Validation of Mixer Double Cone Blender

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 (+ 2--0 1irali p!)lication
page no" 2"32"
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 78m1o3$ #gm
3 Cr&stal violet
2$ 9lasswares -
5r " 1o 1ame Of 9lassware Capacit& /!antit&
# ,ials #- ml #-
2 5tirrer ----- -#
3 :ea'er #--ml -2
3 ,ol!metric flas' #--ml -#
6 ,ol!metric flas' #-ml -6
3$ Instr!ments ;
5r" 1o 1ame of Instr!ment .odel .a'e
# Colo!rimeter Potocal -<62 =%!ip-tronics
2 >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 mixer
T!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
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--<-A of te total capacit&
of )lender " As te )lender rotates te material !ndergoes t!m)ling motion and mixes
te material"
Te do!)le cone )lender is an efficient design for mixing powder of difference
densities and is !sed mainl& for small %!antit& of powder"

Proced!re:- 7 Cali)ration c!rve of cr&stal violet $
#$ >issolve #-mg of cr&stal violet in # . 425O3 to prod!ce #--ml " 4eat te
sol!tion for 6-#-min 7!ntil )oil$"
2$ Cool te )ea'er sol!tion at room temp" and filter wit te elp of cotton pl!g
in f!nnel"
3$ Prepare dil!tion from te a)ove stoc' sol!tion #--mgBml to prod!ce conc"
#- CgBml and also prepare te 2(3(<(2(#- CgBml !sing #. 425O3"
3$ .eas!re te a)sor)ance on colorimeter"

O)servation Ta)le:-
Concentration A)sor)ance
2
3
<
2
#-
Proced!re :-
#$ Deig #--gm of CaCo3 and #gm of cr&stal violet and pass tem tro!g
sieve no <-"
2$ Load tose powder in do!)le cone )lender and note down te rpm of do!)le
cone )lender"
3$ Ta'e te samples from top( middle( and )ottom" >issolve tem in #-ml #.
425O3 in vials"
3$ Eilter it and meas!re te a)sor)ance !sing colorimeter"
6$ >etermine te conc" Fsing cali)ration c!rve and calc!late te std" deviation
of eac five interval( predict te optim!m time of mixing"
O)servation ta)le 7 I $ :-
5r" no Time Top .iddle :ottom
# 6
2 #-
3 #6
3 2-
6 26
< 3-
O)servation ta)le 7 II $ :-
5r" no Time Conc" Erom grap G dil" Eactor 7#--$ 5tandard
deviation Top .iddle :ottom mean
# 6
2 #-
3 #6
3 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!)le
cone )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 $
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 -#23 =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& :-
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 order
2" ,erif& invoice
3" Cec' man!fact!rer and s!pplier
3" ,erif& model n!m)er and serial n!m)er
6" Cec' for an& p&sical damage
<" Confirm location and installation re%!irements per recommendation of
man!fact!rer"
0" ,erif& tat te re%!ired !tilities are availa)le
2" Installation sall )e cond!cted per instr!ction provided in te man!al"
H" =ns!re tat all relevant doc!mentation is received
i$ Fser man!al
ii$ .aintenance man!al
iii$ List of cange parts
iv$ =lectrical drawing
v$ .ecanical drawing

Validation of Mixer Double Cone Blender

Uploaded by

Copyright:

Available Formats

Validation of Mixer Double Cone Blender

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Validation of Mixer Double Cone Blender

Uploaded by

Copyright:

Available Formats

What is the purpose of validation?

What are the mechanisms of mixing?

PRACTICAL PROTOCOL

Roll no- 23 Pages -

You might also like