Water Purification System

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Water is the most widely used raw material in the production of pharmaceuticals. It is a critical ingredient that is used in the manufacture of every type of pharmaceuticals; in some like parenterals it is a vital element. It is also used to clean vessels and systems used to manufacture pharmaceuticals. A unique aspect about high purity water used in the pharma industry is that it is possibly the only element that must as a rule be produced by the drug manufacturer themselves as it is not available in ready to use form.

Irrespective of the system used to generate high purity water, regulatory guidelines around the world mandate validation of the system. Validation is necessary to monitor system performance including that of storage and distribution systems. It ensures that the system is operating within design parameters and also the consistent production of desired quality of water. Validation also prevents unacceptable microbial, chemical and physical impurities from being generated during water generation, storage and distribution.

Validation allows us to prove the performance of processes or systems under all conditions encountered during future operations. This is achieved by consistently producing the same quantity and quality of water during operations and maintaining this according to specific written operating and maintenance procedures.

Validation of high purity water systems involves proving

• Engineering design
• Operating procedures and acceptable ranges for control parameters
• Maintenance procedures to accomplish it
• The system has to be
  • designed
  • installed
  • successfully tested in all operating conditions
• Variations in daily, weekly and annual usage patterns must be validated

A validation report is written at the conclusion of equipment, instrumental and operational qualification and also at the completion of the validation protocol. This report serves as the primary document during FDA inspection and also as a reference document if any changes are made to the system and revalidation is needed.

Documentation required during validation includes

• Verification of design documentation including a description of installation and functions and specifications of functions.
• Operating procedures
• Maintenance instructions & records
• Training of personnel
• Environmental records
• Plant inspection

Once validation is complete, an effective Standard Operating (SOP) procedure is finalised, with the assurance that the system can consistently produce water that meets spec over long periods. If any deviations from SOP are observed, it is necessary to determine the change and impact on the whole system and carry out revalidation based on the change and impact.

Any validation protocol must include the elements outlined above. However the validation process is long, and often small details can be overlooked. A couple of the most commonly overlooked considerations have been outlined below:

UV Lights

When UV lights pass through microorganisms, they inhibit reproduction and disrupt the DNA of the cell. Therefore, the UV lamp must function at optimum efficiency at all times to maintain the quality of UV rays and keep microbial contamination in check.