کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2505980 1557500 2008 4 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Maintaining a frozen shipping environment for Phase I clinical trial distribution
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی علوم دارویی
پیش نمایش صفحه اول مقاله
Maintaining a frozen shipping environment for Phase I clinical trial distribution
چکیده انگلیسی

The need for stringent temperature control provides significant challenges to pharmaceutical distributors operating in all sectors of the industry. Products with a frozen storage label requirement can be significantly problematic. This study aimed to provide evidence of robust and reproducible frozen shipment arrangements to be operated by a Phase I clinical trial unit. Dry ice was used to achieve a deep frozen internal parcel environment and was tested in a laboratory setting using ultra low temperature loggers within dummy product packs within the test parcels. The laboratory dry ice packing configuration was then repeatedly tested in real time transits using a Glasgow to London delivery schedule. An internal temperature specification was set to not exceed −10 °C during the transport. During each delivery, external temperature monitoring measured the temperature stress experienced by the box in transit. Results demonstrated the ability of the chosen system to not exceed −13.6 °C on average (−10 °C maximum) when exposed to external temperatures of up to +20.1 °C (mean kinetic temperature). The effect was maintained for at least 52.5 h.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: International Journal of Pharmaceutics - Volume 346, Issues 1–2, 4 January 2008, Pages 89–92
نویسندگان
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