Monday, November 29, 2010

Table used for making protocol of Process validation

Table No 1:Composition of various process validation batches.

Ingredient
1 PVB
2 PVB
3 PVB
Mesh

















Table No2 :Dry mixing results.
PVB No
% RSD

5 min
10  min
15 min
1



2



3




% RSD  was calculated  by  taking  mean  of  assay of  all 10 locations {Top(Four  location), middle(Two location) & bottom(Four location)}]

Table No 3: Wet mixing results

PVB
No.
Chopper (Speed & Time)
Beater
(speed & time)
Ampere
Reading
Dough
mass
Consistency

Slow
Fast
Slow
Fast


1.






2.






3.







Table No 4:Drying stage results.

PVB No.
Loss on Drying  LOD   (%w/w)
Time
20 min
25 min
30 min
Layer
T
M
B
T
M
B
T
M
B
1









2









3.











Table No 5:Sizing stage results.

PVB No
% Fine
% LOD
BD
CI %
1




2




3








Table No 6: Lubrication stage results.

PVB No.
%    RSD
%
Fine
%
LOD
BD
(gm/ml)
%
 CI
%Yield
Sizing
Time
5 min
10 min
15 min
1








2








3









% RSD  was calculated  by  taking  mean  of  assay of  all 10 locations [{Top(Four  location), middle(Two location) & bottom(Four location)}]


Table No 7: Compression stage results.


Parameter
Speed
PVB -1
PVB-2
PVB-3
Appearance
Minimum



Maximum



Optimum



Uniformity of weight (%)
Minimum



Maximum



Optimum



Thickness (mm)
Minimum



Maximum



Optimum



Hardness (Kg/cm2)
Minimum



Maximum



Optimum



Disintegration
time(min)
Minimum



Maximum



Optimum



Friability
(%w/w)

Minimum



Maximum



Optimum



Assay
(%w/w)
Minimum



Maximum



Optimum




Uniformity of weight (%)
Minimum



Maximum



Optimum



Yield   of   batch   (%)



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