1. INTRODUCTION
Packaging systems, also referred to as container–closure systems, are defined in Packaging and Storage Requirements 〈659〉; these systems are the sum of components that together contain and protect the drug product. Elastomeric components are formulated with elastomeric substances and can be either thermoset or thermoplastic in nature.
Every elastomeric component used in a pharmaceutical packaging/delivery system should be proven suitable for its intended use. The purpose of this chapter is to provide baseline chemical and biological reactivity requirements for the selection of elastomeric injectable packaging/delivery system components.
The establishment of the potential suitability of an elastomeric component does not rely on a single testing strategy. No single strategy can cover all elastomeric component attributes that have the potential to impact suitability. The chemical testing prescribed includes physicochemical tests. Extractable elements may also be relevant to the selection of a packaging system’s materials of construction and therefore a relevant aspect of material characterization. Materials of construction can vary widely in terms of their intentionally and unintentionally added elements and their potential use. Because of this, it is challenging to provide universally effective and efficient test methodologies, lists of target elements, and reporting requirements. It is the material user’s responsibility to evaluate the need for extractable elements testing and, if such testing is necessary, to establish and justify the means by which testing is accomplished, taking into account extraction conditions, target elements, and reporting requirement. Elastomeric components can vary widely in terms of their intentionally and unintentionally added elements as well as the components' potential use. Because of this, it is challenging to provide universally effective and efficient test methodologies, lists of target elements, and reporting requirements. It is the elastomeric component user's responsibility to evaluate the need for extractable elements testing and, if such testing is necessary, to establish and justify the means by which testing is accomplished, taking into account extraction conditions, target elements, and reporting requirements. The physicochemical tests are also augmented with biological reactivity tests.
If elastomeric components comply with the requirements outlined in this chapter, studies should follow to determine their suitability as recommended in Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems 〈1663〉 and Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 〈1664〉.
In summary, establishing chemical suitability of elastomeric components for injectable product packaging/delivery systems involves multiple tests and testing procedures including:
Elastomeric component screening—baseline requirements for biological reactivity and physicochemical tests described in this chapter.
Controlled extraction studies—studies as described in 〈1663〉 to create extractables profile(s) of particular pharmaceutical packaging/delivery systems and/or packaging components.
Pharmaceutical product assessment—Actual-case measurement of confirmed leachables in the pharmaceutical product in the packaging/delivery system intended for the commercial market. (For additional information, see 〈1664〉.)
Source from USP and Please refer to USP for details:
RTU(ready to use) 2ml COP vial
Polymer Vial for cell and gene therapies
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