Tag Archives: data integrity

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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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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