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Isolators

Isolators

Isolators

Product catalog summary
Overview: This document is an enquiry questionnaire designed to gather essential information for specifying a Glovebox Isolator tailored to specific process requirements. It covers various aspects such as application, containment, hazardous area classification, materials, and additional specifications.
Isolator Application: The questionnaire lists potential activities for the isolator, including powder dispensing, sampling, process transfer, milling, blending, and sterility testing, among others. Users are asked to mark the relevant activities.
Containment Requirement Classification: Options are provided for different containment levels based on an 8-hour time-weighted average, ranging from OEB1 to OEB5.
Hazardous Area Classification: The document outlines classifications for both European (ATEX) and USA standards, detailing categories for gas and dust, gas groups, and temperature classes.
Materials of Construction: Users can specify materials for contact and external parts, internal and external finishes, solvents in use, glove materials, and fan case preferences.
Application Specific Items: Options for cleaning processes (CIP/WIP), purge processes, supply voltage, mobility, and glove testing are included.
Control System: Details on operator controls, logic-software, HMI, MCC, and connecting cables are requested.
Sterile Production: Information on sterile application standards, isolator environment, process equipment SIP, biological decontamination, air sampling, and temperature/humidity control is gathered.
Powder Packaging: Users can specify packaging types and sizes for both inlet and outlet categories.
Site Specific Requirements: Details on room dimensions, door sizes, lift capacities, corridor routing, and engineering standards are requested.
Documentation & Services: Options for documentation and services include standard project plans, validation life cycle, installation supervision, start-up, and testing protocols.
Additional Notes: A section is provided for any additional explanatory notes.
Sketch: Users are encouraged to draw a sketch of the expected arrangement or processing steps for the isolator.
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Catalog excerpts

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^ . Powder Handling Excellence The following questions are designed to gain specific basic information related to your required Glovebox Isolator application. Your information will enable us to develop & specify the correct type and configuration of the Isolator which best suits your process requirements. Isolator Application: Please mark the activities intended/required for the isolator. O Powder Dispensing EH Sub-division EH Sampling EH IBC Filling EH Compounding EH Process Transfer (charging) by gravity EH Process Transfer (charging) by suction EH Process Containment EH Milling EH Micronisation EH Blending EH Sieving EH Vacuum Tray Dryer EH Lyophiliser Discharge EH Pack-off EH With check-weighing EH With controlled dosing EH Filter-Dryer Discharge - Large Scale with isolator fixed to discharge port EH Filter-Dryer Discharge - Small Scale With dryer mounted through isolator top EH Sterility Test n Other:

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Powder Handling Excellence Hazardous Area Classification:

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Powder Handling Excellence Sterile Production:

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Powder Handling Excellence Additional Notes - please add any additional explanatory notes applicable: Please draw a sketch of the concept expected arrangement or processing steps applicable to the isolator on the following page.

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Date: ____________________________________ Signature: ____________________________________

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.