Guarding the Sterile Barrier System (SBS) Integrity
Under ISO 11607 (Packaging for Terminally Sterilized Medical Devices), the packaging system is itself classified as a medical device component. A sterile device inside a breached package is clinically worthless and dangerous.
Rigid Thermoformed PETG vs Polypropylene Trays
SterileValley utilizes medical-grade glycol-modified polyethylene terephthalate (PETG) for complex heavy instrument trays. PETG offers exceptional optical clarity, rigid impact resistance, and a broad heat-sealing process window that bonds reliably with breathable Tyvek lidding.
ASTM F88 and ASTM F1929 Seal Integrity Testing
Every cleanroom production run undergoes rigorous peel strength testing on calibrated tensile test machines (maintaining seal peel force between 1.5 N/15mm and 4.0 N/15mm to ensure secure barrier integrity without fiber tear). Dye penetration testing under ASTM F1929 verifies zero micro-channel leaks along the continuous seal flange.
