T H E T W O -P I E C E G E L A T I N C A P S U L E

H A N D B O O K
 CONTENTS
1 PROFILE OF THE QUALICAPS GROUP..................................................................................................................P 3

2 QUALITY SYSTEMS ............................................................................................................................... ........................................P 7

2.1 In-process Measurement and Control
2.2 Quality Auditing
2.3 Official Accreditations
- ISO certificates
- FDA (Food and Drug Administration) Authorisation letter
- Certificates of GMP Compliance

3 CAPSULE CHARACTERISTICS ............................................................................................................................... .......P 11

3.1 POSILOK® Capsule Design
3.2 Capsule Types
3.3 Capsule Sizes
3.4 Colour Selection
3.5 Capsule Print Types

4 CAPSULE SPECIFICATIONS ............................................................................................................................... ............P 19

4.1 Raw Materials Specifications
- Gelatin
- Colourants
- Purified water
- Additives
- Printing inks
4.2 POSILOK® Capsule Specifications
- Size 00-Size 4
4.3 Visual Quality
- AQL definitions and values
- Definition of visual defects
- Classification and descriptions of visual defects
- Visual defect diagrams
4.4 Print Quality
- AQL definitions and values
- Definition of print defects
- Classification of print defects
- Print defect descriptions and diagrams
4.5 Chemical and Microbiological Specifications
- Chemical specifications
- Microbiological specifications

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 5 CAPSULE TECHNICAL INFORMATION..............................................................................................................P 33
5.1 Packaging
- Cartons
- Pallets
- Special protection
- Identification
5.2 Storage
- Moisture content
- Transportation
- Warehousing
- Capsule shelf life
- Incoming quality control and sampling
5.3 Capsule Filling
- Filling area conditions
- Filling equipment settings
- Blister packaging

6 ADDITIONAL INFORMATION ............................................................................................................................... .......P 41

6.1 Other Products

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1. PROFILE OF THE QUALICAPS GROUP

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1

PROFILE OF THE QUALICAPS GROUP

The Qualicaps Group is one of the world’s leading supplier of empty Gelatin Two-piece
Capsules for the Pharmaceutical and Health & Nutrition industries. Qualicaps’
international capsule operation ensures continuous worldwide supply with three
manufacturing sites in Japan, USA and Europe.

The Qualicaps Group has a long-standing tradition of producing high quality capsules
and filling equipment.

USA

QUALICAPS,INC.
6505 Franz Warner Parkway
Whitsett, NC 27377 - 9215 - USA
Phone : (1) 336 449 39 00
Fax : (1) 336 449 33 33

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QUALICAPS EUROPE, S.A. QUALICAPS ROMANIA, SRL QUALICAPS Co., Ltd.
Calle de la Granja, 49 Sos. Chitilei nr. 423M 321-5, Ikezawacho
28108 ALCOBENDAS (Madrid) - SPAIN Bucharest 012391, Sector 1 - ROMANIA Yamatokoriyama, Nara, 639-1032 - JAPAN
Phone: (34) 91 663 08 00 Phone: (40) 372 193 200 Phone : (81) 743 56 0651
Fax: (34) 91 663 08 30 Fax: (40) 372 710 290 Fax : (81) 743 56 5113

ROMANIA

SPAIN
JAPAN

Web site: www.qualicaps.com

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2. QUALITY SYSTEMS
2.1 In-process Measurement and Control
2.2 Quality Auditing
2.3 Official Accreditations

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2

QUALITY SYSTEMS

Qualicaps Europe S.A.U. and Qualicaps Romania S.R.L. capsules are produced using a
continuous manufacturing process. Adherence to the published specifications are
assured using Good Manufacturing Practices (GMP).

The objective of the Qualicaps quality control system is to ensure consistency,

uniformity and performance to specifications through careful process control and
monitoring.

The quality auditing system is designed to maintain specified Acceptable Quality Levels
(AQL).

The quality control system ensures that Qualicaps capsule manufacturing complies with
current Good Manufacturing Practice (cGMP) and the norms of the International Quality
Standard (ISO) organisation.

2.1 I N - P R O C E S S M E A S U R E M E N T AND CONTROL

Statistical process controls are used during the manufacture of each batch. Capsules
are checked during processing by a system of operator self-inspection that consists in
taking regular random samples. In-process measurements, including dimensions of
cap and body, moisture content and a check for visual quality and colour, are made to
ensure conformance to specifications.

