Empty Hard Gelatin Capsule - Size: #00, #0el, #0, #1, #2, #3, #4

Size of Capsule: 00, 0el, 0, 1, 2, 3 and 4, Capsules are DMF certified under US FDA, Halal, ISO, GMP &, Preservative & SO2 free - details see: https://www.packinghere.com/empty-hard-gelatin-capsule-10035413
Place of Origin: Madhya Pradesh IndiaBrand Name: Erawat Pharma LimitedModel Number: Size: #00, #0el, #0, #1, #2, #3, #4Halal Capsules: Hard Gelatin Capslue
Empty Hard Gelatin Capsule Size: #00, #0el, #0, #1, #2, #3, #4
contact supplier for Empty Hard Gelatin Capsule Size: #00, #0el, #0, #1, #2, #3, #4


Certification

1. We are DMF Certified (Type IV – 17515) under US FDA

2. We are ISO certified company.

3. We manufacturing capsules which are absolutely Preservative Free, ETO & SO2 free.

4. We manufacturing capsules which are Halal and Kosher Certified.

5. We manufacture capsules only TSE/BSE free and our gelatin suppliers are all EDQM CERTIFIED.

6. We have shortest lead time in industry. We can supply Empty Capsules within 20-30 days from our factory after the confirmed order.

7. We provide special Metallic & Pearl shades of capsules also.

We are, at present, offering capsules in Size 00, 0EL, 0, 1, 2, 3 and 4 with any possible combination of colors that is required by our customers. Apart from this, we are also offering Premium shades like Iron Oxide, Metallic & Pearl shades of capsules which provide superior brand security, visual attractiveness and differentiation to the special products of our customers.

Raw Material

In order to ensure supply of quality goods to the Customer, the right kind of materials is procured from the right source.
The Principal raw materials involved include TSE/BSE free Gelatin and Color Pigments.


Color Pigments: Colorants are used as per specific requirements of Customers and food colors are confirming to B.I.S. We are providing our customers exact color shades as per their customized requirement. The color shade is consistent in all the batches of production. The color pigments used are strictly as per I.P. 1996. The color shade once developed for a customer is allotted a code and is always reproduced on repeat of orders.

S.NO.COLORCOLOR INDEX NO.
1.Carmosine14720
2.Ponceau 4R16255 (Optional)
3.Brilliant Blue42090
4.Indigo Carmine73015
5.Sunset Yellow15985
6.Quinoline Yellow47005
7.Allura Red16035
8.Patent Blue V42051

OTHER NATURAL COLORS

9.Black Iron Oxide
10.Red Iron Oxide
11.Yellow Iron Oxide
12.TiO2

All the aforesaid colors are permitted under Government of India Drug and Cosmetics Act to be used in manufacturing of drugs. However, any other specified color can also be used as per customers' requirement and approved under the act.

When developing capsules for our export clients, we develop colors using only those colors which are approved & allowed in that country.

Printing & Testing

1.Printing :We are equipped with excellent quality printing machines, which are made in (Erawat Engineering Pvt. Ltd. & have the expertise of printing on capsules as per customized requirements.
We provide printing in several varieties as follows:

  • Linear Printing
    a. Double color oriented
    b. Single color oriented
    c. Regular Linear printing
  • Circular Printing
    a. Double color oriented
    b. Single color oriented
    c. Regular circular printing
  • we also provide metallic printing on capsules which give excellent safeguard from counterfeiting possibilities

Technical Specifications

The various quality variants are controlled as per specification prescribed in I.P. 1996.

However our Quality Control norms are even Stringent than those specified in I.P. 1996. We operate under narrower limits for various attributes, like Dimension, Weight etc. than those permitted in I.P. 1996.

