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   (%)