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SOP for Monitoring of Compressed Air/Gases


Standard operating procedure to monitor the compressed air and gas for Microbiological, Non-Viable Particulate, Oil and Moisture Content.

1.0  Purpose

       To lay down the procedure to monitor compressed air/gases for microbiological, non-viable 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, non-viable 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.

5.1.1  Test 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 0.2µ vent filters.
5.1.1.3  Sterilize the assembly as per SOP.
5.1.1.4  Pre - Incubate the assembly with media at 30 – 35°C 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 and Initials of analyst.
5.1.1.11  Bring the sample to laboratory and incubate assembly at 22.5 ± 2.5 oC for 7 days followed by incubation at 32.5 ± 2.5 oC 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

5.1.2  Test 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 30-35oC 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:
Grade
Action Limit
CFU/m3
Grade A
1
Grade B
10
Grade C
100
Grade D
200
Other Grades (Grade E, O, etc)
For Information

5.2  Non – Viable Particulate Count

5.2.1  Take the air-borne 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 1-cubic 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:
Grade
Particles / ft3
0.5 µ
5.0 µ
Grade A
100
1
Grade B
100
1
Grade C
10000
57
Grade D
100000
571
Other Grades (Grade E, O, etc)
For Information

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 widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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