References & Case Studies
Aseptic Isolator with 2 Incubators
Customer:
Details:
This isolator can be used for the incubation of samples, observation under the microscope and centrifugation.
The purpose of the isolator is to ensure the safety of the operating personnel (protection to <0,1 µg/m3) when handling hazardous materials and to protect the product from contamination during aseptic operations.
Laminar air flow in chambers C1 and C2, turbulent air fl ow in chamber C3.
The device is in over-pressure operating mode.
Tightness Class 3 according to ISO 10648-2.
Purity Class “A” in chamber C1, “B” in chamber C2, “C” in chamberC3 according to EU GMP.
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Weighing/Containment Isolator
Customer:
Details:
This isolator is used for all handling of solid materials, including the HP-API category.
Its purpose is to protect the worker when working with highly potent substances, as well as to protect the materials being handled from air moisture and oxygen.
Turbulent flow.
The device operates in two pressure modes - positive pressure and negative pressure.
Tightness class 2 according to ČSN EN ISO 14 644-7 (ISO 10648-2).
Purity class “C” according to EU GMP.
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Weighing/Containment Isolator
Customer:
Details:
This isolator is used for aseptic processing of materials and sterility testing.
The purpose of this isolator is to protect the product from contamination.
Laminar flow.
The device operates in positive pressure mode.
Tightness class 3 according to ČSN EN ISO 14 644-7 (ISO 10648-2).
Purity class “A” according to EU GMP.
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Dispensing isolator
Customer:
Details:
The isolator is used for the preparation of solution and handling of high potency API substances of category OEB4 (OEL 1-10 µg/m3).
The purpose of this isolator is to ensure the safety of the operator when handling hazardous materials and also to protect the materials being handled from air moisture, oxygen and organic solvents.
Turbulent flow.
The device operates in negative pressure mode.
Tightness class 3 according to ČSN EN ISO 14 644-7 (ISO 10648-2).
Cleanliness class “C” inside the chambers according to EU GMP.
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OEB6 Weighing Isolator
Customer:
Details:
The isolator is used for the preparation of solutions and the handling of APIs of category OEB6.
The purpose of the isolator is to ensure operator safety during the handling of hazardous substances and to protect the materials being handled from air humidity, oxygen, and organic solvents.
Turbulent airflow.
The device operates in vacuum mode.
Tightness class 3 according to ČSN EN ISO 14644-7 (ISO 10648-2).
Cleanliness class “C” according to EU GMP.
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Isolator Workplace for API Production and for weighing
Customer:
Details:
The isolator workstation is used for API production.
The purpose o the isolator Workstation is protection of the worker handling highly efficient substances as well as protection of the manipulated materials from air humidity and oxygen.
Due to the integration of the devices into the isolator and the need to operate them, the isolator is designed as double-sided.
The device is in a negative pressure mode.
In a negative pressure mode.
Leak tightness class 3 according to ISO 10648-2.
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