Why Become A Member/Affiliate to the SBA?

There are two ways to join the SBA.

Full Member – Available only to manufacturers of sterilisation products or relevant services
Affiliate to the SBA – Available to Responsible Users of Sterile Barrier Systems – likely to be Medical Device Manufacturers/In Vitro Device Manufacturers/Pharma or Life Science companies/Healthcare professionals associations

Please note, Companies who fulfil the criteria to become a Full Member are not allowed to become an Affiliate. Similarly if an Affiliate develops manufacturing capability which would enable them to meet the eligibility criteria for a Full Member, then they must upgrade to Full Member.

Full Member of the SBA

The majority of members are long established and experienced international companies supplying to medical device manufacturers and hospitals around the world.

The Association has developed to include members from Europe, countries that border Europe, Asia and the USA. Member companies operate in various stages of the supply chain, many manufacturing sterile barriers, others producing raw materials such as medical grade papers and inks, providing sterilising services, and manufacturers of processing equipment.

This all adds up to a large industry group committed to ensuring that, in partnership with their customers, they continually develop and improve products and services essential for “protecting the patient”, the association’s primary objective.

The current members collectively supply some 80% of the market demand for sterile barrier systems in Europe, and along with their significant sales and manufacturing facilities around the rest of the world, have a strong presence in the global market. Member companies are highly experienced with very good reputations and are able to invest significant funds into researching new innovative products.

A major and very essential mission for the SBA is to provide experts to participate in the process of forming legislation and new standards, and communicating with bodies and organisations responsible for, or having an influence on the outcome of these aspects. This is all done in the pursuit of continual improvement and supporting customers and end users, and demonstrates the SBAs determination to do all that is required to ensure patient safety remains the top priority when developing or changing legislation and standards.

Members are always seeking to find more effective methods of providing information and educating customers and end users, and key to achieving this is the ongoing enhancement of the SBA website. The SBA welcomes requests from all sources on how this can be improved upon.

Affiliate to the SBA

Affiliates share the same values as full members in that they have the same aim to continually develop and improve products and services essential for “protecting the patient”, but will typically be a Responsible User of Sterile Barrier Systems (SBS) rather that a manufacturer of SBS.

As Responsible Users, Affiliates are often at the sharp end of the use of SBS. Thus the SBA provides to the Affiliate support and knowledge to ensure they fully understand how SBS can and should be used to Protect the Patient and are also aware of future legislation that may impact that use. They can then feedback their experience and knowledge to help the SBA in determining the best way to tackle the ongoing challenges that present themselves.

Value of being a member/affiliate

Being in a trade association where members have a reputation for supplying high quality, fit for purpose products, and high levels of service.
Being in a trade association whose companies are recognised as having the credibility and knowledge of supplying sterile barrier systems to the healthcare industry.
Being able to exchange experiences and information with fellow producers and suppliers.
Having the opportunity to put forward ideas and comments to bodies responsible for the forming of legislation and standards.
Having a common voice in lobbying.
Being part of an organisation which publishes papers and carries out projects on issues of common interest and benefit.
Having the capability to better promote the value of sterile barrier systems.
Being better able to develop and deliver educational packages, such as the correct procedures to be adopted to ensure that when SBS are removed at the point of use, sterility is not compromised.
Benefitting from SBA commissioned market studies which only members have access to (not available to Affiliates).
Being able to better develop alliances with users and patient groups, and give assistance as appropriate.

Eligibility For Membership

Requirements for membership are:

1. Be a manufacturer of sterilisation products or provide relevant services, with sales in Europe.

2. At all times, designate a senior representative of that member to attend the Association’s Annual General Meetings and any Extraordinary General Meetings as that member’s representative.

3. Nominate, on occasions, specialists from their companies to participate in the Association’s working groups.

4. Commit to comply with Association’s Code of Practice.

5. Have implemented a quality management system certified by an accredited certification body to be in compliance with ISO 9001 or with a globally acknowledged equivalent quality standard.

Membership of a new company is decided by a vote at one of the biannual conferences, requiring 67% of members present to vote in favour.

Eligibility For Affiliation to the SBA

The key acceptance criteria for a Manufacturer, Pharma or Life Science company to become an Affiliate of the SBA is that the applicant is a Responsible User of Sterile Barrier Systems. For Associations, they will need to demonstrate that they support members who would be designated as Responsible Users.

A Responsible User would be defined as a healthcare sector player who uses SBS to package and protect devices or products it produces or uses, where the packaging forms part of the final assessed and regulated product. The manufacture, usage, or Sales of these products has to be as defined in the Association Articles.

Other eligibility criteria that would apply are as follows:

At all times designate a senior representative of that member to attend the Association’s Conferences as that affiliate’s representative.
Nominate on occasions, specialists from their companies to participate in the Association’s working groups.
Commit to comply with the Association’s Code of Practice, as amended from time to time by the membership.
Have implemented a quality management system certified by an accredited certification body in compliance with ISO 9001/13485 or with a globally acknowledged equivalent quality standard (may not apply to an Association – discuss with SBA).

Affiliation to the SBA is decided by a vote at one of the biannual conferences, requiring 67% of members present to vote in favour.