3. Designed according to GMP practices which
ensures …….
Prevention of cross contamination
Proper air handling systems.
Proper cleaning & sanitary facilities.
Proper Lighting
Proper Plumbing
Proper washing etc.
4. Layout:
It is the organized properly planned
INTERDEPARTMENT and INTRADEPARTMENT
arrangements.
PROPER LAYOUT:
Increases productivity
Helps in proper utilization of - MAN
- MATERIAL
- MONEY
- MACHINES
9. For Uncoated Tablet
For Coating
Section
For Basic Installation
Sq.mtrs.
For Ancillary Area
Sq.mtrs.
60
30
20
10
AREAAREA REQUIREMENTREQUIREMENT
ENVIRONMENTENVIRONMENT REQUIREMENTREQUIREMENT
Temperature : 25 ± 5 C
Humidity : 55 ± 10 %RH
Pressure in Ware House Area: 10 Pascal
Pressure in Weighing Area : 20 Pascal
Pressure in Tableting Area : 15 Pascal
Pressure in Central Corridor : 30 Pascal
10. Proper maintenance is required for :-
o Product Protection
o Employee Comfort
o Controlled Process Parameters
11. Name of Area Pressure
maintained in
pascals
Warehouse 10
Weighing area 20
Tableting area 15
Central corridor 30
12. Low humidity for Effervescent tablets & moisture
sensitive drugs.
Presure with areas like mixing & tableting area
should remain on negative side than central
corridor.
All area should be free from dust & floating
particles , if possible air conditioned .
In coating section suitable exhaust systems.
There should be properly organized & working
air handling system to supply purified air.
13. Temp control & Air control should be such be
that there should be comfortable working
environment.
And no impact on characteristics of in-process
materials such as granulation, raw materials.
All areas should be properly ventilated.