Empty capsules are solid dosage forms in which one or more actives are enclosed in a water-soluble, biodegradable Shell made up of Gelatine.

Ingredients

All ingredients used for capsule manufacturing comply with appropriate regulatory requirements for use in food and drug products and comprise mainly of the following: 

IngredientApplicable Standard
Pharmaceutical Grade GelatineUSP, Ph. Eur
Purified WaterIP & Ph. Eur
Water Soluble ColorantsEEC Directives 2008 / 128 / EC
Iron Oxides (Yellow & Red)EEC, USP
Titanium DioxideUSP & E.P.
AdditivesUSP & Ph. Eur
ingredients.pdf

We supply EHG capsules manufactured with gelatine exclusively procured from India and free of BSE (bovine spongiform encephalopathy).

Based on customer requirements, we also deliver EHG capsules manufactured by using EDQM certified gelatin conforming to European Pharmacopeia monograph and is free of risk of TSE (transmissible spongiform encephalopathy).

Dimensional control

The dimension of EHG capsules are controlled statistically to ensure conformance to the specifications. The dimensions and tolerances are indication for proper filling performance.

Dimensions and tolerances are given in Millimeters. Unless otherwise indicated, these dimensions and tolerances apply to hard gelatin capsules, at a moisture of 12,5 - 16,0 %.

For measuring dimensions of the capsules, it is recommended that measurement should be taken under controlled conditions of temperatue and humidity. Temperature between 20°C to 25°C and relative humidity between 45 % to 60 % are recommended.

Capacity

Empty hard gelatin capsule shells are normally used for the incorporation of actives usually in the form of powders, pellets or granules, tablets, semi-solid materials, pastes and liquids, etc. The useful filling capacity is the volume of the capsule shell body and it depends upon the nature and bulk density of the material. The average volume and capacity for typical powder dose density is as given below:

Capsule SizeBody volume in cc
(approx)
Powder dose in "mgs" at bulk density
0.60 g/cc0.80 g/cc1.0 g/cc1.2 g/cc
000.955707609501140
0el0.78468624780936
00.68408544680816
10.50300400500600
20.37222296370444
30.30180240300360
40.21126168210252
capacity.pdf

Empty capsule weight

The dipping process determines the weight of the capsules. The weight of an individual capsule varies around a target value. The table given below shows the designed target weight in milligrams for EHG capsules of each size on an average of 100 capsules.

SizeAverage weight (mg)Tolerance
00120± 7 %
096± 7 %
176± 7 %
263± 7 %
349± 7 %
440± 7 %
empty-capsule-weight.pdf

The weights in the above table are determined from the gross weight of a sample of 100 capsules at moisture content assumed to be 14 %.

TestTest
Identification
Unlocked cylindrical capsules
DescriptionColourCapAs per approved colour shade
BodyAs per approved colour shade
Print message: text, colour &
orientation
CapAs per approved artwork
BodyAs per approved artwork
Identification of gelatinPositive for gelatin
Identification of colorants/iron oxidesConform to approved composition
Identification of Titanium DioxideConform to approved composition
Performance
Disintegr time in water at 37°C ± 2°CMaximum 15 minutes (with guided disk)
Loss on drying (at 105°C ± 1°C for minimum 4 hours or to constant weight)Between 12.5 % - 16,0 % w/w
Average weight of
capsule shells in mg
(wt of 100 capsules / 100)
Within ± 7 %Size000el012el234
Target000el012el234
Range111.6
-
128.4
96.7
-
111.3
89.3
-
102.7
70.7
-
81.3
61.4
-
70.6
58.6
-
67.4
45.6
-
52.4
37.2
-
42.8
Purity
OdourNo foreign odour after 24 hours when kept at a temperature between 30°C - 40°C
Safety
Sulphated ashMaximum 5 % w/w
ArsenicMaximum 1 ppm
LeadMaximum 1 ppm
Lubricant contentMaximum 0.5 % w/w
Sulphur dioxideMaximum 50 ppm
MercuryMaximum 0.1 ppm
CadmiumMaximum 0.5 ppm
Microbial limits
Total aerobic microbial countMaximum 1000 cfu / g
Yeast & moldMaximum 100 cfu / g
Escherichia coliAbsent / 1 g
SalmonellaAbsent / 10 g
Pseudomonas aeruginosaAbsent / 1 g
Staphylococcus aureusAbsent / 1 g
ShigellaAbsent / 10 g
specification-of-hard-gelatin-capsule-shells-as-per-international-capsule-manufacturers-.pdf

Length of the cap and the body of EHG capsules are controlled at various stages of the manufacturing process,  taking a sample of 20 capsules, to ensute that each batch conforms to the specification as mentioned below:

SizeCap Length
(mm)
Body Length
(mm)
Tolerance
0011.8020.10± 0.40 mm
0el11.5020.50± 0.40 mm
011.1018.70± 0.40 mm
110.0016.60± 0.40 mm
29.2015.20± 0.40 mm
38.2013.50± 0.40 mm
47.5012.20± 0.40 mm
length-.pdf

We use international standard pin molds for manufacturing EHG shells.

