BioPharm June eBook: Single-Use Systems

Issue link:

Contents of this Issue


Page 35 of 46

Single-Use Systems Shipping June 2018 BioPharm International eBook 35 dling, delays, and seasonal variation on product should be established. Shipment tests can be based on international standards such a s t h e A m e r ic a n S o c i e t y f o r Test ing a nd Mater ia ls' (A ST M ) D4169 or the International Safe Transit Association (ISTA) 3 series. Shipping and packaging expertise is necessary to define the appropri- ate validation level depending on the system used and the types of distribution cycles. CURRENT INTERNATIONAL STANDARDS ASTM D4169 (4) and ISTA 3 series (5) are both well-known standards for shipping systems. They provide stan- dardized validation methods using a variety of simulated shipping haz- ards and aim to compare or eval- uate the effectiveness of protective packaging and/or a packaged-prod- uct's ability to withstand the hazards of distribution. Table I compares the main differences between ASTM and ISTA standards for pharmaceuticals. T he level of sever it y for test conditions must be based on real- world shipment conditions and the desired safety margin. To optimize system validation tests, end users must know the distribution cycle, schedule, duration, severity level, and acceptance criteria, each of which may differ between sites or from one product to another. Pac k ag i ng e ng i ne e r s c a n b e i n st r u me nt a l i n de f i n i n g t he system to be tested, as well as in developing the most meaningful testing program. Testing param- eters and sample configurations ca n only be selec ted once t he t ra n sp or t at ion c yc les a nd t he t y pe of impact received by the load dur ing t ra nspor tat ion a re well understood. Developing this understanding, however, requires preliminary testing and analysis. DEFINING ADEQUATE TESTING The test protocol must simulate the lifecycle phases of the shipped product. Knowledge of the product and the type of transportation used (both the means of transportation used and the sequences involved) are crucial to understanding the shipping cycle and to providing adequate safety margin during the qualification testing programs. For e x a mple, A S T M D 4169 's distribution cycle DC12 is repre- sentative of the typical shipment shown in Table II for loads >68.1 kg (150 lb.) or unitized shipments. DC12 includes six modular test prog ra m s ad apte d to si mu late each segment of the projected dis- tribution with impact (horizontal impact, rotational flat drop, and edge drop), low pressure (repre- sentative of shipment by plane or high altitude), and vibration tests. A FOUR-STEP TESTING APPROACH An integrated, four-step approach (Figure 1) has been developed to clearly understand, based on test- ing, the behav ior of the g iven shipping system under real and nor ma lized test ing cond it ions. Table I: International standards for shipping tests under worst-case conditions. ASTM D4169 - Standard Practice for Performance Testing of Shipping Containers and Systems ISTA 3 Series: General Simulation Performance Tests General Simulation tests covering a range of package t ypes and distribution scenarios. The user must choose from tests, alternatives, intensities, sequences and specific procedures based on packaged- product and distribution characteristics. Applicable across broad sets of circumstances, such as a variet y of vehicle t ypes and routes, airplane, boat, rail, or a var ying number of handling exposures. Tests are carried out sequentially on the same package. Distribution Cycles (DC): DC should be chosen close to the projected distribution, e.g.,: - Preconditioning and conditioning - Handling: Manual and mechanical - Shock (Horizontal impact, Rotational flat drop and Edge drop) - Truck vibration - Low pressure (high altitude) - Compression and stacking Three levels of severit y (I, II, III) are described in the ASTM D 4169 Designed to provide a laborator y simulation of the damage-producing motions, forces, conditions, and sequences of transpor t environments. Applicable across broad sets of circumstances, such as a variet y of vehicle t ypes and routes, or a var ying number of handling exposures. For example: 3E & 3H tests consist of seven to 15 individual tests that are carried out sequentially on the same package. These tests simulate the handling and transit required in a road distribution network and cover truck transpor t only. They are composed of sequences, including, for example: - Preconditioning and conditioning - Shock (Horizontal impact, rotational flat drop and edge drop) - Truck vibration only - Compression (stacking) The level of severity for test conditions must be based on real-world shipment conditions and the desired safety margin.

Articles in this issue

Links on this page

Archives of this issue

view archives of BioPharm - BioPharm June eBook: Single-Use Systems