In manufacturing, pharmaceutical companies’ drugs are produced in hopes to save patients as fast as they can. It is a “race to the finish” pharmaceutical online stated. Getting the drug products produced and sent out to patients as fast as possible is every manufactures goal. The third highest number of drug approvals in over twenty…
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Is Your Sterile Injectable Ready for Changes in Raw Materials?
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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Is your Equipment Qualified?
The slightest error or misuse of equipment could lead to an expensive risk, delay manufacturing of a product and minimize the amount of sales. It is necessary to have all items involved in the manufacturing process go through a qualification test. Equipment qualification is extremely critical. Qualification needs to be documented and recorded for both…
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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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