Professional Documents
Culture Documents
Prepared By
Md. Khairul Mamun
1
Definitions
Plant:
It is a place were the 5 M’s
like money, material, man,
method and machine are
brought together for the
manufacturing of the
products.
Definitions
The pilot program is a scare up techniques conducted to the
product and its process
• Leaving the development laboratory.
• Accepted by the full production manufacturing unit.
R&D Pilot
Scale
Large Scale
Scale-Up
Production
Primary function /Scopes/ Objectives/Importance of Pilot Plant:
Scale up
batches
Exhibit batch
Uses
• To support formulation.
Uses
• To detect any problem arise in manufacture of exhibit batch .
Production batch
C. No. of personnel
It’s depends on number of products.
3. Space Requirements
A Pilot plant has the following 4 types of space requirements-
Space Requirements
Why?
Raw materials used in the small scale production cannot
necessarily be the representative for the large scale production
21
5. Raw materials (continue):-
Approved & Validation of the active
and excipients raw materials used in
pharmaceutical product is an
important function of the pilot plant.
Because the raw materials used in
large scale formulation traits may not
be the representative of large volume
shipments of materials used in large
scale production. The evaluation of
alternative suppliers depend on the
several batches of product of
alternative material that their
performance in the formulation &
stability of finished products relative
to the standard product
6. Relevant processing Equipment:-
Based on the known processing characteristics of the product, the
equipment that promises to the most economical. The simplest, the
most efficient and the most capable of consistently producing
product within the proposed specifications should be evaluated.
The size of this equipment should be such that experimental trials
can be run that are meaningful & relevant to the production sized
batches that will eventually be made.
6. Relevant processing Equipment (contin):-
The most economical and the 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 the equipment is too small the process
developed will not scale up. Whereas if
equipment is too big then the wastage of the
expensive active ingredients.
7. Production Rates:-
The immediate & future market requirements
must be considered when determining the
production rates & tile type & size of
production equipment needed.
The size of this equipment should be such that it
is properly utilized. The equipment & process
should be chosen so as to produce batches at a
frequency that takes in to Consideration
Order of mixing of
Drying temp. components Mixin
And drying time g
speed
Mixin
Screen size PARAMETERS g time
(solids)
Rate of addition of
Filters size granulating agents,
Heating and cooling solvents,
(liquids)
Rates solutions of drug
etc.
8. Process Evaluation:-
The purpose of process validation is to confirm that the
selected manufacturing procedure assures the quality of the
product at various critical stages in the process and in the
finished product.
The following points should be examined—
a. Order of addition of materials (amount)
b. Mixing speed
c. Mixing time
d. Rate of addition of granulating agents (solvents,
solution of drugs, slurries etc)
e. Heating and cooling rates
f. Filter sizes (Liquids)
g. Screen sizes (Solids)
h. Drying temperature
i. Drying time
Why to carry out process evaluation????
T h e knowledge of the effects of various process parameters as
few mentioned above form the basis for process optimization
and validation.
9.Preparation of master manufacturing
procedure:-
The three important aspects
Examination of formulae.
Review of range of relevant processing equipment.
production rate adjustment.
Idea about physical space required.
Appropriate records and reports to support GMP.
Identification of critical features to maintain quality.
A pilot plant can be used for
Evaluating the results of laboratory studies and making
product and process corrections and improvements.
Producing small quantities of product for sensory, chemical,
microbiological evaluations, limited market testing or
furnishing samples to potential customers, shelf-life and
storage stability studies.
Providing data that can be used in making a decision on
whether or not to proceed to a full-scale production process;
and in the case of a positive decision, designing and
constructing a full-size plant or modifying an existing plant.
Advantages
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 division.
Access to engineering department personnel is provided for
equipment installation, maintenance and repair.
Disadvantages
T h e frequency of direct interaction of the formulator with
the production personnel in the manufacturing area will be
reduced.
A n y problem in manufacturing will be directed towards its
own pilot-plant personnel's.
Pilot Plant design for Tablets
i. The primary responsibility of the pilot plant staff
is to ensure that the newly formulated tablets
developed by product development personnel
will prove to be efficiently, economically, and
consistently reproducible on a production scale.
ii. The design and construction of the pharmaceutical
pilot plant for tablet development should
incorporate features necessary to facilitate
maintenance and cleanliness.
iii. If possible, it should be located on the ground
floor to expedite the delivery and shipment of
supplies.
Pilot Plant design for Tablets
Extraneous and microbiological contamination must be guarded against
by incorporating the following features in the pilot plant design:
1. Fluorescent lighting fixtures should be the ceiling flush type.
2. The various operating areas should have floor drains to simplify
cleaning.
3.The area should be air-conditioned and humidity controlled.
4. High -density concrete floors should be installed.
5.The walls in the processing and packaging areas should be enamel
cement finish on concrete.
6. Equipment in the pharmaceutical pilot plant should be similar to that
used by production division- manufacture of tablets.