Plant:- It is a place where the 3 M's that are Man, Material and
Money are brought together for the manufacturing of products.
Pilot Plant:- It is the part of the pharmaceutical industry where
a lab scale formula is transformed into a viable product by
development of liable practical procedure of manufacturing.
Scale-up:- The art for designing of prototype usingthe data
obtained from the pilot plant model.
Permits close examination of formulae to determine its ability to withstand
batch scale and process modification.
Review of Equipment - most compatible with theformulation & most
economical, simple and reliable in producing product
.Raw materials - consistently meet the specifications required to produce
the product can be determined.
Production rate adjustment after considering marketing requirements.
Give rough idea about physical space required and of related functions.
R &D group
The formulator who
developed the product can
take into the production
and can provide support
even after transition into
production has been
2. Personnel Requirements
Scientists with experience in pilot plant operations as well as
in actual production area are the most preferable
.*As they have to understand the intent of the formulator as
well as understand the perspective ofthe production
Knowledge of computers & electronics
Standard Pilot-plant Equipment Floor Space :-
Discreet pilot plant space, where the equipment needed for manufacturing
all types of dosage form is located.
Intermediate-sized and full scale production equipment is essential in
evaluating the effects ofscale-up of research formulations and processes.
Equipments used should be made portable where ever possible. So that
after use it can be stored in the small store room.
One purpose/responsibility of the pilot-plant is the approval & validation of
the active ingredient & excipients raw materials.
Raw materials used in the small scale production cannot necessarily be
the representative for the large scale production.
Ingredients may change in particle size, shape or morphology which result
in differences in bulk density, static charges, rate of solubility, flow
properties, color, etc.
The most economical, simplest & efficient equipment which are capable of
producing product within the proposed specifications are used.
The size of the equipment should be such that the experimental trials run
should be relevant to the production sized batches.
If too small the process developed will not scale up.
If too big then the wastage of the expensive active ingredients.
Ease of cleaning
Time of cleaning
The immediate as well as the future market trends/requirements are
considered while determining the production rates.
Regularly process review & revalidation
Relevant written standard operating procedures
The use of competent technically qualifiedpersonnel
Adequate provision for training of personnel
A well-defined technology transfer system
Validated cleaning procedures
An orderly arrangement of equipment
Members of the production and quality control divisions can readily
observe scale up runs.
Supplies of excipients & drugs, cleared by the quality control division, can
be drawn from the more spacious areas provided to the production
Access to engineering department personnel is provided for equipment
installation, maintenance and repair.
The frequency of direct interaction of the formulator with the production
personnel in the manufacturing area will be reduced.
Any problem in manufacturing will be directed towards it's own pilot-plant
PRODUCT CONSIDERATIONSSOLID DOSAGE FORM
Deliver accurate amount to the destination
1. Lifting drums
2. More Sophisticated Methods-
Vacuum Loading System
Prevent Cross Contamination by
Validation Cleaning Procedures.
2. Dry Blending
Powders should be used for encapsulation or to be
granulated prior to tabletting must be well blend
ensure good drug distribution.
Inadequate blending could result in drug content
uniformity variation, especially when the tablet or capsule
is small & the drug concentration is relatively low.
Ingredients should be lumps free, otherwise it could cause
3. GranulationsReasons :-
To improve the flow properties.
To increase the apparent density of the powder.
To change the particle size distribution so that the
binding properties on compaction can be improved.
a) Wet Granulation
b) Dry Granulation
c) Direct Compression Method
A small amount potent active ingredient can be dispersed
most effectively in a carrier granulation, when the drug is
dissolved in granulating solution and addedduring the
Hot air oven
1. air temperature
2. rate of air flow
3. depth of granulation on the trays
Fluidized Bed Dryer
1. optimum loads
2. rate of airflow
3. inlet air temperature
1. conventional coating pan
2. perforated pans of fluidized-bed coating column
1. Sugar coating
2. Film coating
Tablet must be sufficiently hard to withstand the the
tumbling to which they are subjected while coating.
Operation conditions to be established for pan or column
operation are optimum tablet load, operating tablet, bed
temperature, drying air flow rate, temperature, solution
To produce capsules on high-speed equipment, the
powder blend must have,
uniform particle size distribution
formation of compact of the right size and of sufficient
cohesiveness to be filled into capsule shells.
1. Zanasi or Mertalli - Dosator(hollow tube)
2. 2. Hoflinger - Karg - Tamping pins
3. Weight variation problem can be encountered with these two methods
4. .Overly lubricated granules - delaying disintegration.
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