In any manufacturing company, it is likely that raw material will change from time to time. These changes are modifications in API synthesis, key starter materials and intermediates. These changes are expected and necessary for manufacturing improvement. The best approach to alternating materials from a supplier, is to always keep track and maintain data and…
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Innovation Begins with a Problem
Dr. Thomas Ingallinera from Pharmaceuticals International Inc. has a motto, “challenges frame opportunities”. This motto supports many situations within the pharmaceutical industries as well as others. When companies face issues, that is when they decide that they need to make changes and updates. This system is not always the best, because when a problem occurs,…
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Robotics, Isolators & Restricted Access Barrier Systems
Aseptic Process is the process for manufacturing sterile products where microbiological contaminants could not enter the production area or surface of the product. It is challenging for pharmaceutical manufacturers to ensure that the product they are handling will have absolutely no contaminants—especially if involving parenteral drugs. To isolate human contamination, it is beneficial to use…
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Innoveix Pharmaceuticals, Inc. Recall
Innoveix Pharmaceuticals, Inc. recently voluntarily recalled lots of sterile compounded drug products. Semorelin/ Ipamorelin 3mg and injectable AOD-9604 3mg were the products that were recalled from specific Lots. These products were not sterile—when intended to be sterile. Having non-sterile products could lead to life-threatening infections. These products were distributed nationwide to customers and medical facilities.…
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