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Single-Use Systems Shipping www.biopharminternational.com June 2018 BioPharm International eBook 39 Truck ISTA3E 80 100L - 1 alone 100L - 1 on pallet 100L - 2 on pallet 70 60 50 40 30 20 10 100 90 80 70 70 60 60 50 50 40 40 30 30 20 20 10 10 0,2 0,4 0,6 Max. Acc. [g] Max. Acc. [g] Max. Acc. [g] V [m/s] 0,25 0,35 0,3 V [m/s] 0,2 0,15 0,1 0,05 0 0,5 0,6 200L - 2 on pallet 200L - 1 alone 200L - 1 on pallet 500L - 1 on pallet 500L - 1 alone V [m/s] 0,4 0,3 0,2 0,1 0 0 0 0,8 1,0 ASTM Level 2 Truck ISTA3E ASTM L2 Truck ISTA3E ASTM L2 Figure 7. Severity graphs comparing ISTA 3E 240 min and ASTM D4169 level II 90 min. Table IV: Qualification protocol choice. Test sequence Comments on life cycle Chosen test program 1 Pre-conditioning Depend of customer usage temperature range 4 °C (39.2 °F) or 40 °C (104 °F) during 72 hours 2 Mechanical handling Handling, loading, unloading and sor ting (storage area, truck loading, plane tarmac before transpor tation) SCHEDULE A 2.1 Truck handling ASTM D6055 Method A /5 cycles round trip 2.2 Horizontal impact ASTM D880 Method B/each side 1 shock (total 4) 2.3 Rotational flat drop test ASTM D6179 Method C/2 drop tests (shor t and long edge) 3 Vehicle vibration* Transpor tation mean SCHEDULE E 3.1 Truck spectrum By truck ASTM D4728 Method A - 90 minutes truck spectrum 3.2 Air spectrum By plane ASTM D4728 Method A - 90 minutes airplane spectrum 4 Low pressure When transpor tation by plane SCHEDULE I ASTM D6653 40 °C and 4 °C - 595.73hPa - 60 minutes 5 Mechanical handling Handling, loading, unloading and sor ting (storage area, truck loading, plane tarmac af ter transpor tation) SCHEDULE A 5.1 Truck handling ASTM D6055 Method A /5 cycles round trip 5.2 Horizontal impact ASTM D880 Method B/each side 1 shock (total 4) 5.3 Rotational flat drop test ASTM D6179 Method C/2 drop tests (shor t and long edge) 6 Warehouse stacking Stacking in storage area SCHEDULE B ASTM D642 - 3s Table V: Qualification tests results at 4° C (39.2°F) and at 40°C (104°F). Ageing Test samples and number (50kGy) Result 100L 200L 500L Container Total T=0 4 bags per volume Shipping 12*2 Compliant to specifications for systems and bags No leak T=1 year 4 bags per volume Shipping 12*2 Compliant to specifications for systems and bags No leak T=3 years 4 bags per volume Shipping 12*2 Compliant to specifications for systems and bags. No leak damage. After ASTM tests cycles, visual inspection and dye penetration tests were used to inspect the bags for damage or leakage, and to find any system damage. The following crite- ria were used: • Visual inspection during test— no lea k, no d a mage on t he system