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Single-Use Systems Shipping 36 BioPharm International eBook June 2018 www.biopharminternational.com All figures courtesy of the authors This approach provides data that allow a final qualification proto- col to be chosen that will guar- antee the system's safety with a mea su rable sa fet y ma rg i n (6). T his approach for liquid ship - ping validation has been taken with Flexsafe3D shipping systems, shown in Figure 2. Step 1: Real shipping conditions. Recorded data provide snapshots of what can happen during the chosen real transportation cycles, includ- ing a variety of conditions that would be found in truck or airplane transport, or in cases that involve long-distance travel, and severe road conditions. Each of the filled 10 0 -, 20 0 -, and 500-L Flexsafe 3D Bags in its shipping Palletank was equipped with a data logger and shipped u nder t wo rea l t ra nspor tat ion cycles, as shown in Figure 3. Under the supervision of a trained pack- aging engineer, the resulting data can be visualized with an event chronogram (Figure 4). For example, the recorded vibra- tion levels provide complex and chaotic acceleration measurements over time. The v ibration levels must be mathematically transferred Table II: ASTM D4169's Distribution Cycle Number 12. Test name Short description Tests example for unitized load Schedule A: Handling Manual & mechanical handling determines the abilit y to withstand loading, unloading, stacking, sor ting, palletizing operations Example: Mechanical handling: - Fork lif t handling – rotational flat drop test ASTM D6179 - Side impact test – horizontal shock on sides of the shipping unit ASTM D880 - Truck handling – ASTM D6055 Schedule D: Stacked vibration Stacked vibration determines the abilit y to withstand the dynamic compression forces resulting from vehicle stacking Example: - stacked load to be calculated and stacked system submit ted to random vibration profile - ASTM D4728 Schedule I: Low pressure (High Altitude) Hazard Estimates the potential impact of reduced pressure when the system is transpor ted via aircraf t. Usual recommended test conditions: ASTM D6653 at a pressure equivalent to 4267 m (14,000 f t) for a period of 60 min. Schedule E: Vehicle vibration Subjects the load to a random vibrator y profile Truck vibrator y profile ASTM D4728, Method A Air vibrator y profile ASTM D4728, Method A Schedule J: Concentrated Impact Simulates anticipated low level concentrated impacts that are likely to be received by packages during sor ting operations and in transit Test method described in ASTM D6344 Schedule A: Handling Determines the packaged product's abilit y to withstand loading, unloading, stacking, sor ting, and palletizing operations Example: Mechanical handling: - Fork lif t handling – rotational flat drop test ASTM D6179 - Side impact test – horizontal shock on sides of the shipping unit ASTM D880 - Truck handling – ASTM D6055 Lid Lid Holding rods Steel plate Foam Dunnage foams Bottom port protection Shipping kit Figure 1. Four-step testing approach. Figure 2. Testing with 100-, 200-, and 500-L 3D bags.