The document discusses the layout and environmental requirements for a plant manufacturing uncoated and coated tablets. It recommends a layout with three areas - an area for uncoated tablets production of 60 square meters, an area for coating of 30 square meters, and an ancillary area of 20 square meters. Environmental conditions of temperature 25賊5属C and humidity 55賊10%RH are suggested. Different pressure requirements are outlined for different areas like the warehouse, weighing area, and tableting area to prevent cross contamination. Proper air handling systems and controls are necessary to maintain suitable environmental conditions for manufacturing and ensure employee comfort.
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Ds attri
1. By :-
Mr. Dinesh Sharma
M Pharma(2nd
sem)
dsattri592@gmail.com
GUIDE LECTURER :-
Miss. Japinder kaur
M Pharmacist
Global College of
Pharmacy
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 賊 5 C
Humidity : 55 賊 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.