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Controlling Particle Load in NovaPure® Elastomer Components
NovaPure® specs are established based on QTPPs and CQAs, plus their impact on the end patient, the drug product and the pharmaceutical manufacturer.
In the past years, particles in the final drug product have become one major reason for recalls in injectables. Several of the factors potentially contributing to particles in the final drug product are described in the USP chapter Visual Inspection of Injections.
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