You are on page 1of 8

GLIMPSES ON COMPRESSED AIR SYSTEM VALIDATION TEST

 Purpose:
To establish documented evidence that the “Air compressor” Performs as per the process
requirements and in compliance with current Good Engineering Practices requirements.

 System Description:
The Compressed Air system has following major stages of Generation & Distribution
1. Air Compressor
2. Air Dryer
3. Filtration System
4. Air Receiver
5. User points
Air compressor takes air at atmospheric pressure and delivers it at a higher pressure. An air compressor
is a machine that converts power (using an electric motor) into potential energy stored in pressurized
air (i.e., compressed air).

 Performance Qualification Test:


Verify Dew Point temperature in Compressed Air:
Procedure:
1. Open the compressed air valve and let the air to be drain out for 1 minute.
2. Connect the outlet of the compressed air to the inlet of the Dew Point transmitter.
3. Switch on the dew point transmitter indicator.
4. Note the reading display on indicator.
Acceptance Criteria: as per ISO 8573 -1 2010 Dew point ≤ - 40°C
Standard Equipment Used: Dew Point Transmitter
Range: -80°C to 60°C

Vasant Ugale
Spectrum Pharma TECH Consultants Pvt. Ltd. Page1 of 8
GLIMPSES ON COMPRESSED AIR SYSTEM VALIDATION TEST

Verification of Oil Mist for Compressed Air:


Procedure:
1. Open the compressed air valve and let the air to be drain out for one minute.
2. Connect the outlet of the sample point to the inlet of the compressed air kit with the necessary pipe
connection.
3. Open the Air supply valve with the minimum pressure to the compressed air kit.
4. Operate a pressure reducer with gauge with flow meter to compressed air line and adjust the flow meter
to flow rate of 1000 ml/min.
5. Break tips off a fresh detector tube in the tube tip breaker and insert a tube into a tube holder.
6. When breaking the tube ends, keep away from the eyes. Do not touch the broken giass tube, pieces and
reagent with bare hands.
7. Attach the rubber tube holder to the flow meter outlet pipe.
8. Turn on the valve and confirm the flow meter set to 1O0O ml/min.
9. Connect the Gas Detector tube to rubber tube holder and wait f or 20 minutes. The sampling time
represents the time necessary to draw the air sample through the gas detector tube.
10. As soon as sampling time of Approx.20 min has elapsed turn off the valve and remove the tube from the
tube holder and then read the colour change layer immediately.
11. lf Oil Mist content present Then colour change from Pale Red to Pate Blue
12. Record the observation on raw data sheet and total concentration of Oil Mist shall be complies as per
acceptance criteria.
Acceptance Criteria: as per ISO 8573 -1 2010 Oil content NMT 0.1 mg/ m3
Standard Equipment Used: Compressed Air Kit & Range: 100 to 1500 ml/min

Nitrogen & Gas Detector Tube & Range: 0.2 - 5.0 mg/m3

Vasant Ugale
Spectrum Pharma TECH Consultants Pvt. Ltd. Page2 of 8
GLIMPSES ON COMPRESSED AIR SYSTEM VALIDATION TEST

Verification of Non Viable Particle Count in Compressed Air:


Procedure:
1. Flush user point for 5 minutes to clean pipe.
2. Connect the outlet of the compressed air to the inlet of the Diffuser.
3. Connect the outlet of the Diffuser to the inlet of the Particle Counter.
4. Switch on the Particle counter and set the air flow.
5. Set particle counter in order to execute a single 1m3 sample for each user point.
6. Ones the air flow is the set and start the particle counter and take the reading.
7. Note: Ensure that the PU tube is properly washed and dried and is free from any particulate matter.
Acceptance Criteria: as per ISO 8573 -1 2010

1. 0.1-0.5 micron - ≤ 400000

2. 0.5 – 1 micron - ≤ 6000

3. 1-5 micron - ≤ 100

Standard Equipment Used: Particle counter.

