Glass vial failures, specifically breakage, lensing, and cracks, are a source of product loss and process cost in the freeze-thaw, cryogenic preservation, and lyophilization of pharmaceutical products. Lyophilization is a common method for the preparation of freeze-dried pharmaceutical products, which requires low temperature processing to avoid product damage or decomposition. Because process times are long and lyophilization is regarded as an expensive process, considerable
Delamination has existed as a fundamental glass challenge for pharmaceutical manufacturers for decades. Delamination Explained While boron, a volatile element, is the root cause for delamination – the converting process also impacts a container’s chemical durability. During the converting process, specifically the step where the glass cane is parted (or separated) into two containers, the flame releases the boron from the glass network. Boron-containing compounds move around
As well as our article on Rubber Stoppers having a big influence on the performance during freeze drying, selecting the right Glass Vial can also improve the efficiency of your freeze-drying cycle and the lyophilization cake. What can be advisable is to check with a supplier of packaging that this is indeed an item that should be suitable for a freeze-dry application. If an injectable it needs to be Type I glass for example also very important is the method of manufacture, th
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