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97 - News in TRIO.BAS Sampler Software and Hardware

NEW SPECIFICATION (OCT 2016), “Delay” functions is now from 1 minutes to 120 minutes, The range of action of Bluetooth is now about 100 meters

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96 - Subdivision of hospital operating department in different areas depending on the biological risk for staff and patients

The most advanced areas for the control of particulate and microbial contamination in the " contamination controlled " environments are undoubtedly space industry, electronics and pharmaceutical industries. The pharmaceutical industry is the one that comes closest to the hospital sector, at least from a microbiological point of view, and may therefore be useful to draw on its technological innovations in the field of contamination control and in particular to the Good Manufacturing Practice.

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95 - Muestreador microbiológico de aire TRIO.BAS TRIO para la detección de contaminación microbiana en salas limpias y entornos controlados.

MINI, Un cabezal, Cargador mediante cable (duración batería 15 horas), IP65, Conexión Bluetooth para la transferencia de datos (PC, smartphone, Tablet, impresora)

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94 - Instruction for Daily Shift Aspirating Head

Standard Operating Procedure (POS) Use of DAILY SHIFT aspirating head for TRIO.BAS air samplers OBJECT Procedure for the correct use of microbial air sampler in Cleanroom, Isolator, RABS PURPOSE Reduction of the risk of microbial contamination during air sampler handling

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93 - The difference between D.Q., I.Q., O.Q., P.Q.

DESIGN QUALIFICATION, INSTALLATION QUALIFICATION, OPERATIONAL QUALIFICATION, PERFORMANCE QUALIFICATION, TIMING AND APPLICABILITY

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92 - The considerations in selecting an aspirating head for active air samplers

THIS NOTE SHOULD HELP THE USER IN THE SELECTION OF THE ASPIRATING HEAD FOR ACTIVE AIR SAMPLERS. Aspirating head material, advantages, disadvantages

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91 - Standard Operating Procedure for TRIO.BAS ISOLATOR

Three stainless steel satellite aspirating chambers, with long connecting cable, can be positioned in different locations and commanded from outside by a single unit. The satellite aspirating chamber is compatible with the most commonly used sterilizing agents. Contact plates (RODAC) or Petri dish can be used.

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90 - The interval time programmed air sampling in isolator and RABS by TRIO.BAS DUO and TRIO

The sampling aspirating chamber of “TRIO.BAS Isolator” is compact, manufactured in stainless steel; the command – control unit is separated and positioned outside from the isolator. The compact design save space inside the isolator. The connection is only for power and doesn’t compromise the isolator integrity. No vacuum, valves and s/s tubing are involved. The use of “Shift Head” sterile certified aspirating head simplify the daily activity and reduce contamination risk. Three independent separated aspirating chambers are connected to the central command unit.

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89 - TRIO.BAS ISOLATOR microbial air sampler technical details

THE TRIO.BAS ISOLATOR MICROBIAL AIR SAMPLERS TO BE USED IN ISOLATORS OR RABS HAS INNOVATIVE FEATURES: a. Up to three independent aspirating heads (called satellite units) can be used for three sampling cycles in three different isolators or in the same isolator with different culture medium. b. The connection between the comand unit and the satellite units is via a simple electric cable. c. No conduits or valves to interfere with the daily activity. d. Bluetooth capability for sampling data transfer. e. The use of sterile “Daily Shift Head” reduces the risk of contamination.

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88 - Useful information about Pharmaceutical Environmental Microbiology

Most companies have chosen a harmonized approach using the recommendations from the EU and the FDA, to include applying the most stringent criteria where applicable, although some companies stated that they use the most stringent criteria across the board. However, the regulators prefer to see Alert and Action Levels based on historical data once the EM program has been established for a minimum of 12 months.

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87 - Useful information about Pharmaceutical Environmental Microbiology

How do you set Alert and Action Levels in Environmemtal Microbiology? Most companies have chosen a harmonized approach using the recommendations from the EU and the FDA, to include applying the most stringent criteria where applicable, although some companies stated that they use the most stringent criteria across the board. However, the regulators prefer to see Alert and Action Levels based on historical data once the EM program has been established for a minimum of 12 months.

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86 - Indoor air filtration system microbial monitoring

The filtration system of building should be regularly monitored to be sure they are not broken or uncorrectly fixed or contaminated. The HVAC (Heating Ventilation, Air Conditioning) may be responsible for the production and spread of airborne micro-organisms in buildings. The reason of this test is to guarantee the health of rooms, laboratory, hospital and building occupants. The reported “SOP” (Standard Operating Procedure) can help the building servicing engineers in their task. The principle of the test is the comparation of the outdoor microbial population (upstream) with the indoor of the building after filtration (downstream).

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