trio-bas-show-sfondo-triogas-02Qualità microbiologica di aria compressa e gas tecnici

Il controllo microbiologico dell’aria compressa e dei gas per la contaminazione microbica è un importante soggetto all’interno delle fabbriche per assicurare che l’aria che viene a contatto con la produzione asettica o sterile non produca contaminazione.

Il campionatore microbiologico di aria TRIO.BAS GAS è stato ideato e prodotto dalla società ORUM International S.r.l. in Milano, Italy in accordo alle normative ISO 8573-7 e ISO 14698 per testare l’aria ed i gas compressi.

Il sistema è sterilizzabile in un corpo unico assemblato per evitare possibili contaminazioni microbiche durante le fasi di preparazione.

La cattura dei microrganismi si basa sul metodo ad impatto su terreno agarizzato in piastra Petri da 90 mm od a contatto da 55 mm.

I dati di campionamento sono trasferiti via <bluetooth al P.C. in accordo a GMP e GLP.

trio-bas-show-sfondo-triogas-01Microbial Quality of compressed air and gases

The microbiological monitoring of compressed air and bottled gases for microbial contamination is important within manufacturing facilities to ensure that product contact air is contamination free within sterile or aseptic manufacturing process.

The TRIO.BAS GAS is a microbial high pressure sampler according ISO 8573-7 and ISO 14698.

The TRIO.BAS GAS from Orum International S.r.l. in Milan, Italy has been specifically developed and produced to facilitate this microbiological test.

The system is sterilized by autoclaving in a single unique body to avoid possible contamination during the preparation steps.

The viable microorganisms collection is based on impact on culture plate like Petri dish.

Sampling data are transferred via Bluetooth to the P.C. according GMP and GLP.

HEAD-DAILY

“DAILY SHIFT” HEAD

ENGLISH VERSION

“DAILY SHIFT” STERILE ASPIRATING HEAD FOR TRIO.BAS Microbial Air Samplers

• The materials that is used for microbiological testing should be sterile and, according to the cGLP and cGLP, a document of certification should prove that is has been correctly sterilised.

• This rule is also valid for the aspiration head that is used with any type of impact microbial air samplers; each cycle, or series of samplings during a working shift in the same Cleanroom location, should use a documented sterile aspirating head

• The “Daily Shift” head; produced in Italy by ORUM International, is a plastic aspirating head for microbiological air monitoring to simplify the workload of the busy microbiologist.

• It is manufactured from anti-static resin plastic, is sigle unit, double packed, gamma irradiated and comes with certification of sterilisation, conformity

• The shelf-life is 6 years and is suitable for all the line of TRIO.BAS air samplers in two versions: 55 mm Contact Plates (RODAC) or 90 mm Petri dishes.

ITALIAN VERSION

“Daily Shift” Testata sterile di aspirazione per campionatori d’aria TRIO.BAS

• Tutto il materiale che viene impiegato per le analisi microbiologiche deve essere sterile e, secondo le GMP e GLP, un documento di certificazione deve comprovare che sia avvenuta una corretta sterilizzazione.

•  Questa regola è valida anche per la testata di sterilizzazione impiegata con i campionatori d’aria ad impatto: ogni ciclo o serie di campionamenti durante un ciclo di lavorazione nella stessa Clean Room deve utilizzare una testata documentata sterile.

•  La testata “Daily Shift”, prodotta in Italia dalla ORUM International di Milano, per i campionatori microbiologici TRIO.BAS, semplifica il carico di lavoro del microbiologo.

•  E’ fabbricata in resina antistatica, è confezionata in imballo doppio e viene fornita con certificazione di sterilità da ente terzo.

•  Ha una shelf-life di 6 anni ed è idonea per tutti i campionatori TRIO.BAS nelle due versioni da 55 mm Contact plate e 90 mm scatole Petri.

FRENCH VERSION

“Daily Shift” stérile, aspirer la tête pour TRIO.BAS. Microbial Air Sampler

• Les matériaux qui sont utilisés pour les tests microbiologiques doivent être stériles et, selon le CGLP et CGLP, un document de certification doit prouver que est a été correctement stérilisé.

• Cette règle est également valable pour la tête d’aspiration qui est utilisé avec tout type d’échantillonneurs d’air microbiens d’impact; chaque cycle, ou une série de prélèvements au cours d’un quart de travail dans le même emplacement de Cleanroom, doivent utiliser une tête d’aspiration stérile documentée

• Le “Daily Shift” tête, produite en Italie par ORUM International, est une tête d’aspiration en plastique pour la surveillance microbiologique de l’air afin de simplifier la charge de travail du microbiologiste occupé.

