USP对塑料包装系统提出新要求

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药典论坛39（6）颁布了一篇关于未来对塑料包装系统的新要求的文章。

在这篇文章中，专家组概述了关于药用塑料包装系统现有的和计划通则，这两章的目标都是描述了通用的、基于化学的方法来保证包装系统和它们的起始材料的质量和安全。

在这些关键内容中，可以找到：

A 合适安全的塑料材料的选择

B 表征材料和整个系统性质的重要性

C 萃取物和迁移物

产品和包装系统的相互作用可能影响产品质量。这些作用可能是增加的、减少的或者引起变化的。如果是增加了，那么包装系统会将包装材料的组分添加到产品中；如果是减少的，那么产品组分减少。如果能引起变化反应可能导致样品的稳定性的损失。

新的章节是<661.1><661.2>
An interesting article from the USP on thefuture requirements for plastic packaging systems has been published inthe Pharmacopoeial Forum 39(6).

In this article, the USP's experts group provides an overview of the alreadyexisting and also the planned General Chapters on pharmaceutical plasticpackaging systems. Together both chapters aim to describe a general andchemistry-based approach for the quality and safety of packaging systems andtheir starting materials for the construction of these packaging systems.

Among the key topics which are discussed, you can find:

• a. The selection of suitable, safe plastic materials of construction
• b. The importance of characterizing both the materials of construction and the packaging system
• c. Extractables and leachables
  

Interactions between the product and thepackaging system which may influence the quality of the product are ofsignificance. Such interactions can be additive, reductive or transformative.In case of additive interactions, a constituent of the packaging system isadded to the product; if reductive, a product constituent is reduced - forexample due to its uptake into the packaging system. Transformativeinteractions may lead to a loss of stability for example because ofphysicochemical interactions.

The two new chapters:

• <661.1> - Plastic Packaging Systems and their Materials of Construction, and
• <661.2> - Plastic Packaging Systems for Pharmaceutical Use
  

should also be clearly delimited againstelastomeric closures, containers made of glass and containers made of metalwhich have their own General Chapters.

You will find more information on the USP Pharmacopeial Forum (PF) website

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