124483723 Validation of Mixer Double Cone Blender

8/11/2019 124483723 Validation of Mixer Double Cone Blender

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PRACTICAL PROTOCOL

Roll no- 23 Pages -

Aim :- To prepare validation protocol of a mixer and perform its validation of mixing

performance wit respect to low dose dr!g"

P!rpose :-

#$ Red!ction of %!alit& cost"

2$ Process validation"

3$ Ass!rance of %!alit& and safet&"

References :-

#$ Lac'man" L ( Li)erman *Te teor& and practice of ind!strial parmac& (+

,argese p!)lication page no" #-2"2$ Potdar A". *Parmace!tical /!alit& Ass!rance (+ 20 1irali p!)lication

page no" "2"

3$ 4aider 5"I *,alidation standard operating proced!re (+second edition page no

363-366"

Re%!irements :-

#$ Cemicals-

5r" 1o 1ame of Cemical /!antit& Ta'en

# Calci!m car)onate 7CaCo3$ #gm

2 Potassi!m paramagnet 78m1o$ #gm

3 Cr&stal violet

2$ 9lasswares -

5r " 1o 1ame Of 9lassware Capacit& /!antit&

# ,ials # ml #

2 5tirrer ----- #

3 ea'er #ml 2

,ol!metric flas' #ml #

6 ,ol!metric flas' #ml 6


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3$ Instr!ments ;

5r" 1o 1ame of Instr!ment .odel .a'e

# Colo!rimeter Potocal -o!)le cone )lender

Teor& :-

,alidation :-

A doc!mented programmed wic provides a ig degree of ass!rance tat specific

processes will consistenc& prod!ce a prod!ct meeting its predetermined specification

and %!alit& attri)!tes"

Importance of validation#$ Red!ction of %!alit& cost"

2$ Process validation"

3$ Ass!rance of %!alit& and safet&"

.ixing :-

A process tat tends to res!lt in a randomi?ation of dissimilar particles ( witin a

s&stem or to p!t togeter in one mass or assem)lage wit more or less tro!g

diff!sion of te constit!ent elements among one anoter"

.ecanisms of mixing

#$ >iff!sion :- random action of individ!al particles in te mixer"

2$ Convection :- transfer of ad@acent particles gro!ps in te mixt!re "3$ 5ear :- config!ration cange tro!g slip planes"

A$ =%!ipments !sed for mixing :- 7powder$T!m)ler mixer>o!)le cone )lender

Agitated powder mixer

Air mixer

$ =%!ipments !sed for mixing :- 7li%!ids$

Propeller mixerT!r)ine mixer

Paddle mixer

C$ =%!ipments !sed for mixing :- 7semisolid$Triple roller mill

Agitator mixer

Planetar& mixer

>o!)le cone )lender :-

It is developed in an attempt to overcome some of te sortcoming of rotating

mixer" Te mixing of powder in do!)le cone )lender is d!e to t!m)ling and


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searing action wit )lade " Te efficienc& of )lender depends mainl& on speed of

rotation "

Te rate of rotation so!ld )e optim!m wic depends !pon te si?e and sape of

t!m)ler as well as nat!re of material" Te common range is 3-# rpm"

Te material to )e )lended is loaded approximatel& 6-


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O)servation ta)le 7 I $ :-

5r" no Time Top .iddle ottom

# 62 #

3 #6

2

6 26

< 3

O)servation ta)le 7 II $ :-

5r" no Time Conc" Erom grap G dil" Eactor 7#$ 5tandard

deviationTop .iddle ottom mean# 6

2 #

3 #6

2

6 26

< 3

Res!lt :-

.ixing of cr&stal violet wit CaCO3 was carried o!t and validation parameter of

mixing were as )elow

5r" no Parameter .ixing metod 7 do!)lecone )lender$

# i) CaCO3 #gm

ii$ Cr&stal violet #gm

2 Optim!m mixing time

3 Conc" of optim!m time

5OP 1O -#23 =ffective date- ddBmmB&&

Approved )&- .r"a)c

Title - lender 7 do!)le cone $


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A!tor - 1ame B title B department

5ign date

Cec'ed )& - 1ame B title B department

5ign date

Approved )& - 1ame B title B department

5ign date

Revisions :-

5r" no 5ection Pages Initials B date

5OP 1O -#2 =ffective date- ddBmmB&&

Approved )&- .r"a)c

5!)@ect :- lender 7 do!)le cone $

P!rpose:-

To descri)e te proced!re for validation of )lender to ens!re tat it meets installation(

operational( and performance %!alification re%!irements"

Responsi)ilit& :-


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It is te responsi)ilit& of te prod!ction manager and tecnical services manager to

follow te proced!re" Te %!alit& ass!rance manager is responsi)le for 5OP

compliance"

Proced!re :-

#" ,erif& approved p!rcase order2" ,erif& invoice3" Cec' man!fact!rer and s!pplier

" ,erif& model n!m)er and serial n!m)er

6" Cec' for an& p&sical damage

124483723 Validation of Mixer Double Cone Blender

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