ConiSnap Brochure Full
ConiSnap Brochure Full
ConiSnap Brochure Full
Editorial
Quality by design
With the significant advances in life sciences, we are able to treat or at least manage
the majority of communicable and non communicable diseases through efficient
drug therapy, which has and still is increasing our life expectancy every year.
Contents
Quality by design
9
9
Manufacturing process
Gelatin, the primary raw material
Manufacturing process
Quality control
11
11
13
15
17
17
18
20
21
23
23
24
25
26
Applications
The right capsule for the right application
29
29
About Capsugel
Innovative dosage solutions for the healthcare industry
30
30
About Coni-Snap
Hard Gelatin Capsules
Customer focus
Outstanding quality
Dedication to innovation extends beyond
the ConiSnap Hard Gelatin Capsules
itself and well into the production cycle.
The latest high-capacity filling machines
require a precise capsule design to
work at maximum capacity. To meet
this requirement, the ConiSnap Hard
Gelatin Capsules features a body with
a tapered rim that allows more play
between the two parts, reducing the risk
of the two rims meeting and therefore
eliminating the splitting phenomenon.
Furthermore, the pre-lock design with
six dimple-like notches reduces the
chance of premature opening during
both transportation and filling.
6 | Chapter title
Manufacturing process
Gelatin, the primary raw material
High-quality gelatin
Every single Capsugel hard gelatin
capsule originates from high-quality
gelatin derived from collagen, a fibrillar
protein composed of eighteen different
amino acids found in connective tissues
and bones. Natural bovine or porcine
collagen is macerated and purified using
either acids or alkalis, depending on
the production process. The collagen
splits hydrolytically into an unbranched
amino acid chain with a molecular
weight ranging from 40,000 to 100,000.
This results in a high-grade, consistent
granular gelatin.
Manufacturing process | 7
Manufacturing process
Production level and quality
The underlying principles of capsule
manufacturing have remained practically
unchanged since its invention in 1833.
Over the years, modern technology and
automation have significantly increased
production levels and product quality.
Automatic Finishing
Colour
Imprinting
Clients frequently ask Capsugel to imprint the preclosed capsule. All Capsugel hard gelatin capsules
can display useful information such as the product
name, manufacturers name or logo, and dosage
details in either one or two contrasting ink colours.
Capsule manufacturing
The process itself is an engineering feat.
Standardised steel pins arranged in rows on metal
bars are precision-dipped into the dishes containing
the coloured solution. After dipping, the bars are
removed and rotated to distribute the gelatin as
uniformly as possible around the pins. The gelatin
is then allowed to set. Precise bar rotation, gelatin
viscosity and dipping rate all contribute to correct
gelatin distribution, resulting in a homogeneous
capsule wall with an exact, specified thickness.
Drying
Travelling along a conveyor belt, the bars carrying
the pins coated with solidified gelatin pass through
a series of drying kilns until the moisture content is
reduced to the required level.
9 | Manufacturing process
Packaging
Arriving directly from imprinting or quality control,
each individual package must pass a final shipping
confirmation inspection before it is dispatched to the
client.
Colour
Melting Stage
Drying
Automatic Finishing
Capsule manufacturing
Imprinting
Packaging
Quality control
Highly effective process
Water
Colouring agents
Gelatin solution
Production machine
1 Dipping, 2 Rotation, 3 Gelling,
4 Drying, 5 Stripping, 6 Cutting,
7 Joining, 8 Ejection
Inspection
defects
Imprinting
Counting, packaging
Batch release
certificate
Manufacturing process | 11
Properties and
specifications
Colouring agents and pigments
Approved colouring agents and
pigments
According to international studies,
one of the most reliable means of
identifying drugs is colour. Although
to avoid confusion, colour must not
become over-complicated, creating a
risk factor in itself. When defining the
colour palette for hard gelatin capsules,
Capsugel opted to use only approved
colouring agents and pigments cited in
most pharmacopoeias and other official
regulations. As an opacifying agent,
Capsugel exclusively uses the approved
standard, titanium dioxide.
Imprinting
Clear, easy-to-read text certainly assists all types of people, from
medical staff and patients to consumers, correctly identify each
capsule. That is why Capsugel 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.
Axial-Print
Radial-Print
Ink colours
Capsugels specialised
imprinting team is readily
available to offer technical
advice and expertise.
