Heat Exchangers for loops of Purified Water (PW) and Water for Injection (WFI)
The pharmaceutical and biotechnology industries routinely use both, Purified Water (PW) and Water for Injection (WFI) in the production of raw materials and final products, as well as in the washing of equipment and tanks.
The physicochemical and microbiological characteristics of these waters for pharmaceutical uses are defined in the different pharmacopoeias. Consequently, the obtainment processes are different:
Purified water (PW). In a first pre-treatment phase, a feed water (drinking water) is processed in order to be disinfect it, remove dissolved organic matter and particles and remove hardness. After that, a final treatment is applied to reduce the microbial load, generally through reverse osmosis and subsequent application of ultraviolet light.
Water for injection (WFI). It is obtained by condensing the clean steam given by a steam generator, which in turn is fed with purified water (PW). This is a water of the highest chemical purity, perfectly sterile, since its main use is the preparation of injectable solutions.
After these processes, these waters for pharmaceutical uses are sent to the distribution loop, PW or WFI respectively, which is made up of a storage tank and a distribution circuit. The water within the system must be in permanent movement, so that constant pressure must be guaranteed in the loop, regardless of the number of points of use open at any given time.
The main difference between both loops is the temperature at which the water is kept inside them: while the PW loop is kept around the ambient temperature, the WFI loop must remain among 75°C and 90 °C to conserve the physicochemical and microbiological characteristics of the water.
In both cases, the sanitization of the loop is always of vital importance to guarantee the quality of the water, preventing an unwanted growth of pathogenic microorganisms fare above the safe levels. This sanitization is normally carried out by means of heat input, either continuously or periodically. Here the heat exchanger plays a critical role.
Heat Exchangers for Purified Water Loops (PW) and Water for Injection (WFI)
SACOME has the P-TFM-I range of tubular heat exchangers, specifically developed for pharmaceutical applications, by following the guidelines of the main internationally recognized quality standards, such as Pharmacopeia, FDA, 3A, GAMP, CGMP, ISPE or USDA. With more than 40 years in the sector, SACOME has designed and manufactured tubular heat exchangers for the major pharmaceutical companies worldwide, being in collaboration with leading engineering companies in the sector, in compliance with the most demanding quality standards.
SACOME has a wide range of references, not only in the supply of heat exchangers for purified water (PW) and water for injection (WFI) loops, but also to produce sterile and aseptic water, deionized water, demineralized water, distilled water, filtered water and osmotic water, among others.
Some of the main features of our P-TFM-I tubular exchangers are as follow:
- No risk of cross contamination between service and product in case of unexpected operation, regardless of the design conditions by means of a double tube sheet (DTS).
- Sanitizable with hot water and/or steam.
- Specific design to avoid dead spots and inaccessible areas.
- Complete drainability.
- Manufacturing in AISI 316L stainless steel.
- Roughness certification based on the process specifications.
- Access to the channel in contact with product for cleaning and inspection by means of a flanged or clamp type tubular plate.
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