2.2 QUALITY AUDITING

The purpose of the quality audit is to provide a final verification that the in-process
controls have been effective. Before the release of each batch, a thorough review is
made of all process control documents and records to ensure that there was
conformance to the in-process control and operator self-inspection procedures during
manufacture. The final inspection of a capsule batch is based on the evaluation of a
representative sample and includes controls for dimensional uniformity and visual
quality attributes. Sampling and acceptance for this final inspection system is based on

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the Acceptable Quality Level properties of each plan. Customers can be assured that
capsules, which pass these tests, have an extremely high probability of conformance
and therefore, an inherently high level of quality.

2. 3 O F F I C I A L A C C R E D I T A T I O N S
ISO 9001:2008 CERTIFICATE ISO 14001:2004 CERTIFICATE

FDA (FOOD AND DRUG ADMINISTRATION)

AUTHORISATION LETTER

QUALICAPS EUROPE, S.A.U.

- DMF 11090 for USA
- DMF 9896 for Canada
- ISO 9001 : 2008
- ISO 14001 : 2004

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 CERTIFICATE OF GMP COMPLIANCE

ISO 9001:2008 CERTIFICATE

QUALICAPS ROMANIA, SRL

- DMF 21632 for USA
- DMF 2008-109 for Canada
- GMP certification
- ISO 9001 : 2008

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3. CAPSULE CHARACTERISTICS
3.1 Posilok® Capsule Design
3.2 Capsule Types
3.3 Capsule Sizes
3.4 Colour Selection
3.5 Capsule Print Types

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3

CAP S ULE
CH AR ACTE R IS TICS
3. 1 P OS ILOK ® C A P S U L E D E S I G N
POSILOK® is the brand name for the capsule locking feature used by Qualicaps.
This ensures that the contents are securely contained in the capsules. The feature has also
been designed to give an optimum performance in the pre-locked state prior to filling on
high speed machines. The dimensions of the POSILOK® capsule are carefully monitored
throughout the manufacturing process to ensure good filling machine performance.

PRE-LOK®
Good machine performance relies on empty capsules not separating during
transportation and handling. The PRE-LOK® feature holds the cap and body together in
the correct position prior to filling, ensuring a uniform length and preventing
unwanted separation before filling.

The first stage in the filling process is the separation of the cap and body of the empty
capsule. The empty body is presented to a filling device and dosed with material.

POSILOK®
After filling the two parts of the capsule are rejoined :
- The special design of the capsule locking profile fitted with air vents is to avoid
overpressure during rejoining.
- This special desing helps further reduce the risk of reopening and helps to maintain a
constant closed joined length, ensuring the optimum filling of all types of
products.
The POSILOK® locking feature enables the filling of different types of formulation such as:
- Powders
- Pellets
- Tablets
- Semi Solid Matrices
- Liquids
For liquid formulations, the HICAPSEAL 40/100 sealing machines, developed by
Qualicaps, are available.

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SECURE LOCKING
Efficient packing relies on consistent product quality. The POSILOK® capsule is
designed to remain securely closed to a precise length ready for subsequent handling
that ensures efficient filling into blister packages, minimal product loss during
packaging and no separation.

CAP

POSILOK®
(CAP)

POSILOK®
(BODY)

BODY

AIR

AIR

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 3. 2 C A P S U L E T Y P E S
The standard Qualicaps capsule is
the POSILOK® Two-piece Gelatin
Capsule with its positive
mechanical lock made by
indentations in the cap and body.

The vented cap indentation allows
air to escape when the capsule is  

closed on high speed filling  

machines. The capsule has also a
PRE-LOK® feature to prevent
separation of the empty cap and
body prior to filling.

Other types of capsules are also available and described in this document:

PEG/Gelatin Capsule: This is a Two-piece Gelatin Capsule with Polyethylene Glycol that
was specially developed to reduce the brittleness of the gelatin capsule film when
exposed to hygroscopic formulations.

3. 3 C A P S U L E S I Z E S
Qualicaps capsules are available in sizes ranging from size 00 to 4.

00 0E 0 1E 1 2 3 4

Notes: - Other sizes may be available.

- Not in scale.
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3. 4 C O L O U R S E L E C T I O N
Qualicaps manufactures capsules to customer colour specifications and can match
existing formulations or colour appearances. Both transparent and opaque capsule
colours are available.

