The Sterile Barrier Association (The SBA) is an influential trade organisation for companies who produce sterile barrier systems for the medical industry around the world.

The SBA was formerly known as ESPA (The European Sterilisation Packaging Association), changing it’s name in 2004 to better reflect the activities and ambitions of the association’s members.

The majority of members are international companies supplying to medical device manufacturers and hospitals globally, and although the Association principally concentrates on the European market, many member’s interests extend worldwide.

The main reason for the name change was member’s strong belief that the word “packaging” did not adequately describe the technical products and services provided by them. Member companies produce sterile barrier systems. Their production of sophisticated barrier materials allows single use medical devices and products to be sterilised after manufacture, and then to maintain that sterility up to the point of use.

The association has developed to include members (from Europe and the USA) whose companies produce raw materials such as medical grade papers and inks, provide sterilising services, and who manufacture processing machinery. 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 goal.

Formed 12 years ago, the SBA is a non profit making organisation. The current members collectively supply some 70% of the market for sterile barrier systems in Europe. Total sales of all products members produce runs to many billions of pounds, these being companies who are highly experienced, have good reputations, and invest large sums into research.

The association was formed to promote the industry and to assist in creating a positive environment to drive innovation in the technology associated with the production of Sterile Barrier Systems, by promoting high product standards and manufacturing excellence. The association works to educate customers and end users in the safe use of barrier systems, provides experts to participate in the process of forming legislation and new standards, and communicates with bodies and organisations responsible for or having an influence on the outcome of these activities. This is all done in pursuit of continual improvement and supporting customers and end users.

SBA Meetings and Management structure:-

Members meet twice per year, normally in March and October, at a two day conference. On the first day a technical and environmental meeting is held where a range of mutually relevant topics are discussed. On the second day, members attend a plenary meeting to discuss other topics such as for example finances, membership, public relations, new initiatives, concerns. Occasionally guest speakers are invited to the meetings. There is a dinner on the first evening for members, and invited guests.

Prospective members are invited to attend a conference and the dinner in order to meet members and discuss their membership. Potential members are requested to make a short presentation to describe their business and products at the plenary meeting on day two.

Meeting venues change, in 2005 the March venue is Copenhagen, and in October it will be Barcelona.

There is an SBA Board, comprising of up to eight members (one of which is elected Chairman by other Board members) plus the Director General. Board members are from member companies and are elected to their positions by the full membership. Board members undertake their roles on a non expense basis. The Director General is responsible to the Board for managing the day to day activities and finances of the SBA and is paid a fee.

The Board meets four times per year at the bi-annual conferences (after the Technical and Environmental meeting on day one), and normally in June and December.

Eligibility for Membership:-

• Be a manufacturer of sterilisation products or provide relevant services with sales in Europe.
• Have an acknowledged quality system.
• Nominate a senior representative to attend all annual general and extraordinary meetings.
• Nominate on occasions specialists from their companies to participate in the SBA’s working groups.

Membership is decided by a vote at a plenary meeting, requiring a two thirds majority of members present.

Subscription Fee:-

There is just one membership category, being full membership. The fee for 2005 is 6,000 Euros. Annual fees are approved by the full membership.

The key objectives of the SBA are:-

• To maintain, promote and seek to improve the product quality and quality standards relating to the manufacture and supply of single use sterilisation barrier systems to the medical industry.
• To provide a forum within which manufacturers of such products and services can discuss issues relevant to the industry.
• To consider all legislative measures and proposals that may affect the industry, and agree measures considered necessary.
• To establish and maintain links with National Governmental, European and non European legislative and regulatory bodies, Associations or groups of manufacturers, users and others, and to cooperate with these organisations as necessary on any matter which may affect the industry.
• To promote and influence the harmonisation of standards, practices and procedures within our industry in Europe, and to endeavour to extend that influence into other non European markets.
• To act as the voice of the European industry on all relevant matters and at all levels.

Key benefits of being a member of the SBA are seen as:-

• Being in a trade organisation which has a reputation for supplying safe products and high levels of service.
• Being in a trade association where companies are recognised as having the knowledge and credibility of supplying sterile barrier systems to the Healthcare industry.
• Being able to exchange experiences and information with fellow producers and suppliers.
• Having the opportunity of input into the forming of legislation and standards.
• Having a common voice in lobbying and regulatory aspects.
• Being part of an organisation publishing papers and carrying 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 on correct procedures to protect the sterility of devices at the point of use, and other issues affecting sterilisation.
• Being better able to develop alliances with users and patient groups, and give assistance as appropriate.

The SBA’s principle aim is to protect patients from infection.

Dave Harding – SBA Director General

January 2005