2. What is Pharmaceutical Plant layout?
Pharmaceutical Plant layout refers to the allocation of space
and the arrangement of machines,furniture and other
important administration and necessary services needed in a
production process within a factory building.
It’s purpose is to perform the various unit operations involved
in the manufacturing process of dosage forms in a cost
effective manner and with the least amount of handling in
processing the product from the receipt of raw material
through the distribution of the finished product.
3. Factors affecting Pharmaceutical Plant layout
1.Location of the company
The size,shape and topology of the site greatly influence the
layout design.
The idea is to optimally utilize the available space.
2.Economic considerations(Cost)
It has two perspectives:
Construction cost-It can be reduced to the barest minimum if
we have a design that will support minimal material handling
during production processes.
Maintainance cost-It should be considered to avoid spending
more money on the building in the long run.
3.Factory building
The shape,size and nature of factory building also influence the
design of the plant layout.
4. The layout should be such that it should follow the basic
regulatory requirements for construction of pharmaceutical
plant.
Optimal utilization of the available space should be done.
4.Nature of the product
The layout design of an industry that processes raw materials to
create API,excipients/ancillary substances will definitely differ
from industry that processes dosage forms such as
tablets,injections etc from raw materials.
However there may be similarity with respect to QC deptt,raw
material quarantine,approved raw materials etc.
5.Production process
The layout should be such that there is effective and efficient flow
of production processes to avoid mix up and cross contamination.
6.Production volume
Layout design also depend on your company’s scale of production.
5. In large scale production,ther will be requirement of enough
space.In case of small space,the productivity may decrease.
Too much space,may also reduce productivity as it will be a
waste of capital.
7.Nature of equipment and machines
Requirement of each equipment and machines differ with
respect to space,speed and material handling process.
Enough space should be there for accommodation of machines
Sufficient space should be maintained between machines to
avoid accidents during operations.
8.Repairs and maintainance of machines and equipment
Adequate space should be there between machines to access
machine parts and components during replacement,repair and
regular mantainance.
6. 9.Employees needs and safety
The layout should not expose the workers to dangerous
fumes/gases,excess heat etc.
The floor type should be non-slippery and free from
obstructions to avoid occupational hazards.
Arrangements should be made for washroom,drinking
water,other employee facilities etc.
10.Plant environment/Climate
Factors like temperature,light,noise,ventilation and other
aspects should be duly considered while designing a plant
layout.
The quality of raw materials/finished products might be
compromised when exposed to extreme climatic conditions.
7. Special Provisions
The premises should be suitable for the purpose of drug
manufacturing.
The building for the factory shall be contstructed so as to
permit the production under hygienic conditions.
They shall conform to the conditions laid down in the
Factories Act,1948(63 of 1948)
Any part of the building used for manufacture shall not be
used as resting place.
The walls of the room in which manufacturing operations are
carried out shall:
• Have a height of six feet from the floor.
• Be smooth and waterproof.
• Be capable of maintaining cleanliness.
Have no cracks or crevices.
8. The flooring shall:
• Be smooth,even and washable.
• Be in such a way as not to permit any retention or accumulation of
dust.
• Have no cracks or crevices.
9. Storage Space Requirements
A.Storage 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 facilitates better inventory checks.
• Security arrangements can be effective.
• Better layout of stores can be planned.
B.General Storage Space Requirements:
• Adequate storage facilities for raw materials,intermediate
products,recycle material,rejected material and fuels are essential for
the operation of a processing plant.
• Adequate space facilities for stocking incoming raw material,for their
checking,sorting,inspection,temporary sorting before they are placed
at the proper location.
10. C.Special Storage Space Facilities
• Special product that require low temperature storage,special conditions
such as cool place,cold storage,freezer,etc.
• Highly toxic and dangerous substance.
• Narcotic drug and Alcohol must be stored separately
• Substance that present the risk of fire or explosion should be separate.
• Rejected or recoverable rejects.
D.Containers for storage materials
• Bulk storage of liquid is generally handling by a closed spherical or
cylindrical tanks for preventing the escape of volatile material and
minimizing contamination.
• Liquid materials are stored in drums,cans,barrels and bottles.
• Gases are stored(bulk storage) at atmospheric pressure in wet or dry
sealed gas holders.Gases are kept in cylinders.
Solid raw material are stored in weather tight tanks.Solids are placed in
boxes,barrels,bags,containers,etc.
11. Sterile and 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.
Fig:Aseptic quality control area
12. A. Air flow:
• The air(supply) enters from the back(horizontal) at a pressure of 5mm
water gauge above atmospheric pressure to the 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 inter door and venting
to the outside via the entrance floor.
• For toxic material handling,the pressurization will be designed to ensure
that no escape of substance is permitted through the airlock.
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
