There are two ways to join the SBA.
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.
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.
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:
Affiliation to the SBA is decided by a vote at one of the biannual conferences, requiring 67% of members present to vote in favour.
To be part of the SBA you either join as a Full Member or become an Affiliate
For full membership, the current fee is 9,500 Euros per annum. Any change to the annual fee has to be approved by the full membership at the AGM.
If you join as an Affiliate to the SBA, the annual fee is 10% less than that for full members. This means the current fee is 8,550 Euros per annum.