Ink colours*
black
white
grey
red
medium blue
light blue
green
orange
yellow
Size
00
16.40
3.00
4.60
5.90
0.20
0 EL
18.00
2.80
4.60
6.70
0.20
15.70
2.80
4.40
5.65
0.20
1 EL
14.50
2.50
5.00
4.75
0.20
13.90
2.50
4.40
4.75
0.20
2 EL
13.50
2.30
5.00
4.25
0.20
12.70
2.30
4.40
4.15
0.20
11.50
2.10
4.00
3.75
0.20
10.40
1.90
4.00
3.20
0.20
Radial-Print
A Overall height of total imprinting in mm
B Maximum overall length of cap or body imprinting in mm
C Distance between cap and body imprintings in mm
D Maximum length of cap or body imprinting in mm
I Minimum distance between letters in mm
Size
00
16.40
19.00
4.60
5.90
0.20
0 EL
18.00
17.00
4.60
6.70
0.20
15.70
17.00
4.40
5.65
0.20
1 EL
15.00
15.50
4.60
5.20
0.20
13.90
15.50
4.40
4.75
0.20
2 EL
13.50
14.20
5.00
4.25
0.20
12.70
14.20
4.40
4.15
0.20
11.90
13.00
4.40
3.75
0.20
10.80
11.80
4.40
3.20
0.20
Specifications
Below is a table covering a wide variety of Coni-Snap capsule specifications in regards
to size, weight and filling capacity. The various dimensions are listed in metric and
standard.
Consult the chart to select the optimal ConiSnap Capsules.
Coni-Snap Capsules
Size
000
00el
00
0el
0el*
1el
2el
4el
mg
163
130
118
107
110
96
81
76
66
61
48
40
38
28
Tolerance mg
10
10
1.37
1.02
0.91
0.78
0.78
0.68
0.54
0.50
0.41
0.37
0.30
0.25
0.21
0.13
Weight
Capacity
Capsule volume ml
822
612
546
468
468
408
324
300
246
222
180
150
126
78
0.8 g/ml
1096
816
728
624
624
544
432
400
328
296
240
200
168
104
1g/ml
1370
1020
910
780
780
680
540
500
410
370
300
250
210
130
1.2 g/ml
1644
1224
1092
936
936
816
648
600
492
444
360
300
252
156
0.874
0.874
0.796
0.795
0.826
0.726
0.697
0.654
0.656
0.601
0.535
0.538
0.480
0.366
Tolerance inches
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.016
Body mm
22.20
22.20
20.22
20.19
20.98
18.44
17.70
16.61
16.66
15.27
13.59
13.69
12.19
9.30
Tolerance mm
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.40
Cap inches
0.510
0.510
0.462
0.460
0.472
0.422
0.413
0.385
0.382
0.352
0.318
0.308
0.284
0.244
Tolerance inches
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.018
0.016
Cap mm
12.95
12.95
11.74
11.68
11.99
10.72
10.49
9.78
9.70
8.94
8.08
7.84
7.21
6.20
Tolerance mm
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.46
0.40
Body inches
0.376
0.322
0.322
0.289
0.290
0.289
0.261
0.261
0.240
0.239
0.219
0.199
0.199
0.184
Body mm
9.55
8.18
8.18
7.34
7.36
7.34
6.63
6.63
6.09
6.07
5.57
5.05
5.05
4.68
Cap inches
0.390
0.336
0.336
0.301
0.301
0.300
0.272
0.272
0.250
0.250
0.229
0.209
0.209
0.193
Cap mm
9.91
8.53
8.53
7.65
7.66
7.64
6.91
6.91
6.36
6.35
5.82
5.31
5.32
4.91
External diameter**
1.029
0.995
0.917
0.909
0.953
0.854
0.804
0.765
0.760
0.709
0.626
0.621
0.563
0.437
Tolerance inches
0.012
0.012
0.012
0.012
0.012
0.012
0.012
0.012
0.012
0.012
0.012
0.012
0.012
0.016
mm
26.1
25.3
23.3
23.5
24.2
21.7
20.4
19.4
19.3
18.0
15.9
15.8
14.3
11.1
Tolerance mm
0.3
0.3
0.3
0.3
0.3
0.3
0.3
0.3
0.4
0.3
0.3
0.3
0.3
0.4
Easy to differentiate
Filling possibilities
Suitable for a wide range of
formulations
Logically speaking, hard gelatin capsules
are a minor yet vitally important part
of the final product. In order for the
final product to take effect, it must be
released from the capsule. Even under
very extreme conditions, Capsugel
hard gelatin capsules dissolve in vivo
without difficulty. This makes them
a popular medical choice. Active
substance mixtures filling hard gelatin
capsules must have guaranteed content
uniformity to be used in automatic filling
machines. In most cases, the hard
gelatin capsule is filled with a powder
or granule. However, pellets, microcapsules, tablets, drages, small gelatin
capsules, pastes, semi-solids and liquids
can also be placed without difficulty.
Outstanding quality
When determining the viability of a
filling, scientists and experts must
consider numerous factors. This
includes substance size and shape,
uniformity, mixture homogeneity,
consistency, moisture content and
compression ability. The filling must
be able to withstand extremely high
speeds. Because of the absolute need
for constant and accurate quantities not
all substances are suitable for automatic
dosage machines. These speciality
cases are best addressed using other
Capsugel products.
