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.

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