With the click of a button, The Identifier System could have quickly tracked and traced the origin of the Pfizer-BioNTech vaccine defects and its distribution trail. On March 23, 2021, Hong Kong puts a stop on distributing the Pfizer-BioNTech Vaccine to residents. Many containers were flawed among a batch of 585,000 doses due to packaging…
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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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Essentially Free: How A Definition Tamed The Visible Particulate Matter Debate
In an article written by Louis Garguilo, Chief Editor for Outsourced Pharma, it talks about defining the term “essentially free” of visible particulate matter. In 2005, it has become a big concern with the number of injectable drug product batches being rejected or recalled because of particulate matter being present. In 2014, recalls in injectable…
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Visible Particulate Matter in Single-Use Bags
In an article published by BioProcess International, visible particulate matter in single-use systems (SUS) is stated to be a big concern. SUS is a product/equipment designed to be used once; it is primarily composed of plastic that can be discarded easily. It is necessary when creating products with SUS, the parenteral drugs must be “essentially…
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