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Highly purified water for the Red Cross

Belgian turnkey project
Highly purified water for the Red Cross

The Central Fractionation Unit of the Belgian Red Cross (C.A.F.-D.C.F.) headquartered in Brussels supplies the domestic market with plasma proteins and acts as a contract supplier. The company produces highly purified water (HPW) for cleaning and production purposes. Pharmatec, a subsidiary of Bosch Packaging Technology, is a provider of complete solutions. It supplied a distributor system designed according to the customer’s specifications, a system the Belgian company uses to meet a wide variety of requirements.

Author Albrecht Voigt Area Sales Manager, Pharmatec

Fulfilling several specific customer wishes and integrating them into a single plant is the true test of any plant manufacturer’s skill. The challenge lies in balancing and harmonising all the components so as to achieve a homogeneous whole that smoothly fulfils every wish of the customer. To achieve this goal, the manufacturer may have to integrate two diametrically opposed processes.
Pharmatec was faced with such a requirement when C.A.F.-D.C.F. cvba placed an order for a highly purified water plant in August 2010. C.A.F-D.C.F. is an independent unit of the Belgian Red Cross headquartered in Brussels. In addition to supplying Belgium with plasma products derived from the blood of volunteer donors, C.A.F.-D.C.F. acts as a contract supplier for a range of plasma derivatives. 200 employees produce coagulation factors, immunoglobulins and albumin solutions at the facility at Needer-Over-Heembeek. Highly purified water (HPW), which is more economical to produce, is used in place of water for injection (WFI) in several steps in the production process, especially for cleaning. In Europe WFI is obtained solely by distillation and is used to produce infusion solutions whereas a membrane separation process is necessary for HPW. Both water qualities fulfil the same purity requirements. However, substituting WFI with HPW is only allowed in a few situations, for example in the final rinsing process in ampoule filling. To increase its HPW production capacity, C.A.F.-D.C.F. required a highly purified water plant to supply washing machines and cleaning-in-place (CiP) plants.
C.A.F.-D.C.F. was well aware of Pharmatec’s expertise in process engineering as it already had a Pharmatec distillation plant and purified steam generator in service. The company was therefore also awarded the new contract to install a highly purified water plant. Another factor in this decision was that Pharmatec was able to offer a complete solution. This was a turnkey project in which Pharmatec took care of everything from the plant engineering and construction to the installation of the pipes and the entire distributor system. C.A.F.-D.C.F.’s activity as a contract supplier posed the greatest challenges in this project. As the Belgian company must be able to respond flexibly to customer requests, the plant requires specific characteristics. These include combining three different sanitisation methods which to a certain extent are mutually exclusive.
The way to pure water
The core of the system is a classic highly purified water plant. Generating highly purified water from drinking water requires three treatment steps: pretreatment, processing and final cleaning. Pretreatment begins with coarse filtration of the water, after which it flows through a water softening plant. Here, a resin bed removes the hardening components from the water. The water softening plant consists of two filters that are connected in series for safety reasons and can be sanitised with hot water. The treatment step that follows involves initial reverse osmosis and final electrodeionisation.
Reverse osmosis is a physical filtration process that is used to remove the salt from the water. The medium now has only a residual salt content of one to five per cent. This content is then further reduced by electrodeionisation. Electrodeionisation employs an electrical field in combination with an ion exchange resin to reduce the content of carbon dioxide, silicon dioxide and total organic carbon (TOC) in the water by up to 90 %. The purified water (PW) generated in this manner, which C.A.F.-D.C.F. only uses for cleaning purposes, is now transformed into highly purified water by means of ultrafiltration. Ultrafiltration is a membrane separating process for separating specific impurities and solute substances. The separation is effected based on molecular weight or size. The separation limit of 6,000 daltons enables bacteria, viruses and pyrogens to be removed reliably.
Flexible sanitisation
