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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Testing Container Closures
During the manufacturing process of injectable drugs, all pieces and parts need to go through a visual inspection process. The container, closure, product and final product all need to have individual inspections. Container closure integrity is extremely important, especially when involved with parenteral drugs. Parenteral drugs have the highest risk packaging application concern for closure…
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Pfizer’s Newest Vaccine Plant Has History of Mold Issues and Recalls
On Wednesday, March 10th 2021, WebMD posted an article with information on the newest vaccine plant the FDA are allowing to produce COVID-19 vaccines. This plant is owned by Pfizer, located in Kansas and is now booked to produce the most urgently needed drug product. Although, there is one main concern; there is a known…
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Johnson & Johnson Covid-19 Vaccine Recall
15 million Johnson & Johnson vaccines ruined from a manufacturer in Baltimore. These vaccines were scheduled to be delivered within the next month; but quality control is now being questioned. At the manufacturer—Emergent BioSolutions, they mixed up the ingredients for the J&J single-dose vaccine with a different COVID-19 vaccine that was being produced in the…
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