One of the most critical requirement of Pharmaceutical manufacturing facility is to maintain the sanitisation and prevent any microbial growth throughout the sterile manufacturing process. Sanitisation is maintained by ensuring the circulation of WFI/PW in a loop at a velocity of 2.5 m/sec and at an elevated temperature of 85 to 90-degree centigrade. When the process demands, the WFI/PW is cooled at Point-Of-Use.

There are different designs available for Point-Of-Use system to facilitate cold WFI/PW such as

a). The POU system consisting of Isolation valve-heat exchanger assembly connected to the main WFI/PW loop. The isolation valve end is connected to main loop, whereas the heat exchanger end is connected to dispensing line open for cold WFI/PW dispensing. When process demands cold WFI/PW, the hot WFI/PW is tapped from main loop through Isolation valve and cooled in heat exchanger before dispensing. The challenge is sanitization of heat exchanger and maintaining sterility to avoid microbial growth when the POU is not in use.

b). In other design, the POU system consist of two heat exchangers installed inline of main WFI/PW loop, one for cooling the water (before point-of-use) and other for reheating the cooled water (after point-of-use). When process demands cold WFI/PW, the hot WFI/PW running in the loop is cooled through heat exchanger before dispensing and all the cold WFI/PW after POU is again reheated in second heat exchanger to maintain the loop temperature. This design demands high energy for cooling and reheating the WFI/PW which increases the cost. Moreover, there are chances of pressure drop due to frequent cooling and reheating process within the loop

Therefore, above systems either has the risk of microbial growth generation due to sanitisation challenges or cost implication to get the cold WFI/PW. Pharmalab’s R & D team developed an advance Point-Of-Use (POU)cooling system that overcomes these challenges and facilitates convenience to the customer.

Pharmalab POU system is designed to form a small parallel loop when connected to main WFI loop. This is done by tapping inlet and out (with the flow control valve in between) on the main loop. In Pharmalab advance POU cooling system, the hot WFI/PW is circulated continuously through small parallel loop, consisting of a heat exchanger, to maintain sterility. The specially designed heat exchanger facilitates instant cooling of WFI/PW whenever required. The advance POU not only offers a solution to sanitisation and cost challenges but also provides added advantages of time saving, energy saving and reduced pressure drop in main loop.