BioPharm June eBook: Single-Use Systems

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Single-Use Systems Shipping 34 BioPharm International eBook June 2018 Image Courtesy of Sartorius Stedim Biotech An Integrated Approach to Shipping Liquid in Single-Use Systems Increased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms. C urrent regulatory guidelines provide clear insights into end-user responsibility for validating the shipping of liquids in sin- gle-use systems. At this point, however, there is no specific expectation or dedi- cated regulatory guidance on the subject. The US Food and Drug Administration (FDA), the European Medicines Agency (EMA) (1,2), and other regulatory bodies require that companies have quali- fied processes and can prove that the process will meet the quality standards of the final drug product. Guidance like the Parenteral Drug Association (PDA) technical report TR66 (3) provides following recom- mendation: "Shipping systems must be qualified for their intended use through proper design and testing in consultation with a packaging engineer." Drug manufacturing processes include more frequently international shipment which have to be defined. A risk assessment of the potential impacts of vibration, han- ELISABETH VACHETTE, FRÉDÉRIC BAZIN, MAGALI BARBAROUX, AND JEAN-MARC CAPPIA ELISABETH VACHETTE,, is senior product manager; FRÉDÉRIC BAZIN is R&D program manager; MAGALI BARBAROUX is R&D vice-president; and JEAN-MARC CAPPIA is vice-president of marketing for fluid management technology, all at Sartorius Stedim Biotech FMT, Aubagne, France.

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