Hameln Pharma's new, 9200-square-meter sterile production plant, located at the headquarters of this 50-year-old, family-run business in Hamelin, Germany, was built to significantly increase production capacities in the area of parenteral contract manufacturing, create expansion possibilities for the company, and ensure reliable compliance with international regulatory standards.
The plant integrates all process steps required for the production and filling of parenteral products, while the subsequent processes of visual inspection through final packaging remain in the existing building and are being expanded and modernized there in the former site of the sterile operation. The new sterile production facility has new utilities and processing equipment, from weighing to filling and sterilization. Existing process equipment have been moved into the new building, so that all products must be transferred to the new plant. With a risk based approach to qualification and validation and the development of a “best-case strategy” for regulatory impact, the expense for the necessary activities of product-specific validations and stability studies have been reduced to an absolute minimum by using a model substance as evidence. This reduced the cost for all qualification and validation activities to a mere 6% of the total investment. This approach has been accepted by authorities and over 90% of customers.
The layout of the new sterile production plant is designed to maximize effi ciency and is therefore tailored to optimally support the actual production process: The arrangement of the work areas follows the flow of the individual manufacturing steps in a logical manner. Material and personnel movements within the factory are reduced to a minimum. Processing equipment are set up in such a way that processes run efficiently and staff are optimally supported in their activities by an ergonomically designed workstation. For example, all the filling lines are set up in a U-shape and can therefore be operated with 33% fewer staff than the existing sterile plant. The plan was to built a fast, flexible process where the immediate impact is to reduce waste and therefore costs. To achieve this, all process steps were simulated in advance and defined so that each movement can be completed efficiently in a standardized manner. This ensures a smooth process and saves valuable production time. Critical processes such as the cleaning and sterilization of equipment and filters have been automated, not only to increase efficiency, but also process security. For this same purpose, state-of-the-art RABS technology has also been implemented throughout the filling facilities. A sophisticated system of coordinated facility, transport and location reactivities for the cleaning and sterilization of format parts guarantees a process within the cycle that prevents waste of any type.
The planning of this streamlined plant began in March 2006. Only 25 months later, Hameln was able to put a highly innovative and flexible sterile production facility into operation.