PHARMACEUTICAL INDUSTRY

In 1985, IDENOR designed, built and installed its first water treatment plant for the pharmaceutical industry. Since then, the company has maintained a constant technological evolution that has turned IDENOR into a recognized international supplier of systems of this kind. IDENOR can provide part or complete plants for the generation, storage and distribution of Purified Water (PW) and Water For Injection (WFI) that will comply with several international specifications, among which are the United Status Pharmacopoeia (USP), the European Pharmacopoeia (EP) and the Japanese Pharmacopoeia (JP). The main characteristics that distinguish the plants supplied by IDENOR, both for the generation of Purified Water (PW) and Water For Injection (WFI), could be summarized in the following:

  • They comply with international specifications, both in relation to the water quality produced and to the equipment constructive characteristics.
  • They have a fully automatic operation and state-of-the-art design.
  • The equipment is operator friendly and of low maintenance. The components used to construct them are from well-known manufacturers and easily available anywhere in the world.
  • The equipment is mounted on stainless steel skids, which have all components totally interconnected, both electrically and hydraulically. This simplifies enormously the installation, start-up and qualification of the system.
  • They are completely validatable and IDENOR supplies all the necessary documentation for a correct qualification of the system (DQ, IQ, PQ and PQ).
  • IDENOR can supply validatable systems with production flows as low as 50 l/h and as high as the customer requires, although, in general terms, pharmaceutical systems do not require flows much higher than 30 m3/h.

Two different technologies can be used for the generation of Purified Water (PW): Double-Pass Reverse Osmosis (RO+RO) or Reverse Osmosis plus Electrodeionization (RO+EDI). The former has the advantage of a double microbiological barrier but it requires certain additional cares in order to guarantee the continuous generation of water with the appropriate conductivity. The latter makes it easier to obtain water with conductivities bellow 1.3 microsiemens/cm, but requires more controls to avoid microbiological contamination.

In the case of Water For Injection (WFI) generation, IDENOR does not usually recommend the use of electrodeionization and only double-pass RO and distillation (classical equipment or thermo compression) are considered appropriate technologies. Although distillation is extremely reliable with regards to microbial contamination, its capital investment and operation costs are appreciably higher. On the other hand, the design and constructive characteristics of the WFI double-pass RO systems supplied by IDENOR allow for trouble-free operation and validation at a much lower cost. The latter equipment is designed with hot water sanitization capability, which is a feature that has two important advantages: a simple and automated operation and a higher sanitizing efficiency than chemical sanitization. Although heat sanitization has a higher capital cost, this cost is still much lower than that for distillation and the operation advantages are very important.

When designing a pharmaceutical water system it is very important to consider that, whatever sanitization method is used (chemical or heat), the treatment starts at the water source, no matter if it is a municipal or the company’s own source. This concept implies that the final water quality, especially from a microbiological point of view, must be assured starting at the raw water inlet and NEVER rely only on the final stages to achieve a successful process.

A complete pharmaceutical water system designed by IDENOR has the following main sectors:

  • PRETREATMENT: It conditions the water that will feed the main treatment and is composed of equipment such as: booster pumps, multimedia filters, bag filters, cartridge filters, dosing systems (pH adjustment, chlorination, bisulfite addition), softeners, heat exchangers and UV equipment
  • MAIN TREATMENT: It guarantees the production of water with the required chemical and bacteriological quality. The processes involved can be double-pass reverse osmosis (RO + RO) or reverse osmosis plus electrodeionization (RO + EDI), where appropriate materials are used for those parts in direct contact with treated water. In general terms, plastic piping is used for sectors with free chlorine and stainless steel for the rest of the system. .
  • STORAGE TANK: It has a volume such that the supply of water for the production areas is guaranteed, which is calculated considering the water consumption profile (average and peak consumptions). There are strict norms under which tanks of this type are constructed, which are related to materials (usually 316L SS), surface rugosity and accessories (spray-balls, sanitary level controls, vent filters, heating jacket, isolation, etc.)
  • DISTRIBUTION SYSTEMS: Basically, it consists of a closed circuit (recirculation) constructed with 316L stainless steel piping or some other appropriate material (e.g.: PVDF). This circuit starts in the storage tank, feeds all the points of use (POU) and returns to the tank. The system is completed with other necessary equipment such as:
    • o Sanitary centrifugal pumps able to supply the necessary flows and pressures.
    • o Ozonation systems to assure the bacteriological quality of the water container in the distribution system. The tank can be kept continuously ozonized or ozone can be just injected during sanitization periods. In the former case, ozone must be destructed using UV equipment before distributing the water to the POU.
    • o Sanitary heat exchangers to maintain the water at low temperatures (usually below 25°C) or high temperatures (usually over 80°C) or to heat and cool water during periodical sanitization cycles.
    • o UV equipment to maintain the microbiological growth within the storage and distribution system under control. It is also used as a necessary complement of the ozonation system in order to ensure ozone destruction before sending water to the different POU.

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