N.76 – SOP – Standard Operating Procedure for use, maintenance, calibration of “TRIO.BAS” microbiological air samplers

TRIO

OBJECT

The purpose of this document is to describe the procedure for sampling, and reporting of the viable airborne particulates as part of environmental program, using TRIO.BAS Microbiological Air Sampler.

OBJECTIVE

This procedure applies to particulate sampling and evaluation of air quality for viable particulates using a Microbiological Air Sampler

GLOSSARY

Agar, Autoclave, Bacteria, Bioburden, Calibration, CleanRoom, Contact Plate, Cleanroom, CFU: Colony Forming Units, Culture plate, Disinfection, Impact, Yeast, Medium, Petri dish, Microorganism, Mould, RABS, RODAC, SDA: Sabouraud Dextrose Agar, Sterilization, Total Bacterial Count, TSA: Tryptic Soy Agar

Principle of impact using a Microbiological Air Sampler

Air is aspirated at a fixed speed for a variable time through a cover with small holes. The resulted flow of air is directed on to the agar surface of the contact plate (Petri dish) placed inside the sampler, under the cover with holes. When the preset sample time is complete, the plate is removed and incubated for a pre-determined amount of time, and the colony forming units are counted and recorded as CFUs per the volume of measured air.

REFERENCE

– ISO14698

– Air Sampler User’s Manual 

RESPONSIBILITIES

It is the responsibility of Quality Control Staff to ensure proper operation, maintenance and calibration of Air Sampler per this procedure.

It is the responsibility of Quality Control/Quality Assurance to ensure that all personnel performing this procedure is properly trained.

It is the responsibility of Quality Control Personnel to update and revise this procedure as appropriate.

MATERIALS / REAGENTS

A1.1 Active Microbial Air Sampler

A1.2 Battery Charger

A1.3 70% Isopropyl Alcohol.

A1.4 TSA plates with lecithin and polysorbate 80

A1.5 SDA plates with lecithin and polysorbate 80

A1.6 Incubator 32 ± 2.5 º C and 22 ± 2.5 º C.

PROTOCOL

B1 Programming Quantity of Air to be measured

Switch on the ON switch.

B1.1. To select or change the volume of air to be measured, use the arrows to select 1000L or one of the 14 volumes.

B1.2 Press enter to confirm the selection.

B1.3 Push start (GO) to take samples with selected volume each time.

C1 Display Records

C1.1 TRIO.BAS are capable of storing 1000 records in the software file.

C1.2 Each sample is identified in chronological date order and shows the date, time, operator, site and volume of air.

D1 Print Records Using Bluetooth Printer

D1.1 Connect the air sampler to the printer.

D1.2 Turn on the sampler and the printer.

D1.3 The data will be printed in a chronological order: progressive sample number, day, month, year, hour, operator’s name, site, litres of aspirated air.

NON CONFORMITY

E1.1 The correct calibration time of the air sampler must be confirmed in the Calibration Certificate.

E1.2 The culture plates must be with the correct expiration date.