Sterility Assurance: Adapting Facilities for New Products
Although many bio manufacturing facilities were designed around Clean-in-Place (CIP) or Steam-in-Place (SIP) equipment and fixed stainless steel piping, adapting these facilities for new processes demonstrates the advantages of single-use-systems.
One major manufacturer implemented a new process which required flushing of a critical filter element prior to filtering their final drug formulation. This single-use, SIP filter is encased in a stainless steel housing that was not piped for a filter-flush step. Their solution was to design a single-use bag system with a Steam-Thru® II Connection inlet to capture the flush solution. This bag system is received pre-sterilized and routed through their cGMP raw material inspection and release process.
When preparing the filter for SIP sterilization, the bag is connected via the Steam-Thru II to the filter housing’s bleed port. During SIP, steam passes through the filter housing, out the bleed port, into the Steam-Thru II middle port and out the lower port to a steam trap. Once SIP is complete, the Steam-Thru II’s valve is transitioned to the flow position creating a sterile flow path for collecting the flush solution. After the filter flush is complete, the Steam-Thru II’s valve is transitioned back to the steam position isolating the bag system and flush solution.
Sterility assurance is the primary reason the manufacturer selected a single-use bag system with the Steam-Thru II as an inlet. “When filtering during drug formulation steps, maintaining sterility is an absolute priority. The combination of pre-sterile bags and the Steam-Thru II provides the assurance we need without additional process equipment.” Another factor considered was Steam-Thru technology’s track record. “We’ve used Steam-Thru Connections for several points up-stream in other processes over past few years, so when we identified this new problem down-stream, we knew that Steam-Thru would meet our requirements.”
Integrating single-use components with traditional stainless steel processing equipment can help manufacturers increase flexibility and adapt facilities for new processes while maintaining process and product sterility.