Validating pharmaceutical systems

23-May-2016 21:27 by key2universe 3 Comments

Validating pharmaceutical systems - Free Online

Ultrapure water (also UPW or high-purity water) is water that has been purified to uncommonly stringent specifications.Ultrapure water is a commonly used term in the semiconductor industry to emphasize the fact that the water is treated to the highest levels of purity for all contaminant types, including: organic and inorganic compounds; dissolved and particulate matter; volatile and non-volatile, reactive and inert; hydrophilic and hydrophobic; and dissolved gases.

In addition to the fact that UPW has organic particles and dissolved gases removed, a typical UPW system has three stages: a pretreatment stage to produce purified water, a primary stage to further purify the water, and a polishing stage, the most expensive part of the treatment process.A number of organizations and groups develop and publish standards associated with the production of UPW.For microelectronics and power, they include Semiconductor Equipment and Materials International (SEMI) (microelectronics and photovoltaic), American Society for Testing and Materials International (ASTM International) (semiconductor, power), Electric Power Research Institute (EPRI) (power), American Society of Mechanical Engineers(ASME) (power), and International Association for the Properties of Water and Steam (IAPWS) (power).Pharmaceutical plants follow water quality standards as developed by pharmacopeias, of which three examples are the United States Pharmacopeia, European Pharmacopeia, and Japanese Pharmacopeia.The most widely used requirements for UPW quality are documented by ASTM D5127 "Standard Guide for Ultra-Pure Water Used in the Electronics and Semiconductor Industries" Bacteria, particles, organic and inorganic sources of contamination vary depending on a number of factors including the feed water to make UPW as well as the selection of the piping materials to convey it.Bacteria are typically reported in colony-forming units (CFU) per volume of UPW. Total organic carbon (TOC), metallic contaminates, and anionic contaminates are measured in dimensionless terms of parts per notation, such as ppm, ppb, ppt and ppq.

Bacteria have been referred to as one of the most obstinate in this list to control.

Techniques that help in minimizing bacterial colony growth within UPW streams include occasional chemical or steam sanitization (which is common in the pharmaceutical industry), ultrafiltration (found in some pharmaceutical, but mostly semiconductor industries), ozonation and optimization of piping system designs that promote the use of Reynolds Number criteria for minimum flow along with minimization of dead legs.

In modern advanced UPW systems positive (higher than zero) bacteria counts are typically observed in the newly constructed facilities.

This issue is effectively addressed by sanitization using ozone or hydrogen peroxide.

With proper design of the polishing and distribution system no positive bacteria counts are typically detected throughout the life cycle of the UPW system.

Particles in UPW are the bane of the semiconductor industry, causing defects in sensitive photolithographic processes that define nanometer sized features.

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