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.