Verification of Viable Particle Count in Compressed Air:


Procedure:
1. Set up the Millipore instrument.
2. Pass 1m3 (1000 litre) compressed air over the Petri plates, using Soybean Casein Digest Agar or Tryptone
Soya Agar (TSA) plates.
3. Incubate the exposed plates of SCDA / TSA media first at 20-25°C for three days for yeast /mold & then
transfer the plates to 30-35°C for next 2 days for bacterial count.
Acceptance Criteria: Non-aseptic applications: NMT 100 CFU/m3
Standard Equipment Used: Millipore instrument

Vasant Ugale
Spectrum Pharma TECH Consultants Pvt. Ltd. Page3 of 8
GLIMPSES ON COMPRESSED AIR SYSTEM VALIDATION TEST

Verification of General Hydrocarbon for Compressed Air :


Procedure:
1. Open the compressed air valve and let the air to be drain out for 1 minute.
2. Connect the outlet of the sample point to the inlet of the compressed air kit with the necessary pipe
connection.
3. Open the Air supply valve with the minimum pressure to the compressed air kit.
4. Operate a pressure reducer with gauge with flow meter to compressed air line and adjust the flow meter
to flow rate of 100 ml/min.
5. Break tips off a fresh detector tube in the tube tip breaker and insert a tube into a tube holder.
6. When breaking the tube ends, keep away from the eyes. Do not touch the broken glass tube, pieces and
reagent with bare hands.
7. Attach the rubber tube holder to the flow meter outlet pipe. 4.4.8 Turn on the valve and confirm the
flow meter set to 100 ml/min.
8. Connect the Gas Detector tube to rubber tube holder and wait for 1.5 minutes. The sampling time
represents the time necessary to draw the air sample through the gas detector tube.
9. As soon as sampling time of Approx. 1.5 min has elapsed turn off the valve and remove the tube from
the tube holder and then read the color change layer immediately.
10. lf General Hydrocarbon content present Then color change from Yellow to Pale Green.
11. Record the observation on raw data sheet and total concentration of General Hydrocarbon shall be
complies as per acceptance criteria.
Acceptance Criteria: The Hydrocarbon indicator change should correspond to NMT 1 ppm.
Standard Equipment Used: Compressed Air Kit/ Nitrogen Range - 100 to 1500 ml/min
Gas Detector Tube Range - 10 to 1200 PPM

Vasant Ugale
Spectrum Pharma TECH Consultants Pvt. Ltd. Page4 of 8
GLIMPSES ON COMPRESSED AIR SYSTEM VALIDATION TEST

Verification of Carbon Dioxide for Compressed Air:


Procedure:
1. Open the compressed air valve and let the air to be drain out for 1 minute.
2. Connect the outlet of the sample point to the inlet of the compressed air kit with the necessary pipe
connection.
3. Open the Air supply valve with the minimum pressure to the compressed air kit.
4. Operate a pressure reducer with gauge with flow meter to compressed air line and adjust the flow meter
to flow rate of 100 ml/min.
5. Break tips off a fresh detector tube in the tube tip breaker and insert a tube into a tube holder.
6. When breaking the tube ends, keep away from the eyes. Do not touch the broken glass tube, pieces and
reagent with bare hands.
7. Attach the rubber tube holder to the flow meter outlet pipe. Turn on the valve and confirm the flow
meter set to 100 ml/min.
8. Connect the Gas Detector tube to rubber tube holder and wait for 2 minutes.
9. The sampling time represents the time necessary to draw the air sample through the gas detector tube.
10. As soon as sampling time of Approx.2 min has elapsed turn off the valve and remove the tube from the
tube holder and then read the colour change layer immediately.
11. lf carbon dioxide content present then colour change from White to Purple.
12. Record the observation on raw data sheet and total concentration of carbon dioxide shall be complies as
per acceptance criteria.
Acceptance Criteria: The Carbon dioxide indicator change should correspond to NMT 500 ppm
Standard Equipment Used: Compressed Air Kit & Range: 100 to 1500 ml/min
Gas Detector Tube & Range: 100 to 5000 PPM

Vasant Ugale
Spectrum Pharma TECH Consultants Pvt. Ltd. Page5 of 8
GLIMPSES ON COMPRESSED AIR SYSTEM VALIDATION TEST

Verification of Carbon Monoxide for Compressed Air:


