Il existe de nombreux types d'échantillonneurs d'air microbien. Le plus utilisé est l'échantillonneur d'air microbien basé sur la méthode d'impact sur une plaque de gélose (également appelée impacteur).
Ce type d'échantillonneur se compose de deux éléments principaux : une pompe à air et une pièce de tête. La pièce de tête contient une plaque de gélose. La pompe à air aspire l'air à travers un couvercle perforé dans la pièce de tête. L'air fait ensuite un petit tour au-dessus de la plaque d'agar. Sous l'effet de la force centrifuge, les particules présentes dans l'air entrent en contact avec la surface de la gélose et s'y fixent. Les micro-organismes se déplacent toujours sur des particules de poussière ou d'aérosol. Ils se déplacent rarement seuls. En incubant la plaque de gélose après le prélèvement, les micro-organismes se multiplient. Après un certain temps d'incubation, les groupes de bactéries sont visibles sur la plaque et les unités formatrices de colonies peuvent être comptées. Sur la base du volume d'air échantillonné, vous pouvez alors calculer le nombre d'unités formant colonie présentes par volume d'air. Cette méthode est la plus utilisée pour l' échantillonnage actif de l'air ou la surveillance des particules viables .
Quels sont les avantages d'un échantillonneur d'air microbien par impact sur agar ?
This method has a large advantage when you do routine microbial quality control of the air. The most common used parameters for this are total viable count, and total yeasts and molds. Usually, you have an idea of the range of colony forming units in the air, and you only want to measure cultivable micro-organisms. Using the microbial air sampler by impact on agar, you have a very fast, easy, and cheap method to monitor the air quality. You sample directly on the plate, incubate, and count it. Culturing is the easiest and a cheap detection method. It is widely used in different industries and guidelines.
Que dit l'annexe 1 des BPF de l'UE à propos de la surveillance de l'air ?
The EU GMP Annex 1 is a guideline for sterile production (in pharma and biotech production environments). The EU GMP Annex 1 has a section that talks about ‘Viable and non-viable environmental & process monitoring’. Air monitoring is a big part of this section.
L'annexe 1 des BPF de l'UE est une ligne directrice pour la production stérile (dans les environnements de production pharmaceutique et biotechnologique). L'annexe 1 des BPF de l'UE comporte une section consacrée à la "surveillance des processus et de l'environnement viables et non viables". La surveillance de l'air est un élément important de cette section. La directive mentionne trois types de surveillance de l'air :
Échantillonnage passif des particules viables/plaques de décantation : il s'agit d'une simulation de ce qui se passe dans la réalité. Vous ouvrez la plaque de gélose pendant 4 heures maximum, vous la fermez, vous l'incubez et à la fin vous pouvez compter les colonies.
Échantillonnage volumétrique de l'air / échantillonnage actif des particules viables : cela se fait le plus souvent avec un impacteur/échantillonneur d'air microbien. Vous échantillonnez au maximum 1000L par plaque à 100l/min dans un environnement de salle blanche. Si vous appliquez une surveillance continue conformément à la nouvelle annexe 1 des BPF, par exemple à 25l/min, il est possible d'obtenir des volumes plus importants par plaque. Ensuite, la plaque est incubée et les colonies sont comptées. Vous obtenez ainsi des données précises sur le nombre de particules viables par volume d'air.
Surveillance des particules non viables : pour cette partie, vous mesurez le nombre de particules de poussière de <0,5 µm et <5µm à l'aide d'un instrument d'échantillonnage de l'air (souvent appelé compteur de particules).
Pour les trois types de surveillance de l'air mentionnés ci-dessus, l'annexe 1 des BPF de l'UE définit certains seuils pour les différentes catégories de salles blanches : catégories A, B, C et D. La fréquence de l'échantillonnage dépend également de la catégorie de salle blanche. Pour les zones de classe A, les échantillons d'air microbien doivent être en acier inoxydable et des échantillonneurs satellites ou des sondes sont souvent utilisés.