Filling possibilities
Powder
Granulates
Pellets
Two different
pellets and
tablets
Liquid and
powder
Liquid and
capsules
Liquid
Tablets
Capsule
Dosing principle
Output caps/h
Products to be filled
Dosing disk
42.000
GKF1400
Dosing disk
84.000
GKF2500
Dosing disk
150.000
GKF3000
Dosing disk
175.000
GKF705
Dosing disk
42.000
GKF1505
Dosing disk
92.000
GKF3005
Dosing disk
175.000
Dosing disk
3000
Multi functional
200.000
Multi functional
100.000
Multi functional
25.000
Dosator
6.000 40.000
Zanasi 8/16
Dosator
8.000 16.000
Zanasi plus
Dosator
48.000 85.000
Zanasi 70C
Press-Fit
55.000
Adapta
Multi functional
100.000
Dosator
100.000 200.000
Multi functional
3.000
Alterna
Dosing disk
70.000
Suprema
Dosator
48.000
MG Compact
Dosator
6.000 48.000
G70 140 S
Dosator
70.000 140.000
Powder, Pellets
G70 140
Dosator
70.000 140.000
Planeta 100
Dosator
100.000
Planeta
Dosator
6.000 50.000
G100 pre-weight
Dosator
90.000
G250
Dosator
200.000
Dosator
40.000
CD60
Dosator
60.000
000
00
00el
0el
1el
2el
Depth (h)
10.4
9.0
9.0
8.1
8.1
7.3
7.4
6.7
6.7
6.2
5.7
5.3
Length(L)
28.4
25.4
27.4
23.8
26
21.4
22.4
19.6
21.0
17.8
5.7
13.3
Width (d)
11.8
10.2
10.2
9.4
9.4
8.4
8.4
8.0
8.0
7.4
6.8
6.3
Applications
The right capsule for the right application
For healthcare companies of all sizes, Capsugel has a solution
to help your ideas succeed. From assistance with dosage form
options for challenging compounds to differentiating existing
products, we work with you to find the right dosage form to meet
your needs.
Over-encapsulation
Using over-encapsulation for doubleblind clinical trials is an effective way to
shorten development time and reduce
costs.
Brand Protection
Technology
Pharmaceutical products are
increasingly threatened by counterfeit
drugs entering the market that pose
safety risks to consumers and may be
harmful to your brand.
Line Extensions
Extend your reach and grow your brand
by leveraging Capsugels extensive array
of solutions for expanding or enhancing
your pharmaceutical, consumer
healthcare or dietary supplement
products.
Product Differentiation
Create uniquely recognizable dosage
forms through Capsugels unmatched
market knowledge and technology
innovations.
Liquid-filled Products
Capsugels advanced liquid-filled
technologies and manufacturing
facilities can help deliver unique solid
oral dosage products to market faster.
Applications | 25
About Capsugel
Innovative dosage solutions for the healthcare industry
From assisting our customers with formulation challenges to
helping them bring innovative new products to market faster, the
world-class people at Capsugel provide a unique combination of
scientific, technological and global market expertise, delivering
high-quality capsules and services at every step of the dosage
form development process.
Innovative Products
Global Reach
Customer Focus
Outstanding Quality
To ensure our customers receive the
very best quality products and services,
we employ the principles of Six-Sigma
throughout our entire organization. Our
drive to deliver high quality capsules
with speed and efficiency has led us
to regularly implement process quality
initiatives that continuously reduce
defect rates and improve the overall
quality of our products.
26 | About Capsugel
At Capsugel, we uniquely
combine our global reach
and resources with a
collaborative spirit to drive
innovation and growth for
our customers.
Worldwide locations
Bornem
Belgium
Boston
Plormel
Massachusetts
France
Peapack
New Jersey
Greenwood
South Carolina
Puebla
Mexico
Capsugel can meet your global capsule supply needs no matter where you
are in the world providing you peace of mind that our products will be
there when you need them.
Strasbourg
France
Colmar
France
Suzhou
Delhi
Sagamihara
Japan
China
India
Bangkok
Thailand
Jakarta
Indonesia
Sydney
Australia
Capsugel will use reasonable efforts to include accurate and up-to-date information on this brochure but makes no warranties or representations of any kind
as to its accuracy or completeness.Use of the content thereof is at your own risk. Capsugel disclaims all warranties, express or implied, including warranties of
merchantability of fitness for a particular purpose.The entire contents of this brochureare subject to copyright protection. Copyright 2011. The contents may
not be copied other than for noncommercial individual reference with all copyright or other proprietary notices retained, and thereafter may not be recopied,
reproduced or otherwise redistributed.
www.capsugel.com