This presentation discusses capsule manufacturing and common problems. There are two main types of capsules - hard gelatin capsules and soft gelatin capsules. Hard capsules have two shells while soft capsules have a one-piece shell. Common problems in manufacturing include loss of caps, dents, cracks, telescoping, dust, empties, and more. These problems are caused by issues like high vacuum levels, misalignment, overfilling, incorrect pin sizes, and moisture transfer. Solutions include reducing vacuum, ensuring proper alignment, using the correct fill amounts and disc sizes, storing capsules properly, and replacing worn equipment.
1. Welcome to My Presentation
Present by:
Md. Shakil Sarker
ID: PHA 20008
3rd Year 2nd Semester
Department of Pharmacy, MBSTU
Topic:
Problems and Remedy of Capsule Manufacturing
2. Definition of Capsule
Capsules are solid dosage form in which the drug is enclosed in either
a hard or a soft, soluble gelatin shell.
3. Types of Capsule
There mainly two types of Capsule.
1. Hard Gelatin Capsules
2. Soft Gelatin Capsules
1. Hard gelatin capsule
❖ Hard gelatin capsules are made of two shells: the capsule
body/base and a shorter cap.
❖ Hard gelatin capsules are available in a number of sizes, which
varies from 000 to 5.
4. Types of Capsule
❖ The shells of the hard gelatin capsule are made from mixtures of
gelatin, sugar, plasticizer, water, etc.
❖ Examples of hard capsules include Amoxicilin, Tetracycline,
Cephradine, Cloxacillin, etc.
5. Types of Capsule
2.Soft gelatin capsules
❖ Soft gelatin capsules are one-piece
hermetically-sealed soft shells containing liquid,
suspension or semisolid form of medicament.
❖ Soft gelatin capsules are prepared by adding a
plasticizer, preservatives, color, solvent, etc to
gelatin.
❖ Soft gelatin capsules come in various shapes
such as spherical, elliptical, oblong etc.
❖ Examples of soft capsules include Vit E, Vit D,
Vit A, Calcitonin, etc.
6. Problems and Remedy of Capsule Manufacturing
During manufacturing, capsules may get different types of defects.
Some Capsule Filling Problems and Remedies are provided below.
Problems Causes Remedies
Loss of cap
during
transfer
● High vacuum
● Misalignment of cap and
body
● Reduce vacuum
● Check the
alignment of the cap
and body
7. Problems and Remedy of Capsule Manufacturing
Problems Causes Remedies
Dents and
pinholes
● Excess closing/lock
length
● Over-filling of capsules,
● Incorrect pin size or pin
configuration
● Ensure the correct
size disc is used
● Ensure the correct
amount of dose is
filled in the capsule
8. Problems and Remedy of Capsule Manufacturing
Problems Causes Remedies
Cracks in
Capsules
● The transfer of moisture from
the capsule shell to
encapsulated components
● Misalignment of the upper
and lower capsule segments
● Incorrect setting of the cap
hold-down pin
● Store the capsule
properly
● Make a Proper
setting of pin
9. Problems and Remedy of Capsule Manufacturing
Problems Causes Remedies
Telescopic
Capsules
● Misalignment of cap and
body
● Closing pin not in the
center of body
● Damage the rubber sheet
of the closing plate
● Align cap/body
bush to bush
gauge.
● Check pin
straightness using
a gauge pin
● Wear off capsule
closing units rubber
10. Problems and Remedy of Capsule Manufacturing
Problems Causes Remedies
Dusty
Capsules
● Filling dusty fill. ● Use capsule
polisher
11. Problems and Remedy of Capsule Manufacturing
Problems Causes Remedies
Empty
Capsules
● Malfunction in capsule
filling machine
● Make the sure
presence of
safeguards in the
capsule filling
machine
12. Problems and Remedy of Capsule Manufacturing
Problems Causes Remedies
Damaged
band
● Badly tuned banding
process, such as
improper wheel height
and speed, improper
processing temperature,
improper band
thickness, and poor/bad
band wheel.
● Set all the
parameters
accurately.
13. Problems and Remedy of Capsule Manufacturing
Problems Causes Remedies
Capsule
getting
damaged
during
loading
● Misalignment of rectifier
block with bushes
● Verify visually the
alignment of
rectifier block with
the cap/body bush
14. Problems and Remedy of Capsule Manufacturing
Problems Causes Remedies
Capsule
non-
separation
● Insufficient vacuum
● Leakage through filters
● Cap body bush
misalignment
● Worn out bushes
● Proper capacity
pump.
● Right alignment of
cap and body bush
● Replace these
bushes with a new
one.
15. Problems and Remedy of Capsule Manufacturing
Problems Causes Remedies
Weight
variation
● Wrong selection of dosing
disc thickness
● Incorrect gap between
dosing disc and supporting
pad, tamping pin and body
bush,dosing disc and wiper
block, dosing disc and body
bush
● Kindly select the
proper dosing disc
for filling of powder
fully onto the
capsule shell
● Correct the all the
Gaps.
16. Problems and Remedy of Capsule Manufacturing
Problems Causes Remedies
Capsule
lock length
variation
● Excess joined length
● Improper setting of the
closing plate
● Damage the rubber
sheet of the closing plate
● Incorrect setting of the
closing plate
● Check for the standard
locking length
● Check for the gap
between the closing
unit rubber sheet and
capsules
● Wear off of capsule
closing unit rubber
sheet