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BioPharm June eBook: Single-Use Systems

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Single-Use Systems Shipping 38 BioPharm International eBook June 2018 www.biopharminternational.com shipping system when product is shipped in real conditions. Secondly, characterization tests provide the worst-case shipping conditions: depending on the con- figurations (e.g., with or without pallet, or using one or two systems per pallet). Results of the tests can differ significantly, especially in terms of condition severity. Finally, the tests allow for a com- partison of the levels of intensity between ASTM and ISTA testing. In the example ( Figure 7), Physical shakes have been chosen to dem- onstrate the level of severity for ASTM D4169 level II and ISTA 3E for each volume (100-, 200-, and 500-L). The acceleration seen by the shipping system when submit- ted to these normalized tests shows clearly that ASTM D4169 level II is more stringent than ISTA 3E. Step 3: Determination of the final qualification testing program by com- paring real shipping data with labo- rator y characterization data for the shipping systems . Compa r ison of real transportation measurements and data obtained during ASTM D4169 and ISTA3E, in addition to typical transportation cycle anal- ysis, allows the definition of an adequate testing protocol. This comparison is performed on all physical entities. The comparison is illustrated in Figure 8, in terms of PSD, the root mean square or Grms value, and shakes for horizontal and vertical shocks. Step 4: Final qualification testing program performed on filled Flexsafe 3D bags in their shipping Palletank according to ASTM D4169, assurance level II at 4 °C (39 °F) and 40 °C (104 °F). In this stage, 100-, 200-, and 500-L Flexsafe 3D bags that had been gamma irradiated at 50 kilo- gray (kGy), were set as the worst- case level. The bags were filled with water and installed in their shipping palletank, each with a shipping kit. Four bags per volume taken from two different batches were tested under the testing protocol defined previously. Qualification tests were performed at 4 °C (39.2 °F) and 40°C (104 °F) with previously defined worst-case configurations. The same bags were tested after one and three years of acceler- ated ageing. The validation proto- col was based on ASTM D4169-14. Distribution cycles numbers 12 and 14 were selected as the closest to the normal transportation con- ditions in the biotech industry, as shown in Table III. For e ac h te st s e que nc e, t he test met hod a nd sever it y level must be specified for the ASTM D 4169 -14 d i s t r i b ut io n c yc le s . Qualification protocol choices are shown in Table IV. Several options a re ava i lable. T he b est c hoice depend s on k nowledge of rea l transport conditions, the type of system bei ng t ra nspor ted, a nd the severity of conditions in that mode of transport. Configurations 100L PSD graph for 100L for all configurations -without Pallet Truck: Without pallet One per pallet Two per pallet Air: Without pallet One per pallet Two per pallet -one per Pallet -two per Pallet Grms for 100L Vehicle vibration 1- Schedule E - ASTM D4278 Method A – Truck and Air 2- ISTA 3E – Truck Results summary for vibrations (PSD graph), accelerations (Grms graph) and number of shakes PSD 100 L no pallet under ASTM D4169-14 TRUCK LEVEL I,II,III & ISTA-3E excitation PSD 100 L One per pallet under ASTM D4169-14 Truck level I,II,III & ISTA-3E excitation 1,E-01 1,E-02 vibration level (g 2 /Hz) vibration level (g 2 /Hz) 1,E-03 1,E-04 1,E-05 1,E-01 1,E-02 1,E-03 1,E-04 1,E-05 1 10 Frequency (Hz) Frequency (Hz) Frequency (Hz) Frequency (Hz) Frequency (Hz) Frequency (Hz) Response ISTA-3E Response ASTM D4169-14 Truck Level II ASTM D 4169-14 Truck Level I ASTM D 4169-14 Truck Level III Response ASTM D4169-14 Truck Level I Response ASTM D4169-14 Truck Level III ASTM D 4169-14 Truck Level II ISTA 3E Response ISTA-3E Response ASTM D4169-14 Truck Level II ASTM D 4169-14 Truck Level I ASTM D 4169-14 Truck Level III Response ASTM D4169-14 Truck Level I Response ASTM D4169-14 Truck Level III ASTM D 4169-14 Truck Level II ISTA 3E Response ASTM D4169-14 Truck Level l Response ASTM D4169-14 Truck Level lll ASTM D 4169-14 Truck Level ll ISTA 3E Response IST A-3E Response ASTM D4169-14 Truck Level ll ASTM D 4169-14 Truck Level l Response ASTM D4169-14 Air Level Il ASTM D 4169-14 Air Level l ASTM D 4169-14 Air Level lll Response ASTM D4169-14 Air Level lIl Response ASTM D4169-14 Air Level l ASTM D 4169-14 Air Level Il Response ASTM D4169-14 Air Level Il ASTM D 4169-14 Air Level l ASTM D 4169-14 Air Level lll Response ASTM D4169-14 Air Level lIl Response ASTM D4169-14 Air Level l ASTM D 4169-14 Air Level Il Response ASTM D4169-14 Air Level Il ASTM D 4169-14 Air Level l ASTM D 4169-14 Air Level lll Response ASTM D4169-14 Air Level lIl Response ASTM D4169-14 Air Level l ASTM D 4169-14 Air Level Il ASTM D 4169-14 Truck Level lll 100 PSD 100 L no pallet under ASTMD4169- 14 Air level I,II,III excitation PSD 100 L One per pallet under ASTMD4169-14 Air level I,II,III excitation PSD 100 L Two per pallet under ASTMD4169-14 Air level I,II,III excitation 1,E-01 1,E-02 vibration level (g 2 /Hz) vibration level (g 2 /Hz) 1,E-03 1,E-04 2 20 200 2 20 200 1,E-05 3,00 100L - No pallet 100L - 1 no pallet 100L - 2 on pallet Specifcation 2,50 2,00 Grms 1,50 1,00 0,50 0,00 Truck Level 1 Truck Level 2 Truck Level 3 ISTA3E Air Level 1 Air Level 2 Air Level 3 1,E-01 1,E-02 1,E-03 1,E-04 1,E-05 2 20 200 1,E-01 1,E-02 1,E-03 1,E-04 1,E-05 1 10 100 10 100 PSD 100 L Two per pallet under ASTMD4169-14 Truck level I,II,III & ISTA-3E excitation 1,E-01 1,E-02 1,E-03 1,E-04 1,E-05 Figure 6. Results for 100-L system: vibrations and accelerations.

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