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            發布日期:2020-05-08 作者: 點擊:


            From time to time we receive GMP Questions from our Members. Today we cover the subject glass delamination.


            The formation or flakes of glass particles on the inside of glass containers is referred to as delamination. These glass fragments, created by the interaction of the solution with the container walls, can pose a risk - especially when it comes to parenterals. Glass is considered to be an inert packaging material; however that is not wholly correct depending on the composition of the contained solution and the composition of the glass in question.


            Delamination and the resulting particle release have been a recurring reason for recalls in the past couple of years. There aren't any known cases of patients being harmed; authorities like the FDA still see a risk for the particles to cause embolism or thrombosis, though. According to applicable US law, the formation of glass particles in a sterile container is intolerable. 21 CFR 211.94 states that product containers may not be reactive or additive or influence the quality of a product. The pharmaceutical manufacturer is responsible for preventing glass delamination.

            掉屑及其所導致的顆粒異物已經成為過去幾年所發生的召回中常見的原因了。也沒有看到有病人受此危害的案例,然而,監管當局如FDA一直認為顆粒異物會導致血栓。根據當前美國法律,無菌容器不得有玻璃顆粒異物。21CFR 211.94規定產品容器不得化學性質活潑、易釋出、或影響產品質量。藥品生產者有責任防止玻璃瓶掉屑。

            Delamination is facilitated by:


            • Production of vials made of tubular glass; Vials made from molded glass are less susceptible to delamination.

            • 使用管制玻璃瓶的生產;模制玻璃瓶則不容易掉屑。

            • Solutions with an alkaline pH value may facilitate delamination; so may several buffers (e.g. citrate and tartrate).

            • 堿性溶液可能會更容易導致掉屑;如很多緩沖液(檸檬酸鹽和酒石酸鹽)

            • Long contact times between a product and the inner glass surface can also promote glass delamination. This has a direct effect on the storage life of the product.

            • 產品和玻璃內表面長時間接觸也可能導致掉屑,這直接影響了產品的儲存效期。

            • Elevated storage temperatures; lower temperatures make delamination less likely.

            • 較高的儲存溫度,低溫則不容易導致掉屑。

            • The heat treatment during terminal sterilisation also has a negative effect on glass stability and may foster delamination.

            • 最終滅菌過程的熱處理也對玻璃瓶穩定性有不良影響并可能引起掉屑。

            The FDA recommends the use of resistant glass like borosilicate glass for products with elevated risk. Pharmaceutical manufacturers should take special care when it comes to choosing a supplier for glass vials and re-examine established suppliers or rather their quality management systems to minimize the phenomenon of delamination.






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