| Quality |
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| Quality Assurance |
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| The QUALITY ASSURANCE DEPARTMENT is primarily responsible for delivering and assuring the quality in the end product. They check whether the production on line is meeting to the specific quality requirements. |
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| They check specific parameters of the capsule like length, weight, moisture, and disintegration time. |
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| The length is measured by a vernier caliper. |
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| It is performed by taking 0.3gm of capsules and putting it in an oven at 105ºC for four hours and weighed and the loss on weight is due to loss of moisture content in the capsule. We have automatic moisture measuring device installed to control the moisture as per requirement. |
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| This test is done to see the time taken by the capsules to completely disintegrate. The capsules are taken in a disintegration machine and the temperature is maintained at 37ºC +/- 1ºC. The time taken for the capsules to completely disintegrate is the disintegration time for the capsules. |
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| The average weight of the capsules is checked. |
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| The capsules from the machine room are tested for the performance on the capsule filling machine. This is done three times in a shift for every machine. All parameters measured are as per the IP (Indian Pharmacoepia) and the in-house specifications. |
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| Customer complaints are handled. All new colors are developed in the QUALITY ASSURANCE LAB. The QUALITY ASSURANCE DEPARTMENT does complaint handling at the customer end. SHL Capsule strictly adheres to the quality assurance procedures mandated by cGMP. |
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- Sampling & Evaluation of Visible Defects:
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| Method of Inspection : |
| Sample of 1000 capsules from each box are inspected for visual defects by spreading them on a frosted glass with illumination from below and above. Defective capsules are separated as per above categorization. |
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| Evaluation of Visible Defects : |
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| These defects affect the performance of a capsule as a package for the final product or contribute to a major problem on a capsules filling M/c. |
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| These defects may affect Capsules filling operations. |
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| These defects do not affect the performance on the filling M/c. Such defects are cosmetic & make the capsules visually imperfect. |
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| Classification of Visible Defects: |
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| Critical Defects |
Major Defects |
Minor Defects |
| Uncut |
Long Cap |
Dented (Small) |
| Double Dip |
Long body |
Side corrugation |
| Split |
Short Cap |
Bubble |
| Oil hole/Oil spot |
Short body |
Collet pinch (Small) |
| Ring inside |
Badly joined |
Scrap |
| Ring outside |
Loose cap/body |
Star end |
| Mashed capsule |
Rough edges, Dented(large)
Chipped edges, Collet Pinch(Large) |
Spot Printing Defects |
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| Acceptable Quality Level (AQL) of visible defects : |
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| Capsule defect category |
Acceptable Quality Level (AQL) |
| Critical |
0.05% |
| Major |
0.50% |
| Minor |
1.50% |
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| Evaluation Criteria on Dimensions, Moisture, Disintegration Time and Microbial Count |
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| SHL manufactures the capsules as per IP. All the raw material & finished product testing done as per IP standards. But in case of size '00' & 'OEL' SHL have maintained IHS (In-house specification). Our specification based on IP & IHS for capsules dimension is as given below : |
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| Capsule Specification |
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| Size |
Length (m) |
Empty Joined |
Closed Joined |
Diameter (m) |
Double Wall
Thickness |
Empty Weight |
| Body |
Cap |
Body |
Cap |
Body |
Cap |
| 00 |
20.20 + 0.30 |
11.70 + 0.30 |
26.00+ 0.4 |
23.50+0.04 |
8.16 + 0.05 |
8.51+ 0.05 |
0.180-0.220 |
0.187-0.223 |
122 + 6.0% |
| OEL |
