Maintenance of Sterility of Sterile Barrier Systems

To maintain sterility, sterile barrier systems need to maintain a barrier to microorganisms until the point of use. According to ISO 111607 microbial barrier performance requirements can be established by testing:

The microbial barrier properties of materials

The integrity of seals and closures

Characteristics of Seals

According to EN ISO 11607-1 requirements for seal width and seal strength (tensile and/or burst) shall specified and met. Typical tests are listed here below. Further tests are listed in annex B of EN ISO 11607-1.

  • Seal strength testing : ASTM F88
  • Burst and seal creep testing: ASTM F1140
  • Visual inspection (width, uniformity…) ASTM F1886
  • Peel-open characteristics: Peel-open characteristics shall be continuous and homogeneous, without delamination or tearing of the material that can affect aseptic opening and presentation.

Membership is open to Manufacturers of Sterilisation products or related services, with sales in Europe. Potential members also need to have implemented a quality management system certified by an accredited certification body.

For more details see Why become a member?

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