• Il est fabriqué à partir de plastique anti-statique de résine, est l’unité Sigle, double emballé, gamma irradié et est livré avec la certification de la stérilisation, la conformité

• La durée de conservation est de 6 ans et est adapté pour toute la ligne des échantillonneurs d’air TRIO.BAS en deux versions: 55 mm de contact Plaques (RODAC) ou 90 mm des boîtes de Pétri.

SPANISH VERSION

“Daily Shift” estéril, la cabeza de aspiración para TRIO.BAS. Muestreadores de aire microbiana

• Los materiales que se utilizan para el análisis microbiológico debe ser estéril y, de acuerdo con la cGLP y cGLP, un documento de certificación debe demostrar que se ha esterilizado correctamente.

• Esta regla también es válida para el cabezal de aspiración que se utiliza con cualquier tipo de muestras de aire de impacto microbianos; cada ciclo, o una serie de muestreos durante un turno de trabajo en la misma ubicación del recinto limpio, deben utilizar una cabeza de aspiración estéril documentado

• La cabeza “Shift Daily”, producido en Italia por ORUM Internacional, es una cabeza de aspiración de plástico para el monitoreo del aire microbiológica para simplificar la carga de trabajo del microbiólogo ocupados.

• Se fabrica a partir de plástico de resina anti-estática, es la unidad del sigle, dobles para llevar, irradiados con radiación gamma y viene con la certificación de la esterilización, la conformidad

• El periodo de validez es de 6 años y es adecuado para toda la línea de muestreadores de aire TRIO.BAS en dos versiones: 55 mm Contacto Placas (RODAC) o 90 mm placas de Petri.

MICROBIAL MONITORING IN ISOLATORtrio-bas-show-isolator-bluetooth-induction-rfid-web

Until today the typical monitoring of the air is generally performed using active impact samplers with a single head. There are now instruments available with two or three aspirating heads. This new generation of sampler gives the possibility to collect 1,000 litres of air for total bacterial count in less than 3 minutes; this means more tests in less time and better investment of operator time. It is also possible to perform TBC and TYMC at the same time, using two different culture media. 

The TRIO.BAS microbial air samplers DUO and TRIO models, from Italian company ORUM, with more than 35 years of experience in air monitoring, giving the microbiologist an effective help to improve performances and labour quality

TRIO.BAS is the ideal solution for Clean Rooms, RABSs and controlled environments.

SAMPLER WITH 3 ASPIRATING HEADSTRIO.BAS-TRIO

Trio.Bas Air sampler is proposed to customers who make a large number of controls, in different environments, with staff rotation and that comply with the quality standards and QM GLP / GMP. The use of 3 heads allows to carry out at the same time two samples with different nutrient media. The registration of operator, sampling point and plates used for the sampling take place automatically by means of a system of radio frequency RFID. As an alternative to RFID, this air sampler can be equipped with a BARCODE module through the use of a scanner (Barcode Reader) with Bluetooth.

The data collected by the Barcode Reader are transmitted directly to the instrument. This solution proves to be useful for those who already use culture plates with Barcode 1D or two-dimensional Barcode 2D (QR Quick Response Code). The subsequent transfer of the data collected is via Bluetooth between the sampler and a PC or Laptop equipped with Bluetooth. PC or Laptop should have a dedicated software (BAS.PC).

Recharging the battery is done by induction without any cable connection between the instrument and the charger. The Air Sampler is free of any external plug and is IP65 certified. The charging base is equipped with a system that allows, regardless of the auto-calibration already present in the instrument, to be able to check and possibly realign the state of precision of the air flow. This verification is necessary to avoid invalidating the tests between annual inspections of official certification.

The most important customers are the pharmaceutical industries (and all those other industries that need to control microbiological air according to the GPL and GMP rules), cosmetics, medical devices, industries that package sterile products for third parties, hospitals, etc.

SPALLANZANI E PASTEUR: IL TEST DELLA GENERAZIONE SPONTANEA

TRIO.BAS-COVER

L’Italiano Lazzaro Spallanzani nel 1700 ed il Francese Louis Pasteur nell’1800 sono stati i due scienziati che per primi hanno dimostrato la presenza di microrganismi nell’aria con diversi anni di sperimentazione.

Dopo tre secoli è ora possibile eseguire lo stesso test in pochi minuti con la generazione più recente di campionatori microbiologici di aria: i TRIO.BAS.