Continuous viable particle monitoring according to the new GMP Annex 1
This is what is written in the GMP Annex 1 at the Chapter n.9:
9.24 Continuous viable air monitoring in grade A (e.g. air sampling or settle plates) should
be undertaken for the full duration of critical processing, including equipment (aseptic set-up)
assembly and critical processing. A similar approach should be considered for grade B cleanrooms
based on the risk of impact on the aseptic processing. The monitoring should be performed
in such a way that all interventions, transient events and any system deterioration would be
captured and any risk caused by interventions of the monitoring operations is avoided.
The culture agar medium is progressively dehydrated and it loses the nutrient characteristics
for specific nutrients for different micro-organisms. The consequence is that the microorganisms
can have difficult to multiplicate and the risk is the difficulty to have the correct colonies count.
It is necessary to adopt an air sampler with a lower air flow rate (e.g.: 25 l/m) and to adopt
Petri dishes with at least a volume of 30 ml of culture agar medium.
Nos produits
Microbial air monitoring system that samples at 25l/min to comply with continuous monitoring of the new GMP Annex 1 in Grade A and B zones. Unit is constructed in stainless steel to resist H2O2 decontamination. The unit can be connected with up to 3 satellite units to sample different locations simultaneously, or program them to sample in relay. System can also be configured to do remote sampling. Ideal for continuous monitoring.
Each PACK consists of:
- 1 TRIO.BAS RABS ISOLATOR stainless steel command unit with battery charger,
- 1 calibration certificate,
- 1 s/s satellite,
- 1 s/s aspirating head (code 830) with s/s cover head (code 465),
- 1 cable connection (5 mt) (code 265),
- 1 cable for data transfer
- and 1 robustus medium carrying case
Microbial air monitoring system that samples at 25l/min to comply with continuous monitoring of the new GMP Annex 1 in Grade A and B zones. each PACK consists of: 1 air sampler with Bluetooth and battery charger, 1 calibration certificate, 1 s/s aspirating head (code 830) with s/s cover head (code 465), 1 cable for transfer data and 1 robustus carrying case.
Microbial air monitoring system that samples at 25l/min to comply with continuous monitoring of the new GMP Annex 1 in Grade A and B zones. Unit has 2 heads to be programmed to do sampling in relay to cover a longer critical process. Each PACK consists of: 1 air sampler with Bluetooth and battery charger, 1 calibration certificate, 2 s/s aspirating head (code 830) with s/s cover head (code 465), 1 cable for transfer data and 1 robustus carrying case
Microbial air monitoring system that samples at 25l/min to comply with continuous monitoring of the new GMP Annex 1 in Grade A and B zones. Unit has 3 heads to be programmed to do sampling in relay to cover a longer critical process. Each PACK consists of: 1 air sampler with Bluetooth and battery charger, 1 calibration certificate, 3 s/s aspirating head (code 830) with s/s cover head (code 465), 1 cable for transfer data and 1 robustus carrying case.
Including:
1x TRIO.BAS MINI BLUETOOTH Air sampler (100 lts/min) Petri 90 plate with Battery charger 100/240VCA 18VDC 859 mA - cable with adapter for plug Eu/UK/USA - and 1 calibration certificate
1x s/s ASPI HEAD Petri plate
1x COVER HEAD s/s to protect ASPI HEAD
1x LIGHT STANDARD carrying case - 43x35x19h cm
Including:
1x TRIO.BAS MONO BLUETOOTH Air sampler (100 lts/min) Petri 90 plate with Battery charger 100/240VCA 18VDC 859 mA with adapter for plug Eu/UK/USA - and CABLE for transfer data and 1 calibration certificate
1x s/s ASPI HEAD Petri plate
1x COVER HEAD s/s to protect ASPI HEAD
1x ROBUSTUS STANDARD carrying case - 48x38x17h cm
Part of multiple Portable Microbial Active Air Samplers, the
TRIO.BAS™ MONO INDUCTION is a Single aspirating chamber for Petri or Contact plates with Bluetooth and base station induction charger. Suitable for users who perform a large number of controls in different environments with a large staff rotation and need to be compliant with quality standards and QM/GMP.
Sampling data can be exported for further analysis or control by inspectors.