The CAPSULECTOR, showing a

representative sample of available
capsule colours, has been specially
developed to assist customers in
the choice of colour combinations.
It can be obtained from your
Qualicaps representative.

3. 5 C A P S U L E P R I N T T Y P E S
Qualicaps offers the perfect opportunity for product identification with capsules
imprinted with company name, product brand, dosage information, etc.
Four types of printing are available :
- AXIAL-PRINT:Axial printing up to 42°. Single ink colour. Ideal for simple branding
and dosage information.
- MAGNI-PRINT:Axial printing, double size print, coverage up to 84°. Single ink
colour. Your company name or logo can be twice as big with MAGNI-PRINT.
- ROTOPRINT:Rectified radial printing, almost 360° coverage gives the maximum
printable area and legibility. Single ink colour.
- ROTOCOLOR:Rectified radial printing combines almost 360° coverage with
different colours of ink on cap and body. The print choice that provides the
greatest opportunites for creating an effective product identity.

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 AXIAL-PRINT MAGNI-PRINT

ROTOPRINT ROTOCOLOR

* 360° printing may not be achieved for all logos.

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Qualicaps Technical Service can assist customers with the design of their printing.
Qualicaps produces artwork in the actual size that will appear on the capsule once
the design has been selected.

Capsule Imprint

Qualicaps offers the perfect opportunity for product identification with capsules
imprinted with information such as company name, product brand, dosage
information or product identification code.

Qualicaps' imprinting options include:

Axial (or linear) print with a single ink colour.

Rotoprint radial printing with a single ink colour for maximum printable area
and legibility.

Rotocolor radial printing with a two-colour ink option for maximun printable
area and legibility.

Qualicaps can assist customers with information regarding print feasibility of

selected logos and print capabilities.

Print ink

Qualicaps uses only edible printing inks. Ink colourants meet applicable regulatory
requirements.


 

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4. CAPSULE SPECIFICATIONS
4.1 Raw Materials Specifications
4.2 Posilok® Capsule Specifications
4.3 Visual Quality
4.4 Print Quality
4.5 Chemical and Microbiological Specifications

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4

CAPSULE
SPECIFICATIONS
Qualicaps follows the latest editions of the European Pharmacopoeia and the USP/USNF
for the raw materials specifications.
On request, Qualicaps has the capability of using raw materials that meet Japanese
legislation.

4.1 RAW MATERIALS SPECIFICATIONS

Gelatin
The gelatin used is in compliance with the European Pharmacopoeia and the United
States National Formulary.

The gelatin is supplied exclusively by member companies of the Gelatin Manufacturers

of Europe (GME) Association and complies with the latest EMEA CPMP/CVMP guidance.

Each of our gelatin suppliers has obtained “Certificates of Suitability” from the
European Directorate for the Quality of Medicines (EDQM). This confirms that their
gelatins comply with the monograph “Products with risk of transmitting agents of
animal spongiform encephalopathies” in the European Pharmacopoeia.

Colourants
The colourants used are in compliance with the EU Directives and when required with
the requirements of the FDA.

The Qualicaps recommended list of colourants for pharmaceutical use, which takes into
account regulatory needs and stability characteristics, is shown in the table.

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 Name EEC No. USA C.I. No.
Sunset Yellow E 110 FD&C Yellow No.6 15985
Allura Red E 129 FD&C Red No.40 16035
Brilliant Blue E 133 FD&C Blue No.1 42090
Titanium Dioxide E 171 Titanium Dioxide 77891
Iron Oxide Black E 172 Iron Oxide Black 77493
Iron Oxide Red E 172 Iron Oxide Red 77491
Iron Oxide Yellow E 172 Iron Oxide Yellow 77492

Some of above listed colourants are allowed for food supplement use under specific
conditions.

P u r ified w a t er
The water used by Qualicaps is in compliance with the requirements of the European
Pharmacopoeia, USP and JP.

Ad d it ives
Sodium Lauryl Sulphate used as a wetting agent complies with the European
Pharmacopoeia and USP/NF.

The Polyethylene Glycol used by Qualicaps is in compliance with the European

Pharmacopoeia (Material only used for the manufacture of PEG/Gelatin capsules).

