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Pure water – quality monitoring is key to optimising pharmaceutical production

Author : Christof Kundel, Bürkert

03 February 2021

Throughout pharmaceutical manufacturing, pure and ultrapure water is required for many processes and end products. Both OEMs of production skids and end users appreciate the importance of maintaining the water quality standards in the production loop.

Using a proven and flexible monitoring system to collect sensor data, calculate differentials and communicate with a PLC can reduce the time for the initial build, as well as installation costs, and increase the speed of operation. 

Christof Kundel, Segment Manager Water for Bürkert, looks at the importance of monitoring water quality in production loops and how this can be achieved cost effectively.

Various grades of water quality are used in numerous processes in the pharmaceutical and biotech sectors, each with its own production methods and specifications. At the lower end of the scale, purified water is created using processes such as reverse osmosis (RO) or electrodeionisation (EDI).

Water for injection (WFI) is the highest water quality standard, using purified water as the starting point. Either a multi-column distillation plant (MCDP) or vapour compression (VC) technology is used to create WFI. Highly purified water (HPW) is unique to European pharmacopoeia and must meet the same standards as those established for WFI. In both cases, the water must be protected against recontamination and microbial growth.

Increasing speed with automation

Process water is held in a storage tank that feeds the ring line where tapping points, either manual or automated, deliver the water to the production process. Unused water goes back to the storage tank. It is essential that all the water quality specifications are upheld throughout this process.

Careful monitoring of water quality is crucial to ensuring process reliability, allowing any variations to be quickly identified and resolved. The parameters being monitored can include pH, conductivity, oxidation-reduction potential (ORP) and chlorine content, as well as temperature and flow rate.

Any divergence from the pre-set limit values can require production to be halted while cleaning and disinfection procedures are carried out. The resulting downtime can have a significant impact, especially on high-value production lines. Furthermore, if there is any doubt over the exact timing of the drop in water quality, some product batches may have to be rejected to ensure absolute product safety.

Typically, manual processes of monitoring are not very efficient. Individual sensors with their own displays are installed at various stations in the process. Readings must be taken from each sensor and the values then entered into the control system. The additional displays make the sensors more costly, both for the initial purchase and if any replacements are required. In addition, there are no automatic comparison functions between the sensors, whose values could provide early indications of malfunctions. 

Read the full article in the February issue of DPA.

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