compressed air validation

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COMPRESSED AIRVALIDATION

Md.Aftab Siddiqui.

Dept. Of QA & RA

Torrent Pharmaceuticals ltd


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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/SampleValve

Air Dryer - Delair India Pvt. LtdCapacity : - 2400 cfm, 120 0C

Air Receiver - Delair India Pvt. LtdCapacity : - 10 m3, Operating Pressure- 7 to 8 Kg / cm2(g)

Control Air System upto all user points - Godrej-Boyce2400 cfm (max.)P&IDs, circuit and wiring diagrams etc.).backflow preventor

Certificate of FilterPressure Gau e, Tem sensor, Dew oint A aratus

SYSTEM DESCRIPTION


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AIR DRIER

After air compressor, the air is finally passedthrough heat of Compression type air dryer forremoval of moisture. Air dryer consists of twodrying towers. The dryers remove moisturefrom compressed air by adsorption. Activated

Alumina is used as a desiccant in the two dryingtowers and is capable of delivering air at dewpoint of (-) 20 C, while one tower adsorbsmoisture, the other is getting regenerated.


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DRY AIR RECEIVER

Dry air from air dryer goes to dry airreceiver which acts as a short timehold up for the compressed air beforegoing for distribution.


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CONTROL AIR SYSTEM

A control air system is provided tominimize energy wastage duringloading unloading operations.

Where air is coming in contact withproduct, air is filtered through 1micron filter and followed by 0.2micron filter.


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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


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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 asper alternative basis

FILTER INTEGRITY All 12 locations where air comes incontact of product


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Services for Air Compressor

ServicesSpecified

Cooling water to Air

Compressor X

401A/B/C

Inlet Temperature: 32 oC

Outlet Temperature: 37 oC

Pressure:.3 Kg /cm2

Pipe Diameter: 80 mm(for each)

Electricity

Voltage: 41510 % V

Phases: 3

Frequency: 50 Hz3 %


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Services for Air Dryer

ServicesSpecified

Cooling water to

AIR Dryer

Inlet Temperature: 32 oC

Outlet Temperature:

Pressure:.3 Kg /cm2

Electricity

Voltage: 41510 % V

Phases: 3

Frequency: 50 Hz3 %


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Services for Control Air System

ServicesSpecified

Electricity

Voltage: 220 VPhases: 1

Frequency: 50Hz3%

PLC Application

Lubricants List

5 micron Filter


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The following references are used to give addition guidanceFDA/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 andinspections document, Validation Master Plan, Design Qualification,

Installation & Operational Qualification, Non Sterile Process Validation,

Cleaning Validation, October 1999.GAMP Guide, Validation of Automated Systems in PharmaceuticalManufacture, Version 4.0, December 2001.

compressed air validation

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