P r in t in g in ks
Qualicaps uses edible printing in ks that contain pigments and the lake
form of dyes used in capsule shell manufacture which are dispersed in shellac solutions.
The solvents used are covered by a guidance document, CPMP/ICH/283/95, issued by
EMEA, which sets limits for the amounts that may remain in a finished product.
The amounts of residual solvents that remain in the ink applied to a capsule comply
with these limits by an order of magnitude. A certificate confirming this can be
issued on request.

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 4. 2 P O S I L O K ® C A P S U L E D I M E N S I O N S

Standard Size 00 0E 0
Target weight (mg) 126 106 98
Weight
Average weight limits (mg) 116-136 98-115 90-106
Fill material powder (ml) 0.93 0.77 0.69
Capacity Fill material liquid (ml) 0.84 0.69 0.62
Total internal capsule volume (ml) 1.16 0.90 0.81
Cap diameter (mm) 8.56 7.66 7.66
Outside diameter Body diameter (mm) 8.21 7.36 7.36
Tolerance (mm) ± 0.04 ± 0.04 ± 0.04
Cap length (mm) 11.7 12.0 10.9
Length Body length (mm) 20.4 20.9 18.6
Tolerance (mm) ± 0.3 ± 0.3 ± 0.3
Closed joined length (mm) 23.5 24.0 21.8
Closed joined length
Tolerance (mm) ± 0.3 ± 0.3 ± 0.3

Th e a bove s pecifica t ion s a ls o a pply t o Qu a lica ps ® P E G/ Gela t in ca ps u les .

Weig h t : Capsules are manufactured by a dipping process. The weight of the

individual capsules varies about a target value. Customers should determine tare
weights for filling by testing samples from in-house batches. The average weights above
are determined from the gross weight of samples of 100 capsules at the standard
moisture content of 13.0 % to 16.0 % w/w . These values are not applicable to individual
capsules.

Ca pa cit y: Two-piece capsules can be filled with a range of materials with different
physical properties: powders,granules, pellets and liquids. The fill weight of powders can
be estimated by multiplying the capsule body volume by the tapped bulk density of the
formulation. This holds true for most types of filling machines despite their different
dosing mechanisms. Total internal capsule volume is another useful value that allows
the formulator to estimate the porosity of the powder fill. When filling liquids, the
working capacity is 90% of the body volume to reduce the risk of spillage during machine
movement.

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 1E 1 2 3 4 5
83 76 63 50 40 29
76-90 70-82 58-68 46-54 37-43 27-31
0.56 0.50 0.37 0.28 0.21 0.13
0.50 0.45 0.33 0.25 0.19 0.12
0.64 0.59 0.45 0.33 0.25 0.16
6.95 6.95 6.38 5.85 5.34 4.89
6.65 6.65 6.08 5.60 5.07 4.66
± 0.04 ± 0.04 ± 0.04 ± 0.04 ± 0.04 ± 0.06
10.6 9.7 8.9 7.9 7.2 6.0
18.4 16.7 15.3 13.5 12.4 9.4
± 0.3 ± 0.3 ± 0.3 ± 0.3 ± 0.3 ± 0.3
21.2 19.5 17.8 15.8 14.5 11.4
± 0.3 ± 0.3 ± 0.3 ± 0.3 ± 0.3 ± 0.3

Ou t s id e d ia m et er s : The outside diameters, provided as a guideline for

evaluating packaging material dimensions, are measured by passing the caps and bodies
through calibrated bushes under specified conditions that simulate filling machine
conditions. This dimension should never be considered as an approval/rejection criteria.

Length: Capsule lengths are controlled in the manufacturing process and audited
on each batch.

Clos ed join ed len g t h *: This value is given as a filling machine set-up

recommendation and not as an approval/rejection criteria for empty capsules.
The closed joined length has been calculated to ensure the correct location of the special
positive locking features on the cap and body. If the filling machine is set so that the
capsules are closed to a length shorter, then the cap or body may be damaged and the
locking mechanism may fail, if longer, they will come apart. We recommend that this
value is given to packaging equipment manufacturers prior to making a decision on
blister pocket specifications.

(*) Other sizes such as 2 regular, 2 elongated and 5 can be delivered under customer request.
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 4. 3 V I S U A L Q U A L I T Y
Qualicaps capsules are controlled statistically to ensure conformance to the following
specifications.

