Hitung Volume

Shared Surface Area (SSA) of Rinse

Obatine Tablet that contacts with APIs Volume Limit of Rinse Sample
(D) (V) (mg/mL)
2
(cm ) (mL)
Acetaminophen Chlorphenamine Maleate

17.49 3.5 3.5 3.5

144 28.8 28.8
120.89 24.2 24.2
204.1 40.8 40.8

1292.9 258.6 258.6

180 36.0 36.0

197.82 39.6 39.6
186.52 37.3 37.3

993.03 198.6 198.6

1292.9 258.6 258.6

523.49 104.7 104.7

684.41 136.9 136.9

106.96 21.4 21.4

106.96 21.4 21.4

106.96 21.4 21.4 21.4

763.4 152.7 152.7 152.7

109.14 21.8 21.8 21.8

99.75 20 20.0 20.0

85.41 17.1 17.1 17.1

3391.2 678.2 678.2 678.2

785 157 157.0 157.0
139.42 27.9 27.9 27.9
1130.4 226.1 226.1 226.1

71.1 14.2 14.2 14.2

Page 1
 Hitung Volume

187 37.4 37.4 37.4

78 15.6 15.6 15.6
322.02 64.4 64.4 64.4
129.12 25.8 25.8 25.8

Page 2
 Hitung Volume

Rinse Sample
Parameter Acetaminophen
mg/mL)

Dextromethorphan HBr 262.86 mg

MACO (Maximum Allowable Carryover)
262860 μg
3.5 The whole equipment train (C) 381577.99 cm2
Surface Area Limit (SAL) 0.69 μg/cm2

21.4
152.7

21.8

20.0

17.1

678.2
157.0
27.9
226.1

14.2

Page 3
 Hitung Volume

37.4
15.6
64.4
25.8

Page 4
 Hitung Volume

Chlorphenamine Maleate Dextromethorphan Hbr

62.22 mg 128.32 mg
62220 μg 128320 μg
255413.91 cm2 134226.94 cm2
0.24 μg/cm2 0.96 μg/cm2

Page 5
 Sheet2

No. Equipment and Apparatus

1 SS Spatula for Weighing of Acetaminophen, Chlorphenamine Maleate and Dextromethorphan HBr

Yen Chen Super Mixer Granulator Type YC–SEP–SMG–100 Cap. 30 kg
for Wet Granulating of Chlorphenamine Maleate
Mixing Tank
2
Chopper
Impeller Part
Nozzle for Binder Solution
Yen Chen Super Mixer Granulator Type YC–SEP–SMG–250 Cap. 100 kg
for Wet Granulating of Acetaminophen
Mixing Tank
Chopper
3
Impeller Part
Nozzle for Binder Solution
Bag Filter Installation
Bat Filter
Yen Chen Oscillating Granulator Type YC–SEP–OG–2A Cap. 150 kg/hour
for Sieving of Acetaminophen Wet Granules
Powder Loading Hopper
Oscillating Wheel 1
4
Bearing Seat 1
Fixing Stick (Screen Side Fixing Support)
Fixing Stick 1
Fixing Pole (Screen Middle Fixing Support)
Yen Chen Oscillating Granulator Type YC–SEP–OG–2A Cap. 400 kg/hour
for Sieving of Chlorphenamine Maleate Wet Granules
Powder Loading Hopper
Oscillating Wheel 1
5
Bearing Seat 1
Fixing Stick (Screen Side Fixing Support)
Fixing Stick 1
Fixing Pole (Screen Middle Fixing Support)
Yen Chen Dry Oscillating Granulator Type YC–SEP–OG–2 Cap. 200 kg/hour
for Sieving of Acetaminophen Dry Granules
Powder Loading Hopper
6 Bearing Seat 1
Fixing Stick (Screen Side Fixing Support)
Fixing Stick 1
Fixing Pole (Screen Middle Fixing Support)
Yen Chen Dry Oscillating Granulator Type YC–SEP–OG–2 Cap. 400 kg/hour
for Sieving of Chlorphenamine Maleate Dry Granules
Powder Loading Hopper
7 Bearing Seat 1
Fixing Stick (Screen Side Fixing Support)
Fixing Stick 1
Fixing Pole (Screen Middle Fixing Support)
8 Small SS Kape 2 for Sieving of Chlorphenamine Maleate Wet and Dry Granules
9 Small SS Kape 3 for Sieving of Acetaminophen Wet and Dry Granules
10 Small SS Kape 4 for Mixing and Lubricating