Procedure:
1. Open the compressed air valve and let the air to be drain out for 1 minute.
2. Connect the outlet of the sample point to the inlet of the compressed air kit with the necessary pipe
connection.
3. Open the Air supply valve with the minimum pressure to the compressed air kit.
4. Operate a pressure reducer with gauge with flow meter to compressed air line and adjust the flow meter
to flow rate of 500 ml/min.
5. Break tips off a fresh detector tube in the tube tip breaker and insert a tube into a tube holder When
breaking the tube ends, keep away from the eyes.
6. Do not touch the broken glass tube, pieces and reagent with bare hands.
7. Attach the rubber tube holder to the flow meter outlet pipe.
8. Turn on the valve and confirm the flow meter set to 500 ml/min. Connect the Gas Detector tube to
rubber tube holder and wait for 3.5 minutes.
9. The sampling time represents the time necessary to draw the air sample through the gas detector tube.
10. As soon as sampling time of Approx. 3.5 min has elapsed turn off the valve and remove the tube from
the tube holder and then read the colour change layer immediately.
11. lf carbon Monoxide content present Then colour change from White to Brownish Green.
12. Record the observation on raw data sheet and total concentration of carbon Monoxide shall be complies
as per acceptance criteria.
Acceptance Criteria: The carbon monoxide indicator change should correspond to NMT 5 PPM
Standard Equipment Used: Compressed Air Kit & Range: 100 to 1500 ml/min

Gas Detector Tube & Range: 01 to 30 PPM

Vasant Ugale
Spectrum Pharma TECH Consultants Pvt. Ltd. Page6 of 8
GLIMPSES ON COMPRESSED AIR SYSTEM VALIDATION TEST

Verification of Nitrogen oxide for Compressed Air:


Procedure:
1. Open the compressed air valve and let the air to be drain out for 1 minute.
2. Connect the outlet of the sample point to the inlet of the compressed air kit with the necessary pipe
connection.
3. Open the Air supply valve with the minimum pressure to the compressed air kit.
4. Operate a pressure reducer with gauge with flow meter to compressed air line and adjust the flow meter
to flow rate of 200 ml/min.
5. Break tips off a fresh detector tube in the tube tip breaker and insert a tube into a tube holder.
6. When breaking the tube ends, keep away from the eyes. Do not touch the broken glass tube, pieces and
reagent with bare hands.
7. Attach the rubber tube holder to the flow meter outlet pipe.
8. Turn on the valve and confirm the flow meter set to 200 ml/min.
9. Connect the Gas Detector tube to rubber tube holder and wait for 1.5 minutes. The sampling time
represents the time necessary to draw the air sample through the gas detector tube.
10. As soon as sampling time of approx. 1.5 min has elapsed turn off the valve and remove the tube from the
tube holder and then read the colour change layer immediately.
11. lf Nitrogen Oxide content present Then colour change from White to Yellowish orange.
12. Record the observation on raw data sheet and total concentration of Nitrogen Oxide shall be complies as
per acceptance criteria.
Acceptance Criteria: The nitrogen dioxide indicator change should correspond to not more than 2PPM
Standard Equipment Used: Compressed Air Kit & Range: 100 to 1500 ml/min

Gas Detector Tube & Range: 0.5 to 15 PPM

Vasant Ugale
Spectrum Pharma TECH Consultants Pvt. Ltd. Page7 of 8
GLIMPSES ON COMPRESSED AIR SYSTEM VALIDATION TEST

Verification of Sulphur D oxide for Compressed Air:


Procedure:
1. Open the compressed air valve and let the air to be drain out for 1 minute.
2. Connect the outlet of the sample point to the inlet of the compressed air kit with the necessary pipe
connection.
3. Open the Air supply valve with the minimum pressure to the compressed air kit.
4. Operate a pressure reducer with gauge with flow meter to compressed air line and adjust the flow meter
to flow rate of 200 ml/min.
5. Break tips off a fresh detector tube in the tube tip breaker and insert a tube into a tube holder.
6. When breaking the tube ends, keep away from the eyes.
7. Do not touch the broken glass tube, pieces and reagent with bare hands. Attach the rubber tube holder
to the flow meter outlet pipe.
8. Turn on the valve and confirm the flow meter set to 200 mlimin. Connect the Gas Detector tube to
rubber tube holder and wait for 2 minutes.
9. The sampling time represents the time necessary to draw the air sample through the gas detector tube.
As soon as sampling time of Approx. 2 min has elapsed turn off the valve and remove the tube from the
tube holder and then read the colour change layer immediately.
10. lf Sulphur Dioxide content present Then colour change from Greenish Blue to Yellow.
11. Record the observation on raw data sheet and total concentration of Sulphur Dioxide shall be complies
as per acceptance criteria.
Acceptance Criteria: The Sulphur dioxide indicator change should correspond to not more than 1 PPM
Standard Equipment Used: Compressed Air Kit & Range: 100 to 1500 ml/min
Gas Detector Tube & Range: 1 to 25 PPM

References: ISO 8573-1:2010


ISPE Volume 5

Vasant Ugale
Spectrum Pharma TECH Consultants Pvt. Ltd. Page8 of 8

You might also like