Effective process validation contributes significantly to assuring drug quality. The FDA defines process validation “as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product”. Process validation establishes the elasticity and restrictions within the manufacturing process controls to deliver upon the specified attributes of the dosage form while preventing undesirable out-of-specification results.
Proportional valve technology in process automation offers a great a deal of flexibility and produces high-quality control results. A complete system supplied by Festo and installed in Boehringer Ingelheim's new technical centre demonstrates the performance that modern pneumatics can deliver. The project was developed in close communication between the Festo team and automation experts from the pharmaceutical company, allowing it to move forward quickly.
Today’s biotech and pharmaceutical production facilities must drive faster times to market and greater profitability for new products by boosting production yields and accelerating commercialization and scaling of capacity.
AstraZeneca is a global, science-led biopharmaceutical business. They are one of a handful of companies to span the entire life cycle of a medicine – from research and development to manufacturing and supply – as well as the global commercialization of primary care and specialty care medicines. Operating in more than 100 countries, AstraZeneca employs around 57,500 people worldwide. The company has manufacturing operations in 17 countries, and their innovative medicines are used by millions of patients worldwide.
As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount.