OBJECTIVE:
To lay down the procedure for cleaning of Air sampler, Make: MERCK.
SCOPE:
This SOP is applicable for the procedure for cleaning of Air sampler at {Company Name} {Location}.
RESPONSIBILITY:
- Microbiologist: is responsible to perform the activity as per SOP.
- In charge- Microbiology- is responsible to ensure compliance as per SOP.
- Head/Designee Quality Control – Shall be responsible for ensuring compliance as per SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
About Air Sampler:
An air sampler is a device used to collect and analyze airborne microorganisms to monitor air quality and identify potential contamination sources. They are essential tools in the pharmaceutical industry to maintain the cleanliness and sterility of production environments.
PROCEDURE:
CLEANING PROCEDURE:
Air sampler housing:
The external surface of the air sampler should be cleaned with commercial disinfectant solution or 70 % isopropanol/water solution).
Spray the cleaning solution directly on the instrument then wipe with a sterile towel or spray the towel, then wipe. All cleaning/disinfectant solution should be removed/wiped dry properly before using the air sampler.
Sampling head:
The perforated lid and dust cover can be autoclaved for 20 minutes at 121 °C. In case of dirt/blocked holes of the perforated lid: clean them with a needle, or by using an ultrasonic bath.
Note: Always cover the perforated lid with the dust cover when the air sampler is not in use.
Note: The heads should not be allowed to hit on each other.
REFERENCES:
Not Applicable
ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Master Copy : Quality Assurance Department
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Quality Control (Micro.)
ABBREVIATIONS:
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| QC | : | Quality Control |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |