SOP Title-Bio-Load Analysis of Compressed Air
- OBJECTIVE
To lay down the procedure for bio-load analysis of compressed air.
- SCOPE
This SOP is applicable for bio-load analysis of compressed air in Microbiology Lab.
- RESPONSIBILITY
3.1 QC Executive and above shall be responsible for implementation of this procedure.
3.2 QC Head / designee shall be responsible for compliance of this procedure.
- PROCEDURE
- Sampling schedule
- Sampling plan for compressed air analysis shall be prepared as per SOP.
- All points shall be covered for analysis on monthly basis.
- Sampling procedure
- Sterilize 100 ml of purified water or buffered peptone water in a 250 ml Bottle/conical flask along with cap for 15 minutes at 121oC & 15 Psi pressure.
- Allow the sterile purified water or Buffered peptone water to attain room temperature.
- Carry the Bottle/conical flask of sterile purified water or buffered peptone water to the required sampling point.
- Connect the sampling point in the sampling bottle and bubble the compressed air for 10-15 minutes into sampling bottle.
- Carry the sample to the microbiology lab for analysis.
- After sampling make the entries in the Sample Entry Log Book.
- Analysis procedure
- Transfer 10 ml of the sample on to 90 ml soyabean casein digest medium and perform the bio-load test under the laminar air flow.
- Transfer 1 ml above prepared sample into sterile petriplate in duplicate.
- After inoculation of 1 ml sample into plates, pour the 20-25 ml SCDA media cooled to 45-50°C in the petriplates.
- Pour the 20-25 ml SCDA media cooled to 45-50°C in the petriplates into two sterile petriplate.
- Leave the plates for solidification.
- After solidification, expose one above prepared media plates in the environment and this plate shall be consider as positive control while one unexposed plate shall be consider as negative control.
- Incubate all the plates (Sample plates, negative control and positive control plate) in inverted position for a period of 72 hours at 20 to 25°C & further incubate all the plates in inverted position for a period of 48 hours at 30 to 35°C.
- After completion of incubation period, count the number of CFU per plate.
- Record shall be maintained as per annexure.
- Acceptance Criteria:
Standard Limit : NMT 100 CFU/Plate.
Alert Limit : NMT 50 CFU/Plate
Action Limit : NMT 75 CFU/Plate
Fungus : Should be Nil
ABBREVIATION(s)
| Abbreviation | Full Description |
| SOP | Standard Operating Procedure |
| ˚C | Degree centigrade |
| Psi | Pascal square inch |
*Note – Ready to use SOP available in “DOWNLOAD” Section.