20141112 ECA新闻：USP对塑料包装系统的新要求 - 药群论坛

GMP News
" G; r# ~; H8 F4 j( F12/11/2014

New USP Requirements on Plastic Packaging Systems

USP对塑料包装系统的新要求

An interesting article from the USP on the future requirements for plastic packaging systems has been published in the Pharmacopoeial Forum 39(6).
* h. q- k( u0 o+ r2 ^* X" y i药典论坛39（6）刚公布了USP对塑料包装系统在将来的要求。
. N7 ?1 R+ ?, b: T* U) @6 P8 CIn this article, the USP's experts group provides an overview of the already existing and also the planned General Chapters on pharmaceutical plastic packaging systems. Together both chapters aim to describe a general and chemistry-based approach for the quality and safety of packaging systems and their starting materials for the construction of these packaging systems.
; g$ d) n( @5 Q& T- w/ k在该文章中，USP的专家组对已有和计划起草的药用塑料包装系统通则进行了综述。两个章节的目的是描述塑料包装系统在质量和安全方面的通用要求和化学的方法，以及用于生产这些塑料包材的起始物料要求。6 r6 N" e/ n9 c6 y' Q
Among the key topics which are discussed, you can find:

在这些讨论的关键问题中，你可以发现：

a. The selection of suitable, safe plastic materials of construction
选择适当的、安全的塑料原料用于生产塑料包材
b. The importance of characterizing both the materials of construction and the packaging system
塑料原料和包材定性的重要性
c. Extractables and leachables
可萃取物和可浸出物
( n4 s' p. C5 V" s# H: ?& R$ d8 L

Interactions between the product and the packaging system which may influence the quality of the product are of significance. Such interactions can be additive, reductive or transformative. In case of additive interactions, a constituent of the packaging system is added to the product; if reductive, a product constituent is reduced - for example due to its uptake into the packaging system. Transformative interactions may lead to a loss of stability for example because of physicochemical interactions.
' G& P8 F% s, y2 n产品和包材间的相互作用可能会对产品质量产生重大影响。这种相互作用可能是增加、减少或转移。如果是增加，则包材组份会进入药品，如果是减少，药品的成分会减少----例如，由于其成分进入了包材内。转移类相互反应可能会导致稳定性问题，例如由于理化反应。- l: U j7 o3 l+ \& ^
The two new chapters: 两个新的章节为

<661.1> - Plastic Packaging Systems and their Materials of Construction, and
<661.1>--塑料包材系统和其成型原料，以及
<661.2> - Plastic Packaging Systems for Pharmaceutical Use
<661.2>--药用塑料包材系统3 \$ h2 h% f- z, J2 l

should also be clearly delimited against elastomeric closures, containers made of glass and containers made of metal which have their own General Chapters.
: D3 H [ {: \$ T( _7 i 这个要与橡胶塞、玻璃容器和金属容器区别开来，这些包材有自己的通则。
+ F# w6 [) b+ ? You will find more information on the USP Pharmacopeial Forum (PF) website.

更多信息，参见USP论坛。

Source: USP

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201410133333116/