WFI is a key ingredient of many pharmaceutical products, and can also be used in its own right, for example to irrigate wounds. Typically, WFI is recirculated at temperatures in excess of 75°C to prevent microbial growth. However, the take-off points for product manufacturing require WFI at ambient temperatures. The Melbourne site uses WFI as the bulk excipient ingredient in the formulation of sterile pharmaceutical products, as well as in equipment cleaning processes.
The overall engineering design for the new WFI production line was overseen by a third-party contractor as part of an on-site upgrade. That activity saw the replacement of old plate heat exchangers, which required replacement of the plate packs every four years at considerable cost, with new HRS SP Series units, which feature a corrugated tube technology, said to be more efficient than traditional smooth-tube heat exchangers. The SP Series is made entirely from stainless steel with a double tube plate to avoid cross-contamination, and also features an ASME BPE (bioprocessing equipment standard) clamp finish on the tube side.
HRS had to design the system to be installed in a confined area in the manufacturing facility’s ceiling space. To overcome the challenges created by such a location, HRS worked closely with stakeholders to offer a bespoke design that allowed for disassembly on site. This enables the frames and modules to be pulled down and reassembled in the space available.
The three SP Series heat exchangers are capable of cooling up to 14 tonnes of WFI per hour from an average temperature of 80°C to around 20°C using chilled water, with a pressure drop of 0.1 bar.
Commenting on the completed installation, the client’s project engineer adds: “HRS was awarded the tender contract as they offered the best price, with references confirming the quality of similar HRS equipment was good. HRS also offered the most compact design; that was an important factor due to the limited space available in the plant room. At the design stage, the local HRS sales director spent a lot of time working with us to ensure the design and geometry of the units would provide the performance we required and fit within the space available. The new heat exchangers were installed over the Christmas period in 2017 and have provided trouble-free service since installation. We would comfortably use HRS again for heat exchangers in future projects.”