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AMI Standard Line

Product catalog summary

Introduction
The document outlines the features and specifications of the AMI Standard Line by ITECO s.r.l., designed for the safe handling of APIs and HPAPIs in the pharmaceutical industry. The equipment ensures compliance with safety and quality standards.

Specifications
The AMI Standard Line includes High Containment Isolators made from Aisi 316L Stainless Steel, suitable for handling solid forms of APIs and HPAPIs with containment levels OEB5 - OEB6. The isolators are available with two, three, or four gloves, and custom projects are available to meet specific needs.

Technical Features

Conformance to ISO 10648-1, ISO 10648-2, ISO 14644-7 standards and Directive 2006/42/EC for machinery safety.
OEB5 approved with SMEPAC testing.
Wide working chamber with a sloping and opening front wall.
Prismatic Air Lock with pneumatic seals and interlock.
Bottom drain for washing liquids and passages for fluids and cables.
Centrifugal exhauster with inverter and pressure safety valve.
HEPA (H14) input and output filter units with Bag-IN/Bag-OUT system.
Pressure gauges, switches, and low-pressure control.
PLC Touch screen controller with optical and acoustic alarms.
Fixed and manual decontamination systems.
Continuous liner for solid waste discharge with interlocking door.
Automatic inert gas flushing and Rapid Transfer Port.
Oxygen analyzer for safety monitoring.

Optional Accessories
Models AMI502, AMI503, and AMI504 offer varying dimensions for the working chamber and airlock, accommodating different operational needs.

Conclusion
ITECO's AMI Standard Line provides robust solutions for the pharmaceutical industry, ensuring safety and compliance in handling hazardous substances. The equipment is designed to meet high standards of quality and safety, backed by ITECO's extensive experience since 1987.

Catalog excerpts

Our EXPERIENCE at service of your SAFETY and of QUALITY of your products AMI Standard Line The growing demand on the pharmaceutical market for products containing APIs and HPAPIs makes it essential to use protective systems capable of ensuring the handling of these substances under conditions of total safety. HPAPI’s handling API’s handling Process operations cGMP compliance Laboratory applications The AMI line includes a series of High Containment Isolators, made of monolithic Aisi 316L Stainless Steel structure designed for the manipulation of API’s and HPAPI’s in solid form with containment levels OEB5 - OEB6. ITECO s.r.l. - Via Emilia Ponente, 1140/A - 48014 Castelbolognese (Ra) Italy Tel. +39 0546 55525 - [email protected]

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at service of your SAFETY and of QUALITY ofyour products TECHNICAL FEATURES • Wide working chamber with sloping and opening front wall • Pneumatic seals and pneumatic interlock • Bottom drain for washing liquids • Fluid and cable passages • Centrifugal exhauster with inverter • Pressure safety valve • Hepa (H14) input filter unit • Hepa (H14) output safety internal filter unit • Hepa (H14) output filter Bag-IN/Bag-OUT • Pressure gauges • Pressure switches • Control of efficiency of output filter unit • PLC Touch screen controlller • Optical and acoustic alarms • Fixed decontamination system (CIP)...

Open the catalog to page 2

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