BLOCK Technology_Sterility isolator_var 062021
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Sterility Test Isolator Suitable for sterility testing and product protection.

Dimensions Sterility Test Isolator Sterility Test Isolator Dimensions in mm - Sterility test isolator Dimensions in mm - Working chamber Front height Working chamber total volume Working plate height Gloves position* Usable space depth Airlock total volume

This isolator provides a high degree of product protection being handled in aseptic conditions. The main task is performed in the working chamber where sterility testing of final products occurs. Single-chamber isolator for sterility testing Jacket material: stainless steel AISI 304 Chamber with 4 sleeves for work with sterile materials Chamber material – AISI 316L with a thickness of 3.00 mm Airlock for material loading with an option for sterilizing with H2O₂ Polished surface finish, Ra<0.6 µm Leak tightness class 3 according to ISO 10648-2 “A” class cleanliness according to EU GMP “Audit...

Laminar Flow Laminar flow is used for “A” class cleanliness when unidirectional airflow must be ensured in a vertical orientation. A laminar frame is used to direct the flow – comprised of a special very finely perforated fabric. The velocity of laminar flow produced by the isolator technology amounts to 0,45 m/s ±20%. HEPA filters (H14), with an efficiency of 99.995% are used to filter incoming and outgoing air. This system is often coupled with air re-circulation inside the chamber. Fresh air Fresh air + Circulating air Hepa H14 filtered air Contaminated air Filtered exhaust air Hepa...

Working chamber HMI panel Service panel F5 Pre-filter Temperature and humidity sensor - Rotronic Used for monitoring critical parameters and/or to control a decontamination process. Rotronic is an accurate and high-quality product resistant to hydrogen peroxide vapors. Pressure sensor with analogue output Cable glands Cable glands are mounted in the rear isolator wall. Equipped for microbiological monitoring – DN 1“ clamp Equipped for an ISO kinetic sensing unit – DN 10 clamp Built-in LED lights Built-in LED lights ensure illumination levels of at least of 500 lux in the workspace....

Visual and acoustic alarm Front window A beacon light and an acoustic alarm providing a quick audible and visual assessment of operation and failure states for the user. Inflatable sealing safety glass fitted with sleeved flanges and sensors for monitoring safe window closure. A gas spring is used for easy opening. Panel for connection of an external H2O2 generator (Puriter) 04 Clamp pro connection of a ball valve or waste piping 07 This isolator can be sterilised with hydrogen peroxide vapours. These vapours are generated by an additional external device – Puriter ( hydrogen peroxide...

Equipped for an RTP (rapid transfer port) Laminar frame The site for the RTP is placed on the chamber´s right wall. Option to integrate an RTP alpha port and beta container for sterile transfer of materials. The chamber ceiling is fitted with a laminar frame for producing laminar flow, and includes built-in LED lights. Inlet HEPA filters are situated above the laminar frame. Rounded edges/corners inside the chambers This isolator can be sterilised using hydrogen peroxide vapours. A uniform distribution of vapour is achieved using a perforated pipe installed through the whole length of the...

This isolator control system is operated with a Siemens colour touch screen. The Simatic control system from Siemens together with a foot operated switch creates an intuitive and user-friendly experience. The screen displays the actual parameters of the environment and monitors emergency statuses. The system includes remote access for customer service support. As required, it is possible to implement connection to an additional device for production data storage and export. User login and automatic log-off countdown timer Illumination control icons Chamber interior physical values...