BioPharm June eBook: Single-Use Systems

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Single-Use Systems Shipping 40 BioPharm International eBook June 2018 • Visual inspection of the emptied bag—no leak • Dye penetration test on emptied bag—no leak. Results of shipping liquid-filled bags using ASTM D4169 cycle 12 & 14, level II after storage during 72 hours at 4 °C (39.2 °F) and at 40 °C (104°F) are shown in Table V. BUYER BEWARE: END-USERS ARE RESPONSIBLE Shipping is a complex and chal- lenging f unction. The end-user should not simply rely on system or material vendors' claims (e.g., of their products being "ISTA cer- tified" or "ASTM compliant"). It is important to understand what is behind each vendor's claim for its products. In addition, each claim should be verified to ensure that it is applicable to the intended use of the biopharmaceutical product. Finally, the end-user should understand the trial conditions used in the vendor tests and compare them closely to conditions for their specific application. The acceptance criteria (for both bag and shipper), the test protocol, and trial conditions must also be closely considered. Shipping va lidat ion must be caref ully defined. This requires close collaboration between the end-user and vendor, with param- eter setting linked to actual use. Collec ting v ibration data on real shipments will help the end user and vendor to understand the physical constraints of the ship- ping mode and select the best protocol to replicate them in labo- ratory testing. The limits of the system should be defined using knowledge of the safety margin and be tested under real packaging and real transport conditions. REFERENCES 1. FDA, Guidance for Industry Process Validation: General Principles and Practices (January 2011),, / guidances/ucm070336.pdf. 2. EMA, Guideline on Process Validation for the Manufacture of Biotechnology derived Active Substances and Data to be provided in the Regulatory Submission (London, April 2014),, www.ema.europa. eu/docs/en_GB/document_library/ Scientific_guideline/2016/04/ WC500205447.pdf 3. Parenteral Drug Association (PDA) "Technical Report Number 66, Application of Single-Use Systems to Pharmaceutical Manufacturing,", 2014, T ableOfContents/TR66_TOC.pdf 4. ASTM D4169: Standard Practice for Performance testing of Shipping Containers and Systems, 2014, astm. org, D4169.htm 5. ISTA: Guidelines for Selecting and Using ISTA Test Procedures and Guidelines, General Simulation Performance Tests,, ISTA_2017_Guidelines.pdf 6. Technical Report of Flexsafe 3D Bags Qualification for Liquid Shipping according to ASTM D4169 – Sartorius Stedim Biotech, Publication N°: SPT1105-e161201, Order N°: 85037- 557-48, Ver.: 12|2016 BP Number of shakes perceived during real transportation, ASTM all levels and ISTA Grms graph providing the acceleration perceived by the system during real, ASTM and ISTA conditions. Number Shakes Gms PSD Level (g 2 /Hz) Cycle #1 - 1 Rack Cycle #2 - Rack 1 ASTM Level 1 Response ASTM D4169-09 Truck Level I Continuous envelope 200L (all road) Frequency (Hz) Response ISTA-3E Response ASTM D4169-09 Truck Level ll Response ASTM D4169-09 Truck Level lll PSD graph for real, ASTM all levels and ISTA High envelope 200L (all road) Level 1 Level ll Level lll lSTA Eur 2 Eur 2 India Real data recorded ISTA3E - alone ASTM Truck - alone ASTM Truck - 1/pallet ISTA3E - 1/pallet covering the entire transportaion duration India Eur 1 ASTM Level 3 ISTA3E ASTM Level 2 Cycle #2 - Rack 2 Figure 8. Data analysis for a 200-L shipping system. Characterization tests allow the definition of which norm should be used for the final qualification by assessing the most stringent testing program possible.

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