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LIGHTHOUSE
LIGHTHOUSEThe Science of Pharmaceutical ManufacturingHeadspace oxygen monitoring and container closure integrity testing of pre-filled syringesApplication Note 104 Headspace oxygen monitoring and container closure integrity testing of pre-filled syringesIntroductionThe need to monitor headspace oxygen levels in pre-filled syringes arises from the require-ment to ensure the stability and potency of oxygen-sensitive product. Besides a loss of efficacy and reduction in shelf life, exposure of such products to oxygen can result in prod-uct discoloration, changes in dissolution rate and profile, and even toxicity or other phar-macological properties associated with nega-tive side inspection of headspace oxygen in syring-es having a purged nitrogen headspace can also be used to determine whether the con-tainer closure integrity of the syringe has been maintained. A pre-filled syringe that has suf-fered from a container closure integrity fail-ure will immediately begin to diffuse air into the headspace.
Container closure integrity testing Finally, the headspace oxygen measurement can be used to perform container closure integrity testing of a syringe with a purged headspace. If the syringe has lost closure integrity, there will be a diffusion of air into LIGHTHOUSE The Science of Pharmaceutical Manufacturing ...
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