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?
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 药物散装包装
字面上是这样,但是具体是个什么概念呢?
是说很多种不同的成分,放到一个大包装里,用时再混到一起吗?有这种类型的产品吗?
请参照列出的上下文,帮忙解释一下。
是无菌制剂的一种包装形式 VIAL, PHARMACY BULK PACKAGE
FDA 代号是 VIALPHR
根据定义研究一下sterile transfer device 你就会明白,看看下面的网站
这样的品种多的很,随便检索就可以找到
(缩略图,点击图片链接看原图)
明了,!
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 药物散装包装
字面上是这样,但是具体是个什么概念呢?
是说很多种不同的成分,放到一个大包装里,用时再混到一起吗?有这种类型的产品吗?
请参照列出的上下文,帮忙解释一下。
是无菌制剂的一种包装形式 VIAL, PHARMACY BULK PACKAGE
FDA 代号是 VIALPHR
根据定义研究一下sterile transfer device 你就会明白,看看下面的网站
这样的品种多的很,随便检索就可以找到
(缩略图,点击图片链接看原图)
明了,!