The visual quality of a capsule batch is determined using statistical sampling plans
defined in Military Standard MIL-STD 105E.

The specifications are derived from the Military Standard MIL-STD 105E and assessed
on a combined sample taken through the batch from N + 1 cartons (N, is the total
number of cartons in the controlled batch).

AQL d efin it ion s a n d va lu es

Acceptable Quality Level (AQL)
AQL as defined in MIL-STD-105E is the maximum percent defective that for the
purpose of sampling inspection can be considered satisfactory as a process average.

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 Capsule defect classification AQL
Visual Quality
Specifications Major A 0.010 %

Major B 0.040 %

Minor 0.25 %

D efin it ion of vis u a l d efect s

Visual defects are classified according to the following definitions:

Major A: Affects the performance of a capsule as a package for the final product or
could contribute to a major filling problem.

Major B: Would cause a problem on a capsule filling machine.

Minor: Has no effect on the performance of a capsule as a package, it is a slight

blemish that makes the capsule visually imperfect.

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 Cla s s ifica t ion a n d d es cr ipt ion s of vis u a l d efect s
M AJOR A
HOLE An irregular opening in the cap or body
SPLIT A split in the film starting from the cap or body edge
CRACKED A cap or body with many splits
UNCUT CAP/BODY An untrimmed cap or body
FAILURE TO SEPARATE Cap and body may not be separated properly
TRIMMING A piece or the whole trimmed end of a cap or body inside a closed capsule
DOUBLE DIP Extra thick cap due to being dipped twice
SHORT CAP Cap length is 1 mm less than specified length
SHORT BODY Body length is 0.4 mm less than specified length
JOINED IN LOCK Capsule is in locked position
DOUBLE CAP A capsule with an additional cap covering the body end
UNJOINED A single cap or body
THIN SPOT (CAP SHOULDER) A thin area in the cap shoulder which may rupture when the capsule is filled
MASHED A mechanically damaged capsule that has been squashed flat
LONG CAP/BODY Length of cap or body is 1 mm more than specified length
PINCHED Cap or body is damaged in collets. Pinches> 3 mm are classified as a Major A defect
TELESCOPE A closed capsule with a protruding piece of either cap or body produced by a double split

M AJOR B
LONG JOINED Capsule not closed sufficiently to engage the prelock
DYE SPECK A coloured spot of pigment aggregate different from the colour of cap or body
INVERTED END A cap or body with the end pushed inwards
GREASE Mould relase aid spots on the inside of capsule
DAMAGED EDGE-LARGE The edge of the cap is roughly trimmed. The imperfection is v shaped and >1 mm into
the specified length
SMALL PINCHED Cap or body is damaged in collets. Pinches < 3 mm are classified as a Major B defect.
TURNED EDGE Folded over edge on body cut line
THIN SPOT A thin area in the cap or body wall which may rupture when the capsule is filled

MINOR
SCRAPE A scratch mark on the surface of a cap or body
CRIMP Cap or body is damaged in collets outside of the capsule > 3 mm
GREASE LIGHT Small marks of grease
DENT A depression formed in the end of cap or body. The dent is less than half of the diameter
of the capsule part
DAMAGED EDGE SMALL The edge of the cap is roughly trimmed. The imperfection is V shaped and < 1 mm
into the specified length
BUBBLE An air bubble in the cap or body wall which has a diameter greater than 0.4 mm
STARRED END Multiple small imperfections located at the ends of the cap or body
CHIPS, TAILS, STRING Small fragments of gelatine still attached or free within the capsule from different colour
than cap or body
BLACK SPECK A non contaminant black spot
DYE SPECK A small pigment aggregate from the components of the cap or body

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 Vis u a l d efect s d ia g r a m s

Major A Defects Major B Defects

Short body Uncut cap Uncut body Double cap Damaged edge (large) Inverted end

Telescope Hole Cracked Split Thin spot Dye speck

Unjoined Mashed Trimming Short cap Minor Defects

Long cap Long body Bubble Dent Scrape

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 4.4 PRINT QUALITY
Qualicaps printed capsules are controlled statistically to ensure conformance to the
following specifications.

The Print Quality of a capsule batch is determined using statistical sampling plans
defined in the Military Standard MIL-STD-105E.

The specifications are derived from the Military Standard MIL-STD-105E and assessed
on a combined sample taken through the batch from N + 1 cartons (N, is the total
number of cartons in the controlled batch).

