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【求助】请问Pharmacy Bulk Package是指什么

最后编辑于 2007-06-21 · IP 广东广东
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这个帖子发布于 17 年零 359 天前,其中的信息可能已发生改变或有所发展。
USP General Chapter 关于注射剂的阐述中,有一个关于Pharmacy Bulk Package的定义,请问是指什么?
谢谢指教
原文如下:
……
Definitions
PHARMACY BULK PACKAGE
A Pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes.
The closure shall be penetrated only one time after constitution with a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. The Pharmacy bulk package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
Designation as a Pharmacy bulk package is limited to preparations from Nomenclature categories 1, 2, or 3 as defined above. Pharmacy bulk packages, although containing more than one single dose, are exempt from the multiple-dose container volume limit of 30 mL and the requirement that they contain a substance or suitable mixture of substances to prevent the growth of microorganisms.
Where a container is offered as a Pharmacy bulk package, the label shall (a) state prominently “Pharmacy Bulk Package—Not for direct infusion,” (b) contain or refer to information on proper techniques to help assure safe use of the product, and (c) bear a statement limiting the time frame in which the container may be used once it has been entered, provided it is held under the labeled storage conditions.
LARGE- AND SMALL-VOLUME INJECTIONS ……









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