It is common knowledge that water has extensive use in the pharma industry. It is used as an ingredient, solvent and raw material to process, formulate and manufacture API’s (Active Pharmaceutical Ingredients), pharmaceutical products, analytical reagents etc.
Also, water is utilized to clean process equipment and plays a major role in pharma processing. Hence pharmaceutical water treatment is of prime importance. The system of water treatment continually offers the specific quantity and quality of water for ensuring that both the equipment and products are not contaminated.
Water quality must comply with quality attributes that are well defined such as TOC (Total Organic Carbon), conductivity, micro-biological values and any proliferation of contaminants like heavy metals, nitrates and endotoxins. Water must be continually tested for such attributes.
The storage, processing and conveyance system of water must be validated as it is not enough to test end-products for the proper functioning of the system. Such validation is vital for gaining water with all needed attributes. This also helps to screen safety, efficacy and process outcomes. The objective of validation is to enable a process of water treatment that yields products of definite and reliable quality.
The design of a system of water treatment must consider parts of the components. It should be made using off-the-shelf components for purification for controlling costs and maximizing efficacy of validation.
The following are the main elements of the system:
The popular material for pipe network is stainless steel thanks to its corrosion-resistant and non-reactive nature as well as scope for easy sanitization. It can be used for wide scales of temperature. Pipe joints should be butt-welded or use sanitary fittings.
Even for this, stainless steel is the material of popular choice, and it must be tested for resisting chemical sanitizers. Such tanks differ in size, based on need. They must be fitted with a vent for handling fluctuations in levels of water and to avoid potential collapse.
The popular kinds of valves for water treatment are diaphragm, butterfly, ball and gate designs. Diaphragm valves need to be used downstream to remove dissolved solids. In the case of water systems using Ozone process, polymers that do not react with Ozone like Teflon must be used.
Ro (reverse osmosis) units and de-ionizers
The main function of these units is to free feed water of dissolved solids. De-ionizers make use of resins of ion-exchange to get rid of charged particles. Strong acidic and caustic solutions must be regularly used to periodically re-generate resins because they tend to lose the capacity to eliminate charged particles.
RO system comprises of an additional pre-treatment pack that includes a filter for activated carbon and a compound for sequestering Calcium hardness. Pre-treatment helps to avoid damage to RO membrane from scaling, chlorine oxidation etc. To control the growth of bacteria, regular treatments of chemical sanitization should be conducted on RO units.
Typically used for removing organic compounds of Chlorine and low weight compounds of carbon from feed water, these can serve as a source for endotoxin and bacterial contamination if not maintained properly. Organic matter settles down in beds, thus becoming breeding places for bacteria. Hence carbon beds must be regularly heat-treated to combat such bacteria.
UV (ultra-violet) radiation
The major function of this technique is to function as a surface disinfectant and to remove ozone from water systems running on ozone processes and even Chlorine from feed water. For maximum efficiency, the dose of UV rays must be powerful enough to destroy microbes.
Distillation equipment is utilized to get rid of most impurities from water such as Calcium, Sodium, Iron, Magnesium, Nitrate, Fluoride and Manganese. When this equipment functions properly, it kills microbes like Bacteria, Protozoa, Virus etc.
These are some of the sanitary systems for pharmaceutical water treatment.