AQL definitions and values

Acceptable Quality Level (AQL)

AQL as defined in MIL-STD-105E is the maximum percent defective that for the
purpose of sampling inspection can be considered satisfactory as a process average.

Print defect classification AQL

Print Quality
Specifications Major A 0.010%

Major B 0.040%

Minor 1.0%


 

 
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 Definition of print defects

Print defects are classified according to the following definitions:

Unprinted capsules or incorrect logo.

Print illegible or prevents proper identification.

Cosmetic flaws that do not interfere with the identification of the product.

Classification of print defects

MAJOR A MAJOR B MINOR

(ILLEGIBLE PRINT)
Unprinted Ink Line/Spot Ink Line/Spot
Incorrect logo Misplaced Legend Misplaced Legend
(off-register) (off-register)
Multiple Legends Multiple Legends
Partial Legend Partial Legend
Smudged Legend Smudged Legend

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 P r in t d efect d es cr ipt ion s a n d d ia g r a m s

MAJOR A : UNPRINTED

The entire legend is missing.

MAJOR B / MINOR : INK LINE / SPOT

An extra line or spot of ink that does not interfere with the legibility of the logo.

An ink line or spot greater than 5 mm is a Major B defect.

An ink line or spot greater than 1 mm is a Minor defect.

MAJOR B / MINOR : MISPLACED LEGEND (OFF-REGISTER)

The legends are not centred correctly about the cap cut edge of a closed capsule.

A capsule with a legend or legends having missing

characters, which would result in misidentification,
is a Major B defect.

A capsule with a legend with a part of a letter or logo

missing, which is still identifiable, is a Minor defect.

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MAJOR B / MINOR : MULTIPLE LEGENDS

Legend printed more than once on the same capsule.

Major B defect if the legend is illegible.

Minor defect if the legend is still legible.

MAJOR B / MINOR : PARTIAL LEGEND

Part of the legend is missing.

Major B defect when at least half of the legend is missing

and it is illegible.

Minor defect when parts of the legend are missing and it

is still legible.

MAJOR B / MINOR : SMUDGED LEGEND

The legend is smudged or smeared.

Major B defect when the legend is illegible.

Minor defect when the legend is still legible.

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 4.5 C H E M I C A L A N D M I C R O B I O L O G I C A L
SPECIFICATIONS

● Chemical specifications
Items Specification
Identification of Gelatin Meets test
Odour Meets test
Moisture Content/Loss on Drying (LOD) 13.0 - 16.0 %
Identification of Organic Colourants Meets test
Identification of Titanium Dioxide Meets test
Identification of Iron Oxides Meets test
Disintegration Less than 15 min
Sulphated Ash < 3.0 % for transparent capsules
< 9.0 % for opaque capsules
Arsenic < 1 ppm
Heavy Metal < 30 ppm
Lubricant Content < 0.5 %
Sulphur Dioxide < 0.1 %
Identification of Sodium Lauryl Sulphate Meets test

● Microbiological specifications
Items Specification
Total Aerobic Microbial Count 103 cfu/g
Salmonella Absence in 10 g
Escherichia coli Absence in 1 g
Staphylococcus aureus Absence in 1 g
Pseudomonas aeruginosa Absence in 1 g
Total Yeast & Mould Count 102 cfu/g
Bile-Tolerant Gram-Negative Bacteria Absence in 1 g

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5. CAPSULE TECHNICAL INFORMATION
5.1 Packaging
5.2 Storage
5.3 Capsule Filling

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5

CAP S ULE TE CH NICAL

INFOR M ATION
5. 1 P A C K A G I N G
Ca r t on s

Qualicaps capsules are supplied in a package that has two components :

1. An inner liner made of a laminate of pharmaceutical-grade materials :

polyester / polyethylene/ aluminium foil. This is heat-sealed after the capsules have
been packed into it to give a container with minimal moisture transfer properties.