Page 6
 Sheet2

Sample Thieves
11 Part 1 (Outer Part)
Part 2 (Inner Part)
Gylongli Compressing Machine Type GZPL–620
Upper Punch
Upper Punch 1 – 7
Lower Punch
Lower Punch 1 – 7
12
Dies
Dies 1 – 7
Silicone Tubing from Bin to Vacuum Conveying Machine
Tubing for Rejected Tablet
Bulk Discharged 1
Kung Long Stripping Machine Type SP-260 (II)
Sliding Guide
SS Slidding Guide Part 1
13 Mica Slidding Guide Part 1
SS Slidding Guide Part 4
SS Slidding Guide Part 5
SS Slidding Guide Part 6

Page 7
 Sheet2

SSA Rinse Volume (mL) Rinse Volume (mL) Rinse Volume (mL)
(cm2) ACT CTM DMP
23.99 4.8 4.8 4.8

144 28.8 28.8 28.8

120.89 24.2 24.2 24.2
204.1 40.8 40.8 40.8

180 36.0 36.0 36.0

197.82 39.6 39.6 39.6
186.52 37.3 37.3 37.3

993.03 198.6 198.6 198.6

1292.9 258.6 258.6 258.6

298.34 59.7 59.7 59.7

308.81 61.8 61.8 61.8

262.28 52.5 52.5 52.5

1292.9 258.6 258.6 258.6

298.34 59.7 59.7 59.7

308.81 61.8 61.8 61.8

262.28 52.5 52.5 52.5

298.34 59.7 59.7 59.7

308.81 61.8 61.8 61.8

262.28 52.5 52.5 52.5

298.34 59.7 59.7 59.7

308.81 61.8 61.8 61.8

262.28 52.5 52.5 52.5
175.86 35.2 35.2 35.2
175.86 35.2 35.2 35.2
175.86 35.2 35.2 35.2

Page 8
 Sheet2

460.08 92.0 92.0 92.0

303.32 60.7 60.7 60.7

109.14 21.8 21.8 21.8

99.75 20.0 20.0 20.0

85.41 17.1 17.1 17.1

3391.2 678.2 678.2 678.2
785 157.0 157.0 157.0
139.42 27.9 27.9 27.9

71.1 14.2 14.2 14.2

187 37.4 37.4 37.4
78 15.6 15.6 15.6
322.02 64.4 64.4 64.4
129.12 25.8 25.8 25.8

Page 9
 Sheet3

ACT CTM DMP

23.99 4.8 4.8 4.8
144.00 28.8 28.8 28.8
120.89 24.2 24.2 24.2
204.10 40.8 40.8 40.8
180.00 36.0 36.0 36.0
197.82 39.6 39.6 39.6
186.52 37.3 37.3 37.3
993.03 198.6 198.6 198.6
1292.90 258.6 258.6 258.6
298.34 59.7 59.7 59.7
308.81 61.8 61.8 61.8
262.28 52.5 52.5 52.5
1292.90 258.6 258.6 258.6
298.34 59.7 59.7 59.7
308.81 61.8 61.8 61.8
262.28 52.5 52.5 52.5
298.34 59.7 59.7 59.7
308.81 61.8 61.8 61.8
262.28 52.5 52.5 52.5
298.34 59.7 59.7 59.7
308.81 61.8 61.8 61.8
262.28 52.5 52.5 52.5
460.08 92.0 92.0 92.0
303.32 60.7 60.7 60.7
109.14 21.8 21.8 21.8
99.75 20.0 20.0 20.0
85.41 17.1 17.1 17.1
3391.20 678.2 678.2 678.2
785.00 157.0 157.0 157.0
139.42 27.9 27.9 27.9
71.10 14.2 14.2 14.2
187.00 37.4 37.4 37.4
78.00 15.6 15.6 15.6
322.02 64.4 64.4 64.4
129.12 25.8 25.8 25.8

Page 10