pharmaceutical plant layout

1. Pharmaceutical
Plant layout
Arpit Rajaram Suralkar
M Pharmacy (Quality Assurance)

2. Introduction:-
• Plant layout is a coordinated effort to achieve the
final objective to integrate machine, material and
personnel for economic production.
• Plant layout involves the location of different
departments and arrangement of machinery in
each department.
• Potential problems could be analysed rapidly and
an alternative solution could be found.
• A proper layout has the advantages from the
point of workers, labour costs, other production
costs.

3. • Types of plant layout:-
A. Process layout or functional layout:-
Functional layout are arrangement of machines of
a particular class doing a particular type of work or
process as a separate department.
For example, all cutting machines may be placed in one
department i.e., cutting department
B. Product or straight line layout:-
Product layout are arrangement of machine doing
various operation in a line as one department.
For example, in the manufacture of tablet; dispensing,
powder blending, granulation, drying, drying blending,
compression , coating etc.

4. Factor influencing plant layout:-
1. Type of process and product control:-
Smooth and continuous flow in the process is desirable.
The layout should be flexible. The machinery is arranged in
way that the changes of production process can achieved at
the least cost or distance
2. Space available and space required:-
Cubic space utilization is essential. Boxes or bags
containing raw material and good can be stacked one above
the other. This is layout essential for warehousing.
3. Operational convenience :-
Facilities (machinery, raw material and workers) are
integrated in a logical and balanced manner. Free movement of
goods and out of the department is essential.
4. Economic distribution of utilities and services:-
Minimum movement of workers and machinery is
essential

5. 5. Type of building and building code requirements:-
Depending on the space, the choice between
single and multi-store building can be made.
6. Health and safety consideration:-
working space should be safe, well ventilated
and free from dust, noise, fumes, odours and
other hazardous conditions.
7. Waste disposal problems.

6. Special provision of pharmaceutical plant layout
• The premises should be suitable for the purpose of
drug manufacturing.
• It mean that all possible measures should be taken
to prevent confusion or mixing-up of substance or
material and contamination
• The building for the factory shall be constructed so
as to permit the production under hygienic
conditions.

7. • Storage space requirements:-
A. Storages-Location:- Ideally, the stores should be located
adjacent to the manufacturing area and finished goods nearer to
the shipping area, so that handling costs will be minimum.
Advantages
• stores has better supervision and control.
• It requires less personnel to manage and involves reduced cost.
• It facilities better inventory checks.
• Security arrangements can be effective
• Better layout of stores can be planned.
B. General Storage Space Requirements:-
1) Adequate storage facilities for raw materials, intermediate
products, recycle material, rejected material and fuels are
essential for the operation of a processing plant.
2) 2) Adequate space facilities for stocking incoming raw material, for
their checking, sorting, inspection, temporary sorting before they
are placed at the proper location.

8. C. Special Storage Space Facilities:-
• I. Special product that require low-temperature storage, special
conditions such as cool place, cold storage, freezer etc. are provide.
• II. Highly toxic and dangerous substance.
• III. Narcotic drug and alcohol must be stored separately.
• IV. Substance that present the risk of fire or explosion should be
separate.
• V. Rejected or recoverable rejects.
D. Containers for Storage Materials:-
1. Bulk storage of liquids is generally handling by a closed spherical or
cylindrical tanks for preventing the escape of volatile material and
minimizing contamination.
2. Liquid material are stored in drums, cans, barrels and bottles.
3. Gases are stored ( bulk storage ) at atmospheric pressure in wet or
dry- sealed gas-holders. Gases are kept in cylinders.
4. Solid raw material are stored in weather-tight tanks. Solid are placed
in boxes, barrels, bags, containers etc.

9. Sterile or aseptic area-layout
Sterile medication product are prepared in a specially designed and
constructed manufacturing department.
The different operations such as component preparation, filling and
sterilization are effectively separated from one another.
A. Air flow:-
The air (supply) enters from the back (horizontal) at a pressure of 5
mm water gauge above atmospheric pressure to the two Class 1 rooms.
The air leaves via vents to the Class-2 and to the changing rooms
(pressure 2 mm water gauge) flowing in from the inner door and venting
to the outside via the entrance door.
For toxic material handling, the pressurization will be designed to
ensure that no escape of substance is permitted through the airlock

10. B. Personnel movement:-
Access to aseptic area is restricted to
authorized persons who enter through air locked
changing rooms, where normal clothing is exchange
for special protective garments
The rooms should be flushed with filter air
at a protective pressure lower than the clean area or
aseptic area.
From the point of entrance to the
changing room till the entrance of the aseptic area
personnel move against the airflow.