The HPW obtained in this way is temporarily stored in a 25,000 l tank before being conveyed via a distributor system (the loop) to loads throughout the facility. The distributor system must be regularly sanitised to maintain the high microbiological quality of the water. This step represents another big challenge for Pharmatec. As a contract supplier, C.A.F.-D.C.F. responds to its customers’ specific needs, and these require different methods of sanitisation in the loop. As a rule, the company prefers ozonisation owing to its high efficacy and comparatively low energy costs. At the same time, C.A.F-D.C.F. must remain flexible not only in the production of its plasma products but also with respect to the necessary sanitisation methods. This means being able to switch back and forth between ozonisation, hot water san-itisation and pressurised water sterilisation. Implementing these three variants poses some very contradictory requirements.
With ozonisation the gas is dissolved by vortexing in the cold water of the tank, from where it is conveyed throughout the entire loop. The thermal disinfection methods differ in the temperatures used; hot water sanitisation involves a temperature of +85 °C while pres- surised water sterilisation is carried out at +121°C. With the latter method, the tank is also closed to the atmosphere in order to pressurise the system. Since for cost reasons the tank contents are drained to a defined level prior to sanitisation, the free area within the tank increases. Both gasless methods require the use of spray nozzles to ensure proper sanitisation of the surface not covered by highly purified water. These stainless steel nozzles are installed in the return line of the loop and spray the tank at regular intervals. Yet, if the water in the return line contains ozone, the spray heads will cause the latter to escape due to a loss of pressure. It is no longer dissolved in the water as a result. The combination of hot water and ozone is highly unusual for this reason.
The position of the tank presented another di-lemma. The situation at the site required the use of a horizontal tank for the C.A.F.-D.C.F. project. The reduced height of the water column contained within it means a risk that too little gas will dissolve in the water during ozonisation. This problem was solved by extending the pipe that feeds ozonised water into the tank to make it as long as the entire tank. The pipe was designed with a series of holes in the bottom to achieve the best possible distribution within the tank. This design developed by Pharmatec ensures sufficient ozonisation.
Double valve solution
Sanitisation of the loop also includes the branch lines to the consumers. Here, too, Pharmatec had to develop a customer-specific concept to ensure both sanitisation and complete emptying of these branch lines. The engineers opted for a double valve solution. A compressed-air valve is placed at the beginning of every branch line and an ordinary valve at the end. This solution makes it possible to drain residual water from the branch line and dry the line after the load has been disconnected, avoiding microbial contamination. When the loop is sanitised, these valves are opened sequentially for cleaning the branch line. The valves are operated by means of a program-mable logic controller, which is also used to regulate the removal of HPW by the loads. The pressure in the loop would not be able to accommodate simultaneous removal by every load because this would result in air being drawn into the system instead of water being released. To prevent this from happening, each load first sends a query to the control system (removal management system), which then determines the order of release. This is done according to the urgency of the queries.
Even the nozzles in the plant are unique. Their design minimises dead space and requires less piping, which reduces the risk of bacterial contamination for the customer. A novel solution was also developed for removing hot and cold water. The basic circulating temperature of HPW is +20 °C. However, certain loads such as washing machines require a higher temperature. An additional subloop was constructed for these cases. The subloop conducts the water through a heat exchanger and heats it to +80 °C. Only then is it conveyed to the point of removal.
All five of these specific challenges were effectively addressed with customer-specific so- lutions. The result is a complete highly purified water plant tailored to C.A.F.-D.C.F.’s individual needs. The seven-strong team implemented the project on schedule and the plant was able to commence operation in just over a year. “We’re absolutely satisfied with how the plant runs”, says Kris Raspoet, Assistant Manager Engineering at C.A.F.-D.C.F. “Pharmatec’s experienced staff focused squarely on quality and planning in order to achieve the project objectives”, adds Project Manager Eric Hoogenes. This successful cooperative venture paved the way for a subsequent project with Pharmatec.
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