DIMENSIONS (in millimeter)

TABLE 1

OUTSIDE DIAMETER

SizeCAP (mm)BODY(mm)
#008.50-8.568.18-8.24
#0el7.63 - 7.717.32 - 7.40
#07.57 - 7.697.26 - 7.38
#16.85 - 6.976.56 - 6.68
#26.28 - 6.406.01 - 6.13
#35.75-5.875.50-5.62
#45.25-5.375.00-5.12

TABLE 2

LENGTH

SizeCAP (mm)BODY(mm)
#0011.40 - 12.2019.90 - 20.70
#0el11.40 - 12.2019.90 - 20.70
#010.68 - 11.6818.22 - 19.22
#19.51 - 10.5116.22 - 17.22
#28.67 - 9.6714.84 - 15.84
#37.73 - 8 - 7312.98 - 13.98
#47.42 - 8 - 5212.29 - 12.39

TABLE 3

PRELOCK JOINED LENGTH OF EMPTY SHELLS

SizePrelock Joined Length (mm)
#0025.40-26.20
#0el24.32 ­ 25.12
#023.20 ­ 24.0
#120.80 ­ 21.60
#219.02 ­ 20.02
#315.4-16.20
#414.00-14.60

TABLE 4

DOUBLE WALL THICKNESS

SizeCAP (mm)BODY(mm)
#000.196-0.2240.192-0.220
#0el0.186 - 0.2260.180 - 0.220
#00.187 - 0.2230.177 - 0.213
#10.182 - 0.2180.175 - 0.211
#20.180 - 0.2160.173 - 0.209
#30.178-02140.170-0.206
#40.176-02120.164-0.200

TABLE 5

WEIGHT OF CAPSULES (in milligram) & VOLUME (in CC)

AVERAGE WEIGHT (Deviation ± 5%) & VOLUME (in CC)

SizeAverage weight (mg)
(Avg. of 20 Capsules Taken Together)
Volume (CC)
#001190.95
#0el1040.78
#0960.68
#1760.50
#2630.38
#3500.30
#4400.21

TABLE 6

MICROBIOLOGICAL LIMITS

TOTAL COUNTS OF ORGANISM= Less than 1000 / gm
E ­ COLI= NIL (Absent)
SALMONELLA= NIL (Absent)

TESTS AS PRESCRIBED BY I.P. 1996

TABLE 7

MOISTURE CONTENT AND DISINTEGRATION TIME

MOISTURE CONTENT= 13.0 % - 16.0 %
DISNTEGRATION TIME= Less than 15 minutes.

Packing & Labeling

We pack the capsules first in Poly-Bags, and then these bags are put in "Aluminum Foil LLDP co-extruded bags". These bags are then put in corrugated box, which is lined with Thermocol (Styrofoam) on all the six inner sides of the box. Further these packed boxes are then laminated with poly film. Thus we not only take care of the temperature and humidity but also take into consideration the mis-handling that might take place during transportation.

The following table gives our Standard Packing:

SIZEQUANTITY IN PIECESBOX DIMENSION
#0075000590mm X 440mm X 740mm
#0EL95000590mm X 440mm X 740mm
#0100000590mm X 440mm X 740mm
#1140000590mm X 440mm X 740mm
#2175000590mm X 440mm X 740mm
#3200000590mm X 440mm X 740mm
#4300000590mm X 440mm X 740mm

Labeling

Labeling being subset of packaging, the cartons are properly labeled indicating basic information viz., Size, Colour, Quantity, Storage Conditions, Destination etc. Visual test are conducted to ensure that the script is legible and colours are harmonious.
Proper markings box numbers & sample capsules / capsules color image is paste on each box which helps in easy visual Identification of Provide.

Packaging Detail:We pack the capsules first in Poly-Bags, and then these bags are put in "Aluminum Foil LLDP co-extruded bags". These bags are then put in corrugated box, which is lined with Thermocol (Styrofoam) on all the six inner sides of the box. Further these packed boxes are then laminated with poly film. Thus we not only take care of the temperature and humidity but also take into consideration the mis-handling that might take place during transportation.
Delivery Detail:10-15 Days after confirmation

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