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Efficacy of Raja Yoga In the Light of Sahaj Marg by Ram Chandra Founder-President, Shri Ram Chandra Mission Efficacy of Raja Yoga In the Light of Sahaj Marg is copyrighted by Shri Ram Chan...
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This Article is on how Fasting is effective in chemotherapy and how it prevents cancer. Fasting in disease intercept and treatment has recently become a popular topic and fasting is the part of most spiritual tradition in the world. Cell is the basic
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Descripción: Manual para solucionar problemas en la ingeniería de procesos
Chemical Engineering
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Validation Protocol for Efficacy of Chemical Disinfectants Learn how to write a protocol for disinfectant ecacy testing of dierent types of disinfectants in pharmaceutical validated system. Ankur Choudhary | Microbiology Microbiology | | Protocol Protocol | | Vali Valida dati tion on1 1 Comment so far
1.0 Objective
This document describes the testing procedure procedure for the ecacy of dierent dierent types of chemical disinfectants 2.0 Scope This document pro!ides pro!ides the procedure procedure for !alidating the saniti"ers saniti"ers and the saniti"ation procedure procedure being follo#ed in the manufacturing and the testing facilities in pharmaceuti pha rmaceuticals cals 3.0 Reference Document $%P for microbiol microbiological ogical culture media preparation p reparation
&isinfectant 'cacy Test 4.0 Pre-Requisites Prior to conducting(e)ecuting conducting(e)ecuting the *eneral !alidation protocol follo#ing things must be a!ailable +1 Microbial $tandard Cultures +11 ,acillus subtilis +1- 'scherichia coli +1. $taphylococcus aureus +1+ Candida albicans +1/ Aspergillus niger +10 'n!ironment isolates +- &isinfectants All disinfectants used in in the facility +. Micropipettes ++ $terili"ed tips and petriplates 5.0 Responsibilit 2esponsibilities of 3uality Assurance and 3uality control Microbiology 2esponsibilities personnel in!ol!ed in acti!ities related to the *eneral !alidation protocol are de4ned belo# 5.1 !u"lit #ssur"nce $%"li&"tion' /11 Appro!al of protocol protocol 5.2 !u"lit (ontrol
/-1 Preparation of protocol /-- 2e!ie# of protocol /-. ')ecution of protocol ).0 %"li&"tion *et+o& !u"li,c"tion ests A5 $uspension method 6Validation of saniti"er5 ,5 $urface spray ( immersion or #ipe method 6Validation of $aniti"ation method5 ).1 Suspension *et+o& ).1.1 Objective
To establish the test concentration and the contact time a suspension test is generally applied The suspension test estimate the in !itro bactericidal acti!ity of the disinfectant under precise e)perimental conditions including / Microbial strain / Preparation of inoculum / Volume of inoculum !s &isinfectant / Temperature / &isinfectant concentration and contact period / 7nterfering substances 6ie inorganic8 organic matter5 ).1.2 Proce&ure
01-1 Prepare the culture suspension from the original culture as per the $%P for preparation of Microbiological culture media 01-- $elect the dilution #hich #ill yield 19/ to 190 cells per ml 01-. Prepare 19 ml of test dilution to be tested #ith sterile distilled #ater 01-+ Vorte) the tube for 1 minute 01-/ Add 91 ml of any one culture containing 19/ to 190 cells per ml into the test disinfectant #ith the decided concentration 01-0 The 4nal concentration shall be 19+ to 19/ cells per the tube Consider the preparation for 9 min 01-: Prepare like the same abo!e for other . dierent sets for . dierent time inter!als 01-; *i!e a contact time of 9 min8 / min8 19 min and 1/ min 01-< After the speci4ed contact time8 4lter the samples through a 9+/ m membrane 4lter 01-19 *i!e three #ashing of 199 ml each #ith 91 = sterile peptone #ater( $terile >ater
