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disinfectant efficacy study

disinfectant efficacy study

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Published by deepanshsharma
to study the efficacy and self life study of various disinfectants by in use method
to study the efficacy and self life study of various disinfectants by in use method

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Published by: deepanshsharma on Jun 09, 2009
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02/03/2013

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REVIEW OF LITERATURE
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INTRODUCTION
Requirements for aseptic processing areas include readily cleanable floors, walls, and ceilingsthat have smooth, non-porous surfaces; particulate, temperature, and humidity controls; andcleaning and disinfecting procedures to produce and maintain aseptic conditions. Theseconditions combined with careful and thorough evaluation of the chemical agents used for thecleaning and disinfection program should lead to achieving the specified cleanlinessstandards and control of microbial contamination of products. In recent years, the use of disinfectants in pharmaceutical, biotechnology, medical device facilities, and associatedcontrolled environments has been the subject of scrutiny by regulatory agencies.An effective cleaning and disinfection program in aseptic processing areas of a GoodManufacturing Practice (GMP) facility is critical to assure the quality of the products.Manufacturers are being held to a high standard when it comes to product sterility andregulatory agencies are increasingly asking for validation data to support sanitization anddisinfection procedures. Regulatory authorities now expect evidence of the efficacy of disinfection agents against environmental isolates. The FDA Guideline for Aseptic Processingstates, “The suitability, efficacy, and limitations of disinfecting agents and procedures should be assessed. The effectiveness of these disinfectants and procedures should be measured bytheir ability to ensure that potential contaminants are adequately removed from surfaces”.Basic knowledge regarding the effectiveness of different chemical agents against vegetative bacteria, fungi, and spores will aid in selecting chemical agents.A good understanding of test methods used to assess disinfectant effectiveness is important.Most methods are adaptable allowing the user to customize the methods to their specificrequirements.
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HISTORY OF DISINFECTANTS
 JOSEPH LISTER & ANTISEPTIC SURGERY
Introduction:
By the middle of the nineteenth century, post-operative sepsis infectionaccounted for the death of almost half of the patients undergoing major surgery.In 1839 the chemist Justin von Liebig had asserted that sepsis was a kind of combustioncaused by exposing moist body tissue to oxygen. It was therefore considered that the best prevention was to keep air away from wounds by means of plasters, collodion or resins.
 Joseph Lister (1827-1912)
Joseph Lister, a British surgeon, doubted this explanation. For many years he had exploredthe inflammation of wounds, at the Glasgow infirmary. These observations had led him toconsider that infection was not due to bad air alone, and that 'wound sepsis' was a form of decomposition.When the Regius Professorship of Surgery at Glasgow University fell vacant in 1859 Lister was selected from seven candidates. In August 1861 he was appointed surgeon at theGlasgow Royal Infirmary and put in charge of its new surgical building.The hope was that the new building would decrease the number of deaths caused by what wasthen called hospital disease (now known as operative sepsis). This proved a vain hope whenLister reported that between 45 and 50 percent of his amputation cases died from sepsis between 1861 and 1865 in his Male Accident Ward. It was in this ward that Lister began hisexperimental work with antisepsis.Having tried methods to encourage clean healing, with little or no success, Lister began toform theories to account for the prevalence of sepsis. He discarded the popular concept of direct infection by bad air and postulated that sepsis might be caused by a 'pollen-like dust'.Although, there is no evidence
 
GERM CONNECTION WITH WOUND SEPSIS
When, in 1865, Louis Pasteur suggested that decay was caused by living organisms in the air,which on entering matter caused it to ferment, Lister made the connection with wound sepsis.A meticulous researcher and surgeon, Lister recognized the relationship between Pasteur'sresearch and his own. He considered that microbes in the air were likely causing the putrefaction and had to be destroyed before they entered the wound.
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