The cleaning validation processes of companies manufacturing active ingredients continues to be at the forefront of concerns of federal regulators, especially to protect the health and well-being of consumers. Per cGMP and FDA guidelines, cleaning procedures must be repeatable, verifiable and recorded.
In recent times, numerous pharmaceutical companies have been publicly criticized for not properly cleaning their equipment that comes into contact with Active Pharmaceutical Ingredients (APIs) and thus contaminating other products that are manufactured by that machinery. These contaminated products can then be consumed by patients, potentially causing life-threatening complications. More than ever, it’s become essential for these pharmaceutical manufacturing companies to ensure the cleanliness of every piece of apparatus used in manufacturing these products.
Here’s how one multinational pharmaceutical company became GMP compliant whilst increasing production and reducing costs. Find out more by submitting the form below.
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IWT worked to execute an Atorvastatin removal test as the worst-case scenario for a potential new client. The reason for buying a new cleaning system came from failures registered during their own cleaning validation test as a result of the Atorvastatin introduction. In fact, Atorvastatin proved to be resistant to removal due to the high adhesion to the BIN walls, which are used for mixing, with a criticality around the top angles. An integrative test with dihydrate Azithromycin with sugar is requested.
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