01-11 After 4ltration #ith the help of a sterile forceps take the membrane 4lter and place it on a $oybean casein digest agar 01-1- 7ncubate the bacterial culture at .9?./ @C for -+ to +; hours and fungal cultures at -9?-/ @C for :- to 1-9 hours 01-1. After incubation count the number of colonies present on the membrane 01-1+ ote do#n the number of colonies 01-1/ This #ill be the %bser!ed count after the e)posure 01-10 $elect the plates8 #hich ha!e least to il counts 01-1: Proceed in the same manner taking all the cultures to be tested 01-1; Contact time for the usage of the disinfectant #ill be set on the basis of the results8 #hich #ill ha!e least counts ).2 Surf"ce spr" ipe met+o& ).2.1 Objective To establish the eecti!eness of the test concentration and the contact time generally applied The suspension test estimates the in !itro bactericidal acti!ity of the disinfectant under precise e)perimental conditions including / Microbial strain / Preparation of inoculum / Volume of inoculum !s &isinfectant / Temperature / &isinfectant concentration and contact period / 7nterfering substances 6ie inorganic8 organic matter5 >ith the $pray ( immersion or #ipe method the follo#ing surfaces shall be taken for !alidation $tainless steel 6$$5 / 'po)y / Panel / PB Paint #all 6Poly Brethane Paint5 ).2.2 Proce&ure 0--1 Prepare the culture suspension from the original culture as per the $%P for preparation of Microbiological culture media 0--- $elect the dilution #hich #ill yield 19+ to 19/ cells per ml 0--. Take plate of dierent surfaces such as $$8 'po)y8 Panel8 PB Paint #all present in the clean room ha!ing a surface area of -/ cm0--+ rom the pre!iously determined suspension ha!ing 19+ to 19 / cells per ml inoculate one culture on dierent surfaces mentioned abo!e 0--/ >ith the help of a sterile spatula spread the culture on the surface
0--0 Deep it on the EA bench for drying 0--: After the e)posed duration for drying 6a5 spray the disinfectant 6b5 disinfect the surface by #ipe method 0--; *i!e a contact time of 9 min8 / min8 19 min and 1/ min 0--< The e)act procedure for sanitation follo#ed in the clean room should be follo#ed 0--19 >ith the help of a sterile moistened s#ab8 s#ab the surface gently co!ering all the area of the surface 0--11 Place the s#ab sticks in a test tube ha!ing sterile saline solution and do not hold the s#ab more then -+ hours 0--1- Vorte) the test tube gently for /9 minutes 0--1. Aseptically 4lter the samples through a 9+/ m membrane 0--1+ *i!e three #ashing of 199 ml each #ith 91 = sterile peptone #ater ( $terile #ater 0--1/ After the 4ltration #ith the help of a sterile forceps take the membrane and place it on a $oybean casein digest agar 0--10 7ncubate the bacterial culture at .9?./ @C for -+ to +; hours and fungal cultures at -9?-/ @C for :- to 1-9 hours 0--1: After incubation count the number of colonies present on the membrane 0--1; Proceed in the same manner taking all the cultures to be tested #ith the all mentioned disinfectants .0 #ccept"nce criteri" :1 The decrease in the bacterial load to the e)posed disinfectant indicates that the disinfectant is capable of reducing the contaminant #hen used in the area That shall be minimum of +?log reduction for non?spore forming microorganisms8 Feast and minimum of .?log reduction shall achie!e for $pore forming organisms8 molds #ith the decided concentration :- &etermine the contact period #here the abo!e said population log reduction of microorganisms achie!ed .0 Observ"tions ;1 ;.0 .1
2ecord the obser!ation of $uspension method in Anne)ure G7 2ecord the obser!ation of $urface spray ( >ipe method in Anne)ure G77 est Process lo6 (+"rt est for Suspension met+o&
.2 est for Surf"ce spr" ipe met+o&
10.0 %"li&"tion *"tri7
ollo#ing test matri) is prepared for the initial analytical method !alidation and re!alidation criteria for 'cacy of disinfectants Sr. 8o . 1
est Description
$uspension Method
9niti"l %"li&"tion
Rev"li&"tion
'!ery ne# disinfectant
-
All disinfectnats used
Change in &isinfectant Concentration Change in Contact time
All $urface $pray ( >ipe disinfectnats Method used
'!ery ne# disinfectant Change in &isinfectant Concentration Change in Contact time
11.0 #bbrevi"tions
$%P $tandard %perating Procedure @ C &egrees centigrade = Percentage CB Colony forming units $CA $oyabean casein digest agar m Micron PB Poly Brethane #nne7ure :9 Results Suspension *et+o&
