1.0 OBJECTIVE:
To lay down the procedure for monitoring the quality of compressed air / nitrogen gas.
2.0 SCOPE:
This SOP is applicable to compressed air and nitrogen gas used in production area.
3.0 RESPONSIBILITY:
QC – Microbiologist
Head of Department – Quality Control
4.0 PROCEDURE :
4.1 Materials & Equipment:
4.1.1 Air Sampler.
4.1.2 Pre- incubated Soyabean Casein Digest Agar plate.
4.1.3 Incubator.
4.1.4 Sterile compressed air / nitrogen gas sampling accessory.
4.1.5 Gastec (Pump + Tubes)
4.1.6 Balloon
4.1.7 Oxymeter
4.2 Sampling And Testing:
4.2.1 Transfer the air sampler to the location where sampling to be done and flush out compressed air /nitrogen for 10-15 seconds before sampling.
4.2.2 Place pre-incubated Soybean Casein Digest Agar plate on plate holder after removing the lid of the agar plate.
4.2.3 Place sterile compressed air / nitrogen gas sampler accessory on plate holder and adjust the compressed air / nitrogen gas pressure of sampling point at 2.0kg with help of regulator with calibrated pressure gauge.
4.2.4 Compressed air/ nitrogen sampling shall be done from the sampling location as per the sampling plan.
4.2.5 Set the air sampling time of the sampler to sample 1000 liters of compressed air / nitrogen and operate the air sampler as per Respective sop.
4.2.6 Switch on the air sampler by pressing the black button provided at the bottom of instrument or by remote control.
4.2.7 Air sampler will start air sampling.
4.2.8 After 1000 liters of air sampling, air sampler will stop automatically.
4.2.9 Close the sampling valve of the sampling point and remove compressed air / nitrogen gas sampling accessory.
4.2.10 Remove the plate from the holder, cover with lid.
4.2.11 Mark the plate with location no, date and also perform the air sampling in the same way in other locations.
4.2.12 Transfer the plates to microbiology department and incubate the plate at 20?C - 25?C for 72 hours and at 30°C - 35°C for 48 hours.
4.2.13 After incubation, observe number of CFU on plate and record the results as per Annexure-I.
4.2.14 Sampling of Nitrogen for Purity:
Take the Sampling balloon and flush with nitrogen twice and sample the Nitrogen
4.2.15 Sampling of Nitrogen for Oxygen content:
Do the sampling by using Oxymeter, as per Respective sop.
4.2.16 Sampling of Nitrogen for Carbon monoxide content:
Do the sampling by using Gastec pump and suitable detection tube as per Respective sop.
4.2.17 Sampling of Compressed air, for Carbon dioxide:
Do the sampling by using Gastec pump and suitable detection tube as per Respective sop.
4.2.18 Sampling of Compressed air, for Carbon monoxide:
Do the sampling by using Gastec pump and suitable detection tube as per Respective sop.
4.2.19 Sampling of Compressed air, water vapour:
Do the sampling by using Gastec pump and suitable detection tube as per Respective sop.
4.2.20 Sampling of Compressed air, for oil and mist content:
DDo the sampling by using Gastec pump and suitable detection tube as per Respective sop.
4.2.21 Sampling of Compressed air, for Nitrogen monoxide and Nitrogen dioxide:
Do the sampling by using Gastec pump and suitable detection tube as per Respective sop.
4.2.22 Sampling of Compressed air, for Sulphur dioxide:
Do the sampling by using Gastec pump and suitable detection tube as per Respective sop.
4.2.23 Sampling of Compressed air, for Assay:
Do the sampling by using Oxymeter, as per Respective sop.
4.3 Sampling points for Compressed air (Routine Monitoring):
As per anhouse requirement.
4.5 |
Frequency and Limit: |
Area |
Sample |
Test |
Limits |
Frequency |
|||||
Sterile area |
Nitrogen |
Purity |
NLT 97% |
Quarterly |
|||||
Bacteria |
Nil |
Before filling |
|||||||
Fungi |
Nil |
Before filling |
|||||||
Oxygen content |
NMT 1.5% |
Quarterly |
|||||||
Carbon monoxide |
NMT 0.001% |
Quarterly |
|||||||
Compressed Air (Microbial test) |
Bacteria |
Nil |
Monthly |
||||||
Fungi |
Nil |
Monthly |
|||||||
Compressed Air (Physicochemical tests) |
Oil mist |
0.1 mg/m3 |
Quarterly |
||||||
Water vapour |
NMT 67 ppm (v/v) |
Quarterly |
|||||||
Carbon dioxide |
NMT 500 ppm (v/v) |
Quarterly |
|||||||
Carbon monoxide |
NMT 5 ppm (v/v) |
Quarterly |
|||||||
Nitrogen monoxide and Nitrogen dioxide |
NMT 2 ppm (v/v) |
Quarterly |
|||||||
Sulphur dioxide |
NMT 1 ppm (v/v) |
Quarterly |
|||||||
Assay |
20.4-21.4% v/v |
Quarterly |
|||||||
Area |
Sample |
Test |
Limits |
Frequency |
|||||
sterile area |
Nitrogen |
Purity |
NLT 97% |
Quarterly |
|||||
Bacteria |
NMT 5 cfu/m3 |
Monthly |
|||||||
Fungi |
Nil |
Monthly |
|||||||
Oxygen content |
NMT 1.5% |
Quarterly |
|||||||
Carbon monoxide |
NMT 0.001% |
Quarterly |
|||||||
Compressed Air (Microbial test) |
Bacteria |
NMT 5 cfu/m3 |
Monthly |
||||||
Fungi |
Nil |
Monthy |
|||||||
Compressed Air (Physicochemical tests) |
Oil and mist |
0.1 mg/m3 |
Quarterly |
||||||
Water vapour |
NMT 67 ppm (v/v) |
Quarterly |
|||||||
Carbon dioxide |
NMT 500 ppm (v/v) |
Quarterly |
|||||||
Carbon monoxide |
NMT 5 ppm (v/v) |
Quarterly |
|||||||
Nitrogen monoxide and Nitrogen dioxide |
NMT 2 ppm (v/v) |
Quarterly |
|||||||
Sulphur dioxide |
NMT 1 ppm (v/v) |
Quarterly |
|||||||
Assay |
20.4-21.4% v/v |
Quarterly |
Nitrogen, microbiology, soyabean casein