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DESIGN OF PLANT LAYOUT
STERILE & NON STERILE
By- Quality Assurance Department
Guide- Prof. S. Shelke
RSCP, Buldana
1
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
2
 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.
3
4
 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)
5
 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
6
NON STERILE AREA LAYOUT
7
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.
8
LAYOUT NO.2- STORAGE AND PRODUCTION
SIDE-BY-SIDE
9
LAYOUT NO.3- STRAIGHT-LINE TYPE
10

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Design of aseptic area plant layout

  • 1. DESIGN OF PLANT LAYOUT STERILE & NON STERILE By- Quality Assurance Department Guide- Prof. S. Shelke RSCP, Buldana 1
  • 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 2
  • 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. 3
  • 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) 5
  • 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 6
  • 7. NON STERILE AREA LAYOUT 7
  • 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. 8
  • 9. LAYOUT NO.2- STORAGE AND PRODUCTION SIDE-BY-SIDE 9