Manufacturing
Healthcaps India presently produces 3500 million pieces of high quality empty hard gelatin capsules per year. Presently the capsules in size ‘0', size ‘1' and size ‘2' are manufactured strictly according to the norms of the Indian Pharmacopoeia in a wide range of appropriate colors and shades. Healthcaps India also produces size ‘0' elongated (‘0'el) as per clients specifications. We are presently operating 10 machines to achieve the above stated capacity.
Along with 10 machines Healthcaps India has 16 sets of Pin bars so that the product mix for producing sizes ‘0', ‘1' & ‘2' satisfy market demand. Normally we have 4 machines operating on size ‘0', 3 machines on size ‘2' and 1 machine on size ‘1' but in the event of changing market requirements this is interchangeable so that four machines produce size ‘2', Three machines - size ‘0' and One machine - size ‘1'.
Quality Control
Healthcaps India follows strict quality standards in manufacturing. All capsules pass through stringent quality checks right from the manufacturing stage to final dispatch. We have installed four semi-automatic capsule filling machines (almost clones of PD-8 filling machines, without augur) on which the capsules are tested for the defecting of identification and machine suitability. We ensure that the capsules comply with the specifications laid down in IP and as per our Annexure-A.
Steps in capsule manufacturing and quality control
| Production Steps |
Corresponding quality control |
| 1. Preparation of raw material |
| Gelatin |
appearance, odour, colour, grain size, solubility, gelling, (bloom), viscosity, pH value, isoelectric point, bacteriology, chemical purity |
|
| Water |
electrolyte content, pH value, bacteriology |
|
| Colouring agents and pigments |
identity, solubility, bacteriology, chemical purity |
|
| Geletain solution |
viscosity, temperature, colour shade, colour composition |
|
| 2. Production machine |
| 1 Dipping, 2 Rotation, |
temperature, relative |
| 3 Gelling, 4 Drying, |
humidity, viscosity, |
| 5 Stripping, 6 Cutting, |
dimension, colour shade, |
| 7 Joining, 8 Ejection |
laboratory check |
|
| 3. Inspection |
defects |
| 4. Imprinting |
laboratory checks on ink, statistical control |
| 5. Counting, packaging |
final release by Quality Control |
| 6. Batch release |
certificate |
|
Download DMF Document |
SPECIFICATION OF E.H.G. CAPSULES-IP
| 1. |
Description: |
Empty Hard Gelatin Empty Capsules |
| 2. |
Size: |
As per Empty Hard Shell Capsules Standard Dimension.(Point 9) |
| 3. |
Colour: |
The colour of the product should visually match to the sample provided by the customer, when viewed under normal lighting conditions. |
| 4. |
Weight : |
‘0' ‘1' ‘2'
Per piece at 14% moisture) : 97±3mg 77±3mg 64±3mg |
| 5. |
Weight Variation: |
The weight of individual capsules should be within ± 10% of the average weight of 20 capsules. |
| 6. |
Moisture Content: |
12.5% to 16% (At 105°C for 4 hours) (Referral test at 105°C for 18 hours) |
| 7. |
Disintegration: |
Maximum 10 minutes (Method followed as in
Indian Pharmacopoeia) |
| 8. |
Microbiological: |
Total Counts (Max.) 1000/gm (As per IP) LIMITS E.ColiAbsent/gm (As per IP) Salmonella Absent/gm (As per IP) Fungal Counts Absent/gm (As per IP) |
Empty hard shell capsules' standard dimensions:
|
Size ‘0' |
Size ‘1' |
Size ‘2' |
Empty Joined Length (mm) |
2 3.4±0.7 |
21.1±0.7 |
19.5±0.7 |
Cap Length (mm) |
11.18±0.36 |
10.01±0.36 |
9.17±0.36 |
Body Length (mm) |
18.72±0.36 |
16.72±0.36 |
15.34±0.36 |
Cap Diameter (outside) (mm) |
7.63±0.06 |
6.91±0.06 |
6.34±0.06 |
Body Diameter (outside) (mm) |
7.32±0.06 |
6.62±0.06 |
6.07±0.06 |
Cap Thickness (D.Wall) (Thou) |
8.4±0.4 |
8.2±0.4 |
8.1±0.4 |
Body Thickness (D.Wall) (Thou) |
8.0±0.4 |
7.9±0.4 |
7.8±0.4 |
Shoulder Thickness (Thou) |
3.0±0.5 |
2.5±0.5 |
2.5±0.5 |
Dome Thickness (mm) |
0.13±0.02 |
0.13±0.02 |
0.13±0.02 |
Packaging
95000 Pieces per Box in Size ‘0 el'
100,000 Pieces per Box in Size ‘0'
125,000 Pieces per Box in Size ‘1'
175,000 Pieces per Box in Size ‘2'
These lot sizes are determined after taking into consideration the safeguard of the empty hard gelatin capsules as well as the existing capacities of containers/trucks through which our empty hard gelatin capsules are transported to different destinations in India and abroad. The empty hard gelatin capsules are packed in durable multilayered poly bags, which are securely sealed. These poly bags are then packed in securely strapped and taped heavy duty seven ply corrugated boxes made out of virgin craft material having outer dimensions of 67.0 Cms. (length) X 45.0 Cms. (Width) X 59.5 Cms. (Height).
PRINTING
Clear, easy-to-read text makes it easy for users from medical staff and patients to off the shelf consumers correctly identify each capsule's name. That is why Healthcaps empty hard gelatin capsules can be clearly imprinted in one or two colours with useful information like a logo, product name, company or even dosage details. Healthcaps India expert imprinting team is readily available to offer technical advice and expertise.
|
Linear-Print
Using an offset printing process, hard gelatin capsules can be printed length-wise using the Axial-Print process. It is a simple solution suitable for several lines of text such as a company and product name.
Circular-Print
For circumferential printed capsules, Healthcaps India suggests the Radial-Print process. This means that the capsules rotate while being printed and the design is printed around the capsule. Up to 320° of the capsule circumference is printable, including additional room for legibility. The advantage of the Radial-Print technique is space: the printable area is five times larger than the area available using the Axial-Print technique. For both Axial-Print and Radial-Print techniques, Healthcaps offers rectified and non-rectified imprinting.
Ink colours
Healthcaps' capsules can be imprinted with a variety of standard approved edible inks that easily contrast with the many capsule colour combinations. To meet specific marketing and labelling needs, special ink colours can be developed on demand. |
Storage & Transportation
Healthcaps India makes certain that the desired conditions are maintained during the storage and transportation of the empty hard gelatin capsules. Storage areas are maintained at temperatures ranging between 15°C to 25°C and relative humidity at 45% to 55% RH. These conditions are maintained exactingly and are essential from the manufacturing stage to the time of usage. We transport all our ready to use high quality capsules by air conditioned vans or trucks, air and sea in reefer containers depending upon the volume of the material being transported. |
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