2. A cuboid cardboard carton of standard dimensions. This protects the inner liner
during transportation.

Capsule Capsules per Net Weight Gross Weight

size carton in 000’s (kg*) (kg*)

00 75 8.5 - 10.5 10.5 - 12.5

0E 75 7.0 - 9.0 9.0 - 11.0
0 100 9.0 - 11.0 11.0 - 13.0
1E 120 9.0 - 11.0 11.0 - 13.0
1 135 9.5 - 11.0 11.5 - 13.0
2 175 10.0 - 12.0 12.0 - 14.0
3 225 10.5 - 12.0 12.5 - 14.0
4 300 11.0 - 13.0 13.0 - 15.0

Cartons for sizes 00-4: 60 cm long x 40 cm wide x 75 cm high

* weights are given to the nearest 0.5 kg

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 P a llet s

A number of cartons can be assembled together with a protective covering and placed
on a pallet.

The standard pallet assembly consists of four or six wrapped cardboard cartons on a
Europallet base (1.20 m x 0.80 m) with a height varying between 0.85 m and 1.27 m.

S pecia l pr ot ect ion

For shipments to countries which have extreme climatic conditions, a special

protection is used instead of the wrapping used normally.

This protection, called a TROP-PACK, consists of an outer cardboard cover combined

with expanded polystyrene sheets placed between the cardboard cartons and the cover.

This provides a barrier to avoid damage caused by temperature fluctuations and

physical damage during transit.

Id en t ifica t ion

Each carton and/or pallet is identified with a Qualicaps label containing the
following data :

- Name and address of Customer

- Type of capsule
- Qualicaps batch number
- Capsule size
- Description
- Quantity
- Carton number
- Print information
- Specific customer information as requested

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 5. 2 S T O R A G E
It is essential to read and understand the following information in order to ensure that
Qualicaps Two-piece Gelatin Capsules maintain their quality during the period between
manufacture and filling.

M ois t u r e con t en t

Qualicaps Two-piece Gelatin Capsules are manufactured with a moisture content between 13.0
and 16.0 %w/w and should be maintained at this level for optimum filling performance.

Capsule dimensions are directly related to the moisture content. Certain elementary
precautions are required to prevent undue moisture gain or loss. The moisture content
varies in relationship to the relative humidity of the air to which they are exposed. If the
moisture content rises significantly, the capsules will swell and may become soft and
sticky. If the moisture content falls too low, the capsules will shrink and may become
brittle. Either way, there will be some deterioration in the capsule properties and
difficulties may occur during filling.

Tr a n s por t a t ion

Qualicaps capsules are supplied in sturdy cardboard cartons, each having sealed
moisture proof liners. These cartons may be grouped on an European size case pallet.

For supplies to countries that have extreme climatic conditions, capsules are further
protected by Qualicaps TROP-PACK packaging. This is designed to protect the capsules from
the sudden temperature changes and adverse conditions during transportation. Pallets
should not be left standing in the open or exposed to direct sunlight during transit.

Wa r eh ou s in g

The ideal condition for the storage of capsules is at a temperature between 15°C and 30°C.
Capsules stored correctly in Qualicaps packaging will give the optimum performance in
production. Care should be taken to maintain them at an even temperature. Any relatively
even temperature between 5°C and 35°C could be used provided that it does not fluctuate
too rapidly. Storage near heat sources in warehouses should be avoided, e. g. radiators,
heaters or sunlight shining through windows. These will cause localised heating and
moisture migration within the capsules with corresponding dimensional changes that will
result in poor performance on the filling machine.

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 Ca ps u le s h elf life

Qualicaps Capsules stored correctly in our packaging will have a satisfactory 3 year shelf-life.
The temperature of the environment should not exceed the recommended limits to avoid
water migration inside the vapour-proof liners leading to possible capsule wall distortions.

The maintenance of the moisture content between 13.0% and 16.0% w/w is necessary for
two reasons : firstly, it maintains the capsule dimensions within specifications, secondly
at moisture contents less than 16.0% the growth of micro-organisms is discouraged,
because the water activity is too low.

Qualicaps packaging is designed to maintain the quality of the empty capsule between
manufacturing and filling. If the recommendations given in this section are followed, you
will achieve the benefits that the Two-piece Gelatin Capsule gives to the user.

In com in g qu a lit y con t r ol a n d s a m plin g

The integrity of the packaging is important in order to maintain the quality of the
capsules. Taking samples for incoming inspection must be done with care.

Sampling plans require that a number of cartons have to be opened, e. g. the square root
of the number of cartons plus one. When the inner liner has been opened it loses its
moisture barrier properties.

