2. VALIDATION:
o Process of establishing documentary evidence, demonstrating
that a procedure, process or activity carried out in testing & then
production maintains the desired levels of compliance at all
stages.
Validation can be applied in
o Operation
o Training
o Manufacturing
o Maintenance
o Support services
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3. COMPRESSED AIR:
• Air kept under a pressure that is greater than
atmospheric pressure.
• Important medium
To transfer of energy in industrial process
To operate air cylinders for automation
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4. USES:
Used as
• Breathing gas by underwater divers.
• Pneumatics, (use of pressurized gases to work)
• HVAC control system (Heating Ventilation and
Air Conditioning)
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5. COMPRESSED AIR VALIDATION:
It is a critical component in the production of
pharmaceutical industry and its effect is on the quality of
the end product.
Used by operatives working in a number of
industrial sectors including oil & gas, Pharmaceutical,
Manufacturing, nuclear, diving & in medical applications.
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6. PARAMETERS TO SPECIFY THE QUALITY
OF COMPRESSED AIR:
• Dew point
• Moisture content
• Viable count
• Oil content
• Particulate matter
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7. Nitrogen gas validation
It is a critical component in the production of
pharmaceutical industry and its effect is on the quality of
the end product.
The most common gases --Pharmaceutical Industries
It is used for providing an inert gas -vial, ampoule, used
for creating an inert pressure pad in processes.
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8. PARAMETERS TO SPECIFY THE
QUALITY OF Nitrogen gas:
Purity
Gases such as O2 & CO2
Odour
Dew Point
Oil Content
Particulate matter
Moisture Content
Viable Count
Identification Test
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9. DEW POINT TEMPERATURE OR
SATURATION TEMPERATURE
Temperature at which Water vapour begins to condense.
Quantity of any gas in a mixture can be expressed as a
pressure.
Gas of unknown water vapour concentration is passed
over a temperature-controlled surface. The surface is
cooled until condensation forms.
The temperature at which condensation forms is called
the “Dew Point temperature.
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10. Dew point temperatures in compressed air range from
ambient down to -112 °F.
Dew point temperatures in nitrogen gas range from
-40°F.
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11. Moisture content
All atmospheric air contains some water vapour which will begin
to condense into liquid water in the compressed air or gas system
The condensed moisture must be removed by a separator and
trap.
Moisture in compressed air used in a manufacturing plant causes
problems-
Operation of pneumatic air systems,
Solenoid valves
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12. Causes –-rust and increased wear of moving parts, clogged
orifices
Moisture adversely affects the
colour,
adherence.
Corrosion of air or gas -false readings, interrupting or shutting
down plant processes.
Result -- damage to product or in costly shutdowns
Moisture content should be less than <0.01% for Compressed Air
System
Moisture content should be less than < 67ppm v/v for Nitrogen
Gas System.
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13. Particulate matter
Compressed air /Nitrogen gas is in direct contact or
indirect contact with product
The impurities - Nitrogen/Compressed air - contaminate
the product --result in change of colour and taste, reduced
shelf life.
Compressed air, which is generated on site by pulling in
ambient air and compressing it, contains water vapour,
particulate matter
In the filtration systems --employed to protect process
equipment from large slugs of water, oil, and rust
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14. Compressed Air has the Particulate Matter to a level less
than 0.02 mg/m3.
Nitrogen has the particulate matter of < 5 mg/m3.
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15. Oil content
Determine the amount of Oil flowing in a Compressed
Air stream
Many Compressed air systems are supplied using
lubricated compressors.
Oil free air is generally required for a Compressed Air
System
Oil content of less than 0.01 mg/m3.(compressed air)
Oil content of less than 0.01 mg/m3.(nitrogen)
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16. Method to determine the oil content
Presence of oil (by using oil mist detector tube).
Connect the flow meter through tubing's
Adjust the flow rate to 1 litre per minute (adjusting knob).
Break tips off a fresh Oil mist detector tube
Insert a tube into tube holder.
Attach the rubber tube holder to the flow meter outlet.
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17. Make the connection of the Oil mist detector tube
Sample inlet from arrow G ► on the Oil mist detector tube and outlet
from another end.
Turn on the flow of compressed air and confirm the flow meter
Allow the compressed air to pass through the Oil mist detector tube
for 7 hours (420 minutes).
As soon as sampling time is elapsed turn off the flow and remove the
tube from the tube holder.
Observe the colour change 17
18. e.g. For Gastec oil mist Airtec tube colour changes from
Salmon Pink to Pale Blue.
Calculate the true concentration by the formula:
20000
True concentration (mg/m3) = Tube reading x -------------
420000
Note: If the tube reading is less than 0.2 mg/m3 report the
results as less than 0.01 mg/m3
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19. Viable count
Microbial contaminant - adversely affect the product, including
operational characteristics.
Quality of supplied air may not be obvious unless microbiological
testing is performed.
Microbial assay –alert the manufacture –various type of viable
microorganism(present).
Manufacture of medical devices, pharmaceutical operation– free
from microorganism
For Compressed Air System, Viable count should be
<100CFU/m3(colony forming unit).
For Nitrogen Gas system, Viable count should be <1
CFU/m3.(colony forming unit)
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20. Method to determine Microbial Evaluation
Sterilise the air sampling flask ,100 ml SCDM,(soya bean casein
digest medium)silicone tube for inlet & outlet
Sanitize the sampling site with 70% IPA(Iso propyl alcohol).
Open the valves of the compressed air system (5 minutes), allow air
to pass out.
Insert the end of the inlet silicone tube over the sampling site 20
21. Connect to flow meter
Place the outlet of silicone tube connected to flow meter in sampling
flask.
Impinge air in 100 ml of sterile SCDM for 20 minutes
Filter the whole content through 0.45 m membrane filter.
After filtration place the paper on Soybean Casein Digest Agar plate
Incubate at 30-35°C for the total viable aerobic count for 5 days.
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22. After incubation streak a loopful on the selective media (organism-
E.coli, selective media- MacConkey's agar.).
Incubate the plates at 36-38°C for 48 hrs.
Observe the plates for colony characteristics & compare with the
standard
Brick red coloured colonies are formed with precipitation of bile.
For confirmation, carry out Gram staining.
Total Viable Aerobic Count: Alert: NMT 25 CFU/m3 Action: NMT
50 CFU/m3
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23. Conclusion
Testing and monitoring of compressed air and other process
gases such as nitrogen, oxygen, argon, carbon dioxide that come
into direct contact with pharmaceutical products is vital to
assuring the quality and safety of those products.
It is also a component in the production of pharmaceutical
industry and effect on the quality of the end point.
Nitrogen gas is enormous cost savings compared to conventional
gas cylinders.
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24. Reference
Senra. A, Leyva. A, Perez. Qualification and continuous
validation of a compressed air system.
Website:www.ivtnetwork.com.
Website :www.imimg.nitrogen-gas-validation-
services.com.
www.pharmaguideliness.com.
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