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125 - TRIO.BAS Air Sampler - Care, Maintenance, Battery Charging

The TRIO.BAS microbial air samplers should be cleaned at regular intervals. The body of the unit should be treated with mild detergent or ethanol. The stainless steel aspirating head should be cleaned with different type of detergents (exclude chlorine detergent).

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108 - The correct use of the I.Q., O.Q., P.Q. Qualification Manuals

O.Q. Manual has the target to verify that the instrument is working according to the supplier speci cation during operational activities.

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107 - SOP (Standard Operating Procedure) for TRIO.BAS ISOLATOR Microbial Air Sampler

The TRIO.BAS ISOLATOR Microbial Air Sampler has been speci cally developed to be used in Isolator and in Multi Clean Rooms. The aspirating heads of the satellite units (1, 2 or 3) can be positioned in different location and commanded via cable from outside by a single comand unit. The main advantage is the fact that vacuum is not involved and all the potential problems due to the vacuum are not present. The connecting electrical cable may have different lenghts and it is easily connected and disconnected from the satellite units. The satellite units are compatible with the most commonly used sterilizing agents. 90 mm Petri dish or 55 mm Contact plates may be used.

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100 - The physical tests to obtain the safety certifications of TRIO.BAS

The TRIO.BAS air samplers were tested by the official authorities to evaluate their safety performances according to the european and international rules.

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

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

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73 - Air sampler disinfection

CLEANING AND DISINFECTION OF MICROBIAL ACTIVE AIR SAMPLERS IN CLEAN ROOM INTRODUCTION All the materials that are used with a microbial air sampler (protective aspirating head, aspirating head, body of the air sampler, bags, etc) should be cleaned and disinfected before the sampling cycles.

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69 - TRIO.BAS Air Sampler Biological ef ciency test according ISO 14698-1

CMA – CENTRO DI MICROBIOLOGIA APPLICATA Via Cusago 154 20019 Settimo Milanese Laboratorio accreditato ACCREDIA n. 1087 Direttrice Dr Miriam Magrì. Biological efficiency testing of several active microbiological air samplers according ISO14698-1 in a dedicated microbial wind tunnel.

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40 - Installation and use of TRIO.BAS DUO and TRIO microbial air samplers

The suggested steps to follow for a correct installation and use of the TRIO.BAS DUO and TRIO microbial air samplers.

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39 - Installation and use of TRIO.BAS MONO microbial air sampler

The suggested steps to follow for a correct installation and use of the TRIO.BAS MONO microbial air sampler.

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26 - Maintenance and Calibration of air sampler according GMP and GLP – EN 14042

Chapter 12 “Quality Assurance” of the European Standard EN 14042 – “Workplace atmosphere – Guide for the application and use of procedures for the assessment of exposure to chemical and biological agents”. “It is good practice to set up a Quality Assurance scheme for the maintenance and calibration of the samplers.

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