BIOAIR ISOLATION TECHNOLOGY

Product catalog summary

Description
ISOMATE Steri is a positive pressure isolator designed to protect products and processes in sterile environments by preventing external contamination. It maintains positive pressure in the working area and uses HEPA H14 filters for air purification. The inner chamber is made of AISI316 stainless steel, and the system includes motorblowers to maintain airflow and pressure.

Guide Lines & Reference Normatives
The document references several standards, including ISO 14644-1 for cleanrooms, ISO 14644-7 for separative devices, EU GMP for good manufacturing practices, and others related to safety and containment.

Main Specifications
The isolator features HEPA H14 filters with high efficiency, an ISO 3 cleanliness classification, automatic pressure regulation, and a stainless-steel inner chamber. It includes a UV-C germicidal lamp, auxiliary power sockets, and a PLC-based control system with a touchscreen interface.

Standard Sizes
The ISOMATE is available in two sizes: a 2-glove model and a 4-glove model, both with specific dimensions and features such as HEPA filters, motorblowers, and ISO 3 classification.

Available Options
Optional features include an IV bar, camlocks for VHP generator connection, a fully automated leak test system, integrated VHP generator, particle and microbiological monitoring systems, a fully stainless-steel chassis, SCADA control system compliance, and a glove leak tester.

Catalog excerpts

BIOAIR ISOLATION TECHNOLOGY

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ISOMATE Steri is a positive pressure isolator, designed to ensure product and process protection during all activities requiring a sterile environment, and avoiding the risk of external contaminants pollution. Product protection is achieved via the creation of a positive pressure inside the working area with respect to the surrounding environment. Products inside the working chamber are manipulated using the gloves installed on the front window. The inner chamber is provided with a laminar flow of HEPA H14 filtered sterile air. The pass-boxes are provided with a turbulent air flow of HEPA H14...

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MAIN SPECIFICATIONS Inlet air filter: HEPA H14 efficienza 99,995 MPPS (particelle 0,12 – 0,24 μm), ≥ 99,999 DOP (0,3 μm). Main chamber downflow filter: HEPA H14 efficienza 99,995 MPPS (particelle 0,12 – 0,24 μm), ≥ 99,999 DOP (0,3 μm). Exhaust air filters on each passbox: HEPA H14 efficienza 99,995 MPPS (particelle 0,12 – 0,24 μm), ≥ 99,999 DOP (0,3 μm) Inner chamber cleanliness classification: ISO 3 according to ISO 14644-1 Leaktightness class 4 according to ISO 10648-2 Automatic regulation of the positive pressure gradient inside the working chamber. Automatic regulation of the motorblower...

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STANDARD SIZES 2 GLOVES HEPA filters External Size - mm Inner working area size - mm Working area classification Power supply

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AVAILABLE OPTIONS Camlocks to connect to an external VHP generator Fully automated leak test system Integrated hydrogen peroxide vapours generator (VHP) Particle monitoring system (in working chamber) Microbiological monitoring system (in working chamber) Fully stainless-steel external chassis SCADA Control system CFR 21 part 11 compliant Glove leak tester (Safegl

Open the catalog to page 6

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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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