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BIOAIR ISOLATION TECHNOLOGY

BIOAIR ISOLATION TECHNOLOGY

BIOAIR ISOLATION TECHNOLOGY

Product catalog summary
Description
ISOMATE Cyto is a negative pressure isolator designed to protect operators, the environment, and products during the handling of cytotoxic and mutagenic substances. It features a sealed work area with lower internal pressure, accessed via lateral pass-boxes. The chamber uses HEPA H14 filtered air for laminar flow, and additional filters prevent contamination of technical areas. Constructed from AISI316 stainless steel, it includes centrifugal motor blowers for airflow and pressure maintenance.
Guidelines & Reference Normatives
The document references several standards, including ISO 14644-1 for cleanrooms, EU GMP for manufacturing practices, and ISO 10648-2 for containment enclosures, among others.
Main Specifications
The isolator uses HEPA H14 filters with high efficiency for various airflows. It features interlocked pass-boxes with turbulent airflow, maintaining cleanliness level ISO5. The inner chamber is classified as ISO 3, with automatic pressure and airflow regulation. It includes a UV-C germicidal lamp, power sockets, and a touch-screen control interface.
Standard Sizes
Two configurations are available: 2-glove and 4-glove models, differing in external and internal dimensions, number of motor blowers, and gloves. Both maintain ISO 3 classification and require a 230V-50 Hz power supply.
Available Options
Options include an IV bar, camlocks for VHP generator connection, automated leak test systems, integrated VHP generator, particle and microbiological monitoring systems, stainless-steel chassis, SCADA control system compliance, and a glove leak tester.
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Catalog excerpts

BIOAIR ISOLATION TECHNOLOGY-1

BIOAIR ISOLATION TECHNOLOGY

 Open the catalog to page 1
BIOAIR ISOLATION TECHNOLOGY-3

ISOMATE Cyto is a negative pressure isolator, designed to provide protection to operators, environment and products during processes requiring the manipulation of cytotoxic and mutagen (CMR) substances. Operator and environment protection is achieved via a sealed work area with an inner pressure lower than the surrounding environment; the only access to the work area, when in operation, is through the lateral pass-boxes. 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...

 Open the catalog to page 3
BIOAIR ISOLATION TECHNOLOGY-4

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) First filtering stage (recirculated air, below work surface) with bag-in/bag-out filter removal system; Two (2) interlocked pass-boxes, with turbulent air-flow, more than 500 air changes per hour and an inner pressure between -30Pa and -50Pa with...

 Open the catalog to page 4
BIOAIR ISOLATION TECHNOLOGY-5

Pass-box doors are interlocked. Pass-boxes are provided with a sliding tray for easier loading/unloading of products in the working chamber. PLC based control system. Full colour touch-screen control interface with graphical UI. Working chamber lighting provided by LED lamps. Semi-automatic leak-tighteness test sytem (fully automatic test available as an option). STANDARD SIZES 2 GLOVES HEPA filters External Size - mm Inner working area size - mm Working area classification Power supply

 Open the catalog to page 5
BIOAIR ISOLATION TECHNOLOGY-6

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
*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.