2017515 SOPforMonitoringofCompressedAir/Gases:PharmaceuticalGuidelines

SOPforMonitoringofCompressedAir/Gases
Standard operating procedure to monitor the compressed air and gas for Microbiological, NonViable Particulate, Oil and Moisture Content.
1.0 Purpose
To lay down the procedure to monitor compressed air/gases for microbiological, nonviable particulate, oil and moisture content.
2.0 Scope
Applicable for monitoring of compressed air and gases Nitrogen, Oxygen and Carbon Dioxide in different production facilities for microbiological,
nonviable particulate, oil and moisture content.
3.0 Responsibility
Trained QC Microbiology Officer is responsible for performing tests as per SOP.
4.0 Accountability
Head of Department
5.0 Procedure
5.1 Microbiological Monitoring
Note: Microbiological monitoring is performed by sterility testing for user points in aseptic zone filling and filtration area and by Total Aerobic Microbial
Counts using M Air T CG Sampler for other user points.
5.1.1Test for Sterility
5.1.1.1 Prepare the Soybean Casein Digest medium as per SOP for media preparation.
5.1.1.2 Dispense 100 ml of Soyabean Casein Digest Medium in cleaned gas sampling assembly. Close the inlet and out let tubes with air 0.2 vent filters.
5.1.1.3 Sterilize the assembly as per SOP.
5.1.1.4 Pre Incubate the assembly with media at 30 35C for 48 hours before use.
5.1.1.5 Bring the sample assembly to sampling location.
5.1.1.6 Disinfect the outer surface of sampling point by the spraying of 70% v/v isopropyl alcohol or recommended disinfected solution
5.1.1.7 Flush the gas sample for 1 min.
5.1.1.8 Remove the vent filter from the inlet tubing and attach to filter outlet connected to the sampling point.
5.1.1.9 Open the air/gas sample valve slowly and take sample for 10 min.
5.1.1.10 After collecting the sample replace the vent filter of inlet tubing and label the assembly with appropriate details viz. Sample Identification, Date an
Initials of analyst.
5.1.1.11 Bring the sample to laboratory and incubate assembly at 22.5 2.5oC for 7 days followed by incubation at 32.5 2.5oC for 7 days. In case of
Nitrogen Samples, incubate the samples in anaerobic conditions.
5.1.1.12 After completion the incubation period record the results.
5.1.1.13 Frequency: Once in One month
5.1.1.14 Acceptance Criteria:No Growth Should be Observed
5.1.2Test for Total Aerobic Microbial Counts
5.1.2.1 Transfer the pre incubated Soybean Casein Digest Agar cassette, M Air T CG Sampler and accessories to the area to be monitored in a closed
container to avoid any contamination.
5.1.2.2 Write the sampling location ID and date of sampling on the base of cassette.
5.1.2.3 Connect the sampling point to M Air T CG Sampler to and perform sampling as per SOP for 1000 litres.
5.1.2.4 After completion of air sampling close the cassette with lid.
5.1.2.5 Collect all exposed cassette in a closed container and transfer the plates to incubators for incubation.
5.1.2.6 Incubate the exposed cassettes along with negative control in inverted position at 3035oC for 5 Days.In case of Nitrogen Samples, incubate the
samples in anaerobic conditions.
5.1.2.7 After incubation observe and count the number of colonies and record the results.
5.1.2.8 Frequency: Once in One month
5.1.2.9 Acceptance Criteria: Shall Comply for Room Classification Limits as follows:
Action Limit
Grade
CFU/m3
Grade A 1
Grade B 10
Grade C 100
Grade D 200
Other Grades Grade E, O, etc For Information

5.2Non Viable Particulate Count

5.2.1 Take the airborne particle counter LASAIR and accessories to the respective sampling rooms.
5.2.2 Connect the user point to a stainless steel box with inlet and out let to diffuse the high pressure of air/gas to appropriate pressure to enable
counting. Slowly open the user point and allow some air/gas to flush the box.
5.2.3 Place the sampling probe of the particle counter at the out let of the SS box and sample for 1cubic feet of air or volume.
5.2.4 Take the print of the particle counter and record results.
5.2.5 Frequency: Once in One month
5.2.6 Acceptance Criteria: Shall Comply for Room Classification Limits as follows:
Particles / ft3
Grade
0.5 5.0
Grade A 100 1
Grade B 100 1
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Grade C 10000 57
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Grade D 100000 571
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Other Grades Grade E, O, etc For Information
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5.3 Test for Oil and Moisture Content
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2017515 SOPforMonitoringofCompressedAir/Gases:PharmaceuticalGuidelines
5.3 Test for Oil and Moisture Content
Note: These tests are applicable for Compressed air points only.
5.3.1 This test shall be performed by external testing laboratory as per protocol or by using gas detector tubes Gastec.
5.3.2 Frequency:
Sample Point from Compressed Air Generation System: Once a Month
Process User Points: One point monthly on rotation
5.3.3 Acceptance Criteria:
Oil: 0.5 mg/m3
Moisture: 0.5 g/m3
6.0 ABBREVIATIONS
6.1 SOP Standard Operating Procedure
6.2 % Percent
6.3 C Degree centigrade
6.4 CFU Colony Forming Unit
6.5 ft3 Cubic Feet
6.6 m3 Cubic Meter
6.7 g Gram
6.8 mg Milligram

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widelyread pharmaceutical
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concordaqueomesmoutilizecookies.

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