INTRODUCTION
Cured silicone components are used as elastomeric closures for pharmaceutical packaging and also as components in manufacturing operations for drug substances and drug products. Silicone elastomers are obtained by cross-linking (curing) a linear polysiloxane constructed mainly of dimethylsiloxy units with small quantities of methylvinylsiloxy groups, where the chain ends are blocked by trimethylsiloxy or dimethylvinylsiloxy groups.
The cross-linking is carried out via high-temperature vulcanization, either by a free-radical reaction using organic peroxides, or by an addition reaction using platinum as a catalyst. The free-radical reaction uses 2,4-dichlorobenzoyl peroxide or a lower amount of peroxide together with alkyl or alkaryl peroxides such as di-tert-butyl peroxide or dicumyl peroxide. The addition reaction is a hydrosilylation of polysiloxane with silicon–hydrogen groups using a platinum catalyst and has the advantages that no by-products are formed, and only very small amounts of catalysts (ppm range) are required.
In all cases, appropriate additives such as silica are used. Organosilicon additives such as α,ω-dihydroxy polydimethylsiloxane can also be used in small quantities.
[Note—There are separate analytical test methods for platinum and free-radical and/or peroxide cross-linking silicone elastomers according to the cross-linking process utilized.]
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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