization (CEN): CEN is the EU-recognized standards body whose technical committees develop harmonized European standards relevant to medical device packaging. CEN membership and committee participation by SBA's leadership make it a broad-incumbent peer in European standardization.
• ASTM International: ASTM is a major consensus standards organization with which SBA collaborates through Committee F02 on Primary Barrier Packaging. It is a broad incumbent standards body whose work overlaps with SBA's guidance on validation, labeling and aseptic presentation.
• MedTech Europe: MedTech Europe is the larger trade association representing the broader medical technology industry in Europe. SBA collaborates with it on EU sustainability and regulatory policy, making MedTech Europe the broad incumbent that operates in the same regulatory and policy ecosystem as SBA.

Emerging players

• International Association of Healthcare Central Service Materiel Management (IAHCSMM): IAHCSMM is the US-based association for sterile processing and distribution professionals. While smaller in sterile-barrier-specific scope than SBA, it represents an adjacent end-user community with overlapping educational and certification missions.

Regional players

• European Operating Room Nurses Association (EORNA): EORNA represents European operating room nurses and is sponsored by SBA at its congresses. It is a regional clinical-user association whose members are key downstream users of sterile barrier systems, making it a peer in education and aseptic practice.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/sterile-barrier-association

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sterile Barrier Association