The principle is the Anderson according to ISO 14698

1. A known volume of air is conveyed onto a surface of a culture plate (Petri dish) containing a sterile nutrient medium suitable for the multiplication of microorganisms (bacteria, fungi, yeasts, etc.). The microorganisms present in the air impact on the surface and are retained.
2. The culture plates are incubated in the laboratory and after 24-72 hours the microorganisms are visible to the naked eye forming the colonies (CFU).
3. From the number of colonies counted and related to the volume of aspirated air, the environmental hygienic conditions can be assessed for any appropriate corrective actions.

1. Stainless steel “ASPI head” (330-331);
2. Thermopolymer “ASPI (336);
3. Daily Shift sterile (340-341)

The s/s head should be autoclaved for 20 minutes at 121°C.

The disinfection is obtained by using 70% sterile IPA.

In Cleanroom: Wipe the surface with a clean sterile cloth moistened with 70% sterile IPA. In Normal environment: Use a clean cloth moistened with 80% alcohol/deionized water.

Yes. They are because they are produced under strict control machines. The operator should only check if the holes are dirty.

Probably the agar medium is dehydrated. Be sure it is not too old.

MINI is a typical instrument, cheaper, for agro, food, dairy, beverage fields where the use is not very stringent and there is not need of Data Integrity for result registration.

It is suggested a re-calibration after 12 months.

Yes. It is.

All TRIO.BAS models can be fixed on a tripod.

When the set time has elapsed, the screen will inform to remind that a re-calibration is necessary.

It can happen. In these circumstances a cleaning with compressed air is suggested.

Any type of plastic 90 mm Petri dish or 55 mm Contact Plates (RODAC).

Yes. It is, following the recommendation of the producer.

You have just to open the bottom of the sampler, disconnect the old battery and connect a new one.

The standard 5 metres can be prolonged up 20 metres.

No

TRIO.BAS generates minimal turbulence because the exhaust of the impacted air is in the same direction of the air flow.

TRIO.GAS, EASYGAS, FLUGAS are accessories for TRIO.BAS air sampler to monitor the presence of microorganisms in compressed gas.

Compressed air, nitrogen, carbon dioxide, argon.

The performances are the same. The TRIO.BAS ATEX model is used for security reasons in potentially explosive atmosphere according the international directives.

The portable instruments are included in the yellow line: TRIO.BAS MINI, TRIO.BAS MONO, TRIO.BAS DUO, TRIO.BAS.TRIO, ETC.
The stationary instruments are included in the stainless steel line: TRIO.BAS ISOLATOR, TRIO.BAS MULTIFLEX,1, MULTIFLEX 1+2, TRIO.BAS RABS, TRIO.BAS ISOLATOR.

First of all, it is necessary to consider that microbiology is not math and that the microorganisms are not even distributed in the air.
It is necessary to check if the samples were taken at the same conditions and place, if the sampler was decontaminated, if the sampler was calibrated.

• TRIO.BAS 100 aspirates 100 litres of air per minute = 1000 litres in 10 minutes
• TRIO.BAS 200 aspirates 200 litres of air per minute = 1000 litres in 5 minutes

TRIO.BAS 200 is more convenient for Clean Room where the contamination is lower and a higher volume of air should be collected.

32 volumes from 30 to 2000 litres of air.

• The number of collected C.F.U. on the agar surface, after incubation, should be easily countable (up to 200 C.F.U.).
• Therefore the most common volumes are 100-300 litres in normal environments (high contamination) and 1000 litres in Clean Room (low contamination).

14/16 ml in 55 mm Contact plate
24/30 ml in 90 mm Petri dish.

The induction is by contact and therefore there are no connections and cable.

• To obtain a representative sample “in operation” conditions.
• More than one air sample, on the same culture plate, in sequential order.

Typically it is used in Clean Rooms from the outside of the core to reduce risk of contamination from the operator.

Typically it is used in Clean Rooms from the outside of the core to reduce risk of contamination from the operator.

The “Daily Shift” can be used during the complete working shift, all day round.
They have a certification of sterility.
They are used in case of autoclave problems or shift over activity.

“In House Monitoring” is a test performed by the company staff to control the unit works properly and it is not damaged (e.g.: dropped, mishandles, battery worn out, etc.).
“Official Calibration” is a test performed by a third party to obtain an official document requested by official institutions like the FDA.

If the CFU on a culture plate is very high, there are high probabilities that more microorganisms impacted on the same points of the agar.
For this reason a statistical table (Feller) is used for the correction.

Example: Counted colonies in a plate:20 - Volume of sampled air:200 litres
Calculation:
If 20 C.F.U. in 200 lts = X in 1000 lts
20 x 1000
X=---------------- = 100 C.F.U. per m³
200

To express the final result in CFU/ft³ or CFU/m³ multiply the CFU/litre value by 28,32 or 1000 respectively.

The flat surfaces are monitored to evaluate the microbial contamination using the CPS System (Contact Plate System).

A SOP should include: Identification number, Title, Purpose, Glossary, Responsibility, Safety, Standard, Material, Protocol, Non-conformity, Reference.
Several SOP are available on Application Notes

CFU Photo Camera. As requested by Good Laboratory Practice and Data Integrity 21 CFR part 11, the BAS Software records culture plates’ photos immediately before and after the manual CFU count thanks to the CFU Photo Camera (code 337). The CFU Photo Camera is connected to the PC with the BAS Software installed and the two pictures are automatically recorded and saved in the software. It is possible to export all detailed information of a single sample in a pdf file or print a paper copy.

Guidelines on test methods for environmental monitoring for aseptic dispensing facilities.
Click here to read the guidelines.

Draft Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products.
Click here to read the guidelines.

Microbiological Air Sampling of Operating Rooms in Western Australian Healthcare Facilities.
Click here to read the guidelines.

WHO Guidelines for indoor air quality.
Click here to read the guidelines.

Guidelines for Indoor Air Quality.
Click here to read the guidelines.

WHO Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities.
Points to consider for manufacturers of human vaccines.
Click here to read the document.

CDC Center for Disease Control and Prevention - Guidelines for Environmental Infection Control in Health-Care Facilities.
Click here to read the guidelines.

Guideline on WHO Data Integrity
Click here to read the guidelines.

Data Integrity and Compliance - With Drug CGMP Questions and Answers Guidance for Industry.
Click here to read the FDA information.

It is the European Standard EN17141
Click here to read the standard.

ISO 18593:2004
Microbiology of food and animal feeding stuffs — Horizontal methods for sampling techniques from surfaces using contact plates and swabs.

“BAS SOFTWARE” CONFORMANCE DECLARATION
BAS SOFTWARE for TRIO.BAS microbial air samplers conforms to FDA CFR Reg. 21 Part 11 according electronic records and signature.
The features of “BAS SOFTWARE” are:

• A login name and password can be attributed to each user.
• Different software functions are reached by each user according to their profile.
• Audit trail on all record.
• Electronic signatures for author authentication.
• Data and results are saved by user into protected file and for report generation.

The World Health Organization suggests that 70% ethyl alcohol is superior to isopropyl alcohol against the influenza virus, however, both provide adequate germicidal properties. ... It's widely recognized that ethanol in this concentration is effective against many viruses and bacteria.
Ethanol and isopropyl alcohol are similar small molecules but differ in the location of the alcohol group on their chemical structures. Both alcohols are flammable and both are used as disinfectants.