Transcript
COMPRESSED AIR VALIDATION Md.Aftab Siddiqui. Dept. Of QA & RA Torrent Pharmaceuticals ltd
SYSTEM DESCRIPTION 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
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
≤
Monthly
MICROBIAL LIMIT
NMT 3 cfu/m3
HYDROCARBON
Less than 5 ppm
Six Monthly
FILTER INTEGRITY
_____________
Six Monthly
- 20°C
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 contact of product
All 12 locations where air comes in
Services for Air Compressor Specified
Services
Inlet Temperature: 32 oC Outlet Temperature: 37 oC Pressure:.3 Kg /cm2 Pipe Diameter: 80 mm (for each)
Cooling water to Air Compressor X – 401 A/B/C
Voltage: 415 ± 10 % V Phases: 3 Frequency: 50 Hz ± 3 %
Electricity
Services for Air Dryer
Specified
Services
Inlet Temperature: 32 oC Outlet Temperature: Pressure:.3 Kg /cm2
Cooling water to AIR Dryer
Voltage: 415 ± 10 % V Phases: 3 Frequency: 50 Hz ± 3 %
Electricity
Services for Control Air System
Specified
Services
Voltage: 220 V Phases: 1 Frequency: 50Hz
Electricity
5 micron Filter PLC Application Lubricants List
± 3%
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 Commission’s 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.
