Gelatin Empty capsule
Gelatin empty capsule is the cap and body by the combined two piece of hard quality and flexibility of the space capsule.The capsule should be smooth, uniform color, smooth incision，no deformation and strange smell. The product has three kind of type transparent, translucent, opaque. There are various size of capsule,the company can produces different specifications O #, 1 #, 2 #, 3 #etc. Capsule color is various, modulated of their desired color according to customer requirements. The capsule also can color printing, showing a unique custom appearance.
Characteristics and advantages
The capsules can be very effective cover up to drugs the unpleasant taste and odor, slender shape of capsules. easy to swallow, the most popular consumer formulations.
Pullulan polysaccharide empty capsule
The natural of pullulan polysaccharide empty capsule is different from traditional animal source capsule, it is from starch or sugar as raw material, produced by microorganism fermentation extracellular natural polymer polysaccharide products. has wide applicability, no gelatin crosslinking reaction of amino acid in the risk (crosslinking easily after cause disintegration or dissolve out lower), drug release speed is relatively stable, the advantages of smaller individual differences.
Hydroxypropyl methyl cellulose (hpmc) empty capsule
Hydroxypropyl methyl cellulose empty capsule as a new plant capsule, with greater dissolution, high humidity tolerance, low steam through quantity etc, and with its unique sources, mature technology and variaus technical advantage, for preparation industry provides a larger development space.
Vegetable empty capsule features:
> Low moisture content , HPMC capsules cantains 60% less moisture than gelatin capsule.
> Resilient and non brittle at low moisture content. it is perfect for hydroscopic materials.
> Excellent stability.
> Easy to go further coating with GRAS or traditional formula.
> Environment friendly and health conscious.
ICATION OF GELATIN EMPTY CAPSULE
| Size |
00 |
0 |
1 |
2 |
3 |
4 |
| weight |
mg |
118 |
96 |
76 |
61 |
48 |
38 |
| Tolerance mg |
+7 |
+6 |
±5 |
±4 |
±3 |
±3 |
| capacity |
Capsule volume ml |
0.95 |
0.68 |
0.50 |
0.37 |
0.30 |
0.21 |
|
Powder denisity/
Capsule capacity mg
|
0.6g/ml |
546 |
408 |
300 |
222 |
180 |
126 |
| 0.8g/ml |
728 |
544 |
400 |
296 |
240 |
168 |
| 1g/ml |
910 |
680 |
500 |
370 |
300 |
210 |
| 1.2g/ml |
1092 |
816 |
600 |
444 |
360 |
252 |
Length of the capsule parts (body and cap)
|
Body inches |
0.796
|
0.726 |
0.654 |
0.601 |
0.535 |
0.480 |
| Tolerance inches |
±0.018 |
±0.018 |
±0.018 |
±0.018 |
±0.018 |
±0.018 |
| Body mm |
20.22 |
18.44 |
16.61 |
15.27 |
13.59 |
12.19 |
| Tolerance mm |
±0.46 |
±0.46 |
±0.46 |
±0.46 |
±0.46 |
±0.46 |
| cap Capinches |
0.462
|
0.422 |
0.385 |
0.352 |
0.318 |
0.284 |
| Tolerance inches |
±0.018
|
±0.018 |
±0.018 |
±0.018 |
±0.018 |
±0.018 |
| Cap mm |
11.74 |
10.72 |
9.78 |
8.94 |
8.08 |
7.21 |
| Tolerance mm |
±0.46 |
±0.46 |
±0.46 |
±0.46 |
±0.46 |
±0.46 |
| External diameter |
Body inches |
0.322 |
0.289 |
0.261 |
0.239 |
0.219 |
0.199 |
| Body mm |
8.18 |
7.34 |
6.63 |
6.07 |
5.57 |
5.05 |
| Cap inches |
0.336 |
0.300 |
0.272 |
0.250 |
0.229 |
0.209 |
| Tolerance mm |
8.53 |
7.64 |
6.91 |
6.35 |
5.82 |
5.32 |
| Overall closed length |
Inches |
0.917 |
0.854 |
0.765 |
0.709 |
0.626 |
0.536 |
| Tolerance inches |
±0.012 |
±0.012 |
±0.012 |
±0.012 |
±0.012 |
±0.012 |
| mm |
23.3 |
21.7 |
19.4 |
18.0 |
15.9 |
14.3 |
| Tolerance mm |
±0.3
|
±0.3 |
±0.3 |
±0.3 |
±0.3 |
±0.3 |
PHYSIOCHEMICAL STANDARDS OF GELATIN EMPTY CAPSULE
| Item |
Require |
| ldentification |
Positively reaction |
| Degree of tightness |
≤1/10 |
| Brittle |
≤5/50 |
| Disintegration |
≤10min |
| Heavy metals |
≤40ppm |
| Sulfita |
≤O.01% |
| C2H5CIlO |
In line with the provisions |
| Loss on drying |
12.5% - 17.5% |
| ASH |
Transparent |
≤2.0% |
| Translucent |
≤3.0% |
| Opaque |
≤5.0% |
Viscosity
|
≥60mm2/s |
| Chrominm |
≤2ppm |
| Ethylene Oxide |
≤0.0001% |
| Metyl Parabe |
≤0.05% |
| MICROBIAL |
Bacteria |
≤lOOO piece/g |
| Mildew |
≤lOO piece/g |
| Escherichia coli |
NEG |
| Salmonella |
NEG |
FUNDAMENTAL REQUIREMENT OF FILLING ROOM
To keep thermometer and hygrometer qualified
> The instruments should be kept in good working conditions
> To be examined and maintained regula rly
> To be put in a suitable place for away from the air outlet of air conditioner
> To be calibrated to their qualification at regular intervals by concerning measuring department
The recommended filling room environment
Temperature:20°C to 24°C Relative humidity: 45 %-55 %
Environmental Control
> The filling room should be conformed to the GMP requirement
> To note down the temperature and humidity twice a shift
> Air conditioner . dehumidizer and humidifier are ready for use
> The filling room operation procedure should be observed
Miscellaneous
> To avoid heat generation source radiation
> Filling room to be well insulated from outside
> To use curtains if sunlight shines directly into the room through windows
Storage and using of capsules:
> Capsules should be stored in the room with the temperature between l01: t0 251: and the relative humidity of 35%-65%.
> Capsule cartons should be kept away from walls and a certain distance from the floor to avoid moisture.
> Tighten up tha plastic bags with capsules inside
> Avoid direct sunshine, keep away from heat generation and water sources.
> Capsule cartons should be stored in the place where there is the similar condition with filling room at least half-day before they can be open for filling, in case there are big differences of the temperature and humidity between warehouse and filling room.
> Scoop out and put down capsules gently to prevent defects of mashes, loose pieces and Snap-Fit closed etc. Caused by the improper handling of the capsules.
> No capsules can be used for those touched by bare hands.
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