BioPharm June eBook: Single-Use Systems

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Single-Use Systems Shipping June 2018 BioPharm International eBook 37 from a time axis to a frequency axis using Fast Fourier Transform, in order to obtain the vibration level reading in a power spectral density (PSD) curve, as shown in Figure 5. In this example, the num- ber of vibratory events per hour varies greatly during the distribu- tion cycle. This is due to the fact that events are especially intense during truck transport in India and the final phases of transport on the airport tarmac. Step 2: Te st ing under lab condi - tions, following ASTM D4169 and ISTA 3E. One each of a 100-, 200-, and 500-L Flexsafe 3D Bags was filled with water in its shipping palle- tank and equipped with a data logger. Each bag was then tested according to ASTM D4169 Levels I, II, and III and ISTA 3E require- ments. Transportation configura- tions (with and without a pallet between the vibratory table and the palletank) were tested to define the worst-case scenario for qualifi- cation testing. Analysis of the results provides complete k nowledge about t he shipping system behavior when submitted to severe physical condi- tions (Figure 6). Cha rac ter i z at ion test s a l low t he def i n it ion of wh ich nor m shou ld b e u s e d for t he f i na l qualification by assessing the most stringent testing program possi- ble. Qualification tests should be established in order to provide adequate safet y maragins, thus guaranteeing the reliability of the Cycle 1 – This shipment represents a transportation of more than 3,000kms / ~1,900 miles. Reims Paris France France Spain Valence 3,000 km or 1,900 miles 3,000 km or 19,000 miles India 400 km or 250 miles Bangalore Data were recorded during each cycle to quantify vibrations (intensity, duration, shakes) and the level of shocks experienced by the load during the transportation of different system configurations. Cycle 2 – This shipment from Europe to India represents a transportation of more than 30,000kms / ~19,000 miles including 400 km of truck driving in severely challenging road and other conditions. 100L-2 100L-1 INDIA Date in Europe (US format) Number of events per hour Tarmac Truck Plane Figure 3. Real transportation cycles. Figure 4. Event chronogram for two 100-L bags in their Palletank. PSD Level (g 2 /Hz) Frequency (Hz) High envelope Continuous envelope Figure 5. PSD graph for 100-L real transportation. Table III: Choice of ASTM D4169-14 distribution cycles. Distribution Cycle 12 Air (intercity) and motor freight (local), over 150 lb. (68.1 kg), or unitized Shipping 14 Warehousing (par tial cycle to be added to other cycles as needed) Shipping Testing parameters and sample configurations can only be selected once the transportation cycles and the type of impact received by the load during transportation are well understood.

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