Application Note – Bioaerosol N.14 – Standard Operative Procedure for Microbial Air Sampling in Clean Room
It is important to organize a correct and clear sampling plan when several clean rooms or controlled contamination areas are to be monitored at the same time for microbial bioburden.
To reach this goal it is necessary to have a suitable set of air samplers and a specific SOP that gives to the operators all the information to avoid mistakes and / or misunderstanding.
The reported Standard Operating Procedure (SOP) can be used as a guide to be adopted to each individual case.
STANDARD OPERATING PROCEDURE
- SUBJECT
Microbial air sampling of multi Clean Room premises
- OBJECTIVE
To obtain reliable and consistent microbial air monitoring of the Clean Room
- RESPONSIBILITY
Clean Room Manager in close co-operation with Microbiology Laboratory Manager
- TERMINOLOGY
Agar, Air Sampler, Aseptic, Bioaerosol, Bioburden, Clean Room, Contact Plate, Contamination, Delay Time, Disinfection, Incubation Time, Incubation Temperature, Interval time, Irradiation, Microbiology Medium, Micro-organisms Captured by impact, Numbers of run, Poured Contact Plates, Sampling Site, Single Run Volume, Sterilization.
- MATERIAL
Microbiology air sampler
Battery charger
Clean Room transfer case
Tripod for air sampler
Poured Contact Plates (Plate Count Agar) tripled bagged and irradiated
Disinfectant spray (70% ethanol) tripled bagged, filtered and irradiated
- PROTOCOL
Introduction of the air sampler into the Clean Room
Follow the Good Aseptic Practice
Introduction of poured Contact Plates into the Clean Room
Use the irradiated triple bagged Contact Plates
Introduction of disinfectant spray into the Clean Room
Use the irradiated triple bagged disinfectant spray
Identification of Contact Plates
Each plate must be identified by sampling site (XXXX), date (XX / XX / XX), hour (XX.XX).
Disinfection of air sampler
Follow the Good Disinfection Practice
Use of air sampler
Follow the instruction manual.
Air sampler positioning inside the Clean Room
The microbiology air sampler can be positioned:
a) directly on the surface, close to the considered most critical area
b) fixed on tripod, at the height considered most critical
c) fixed on the wall, using the wall arm
Air sampler programming
The volume of air to be sampled and the sampling program are a choice of the Clean Room Manager. The suggested amount of air per each plate in a Clean Room should be 1000 / 1800 litres of air.
Sampling data downloading
Each sampler should be connected to the printer for sampling data downloading (date, operator identification, sampler identification, sampling site, volume of air).
Transfer of Contact Plate to incubation
At the end of sampling operation, each identified Contact Plate must be protected by its sterile bag and sent to the lab for incubation.
-NON CONFORMITY
| Contaminated Contact Plates | Do not use them |
| Expired Contact Plates | Do not use them |
| Torn plastic bag | Do not use them |
| Low Battery warning signal | Charge the air sampler |
