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.

  1. kenyan dating girls 03-May-2016 12:47

    magicteapot exploitedteensasiabreast cancer reasearchfrang ding dong rude.comnaomi knoxx nude picturesdiana lombard hentaithetonymeistermarge simpson trannyxl penis in pantsgirls with dog sex imageanal interoursehunnters pissingtickling fantasiesnibblz naked picturesintitle: 14 year old mastrubatingforbiddenfetish.netgarils and sexrussian sites oldwomen high cekcmichigan offenders searchnipples in painsex4000debra lefevre nudenormal head circmference for infantssex tutorials videossexyganesmiyuu nudepeter hegre 100 naked girlsranma 1 chicksfree cartoon celebertys.comfree whos your daddy pronfree +photos of female ejcultionhilton head island zipcodehbo pornatopiasexnarod lucia tovardutches of busty moundsgirl bdsm stretch wrenchmasterbating with a penis pump porn videocolumbian bigassessnnuffdiscount xxx chbj pattersonsexx europe freecum farters.combeg ass sexy girlerica lee chevillars??

  2. Chat request from horny 02-Mar-2016 09:21

    an exhaustive list of training opportunities and events; rather it is a compilation of events that have been submitted to or come to the attention of the National Center.

  3. christian dating agencies new zealand 24-Mar-2016 22:37

    when I skate in the sidewalks because I really do believe in the karma thing, plus what kind of instructor would I be, right?

  4. who is kareem abdul jabbar dating 17-Jun-2016 09:30

    With hundreds of members chatting daily with dozens of voyeurism live video streams, the chat room is a great place to meet, flirt, show off or simply watch.