BEXIMCO PHARMACEUTICALS LTD.

PRODUCT DEVELOPMENT DEPARTMENT

Lab Scale / Pilot Batch Evaluation Sheet
Dosage Form : Tablet

Batch formula
Sl. Name of Materials Quantity Remarks
No B/N: B/N: B/N: B/N: B/N: B/N:
Active Ingredients R-No.
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20

SOP Ref.: PDD-009 From No.: PD-18

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Batch formula
Sl. Name of Materials Quantity Remarks
No B/N: B/N: B/N: B/N: B/N: B/N:
Excipients R-No.
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24

SOP Ref.: PDD-009 From No.: PD-18

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Batch formula
Sl. Name of Materials Quantity Remarks
No B/N: B/N: B/N: B/N: B/N: B/N:
Coating Materials R-No.
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24

SOP Ref.: PDD-009 From No.: PD-18

Page 3 of 10
 Process Parameters Observations Remarks
Steps Dt.: Dt.: Dt.: Dt.: Dt.: Dt.:
B/N: B/N: B/N: B/N: B/N: B/N:
Granulation In-process parameters
& Blending
Qty of water for paste

Dry mixing time

Wet mixing time

a) Dry milling
Sieve______RPM_____
b) Wet milling
Sieve______RPM_____
c) Milling after drying
Sieve______RPM_____
d) Final milling
Sieve______RPM_____

Milling time

Drying temp. & time

Blending rpm & time

Appearance

SOP Ref.: PDD-009 From No.: PD-18

Page 4 of 10
 Process Parameters Observations Remarks
Steps Dt.: Dt.: Dt.: Dt.: Dt.: Dt.:
B/N: B/N: B/N: B/N: B/N: B/N:
Granulation Loss on drying (LOD)
& Blending
(continued) Tap density

Bulk density

Sieve analysis
a) __________mesh
b) __________mesh
c) __________mesh

Compressibility

Assay

Compression In-process parameters

Machine name

Pre-compression force

Machine speed

Description

Diameter

Thickness

Hardness

SOP Ref.: PDD-009 From No.: PD-18

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 Process Parameters Observations Remarks
Steps Dt.: Dt.: Dt.: Dt.: Dt.: Dt.:
B/N: B/N: B/N: B/N: B/N: B/N:
Un-coated / Friability
Core Tablet
Disintegration

Description

Diameter

Thickness

Hardness

Friability

Disintegration

Dissolution

Assay
Coating In-process parameters
Machine name
Inlet temperature

Bed temperature

Exhaust temperature

SOP Ref.: PDD-009 From No.: PD-18

Page 6 of 10
 Process Parameters Observations Remarks
Steps Dt.: Dt.: Dt.: Dt.: Dt.: Dt.:
B/N: B/N: B/N: B/N: B/N: B/N:
Coating In-process parameters
(continued)
Air Seal Coating
pressure
Drug Coating

Color Coating

Enteric Coating

Sub-coating

Smoothing

Coloring

Pan rpm Seal Coating

Drug Coating

Color Coating

Enteric Coating

Sub-coating

Smoothing

Coloring

Pump rpm Seal Coating

Drug Coating

Color Coating

Enteric Coating

Sub-coating

Smoothing

Coloring

SOP Ref.: PDD-009 From No.: PD-18

Page 7 of 10
 Process Parameters Observations Remarks
Steps Dt.: Dt.: Dt.: Dt.: Dt.: Dt.:
B/N: B/N: B/N: B/N: B/N: B/N:
Spray rate Seal Coating

Drug Coating

Color Coating

Enteric Coating

Sub-coating

Smoothing

Coloring

Distance of Seal Coating

gun to tab
bed Drug Coating

Color Coating

Enteric Coating

Sub-coating

Smoothing

Coloring

Number of Seal Coating

guns
Drug Coating

Color Coating

Enteric Coating

Sub-coating

Smoothing

Coloring

SOP Ref.: PDD-009 From No.: PD-18

Page 8 of 10
 Process Parameters Observations Remarks
Steps Dt.: Dt.: Dt.: Dt.: Dt.: Dt.:
B/N: B/N: B/N: B/N: B/N: B/N:
Nozzle Seal Coating
diameter
Drug Coating

Color Coating

Enteric Coating

Sub-coating

Smoothing

Coloring

Loss on Seal Coating

drying
(LOD) Drug Coating

Color Coating

Enteric Coating

Sub-coating

Smoothing

Coloring

% weight Seal Coating

gain
Drug Coating

Color Coating

Enteric Coating

Sub-coating

Smoothing

Coloring

Polishing

SOP Ref.: PDD-009 From No.: PD-18

Page 9 of 10
 Process Parameters Observations Remarks
Steps Dt.: Dt.: Dt.: Dt.: Dt.: Dt.:
B/N: B/N: B/N: B/N: B/N: B/N:
Coated Tablet Description

Diameter

Thickness

Hardness

Disintegration

Dissolution

Assay

SOP Ref.: PDD-009 From No.: PD-18

Page 10 of 10