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Quality Control of HPMC Capsule Shells

Acceptable Quality Level
(Sample size 1250 nos. capsules)

Capsule Defect Category Acceptable Quality Level (AQL %)
Critical 0.01
Major 0.40
Minor 1.0


Capsules are manufactured under controlled condition to ensure conformance to specifications.

Classification of capsule defects
(Sample size 1250 nos. capsules)

Critical defect A defect that affects the performance of a capsule
For the final product
For capsule filling
Major defect A defect that may not affect the machine performance critically.
Minor defect A defect that has no effect on the performance of a capsule as a package. It is a slight blemish that makes the capsule visually imperfect.





Dimensional Analysis of HPMC Capsule Shells

Dimension of capsules are controlled to ensure conformance to specifications.

CAPSULE SIZE 00 0 1 2 3 4
Body volume (ml) 0.95 0.68 0.50 0.37 0.30 0.21
Capsule Capacity(mg) for powder density
0.6 g/cc 570 408 288 222 180 126
0.8 g/cc 760 544 384 296 240 168
1.0 g/cc 950 680 480 370 300 210
1.2 g/cc 1140 816 576 444 360 252
Avg. wt in mg 119 96 76 63 50 40
Tolerance in % ±10 ±10 ±10 ±10 ±10 ±10
Cap nominal (mm) 11.8 10.7 9.8 9.00 8.10 7.2
Tolerance (mm) ±0.5 ±0.5 ±0.5 ±0.5 ±0.5 ±0.5
Body Nominal (mm) 20.2 18.5 16.6 15.2 13.6 12.2
Tolerance (mm) ±0.5 ±0.5 ±0.5 ±0.5 ±0.5 ±0.5
Nominal Joined length (mm) 23.5 21.8 19.5 18.0 15.6 14.2
Tolerance (mm) ±0.4 ±0.4 ±0.4 ±0.4 ±0.4 ±0.4
Cap Nominal (mm) 8.55 7.66 6.93 6.37 5.83 5.33
Tolerance (mm) ±0.06 ±0.06 ±0.06 ±0.06 ±0.06 ±0.06
Body Nominal (mm) 8.22 7.34 6.63 6.08 5.56 5.07
Tolerance (mm) ±0.06 ±0.06 ±0.06 ±0.06 ±0.06 ±0.06
Cap Nominal (mm) 0.210 0.205 0.200 0.198 0.196 0.194
Tolerance (mm) ±0.018 ±0.018 ±0.018 ±0.018 ±0.018 ±0.018
Body Nominal (mm) 0.206 0.195 0.193 0.191 0.188 0.182
Tolerance (mm) ±0.018 ±0.018 ±0.018 ±0.018 ±0.018 ±0.018



Final Test of HPMC Capsule Shells


Dimension of capsules are controlled to ensure conformance to specifications.

TEST SPECIFICATION METHOD
Description Cylindrical, Opaque, Telescopic Capsules I.P.
Identification The smoke of burned capsule smells like burning woodchip or paper I.P.
Odour No Foreign Odour I.P.
Disintegration Time in 0.1N HCl at 37 + 1 °C Less Than 15 Minutes I.P.
Loss on Drying 3.0-8.0 % I.P. / USP
pH ( 1% aq solution) 5.0-7.0 IHT
Heavy Metals < 0.001% I.P.
Arsenic <3 ppm I.P.
Self Locking Feature Shell and body lock together and are not readily separated. IHT
Brittleness Shell deforms under pressure but does not crack IHT
Microbiological Test
Total Bacterial Count Less Than 1000 cfu / gm I.P. / USP
Escherichia Coli Absent in 10 gms I.P. / USP
Salmonella Absent in 10 gms I.P. / USP
Staphylococcus Aureus Absent in 10 gms I.P. / USP
Pseudomonas Absent in 10 gms I.P. / USP
Clostridium Spec. Absent in 10 gms I.P. / USP
Yeast and Moulds Below 100 cfu/ gm I.P. / USP


Pacaking, Transportation, Storage & Filling of HPMC Capsule Shells


Packaging

  • Capsules are packed in food grade antistatic plastic bags.
  • These plastic bags are then packed into heavy duty corrugated boxes.
  • The box is then sealed with BOPP tapped from top and bottom.
  • Finally label is pasted on the box having information of size, colour, Batch no., Box No., Quantity and other relevant information


Transportation
  • Capsule packed in boxes are transported in conditions through reefer container vehicles.
  • Temperature is maintained between 10°C to 30°C and Rh is maintained between 40% to 65%.
  • All the dedicated vehicles used for capsules transportation have temperature Data logger fitted in the vehicle, to ensure that the temperature during transit is within specification


Warehousing/ Storage
  • When not in use, Capsules are to be stored in unopened packed condition
  • The Temperature and Rh during storage should be between 20°C to 35°C & 40%to 65%.


Other Precautions:
  • Store capsules away from direct sunlight/ Hot water/ Air radiators, hot water pipes & steam pipes.
  • Store capsules on pallets of the ground.
  • Store capsules away from potential sources of water condensation e.g. under water pipes.
  • Do not store empty capsules in freezers.


Caution:
  • If for any reason inner Poly bag is opened then the opened poly bag containing capsule should be closed in the best manner possible either by heat sealing or usage of good quality adhesive taps to reduce moisture loss/gain during storage
  • The storage condition beyond the recommended limits will result in damage to capsules Quality and its performance on filling Machine.



Shelf life
If the above precautions mentioned earlier are taken during transportation and storage,HPMC capsules can remain in good condition for 5 years from date of manufacturing

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