By Chrissie Fuchs, Marketing & Communication at Fedegari Group; Sergio Mauri, Director, Marketing & Business Intelligence at Fedegari Group
According to the FDA (Food and Drugs Administration), pharmaceutical manufacturing has been well known for its inefficient and costly operations (2004). Recently, the need to increase efficiency and reliability has developed the necessity for improving the Quality by Design (QbD) of the solutions adopted by this traditional market. However, the main challenge for the pharmaceutical industry in moving towards cost-effective manufacturing is to design new operational procedures and workflows that comply with all regulatory requirements, but at the same time support continuous improvement by minimizing costs, time and resources needed (O'ROURKE & GREENE, 2006). Fedegari Group was chosen as the preferred supplier of contamination control systems for a multinational pharmaceutical company with a new sterile antibiotic powder plant. The requirements for the new pharma plant emphasized the need for Grade A continuity in the manufacturing process with a barrier between operator and sterile process. The main challenges of the customer were to optimize the powder filling process and benefit from the cost-effectiveness of process integration with the best ergonomic design for the operators as well as ensuring a reliable and safe pharmaceutical process.