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Dispensing
Sizing
Milling
Blending
Coating
compress
Drying
Granulation
TABLET MANUFACTURING PROCESS
Milling operation: which aims to deliver the API with uniform particle
size.
There are three (3) methods by which the tablets can be prepared
DRY BLENDING :
WEIGHING
SIZING
BLENDING
LUBRICATION
COMPRESSION
COATING
DRY
GRANULATION :
WEIGHING
SIZING
BLENDING
COMPACTION
MILLING
LUBRICATION
COMPRESSION
WET GRANULATION :
WEIGHING
SIZING
GRANULATION
DRYING
BLENDING
LUBRICATION
COMPRESSION
1.
Direct Compression
2.
Dry Granulation
3.
Wet Granulation
1. DRY GRANULATION
This method has been utilized when one of the constituents, either the drug or
the excipients has insufficient cohesive or flow properties to be directly
compressed into tablets.
WET GRANULATION
With wet granulation, extra process steps are necessary to produce a tablet
mass with sufficient tableting properties.
After dry blending the tablet mixture to uniformity, a binder solution is added
to the mixture to moisten the particles.
Introduction of the binder solution improves binding between the particles and
therefore can produce stronger tablets.
This wet mass is then screened to remove large lumps, and dried in oven to
remove granulation fluid.
Finally, the granules are sieved to remove the agglomerates that are formed
during drying followed by lubrication of the granules.
Direct Compression
Tablets are compressed directly from powder blends of the active ingredient
and suitable excipients
Additives:
Diluents
Disintegrating agents
Organoleptic additives
Then another sheet of gelatin is placed over it and the pressure is then
applied to the combined plates.
The capsules are then simultaneously shaped, filled, sealed and cut into
individual units.
Two continuous sheets of gelatin are supplied to the die rolls of the machine
which has a number of matching dies and rotate at the same speed and in the
opposite direction.
The pressure exerted by the material forces gelatin sheet to go in the cavities
of the die rolls to form two halves of the capsule and fill them.
The heat and pressure exerted by the die rolls seals and cuts out the
capsules.
The finished capsules are then passed through a series of naphtha baths to
remove lubricants and then dried.
These rotary die machines are produce 25000 to 30000 capsules per hour.
PQA
Sum of all activities and responsibilities required to ensure that the medicine
that reaches the patient is safe, effective, and acceptable to the patient.
in-process,
packaging,
labeling, and
assuring the quality, safety, purity and effectiveness of the drug supply.
assures that at each stage of manufacturing the necessary test are made &
the product is not released until it has passed these tests.
To assure that the testing results are in compliance with the standards or,
specifications
MATERIAL MANAGEMENT
Material management is defined as an organizational concept, which
has the authority and responsibility of all activities, concerned with
the flow of materials in the organization.
It is concerned with planning, organizing and controlling the flow of
materials from their initial purchase through internal operations to
the service point through distribution.
Material management is a scientific technique, concerned with
Planning, Organizing & Control of flow of materials, from their initial
purchase to destination.
The aims of material management are following:
1. To get the right quality
2. To get right quantity of supplies
3. To get at the right time
4. To get at the right place
5. To get For the right cost
The purpose of material management are following:
1. To gain economy in purchasing
2. To satisfy the demand during period of replenishment
3. To carry reserve stock to avoid stock out
4. To stabilize fluctuations in consumption
5. To provide reasonable level of client services
RAW MATERIAL
RAW MATERIALS is basically the chemical ingredients of a process.
Basic raw materials are starting material, which is used in
production of final product.
Good raw material specifications must be written in precise
terminology, must be complete, must provide specific details of test
methods, type of instruments, and manner of sampling, and must
be properly identified.
QC
QC is lab based
QA
QA is company based