COMPRESSED AIR

VALIDATION

Md.Aftab Siddiqui.
Dept. Of QA & RA
Torrent Pharmaceuticals ltd
To generate oil free compressed air with dew point
(-) 20 C for process & instrumentation application.

Compressed Air System comprises of -

Air Compressor - Chicago Pneumatic India Ltd.
Capacity : - 600 cfm each @ 8 Kg / cm2
Inter cooler, Moisture Separator , Auto/Manual/Sample
Valve

Air Dryer - Delair India Pvt. Ltd
Capacity : - 2400 cfm , 120 0C
Air Receiver - Delair India Pvt. Ltd
Capacity : - 10 m3 , Operating Pressure- 7 to 8 Kg / cm2(g)
Control Air System upto all user points - Godrej-Boyce
2400 cfm (max.)
P&IDs, circuit and wiring diagrams etc.).
backflow preventor
Certificate of Filter
Pressure Gauge, Temp sensor, Dew point Apparatus
SYSTEM DESCRIPTION
AIR COMPRESSOR
Compressor comprises of low pressure (LP) &
High pressure (HP) cylinders that are spaced
and arranged to permit access to all the
openings and components without removing
cylinder, cylinder head, water or air piping. The
compressor is equipped with shell & tube type
inter-cooler and Surge vessel to store
compressed air and to reduce dampening from
the respective air compressor.

Total Air Compressors - ____Nos.
AIR DRIER
After air compressor, the air is finally passed
through heat of Compression type air dryer for
removal of moisture. Air dryer consists of two
drying towers. The dryers remove moisture
from compressed air by adsorption. Activated
Alumina is used as a desiccant in the two drying
towers and is capable of delivering air at dew
point of (-) 20 C, while one tower adsorbs
moisture, the other is getting regenerated.
DRY AIR RECEIVER

Dry air from air dryer goes to dry air
receiver which acts as a short time
hold up for the compressed air before
going for distribution.
CONTROL AIR SYSTEM
A control air system is provided to
minimize energy wastage during
loading unloading operations.

Where air is coming in contact with
product, air is filtered through 1
micron filter and followed by 0.2
micron filter.
TEST AND FREQUENCY
TEST LIMIT FREQUENCY

DEW POINT - 20C Monthly

MICROBIAL LIMIT NMT 3 cfu/m3 Monthly


HYDROCARBON Less than 5 ppm Six Monthly

FILTER INTEGRITY _____________ Six Monthly

SAMPLING POINTS
TEST SAMPLING POINTS

DEW POINT OUTPUT OF AIR DRYER

MICROBIAL LIMIT 12 Sampling points as per drawings

Total air outlets ; -
HYDROCARBON OUTPUT OF AIR DRYER & user points as
per alternative basis

FILTER INTEGRITY All 12 locations where air comes in
contact of product

Services for Air Compressor

Services
Specified
Cooling water to Air
Compressor X 401
A/B/C
Inlet Temperature: 32
o
C
Outlet Temperature: 37
o
C
Pressure:.3 Kg /cm
2

Pipe Diameter: 80 mm
(for each)
Electricity
Voltage: 415 10 % V
Phases: 3
Frequency: 50 Hz 3 %
Services for Air Dryer

Services
Specified
Cooling water to
AIR Dryer
Inlet Temperature: 32
o
C
Outlet Temperature:
Pressure:.3 Kg /cm
2

Electricity
Voltage: 415 10 % V
Phases: 3
Frequency: 50 Hz 3 %
Services for Control Air System

Services
Specified
Electricity
Voltage: 220 V
Phases: 1
Frequency: 50Hz 3%
PLC Application
Lubricants List
5 micron Filter
The Principle Reference is the following
Master Validation Plan for Torrent Pharmaceuticals
Limited, Baddi, Himachal Pradesh (India) Tablets,
Capsules and Liquid Orals Manufacturing Facility,
VMP/00, Revision 00.
Schedule M Good Manufacturing Practices and
Requirements of Premises, Plant and Equipment for
Pharmaceutical Products.
WHO Essential Drugs and Medicines Policy, QA of
Pharmaceuticals, Vol 2 Good Manufacturing Practices
and Inspection.
The following references are used to give addition guidance
FDA/ISPE Baseline Pharmaceutical Engineering Guide-Volume 5:-
Commissioning and Qualification Guide, First Edition / March 2001.
Code of Federal Regulations (CFR), Title 21, Part 210, Current Good
Manufacturing Practice (cGMP) in Manufacturing, Processing, Packing,
or Holding of Drugs, General. April 1, 1998.
Code of Federal Regulations (CFR), Title 21, Part 211, Current Good
Manufacturing Practice (cGMP) for Finished Pharmaceuticals, April 1,
1998.
EU Guide to Good Manufacturing Practice, Part 4, 1997.
European Commissions working party on control of medicines and
inspections document, Validation Master Plan, Design Qualification,
Installation & Operational Qualification, Non Sterile Process Validation,
Cleaning Validation, October 1999.
GAMP Guide, Validation of Automated Systems in Pharmaceutical
Manufacture, Version 4.0, December 2001.