TRIO.BAS MONO 100 Petri PACK [ORU-201K] is including:
- 1x TRIO.BAS MONO BLUETOOTH Air sampler (100 lts/min) Petri 90 plate and 1 calibration certificate
- 1x Base Station Induction battery charger 100/240VCA 50/60Hz 35W - Power supply cable with plug SHUKO
- 1x s/s ASPI HEAD Petri plate
- 1x COVER HEAD s/s to protect ASPI HEAD
- 1x ROBUSTUS STANDARD carrying case - 48x38x17 cm
Single aspirating chamber for Petri plates with Hepa filter on air outlet.
The TRIO.BAS microbial air samplers have an electrical motor that do not produce particles after the cleaning procedure.
If the same air sampler is transferred in different environments with different levels of microbial contamination (from high to low – e.g. from C to A area), a risk of cross-contamination is possible.
In this case, to avoid this risk of transferring particles from the inside part of the aspirating chamber, it is suggested to adopt those air samplers that include an HEPA filter fixed on the air outlet of instrument.
The purpose of the filter is to stop the potential transfer of particles.
The HEPA filter is positioned externally and therefore its replacement is very simple.
- Main customers of TRIO.BAS MONO FILTER are pharmaceuticals, cleanrooms and biotech industries. The HEPA filter allows to capture the particulates
- The data is transferred via Bluetooth between the air sampler and a smartphone or tablet (Android version) and then to a PC or laptop
- The data may be transferred via cable, too. This is helpful for all companies that, due to internal policy, are not allowed to use wireless transfer
- It is possible to work either in manual or automatic mode
- Body IP 65 certified for protection from dust and water
- The battery is recharged by a power cable connected directly to the air sampler
- The use of sterile "Daily Shift" aspirating heads reduces the risk of contamination
Including with this reference:
- 1x TRIO.BAS MONO BLUETOOTH FILTER Air sampler (100 lts/min) Petri 90 plate with battery charger 100/240VCA 18VDC 859 mA with adapter for plug Eu/UK/USA - and CABLE for transfer data,
- 1 box HEPA filter and 1 calibration certificate
- 1x s/s ASPI HEAD Petri plate
- 1x COVER HEAD s/s to protect ASPI HEAD
- 1x ROBUSTUS STANDARD carrying case - 48x38x17h cm
Including:
1x TRIO.BAS MONO BLUETOOTH ATEX Air sampler (100 lts/min) Petri 90 plate and 1 calibration certificate
1x Base Station Induction battery charger 100/240VCA 50/60Hz 35W - Power supply cable with plug SHUKO
1x Stainless steel ASPI HEAD Petri plate
1x COVER HEAD stainless steel to protect ASPI HEAD
1x ROBUSTUS STANDARD carrying case - 48x38x17h cm
Including:
1x TRIO.BAS DUO BLUETOOTH Air sampler (100 lts/min) Petri 90 plate with Battery charger 100/240VCA 18VDC 859 mA with adapter for plug Eu/UK/USA - and CABLE for transfer data and 1 calibration certificate
2x s/s ASPI HEAD Petri plate
2x COVER HEAD s/s to protect ASPI HEAD
1x ROBUSTUS STANDARD carrying case - 48x38x17h cm
Including:
1x TRIO.BAS DUO BLUETOOTH Air sampler (100 lts/min) Petri 90 plate and 1 calibration certificate
1x Base Station Induction battery charger 100/240VCA 50/60Hz 35W - Power supply cable with plug SHUKO
2x s/s ASPI HEAD Petri plate
2x COVER HEAD s/s to protect ASPI HEAD
1x ROBUSTUS STANDARD carrying case - 48x38x17h cm
Including:
1x TRIO.BAS DUO BLUETOOTH ATEX Air sampler (100 lts/min) Petri 90 plate and 1 certificate with 4 calibrations (2 for instrument and 2 for Selftest)
1x Base Station Induction battery charger 100/240VCA 50/60Hz 35W - Power supply cable with plug SHUKO
2x Stainless steel ASPI HEAD Petri plate
2x COVER HEAD stainless steel to protect ASPI HEAD
1x ROBUSTUS STANDARD carrying case - 48x38x17h cm