Dear team,
What is quality parameter of compressed air and Nitrogen used for aseptic area??? which guideline reference??? we currently used as per below table from outside vendor but we have no idea for guideline reference.
For Compressed Air:
| Parameters | Unit | Utility Area | LIMITS |
|---|---|---|---|
| Appearance | – | Colourless | Colourless |
| Odour | – | No Appreciable odour | No Appreciable |
| Carbon Dioxide | ppm | 268.21 | NMT 500.0 |
| Carbon Monoxide | ppm | 3.21 | NMT 5.0 |
| Oxygen | % | 19.82 | 19.5% to 21.5% |
| Sulfur Dioxide | ppm | Not detected | NMT 1.0 |
| Oxides of Nitrogen | ppm | Not detected | NMT 2.0 |
| Hydrogen Sulphide | ppm | Not Detected | Not Specified |
| Oil Mist | mg/m3 | < 0.01 | NMT 0.10 |
| Non Viable Particle | No. of Particle/ m3 | 120 | NMT 1,00000 Particle of |
(≤ 0.5 µ)|
|0|NMT 100 Particle of
(1 - 5.0 µ)|
|Moisture|ppm|165.2|NMT 870|
|Dew Point|ºC|-35.9|NMT – 20|
|Total Viable Count|CFU/m3|12|NMT 100|
For Nitrogen
| Parameters | Unit | Locations | Limits |
|---|---|---|---|
| Utility | |||
| Description | – | Complies | A Colouless, Odourless Gas |
| Carbon Dioxide | ppm | 221.33 | NMT 300.0 |
| Carbon Monoxide | ppm | 2.65 | NMT 5.0 |
| Oxygen content | % | 0.3 | NMT 0.5 |
| Dew Point | °C | - 52.8 | NMT - 40 |
| Oil Mist | mg/m3 | Not Detected | NMT 0.1 |
| Nitrogen | % | 99.7 | NLT 99.5 |