Improving production, maintaining GMPs with a revamped purified water system

摘要

At a pharmaceutical production facility in Germany, a con-cept was conceived to optimize production while maintaining actual GMP (Good Manufacturing Practices). To achieve the required plan, production had to be relocated along with the supporting processes. The purified water system, installed with polyvinylidene fluoride (PVDF) piping, had to be modified to supply the necessary water quality to the new location and to ensure a successful and timely installation. This production facility manufactures oral pills, and due to the product's success, production utilization was near capacity and optimization was required to meet demand. The existing water system had performed to specification, but the company had not made modifications to it. The scope of the work called for an expansion of the existing system while maintaining purity and integrity features. With a tight schedule and little room for error, PVDF had to live up to its reputation as a flexible product ideal for both new and retrofit projects. The specified water quality for purified water is monitored periodically according to established standards, and PVDF had proven to be an optimal material selection for many years. To maintain the water quality and prevent microbiological contamination, it is sterilized with ozone (0.02 to 0.05 milligrams per liter) and, if necessary, heated to 85℃ for further sterilization.