Self-seal, pre-formed sterilization pouch, with a medical-grade paper side and a transparent plastic film side. Sealed by a double-layer adhesive flap, with an integrated sterilization indicator. Meets the requirements of EN ISO 11607-1 for sterile barrier systems for medical devices.
Double adhesive flap: the first strip bonds paper to film to create the seal, the second reinforces and protects the seam. This redundancy compensates for uneven pressure when sealing by hand, and makes any tampering visible (torn paper fibers or misaligned strips).
Usage: no fold-over is needed, unlike some heat-seal formats; place the instrument, expel air toward the opening before sealing, press the double strip firmly and evenly along its full width with no wrinkles or gaps, leaving adequate margin between the seal and the instrument. In the autoclave, rack pouches on edge (paper side facing paper side, film facing film) rather than stacking flat, to allow steam penetration and drying.
Advantages over a heat-sealed reel: no sealing machine or warm-up time needed, single-step closure, consistent pre-formed size that avoids cutting and seal-width variability, less per-batch quality control.
The printed indicator only confirms exposure to the sterilization process, not the actual sterility of the contents, which depends on full cycle validation.
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