It is recommended that when taking a sample the minimum size cut in the liner is made. It
should be reclosed in the best manner possible, preferably by heat sealing, which
maintains the moisture barrier properties of the liner. If this is not possible then special
heat adhesive tape or other types of sealing should be used to close the cut.

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 5. 3 C A P S U L E F I L L I N G
Fillin g a r ea con d it ion

The moisture content of capsules is directly related to the relative humidity of air to
which they are exposed. Capsules are removed from their packaging and exposed
during the filling process. Particular care needs to be taken to ensure their optimum
performance especially with high speed filling machines.

The ideal conditions for a filling area are a temperature between 20°C and 25°C and a
relative humidity between 35% and 55% which will maintain the moisture content of
the capsules within the desired range of 13.0% to 16.0% w/w . Capsules can be filled
outside these conditions if sufficient care is taken.

The important consideration is to expose the minimum number of capsules required for
the process at any one time. Some filling machines can generate significant heat
during running and this may affect capsules in use.

The capsule filling machine may be sited in a controlled area but the conditioning
system may be operated only during the working day. Empty capsules should preferably
be removed from the hopper on the filling and/or intermediate conveying equipment if
climatic conditions vary from the ideal during idle hours.

For capsule handling, it is best to avoid the use of plastic utensils because this could
result in static electrical charging that could cause feeding problems on the filling
machine.

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 Fillin g equ ipm en t s et t in g s

Qualicaps capsules are manufactured with the greatest care to ensure optimum running
on the filling machines.

The capsule specifications described previously, are the result of extensive tests
performed with different equipment manufacturers on machines adjusted to normal
filling conditions with bushes or segments within official diameter limits.

To achieve the best results, it is recommended that the bores in the bushes on the
filling machine should be checked to ensure that they are within the machine
manufacturer’s specifications (check these with the machine manufacturer or your
Qualicaps technical coordinator).

Care should be taken to reclose the capsules to the correct closed joined length after
filling. If the capsules are overclosed, faults will be caused due to distortion of the
shells with the possibility of cracking or splitting and possible reopening. If the
capsules are underclosed, due to poor machine settings or if they are over filled with
product, they will come apart causing problems during packaging.

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 B lis t er pa cka g in g

The chart below gives the recommended minimum dimensions for the die roll cavities
for the blister packaging of filled capsules. These values correspond to a film thickness
of 0.1 mm. Variations in film thickness must be taken into account when determining
actual measurements.

H L W
00 9.10 25.0 9.80
0E 8.20 25.1 8.90
0 8.10 22.8 8.80
1E 7.50 22.2 8.20
1 7.40 20.5 8.10
2 6.90 18.8 7.60
3 6.30 16.8 7.00
4 5.80 15.5 6.50
5 5.40 12.4 6.10

H Depth of cavity of blister die roll (mm)

L Length of cavity of blister die roll measured at H/2 along the

axis of the capsule (mm)

W Width of cavity of blister die roll measured at H/2 along the

perpendicular axis of the capsule (mm)

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6. ADDITIONAL INFORMATION
6.1 Other Products

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 6. 1 O T H E R P R O D U C T S

Qualicaps Group
provides QUALI-V®
1 Capsule Filling Machines
cellulose capsules with for Laboratories.
a low moisture
content, an 2 Capsule Filling Machines
outstanding dissolution for Powders, Granules,
profile and improved Tablets and Liquids.

mechanical properties.
In addition, Qualicaps 3 Hard Capsule Sealing
Group develops and Machines.

supplies a full range of

equipment for the 4 Weight Inspection Machines
for Capsules and Tablets.
pharmaceutical
industry.
5 Visual Inspection Machines
for Capsules and Tablets.

6 Tablet Imprinting Machines.

1 LIQFIL Super 5

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 2 LIQFIL Super 40 2 LIQFIL Super 80/150 3 HICAPSEAL 40/100

4 CWI 40/90/150 5 CES 50/100/150 6 IS 500

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 QUALICAPS EUROPE, S.A.
Calle de la Granja, 49
28108 ALCOBENDAS (Madrid) - SPAIN
Phone: (34) 91 663 08 00
Fax: (34) 91 663 08 30
QUALICAPS ROMANIA SRL
Sos. Chitilei nr. 423M
Bucharest 012391, Sector 1 - ROMANIA
Phone : (40) 372 193 200
Fax : (40) 372 710 290
www.qualicaps.com
Q 026 / 1 – 2011 E