This document provides guidelines for the layout of sterile and non-sterile areas in a plant. For sterile areas, it outlines airflow patterns with air entering at positive pressure above atmospheric pressure. It describes personnel movement through airlocks and changing rooms to maintain cleaner conditions moving from potential contamination to less. Material passes through hatches and airlocks. For non-sterile areas, it presents three layout options: a central storage warehouse with perimeter production, side-by-side storage and production, and a straight-line layout. The layouts aim to optimize space, traffic flow, and separation of functions.

1. DESIGN OF PLANT LAYOUT
STERILE & NON STERILE
By- Quality Assurance Department
Guide- Prof. S. Shelke
RSCP, Buldana
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2. STERILE AREA LAYOUT
a = transfer hatch
b = step over
barrier
C = viewing pannel
d = gown racks
e =water still
f = vertical barrier
tube
g = wash
basin/dryer
mm = air press. In
mm water
A /c =air changes
per hr.
LF= laminar flow
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3.  Air flow:
 As per figure the air supply enters from the back at a press.
Of 5mm water gauge above atm. Press. To the class-1
rooms.
 Alternatively, air enters through roof of the laminar bench
to the workstations at a press. Of 5mm water gauge.
 Air leaves via vents to the class-2 and to the changing
rooms flowing in from the inner door and venting to outside
via the entrance door.
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4. 4

5.  Personnel movement
 Acess to area is restricted to authorized persons who enter
through air locked changing rooms where normal clothing is
exchanged for special protective garments
 The rooms should be flushed with filtered air at a positive
pressure lower than that in the clean area or aseptic areas.
 From the point of entrance of the aseptic area, personnel
move against the airflow and the area is enclosed in cleaner
conditions (from black to grey white)
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6.  Material traffic
 Hatchways and airlocks are used for the passage of
materials and equipments into clean and aseptic area.
 These should be interlocked so that only one side is opened
at any one time
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7. NON STERILE AREA LAYOUT
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8. LAYOUT NO. 1- CENTER STORAGE AND PERIMETER
PRODUCTION
 At the center, the storage or warehouse area is
provided for raw materials, packing components
and bulk stocks.
 The mfg. and packaging operations are located at
the outet perimeter
 Advantage of this layout is space conservation
and disadvantage is the cross over of traffic
pattern of materials.
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9. LAYOUT NO.2- STORAGE AND PRODUCTION
SIDE-BY-SIDE
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10. LAYOUT NO.3- STRAIGHT-LINE TYPE
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