Before a device reach­es its tech­ni­cal file or 510(k), the pack­ag­ing has to hold up as well as the prod­uct itself. Use this check­list to con­firm your ster­ile bar­ri­er sys­tem, design and process­es are ready. Every test named here is one we run in our ISO/IEC 17025-accred­it­ed lab.

Mate­ri­als and ster­ile bar­ri­er system

• Bar­ri­er mate­r­i­al select­ed and jus­ti­fied for the intend­ed ster­il­iza­tion method
• Micro­bial bar­ri­er main­tained across the claimed shelf life
• Mate­r­i­al com­pat­i­bil­i­ty with the device and, where rel­e­vant, bio­com­pat­i­bil­i­ty considered

Design

• Pack­ag­ing pro­tects the device through han­dling, stor­age and distribution
• Ster­ile bar­ri­er allows asep­tic pre­sen­ta­tion at the point of use
• Design suits the device geom­e­try and mass, includ­ing sharp or heavy devices

Process val­i­da­tion

• Form­ing, seal­ing and assem­bly process­es val­i­dat­ed (IQ, OQ, PQ)
• Crit­i­cal process para­me­ters defined, mon­i­tored and controlled
• Clean­room con­di­tions qual­i­fied (ISO 7 / ISO 8) with envi­ron­men­tal monitoring

Test­ing

• Seal strength char­ac­terised (ASTM F88)
• Seal and pack­age integri­ty ver­i­fied: dye pen­e­tra­tion (ASTM F1929 / F3039), bub­ble emis­sion (ASTM F2096 / D3078), visu­al seam inspec­tion (ASTM F1886)
• Per­for­mance and dis­tri­b­u­tion sim­u­la­tion for the real sup­ply chain (ASTM D4169 or ISTA 3), plus cli­mate test­ing (ASTM D4332)
• Shelf life sup­port­ed by accel­er­at­ed and real-time aging (ASTM F1980)
• Integri­ty re-test­ed after aging and dis­tri­b­u­tion, not only at time zero

Doc­u­men­ta­tion

• Pro­to­cols and reports com­plete and trace­able for the tech­ni­cal file / 510(k)
• Change con­trol in place to trig­ger re-validation
• Sup­pli­er oper­ates an ISO 13485 qual­i­ty sys­tem with FDA-aligned processes

Fruh Pack­ag­ing is ISO 13485 cer­ti­fied and runs an ISO/IEC 17025-accred­it­ed test­ing lab, with court-valid results and FDA-aligned process­es. The seal-strength, integri­ty, aging and dis­tri­b­u­tion checks named here are part of the accred­it­ed meth­ods we run every day (ASTM F88, F1929, F2096, F1980, D4169).