COMPRESSION PARAMETERS START UP & INPROCESS

Sr Parameter Standa No of In-

. rd Tablets Process
N Frequenc
o y
1 Temperature (37.0±0.5)C˚ - 2
- hours
2 Relative humidity NMT 22% - 2
- hours
3 Hydraulic Pressure 20 kN/cm2 compression pressure - --
tablet press machine -

4 Machine speed 30 rpm compression speed - --

-
5 Punch size a 12 mm flat-faced punch All stations --
6 Description A White to off - white colored All station 2
hours
oval shaped biconvex sugar
coated tablet.
7 Average- length 21.8 – 22.2 mm 6 / Individual 2
hours
8 Average -width 9.4 – 9.6 mm 6 / Individual 2
hours
9 Thickness 12 to 12.1 mm 6 / Individual 30
Min.
10 Hardness 7.06±0.23 Kg/cm2 6 / Individual 30
Min.
11 Disintegration time NMT 12 minutes 6/ 2
Composite hours
12 Friability NMT 1 % w/w 10/ 2
Composite hours
13 Weight of 20 tabs. 18 g ± 3% 20/ 15
Composite Min
14 Uniformity of weight NMT 2 tablets in 20 deviate 20/
from the average weight by Composite
2
more than
Hour
5% No tablet deviates from the
average weight by more than 10
%.
Average weight
15 18g ± 3% 20/ 15
of tablets
Composite Min
16 Lower weight Should be satisfactory - ---
assembly -
-

Manufacturing process sheet

S.N Operati
o. on
11. PREPARATION OF COATING DISPERSION :
0 Coating Composition
Gluceryl behenate or Methyl cellulose as coating agent
11.
0.2mg Qty/unit(mg)
 0.1kg Qty/Batch(kg)
1
11. The equipment used
2
Sugar coating machine
11.
Note: Withdraw the sample for release & Hold time study
3

11.
4
11. Use the coating dispersion freshly prepared.
5
12. COATING PROCESS:
0 The mixture introduced for coating by
12. filling packets or similar containers.
1
Before starting the coating maintain the bed temperature to 38 + 3°C
12.
2 Apply the film coating solution to the tablets using a clean spray gun assembly to get 3.0 to 3.2 %
12. weight gain (Target weight gain: 3.0%)
3
12.
4
12. Coating dispersion to be stirred continuously throughout the coating process at RPM 200 to 1000.
5 Note down the stirrer RPM in BMR.
12.6 Check the tablets intermittently for twining, shade variation during film coating process.

12. Record the inlet & outlet Temperature at every 20-min. & record the same in BMR.
7
12. Before coating & After coating check the parameters & record the observations in BMR.
8
12.9 Check & record net weight of coated tablet. Keep the batch tightly closed with proper labels.

12. Sealing (Water proofing)

10 seal and dry the core and cheak its free from any moisture then seal coat to protect the core from
absorbing any moisture.
apply scound coat after first dry to ensure that the core is effectively sealed
Sealants that are commonly used include: shellac, zinc oxide, cellulose acetate phthalate,
polyvinylacetate phthalate, hyroxylpropylcellulose, hyroxypropylmethylcellulose

12. Subcoating
11 coat the tablet by gum solution or syrap
Dry the tablet.
Repeats the procedure until the desired tablet shape is achieved.
Subcoating usually involves alternating gum solution with dusting powder (talc or calcium carbonate)
until the desired shape and consistency is achieved
Add the colour during the process.
Remove the water after every syrup application.
 Paramet Limi
er ts
Appearance A White to off -white coloured oval sugar coated plain tablet.
Average Weight of 20 coated 18g ± 3%
tablets
Uniformity of weight NMT 2 tablets in 20 deviate from the average weight by more than
5% No tablet deviates from the average weight by more than 10%
Average Length 21.8 – 22.20 mm
Average Width 9.40 – 9.60 mm
Thickness of 6 coated tablets 6.9 to 7.3 mm

Hardness of 6 coated tablets 12 - 22 Kg/cm2

Disintegration time of 6 coated Not more than 30 minutes

tablets