presentation in capsule manufacturing & packaging of capsule,problem in capsule manufacturing, packaging materials, tablet manufacturing

1. Topic : Problems in
capsule manufacturing
and packaging of capsule
Presented by:
Group- D

2. 2013.09.01
Contents:
•What is a Capsule ?
•Types of Capsule
•Process Manufacturing
•Capsule Manufacturing Problem and Remedies
• What is Packaging ?
•Packing versus Packaging
• Importance of Packaging
•Functions of Packaging
•Concept of Packaging
•Packaging Excellence
•Steps of Packaging
•Types of Packaging for Capsule
•Packaging Documentation
•Conclusion

3. What is a Capsule ?
3
Capsules are solid dosage forms in which one or more medicinal
and or inert substances are enclosed within a small shell or
container generally prepared from a suitable form of gelatin.
- Capsules are usually intended to be administered orally
- Occasionally, capsules may be administered rectally or vaginally.
There are two types of capsules….
 Hard capsules
 Soft capsules

4. Types of Capsule
4
1. Consists of a rigid shell
in two pieces that fit
together. One is body
& other is cap.
2. Filled medicaments are
usually solids.
3. Usually cylindrical
1. Soft capsule are
formed in a single
piece.
2. Filled medicaments
are usually liquid or
semi-solid matrix.
3. Usually spherical,
oval, cylindrical &
tube.

5. Process Manufacturing
5
Process manufacturing is the production of goods by
combining supplies, ingredients or raw substances
using a formula.
Example: Manufacturing of capsule, tablet
In capsule manufacturing, we usually manufacture
 Hard gelatin capsule
 Soft-gelatin capsule

6. Capsule Manufacturing Problem and Remedies
6
Problems Causes Remedies
Loss of cap during
transfer
 High vacuum
 Misalignment of cap
and bush
 By adjusting the
vacuum
 Check the alignment
of cap and body
bush
Capsule non separation  Incorrect vacuum
pump
 Leakage through
filters
 Worn out bushes
 Loss of spring
tension at top slide
 By adjusting the
vacuum
Cleaned and/or replace
the filter
Replacing the bushes
with new one

7. Capsule Manufacturing Problem and Remedies
7
Problems Causes Remedies
Target weight not achieved Wrong selection of
capsule size
Incorrect slug formation
due to incorrect setting
parameter
Insufficient binding
Poor flow of product
Formulation is sticky
Check the variation in
physical parameters
Proper selection of
dosing disc
Tamping block 1-5 are
placed along the direction
of rotation of dosing disc
Improve the flow
property
Powder must be non-
hygroscopic
Length variation Excess joined length
Improper setting of
closing plate
Damage rubber sheet of
closing plate
Checking the standard
locking length
The gap should be
between 0.5-0.8 mm
Replacing the rubber
sheet with one

8. 8
Packaging is the science, art and technology of
enclosing or protecting products for distribution,
storage, sale, and use. Packaging also refers to the
process of designing, evaluating, and producing
packages.
Drug Quality + packaging Quality = Product Quality
What is Packaging ?
Aluminium foil packaging Blister Packaging

9. Packing versus Packaging
9
Packing Packaging
Packing is the preparation of a
product for storage or
transportation.
Packaging is the preparation
of a product for transport,
storage or sale.
Packing can be considered as
the first step of packaging as it
only includes wrapping or
storing the product
protectively.
Packaging also include
labeling, marketing and sales
promotion.
Packing is done to ensure the
safety of the product.
Packaging is done to protect
the product and attract
consumers.

10. Importance of Packaging
10
• To attract the attention
• Protection of the goods inside
• Assist in promotion
• Help in utilization and consumption
• Used for track and trace purposes
• It differentiates your brand from others
• Packaging Creates Brand Recognition
• Creation of Demand

11. Functions of Packaging
11
1. Primary Function
Presentation
ProtectionConvenience
Economy Preservation
2. Secondary Function
Containment
Handling Identification
Labeling Suitability

12. Concept of Packaging
12
The concept of pharmaceutical packaging developed stage
by stage with…
 presenting a product with physical protection
 Environmental protection
 Patient/dosage information
 Regulatory compliance
 Perceived quality
 Pack security

13. Packaging Excellence
13
Safe
Stable
Compan
y image
Productive
Cost-
effective
Perceived
Quality
Regulatory
compliance
Secure
Packaging
Excellence

14. Steps of Packaging
14
1.Primary packaging: It is the material that first envelops the product
and hold it. This usually is the smallest unit of distribution or use.
Example: Blister packs, Bottle packs
2. Secondary packaging: It is outside the primary packaging perhaps used
to group primary package together.
Example: Boxes
3.Tertiary or Transit Packaging: It is used for bulk handling, warehouse
storage and transport shipping.
Example: Cartons, Pallets
Primary packaging Secondary packaging Tertiary Packaging

15. Types of Packaging for Capsule
15
There are many types of packaging. The
commonly used packaging are….
1. Blister packaging
2. Strip packaging
3. Alu-alu packaging
4. Bottle Packaging

16. 1. Blister packaging
16
There are many types of packaging. Such as…
1.Blister package:
Blister packs are commonly used for unit dose packaging for capsule.
The principal components of a blister pack comprise of:
a. Forming film (blister): A pocket inside which the product fits and
b. Backing: the lidding foil sticked over the back of a blister.

17. 1.Blister package
17
Materials used for forming films (blisters):
 Polyvinyl chloride/polyethylene combinations
 Polystyrene
 Polypropylene
 Polyvinyl chloride (mostly used)
Materials used for backing:
 Paper
 Paper-aluminium combination
 Aluminium foil

18. 2. Strip packaging
18
A strip package is formed by feeding two webs of a heat sealable flexible
film through a heated crimping rollers.
Materials used:
 Foil laminations (for moisture sensitive product)
 Paper
 Polyethylene
 Cellophane (Transparent plastic film formed from processed cellulose)

19. 3. Alu-alu packaging
19
Alu-alu packaging means aluminium foil at both upper and lower side of pack.
Alu-alu packaging is similar to that of blister packing the only difference is that
the forming film is formed of aluminium foil instead of material.
- It is the most beneficial packaging type.

20. 4. Bottle Packaging
20
Bottles are commonly used for liquid pharmaceuticals
as wall as for tablets and capsules.
Materials used:
Bottle:
 Polyethylene
 Polypropylene screw cap
 Polystyrene
Bottle mouth seal:
 Aluminium foil

21. Packaging Documentation
21
The WHO guideline states that the “ manufacturing
records must provide a complete account of the
manufacturing history of each batch of a drug, showing
that it has been manufactured, tested & analyzed in
accordance with the manufacturing procedure and
written instructions”.
The packaging documentation must fulfill following
criteria:
 Compliance
 Control
 Accountability
 Traceability

22. Conclusion
22
In case of capsule production, both manufacturing
and packaging are the essential steps through the
pharmaceutical capsule dosage form turns into it’s
desired form. Manufacturing depends on the right
formulation and proper storage of pharmaceutically
manufactured capsule mainly depends on how the
packaging quality used.

23. 3/2/2013