20.20 + 0.30 |
11.70 + 0.30 |
25.15+ 0.5 |
23.3+0.04 |
7.32 + 0.06 |
7.63+ 0.06 |
0.117-0.213 |
0.187-0.223 |
107 + 5.0% |
| 0 |
18.50 + 0.30 |
11.00 + 0.30 |
23.5 + 0.4 |
21.4+0.04 |
7.32 + 0.06 |
7.63+ 0.06 |
0.177-0.213 |
0.187-0.223 |
96.0 + 5.0% |
| 1 |
16.60 + 0.30 |
9.80 + 0.30 |
21.2 + 0.4 |
19.3+0.04 |
6.62 + 0.06 |
6.91 + 0.06 |
0.175-0.211 |
0.182-0.218 |
76 + 5.0% |
| 2 |
15.20 + 0.30 |
9.00 + 0.30 |
17.5+ 0.4 |
17.8+0.04 |
6.07 + 0.06 |
6.34 + 0.06 |
0.173-0.209 |
0.180-0.216 |
64 + 5.0% |
| 3 |
13.50 + 0.30 |
8.10 + 0.30 |
16.2 + 0.4 |
15.8+0.04 |
5.56 + 0.06 |
5.81 + 0.06 |
0.170-0.206 |
0.178-0.214 |
50 + 5.05% |
| 4 |
12.20 + 0.25 |
7.30 +0.25 |
16.2+ 0.4 |
14.5+0.04 |
5.06 + 0.06 |
5.31 + 0.06 |
0.164-0.200 |
0.176-0.212 |
40 + 5.0% |
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| Capsules Length is controlled during manufacturing and each lot is audited for conformance to specification. Length is measured with a vernier caliper capable of measuring up to 0.02 mm. |
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| Capsules are manufactured by a dipping process. The average capsules weight is estimated by a representative sample of 100 capsules. Significant variation in capsules will occur if moisture content changes. In the table above the moisture content of capsules is assumed to be 14% and tolerance is given at 99.7% confidential level. Therefore the target weights in the table should not be used as tare weights in capsules filling. An actual tare weight should be determined at regular intervals during filling in order to assure proper filled weight. |
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- Recommended Closed Joined Length:
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| The recommended closed joined of capsules has been calculated to ensure the correct location of capsules locking. Capsules longer than the listed values will tend to come apart. If the filling machine is set so that the capsules are closed to a length shorter than the listed values then the cap or body may get dented after locking. |
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The following outside diameters are provided as a guideline for evaluating packaging material dimensions.
Note : The body diameters are indicative only. Body Diameters are adjusted to achieve correct fit, oriented towards better machinability.
Note : Exact outside diameter of the cap & body are difficult to measure, because of their slight tapered shape and also due to the flexibility of the capsules shell. Hence the above dimensions are not recommended to be the basis for acceptance/rejection of a lot.
Double wall Thickness : Double wall thickness is measured using a specially designed dial gauge with readability of one micron. |
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| Moisture of capsules checked at each stage from capsules manufacturing to final Packing. To ensure that the moisture content is between 12.5-16.0% w/w. This is determined by the loss of drying method at 105ºC +/- 1ºC for minimum 4 hours. Moisture value below than 12.5 % can make capsules fracture under stress & above than 16.0% can cause the capsules to become soft & lose shape. High humidity capsules gains the moisture & in low humidity capsules will lose the moisture. |
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| Disintegration time for empty hard gelatin capsules shells should be less than 15 minutes at 37ºC +/- 2ºC. Procedure is provided in IP-96. |
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| Total bacterial count does not exceed 500 cfu per gram with E.Coli & Salmonella absent in 1.0 gm. |
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| Filling Capacity of Capsules according to Different Sizes & Different Density: |
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| Two-piece hard gelatin capsules can be filled with a range of materials with different physical properties: powders, granules, pallets, tablets, semisolid material, pastes etc. In order to calculate the quantity of material that can be filled in to a capsule, the nature of the material needs to be taken into account. The most useful capacity value is the available volume of the capsules body. |
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| The above data is to be considered as approximate since filling products variables and filling machines types can significantly affect the capsules weight. The maximum fill weight for each size can be estimated by multiplying the capsules volume by the tapped density of the formulation. The maximum capacity for liquid and paste formulations is 90% of the body volume. |
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