The following is the specification for the outside diameter of EHG capsules:

SizeCap Diameter
(mm)
Body Diameter
(mm)
Tolerance
008.558.21± 0.03 mm
0el7.667.34± 0.03 mm
07.667.34± 0.03 mm
16.936.63± 0.03 mm
26.376.08± 0.03 mm
35.815.56± 0.03 mm
45.335.09± 0.03 mm
outside-diameter-.pdf

Note: The outside diameter measurements are to be taken with the help of special go, no-go gauges and not by vernier caliper or micrometer.

The data above is an indication of the external diameter and should not be considered as an accept/reject criteria (due to the tapered shape of the capsule and the difficulty to measure the exact diameter). These data can be used for specifying packaging material dimensions.

Double wall thickness is measured with the help of calibrated micrometers just 2 mm above the cutting edge of the cap and 3 mm below the ring in body.

Double wall thicknesses are as follows:

SizeCap
(mm)
Body
(mm)
Tolerance
000.2200.210± 0.018 mm
0el0.2180.204± 0.018 mm
00.2180.204± 0.018 mm
10.2100.200± 0.018 mm
20.2080.196± 0.018 mm
30.1980.188± 0.018 mm
40.1940.182± 0.018 mm
double-wall-thickness-.pdf

The specifications for closed length of filled capsules are as follows:

SizeClosed Length
of filled Casules
(mm)
Tolerance
0023.00± 0.40 mm
0el23.20± 0.40 mm
021.40± 0.40 mm
119.30± 0.40 mm
217.80± 0.40 mm
315.80± 0.40 mm
414.50± 0.40 mm
closed-length-of-filled-capsules-.pdf

Moisture content

The moisture content of capsule shells is maintained between 12.5 % and 16.0 % w/w.

Disintegration time (solubility)

The empty hard gelatine capsules are soluble in warm water and disintegrate within 15 minutes at 37°C ± 2°C (test procedure as per IP/BP or eqivalent).

Microbial limits

  • Total bacterial count not more than 1000 cfu / g in the EHG capsule shell.
  • EHG capsules are free from Escherichia coli per 1 g.
  • Salmonellae absent per 10 g.
  • The fungal counts are not more than 100 cfu / g.
  • Pseudomonas aeruginosa and S. aureus absent per 1 g.
  • Shigella absent per 10 g.

Test procedure as per IP/BP/USP or eqivalent.

Certificate of Analysis

Certificate of Analysis compliant to specification accompanies each batch.

Packaging

In order to protect capsules from variations in surrounding temperature and humidity, capsules are packed in heat sealed food grade co-extruded multilayer poly bags and placed in a 5 or 7 ply rigid corrugated box. High density thermocol sheets and aluminium foil are also provided in corrugated boxes as and when required.

The packaging material used for capsules packaging have adequate mechanical sturdiness to withstand rough handling and also provides a good moisture barrier and heat isolation. It also protects capsules against any possible contamination.

Each box is assigned a number for identification. A product label containing various packing details such as size, color, batch no, weight, quantity and consignee etc. is also pasted on it.

Transportation

In spite of the protective packaging used, care must be taken during transportation that hard capsules are not left on a loading dock or in an unattended truck for several hours during warm weather. The ideal storage conditions are relative humidity of 50% and a temperature of 20°C.

The producer recommends that our capsules be stored in the closed containers in which they are dispatched in areas where the ambient temperature is 15°C to 25°C and the relative humidity 40% to 65%.

Prolonged storage in areas outside these conditions may cause capsules to soften and lose their shape or to become difficult to separate, with the result that problems may encountered during the filling operations. In order to prevent such problems arising, it is recommended that containers of capsules are not stored for prolonged periods of time directly on the floor. They should also be stored away from radiators and direct sunlight. Storage closed to potential sources of water damage should be avoided.

If these recommended precautions for storage conditions and warehousing are observed, the hard gelatin capsules will remain in good condition.

Capsules filling

There are many factors that contribute to efficient filling of the capsules on filling machines. Optimum conditions recommended for the filling operations are 23°C  + 2°C and relative humidity of 45% to 55%. Under these conditions the capsule will maintain the recommended moisture content to avoid brittleness and retain the required dimensional stability.

A word about electro-static charge

The use of plastic containers or scoops can cause electrostatic charge to build up on the capsules and result in problems during filling. Hence it is recommended to use steel scoops or containers.