The dye ingress test method is a routine test for container closures attached to parenteral drugs and large molecule drugs. Traditionally, this method uses ten test samples and three positive controls. During this testing, the test samples are place in a vacuum chamber and pressurized with dye. Three vials are punctured to allow dye to…
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The Cloud Benefits Life Science
The cloud is an on-demand accessible computer network hosted on the internet that stores data and allows easy access for collaboration. Due to current events, moving to the cloud has helped a lot of companies keep track of their data in one location. It held a lot of value when job locations were compelled to…
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Particulate Identification
In USP <1790> it focuses on detecting and removing units of visible particles; in addition, it promotes the need of preventing particulate contamination—which only comes from identifying the particle. Most pharmaceuticals require an understanding of particulate matter contamination. The ability to identify and characterize a particle is extremely beneficial with improving products within the development…
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What is a Recall?
About 4,500 drugs and devices are recalled yearly in the United States. Prior to these recalls, they were approved by the FDA, widely injected, implanted and ingested by customers. The FDA does not initiate a recall, they simply express concern and leave it up to the manufacture to execute a recall. The FDA can only…
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