Sterility Test Isolator – Sitting or Standing Activity

Product catalog summary

Overview
This document provides technical specifications and descriptions for Sterility Test Isolators, focusing on product protection under aseptic conditions. It includes details on design, functionality, and compliance with industry standards.

Specifications
The isolators are constructed with fully welded stainless steel housing, featuring a laminar air flow system with positive pressure control to ensure product safety. They include glove ports for operator interaction and are equipped with an integrated H2O2 gas supply system for sterilization.

Design and Features

Electrically monitored safety glass front panel with pneumatic seals.
Integrated sterility test pump and shelving for consumables.
Gas-tight butterfly valves for air supply and exhaust.
Automatic pressure decay test with a leakage rate of 2 vol%/h.
LED lighting and integrated PLC control system with a touch panel.

Compliance and Documentation
The isolators are designed to comply with GMP/FDA standards and include CE declaration of conformity. Technical and qualification documentation is provided according to the Machinery Directive.

Additional Features for STI4c Model
The STI4c model includes additional HEPA filters for contamination-free filter changes, enhancing containment capabilities.

Catalog excerpts

Sterility Test Isolator – Sitting or Standing Activity-1

Standard Products

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Sterility Test Isolator – Sitting or Standing Activity-2

Sterility Test Isolator - DimensionsSitting ActivityStanding Activity 1050mm Standard Products

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Sterility Test Isolator – Sitting or Standing Activity-3

Standard Products Sterility Test Isolator – Description Steriltest-Isolatoren mit Produktschutz für den Steriltest unter aseptischen Bedingungen. Wahlweise ist die Anbindung einer Rapid Decon Hatch möglich. Der Produktschutz wird durch eine Barriere (Isolatorgehäuse mit Handschuheingriffen) zwischen dem Bediener und dem Produkt erreicht. Durch das Laminar Air Flow System inkl. einer kontrollierten Überdruckregelung erhöht sich die Sicherheit für das Produkt. Das Ein- und Ausschleusen von Produkten und Material erfolgt über geeignete Transfersysteme. Die Isolatoren werden vor dem Steriltest durch...

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Sterility Test Isolator – Sitting or Standing Activity-4

Standard Products Sterility Test Isolator – Description           Automatischer Druckabfalltest Leckrate: 2 Vol%/h LED-Beleuchtung Integration von Transfersystem Ø270 Integrierte SPS-Steuerung (Siemens S7-300) mit 12“ Touch Panel (B&R) Panel Printer zur Prozessdatenaufzeichnung Technische Dokumentation nach Maschinenrichtlinie Qualifizierungsdokumentation GMP/FDA-konforme Ausführung CE-Konformitätserklärung Steriltest Isolator STI4c  (Ausführung siehe STI inkl. folgender Zusatzausstattung für die Containment Ausführung:)  Zusätzliche Umluft-HEPA-Filter H13 unterhalb der Tischplatte...

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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.

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