Block Technology Sterility Test Isolator

Description

• Single-chamber isolator for sterility testing
• Chamber with 4 sleeves for work with sterile materials
• Possible to add airlock chamber and provide sterilization with with H2O2
• Leak tightness class 3 according to ISO 10648-2
• 'A' class cleanliness according to EU GMP
• 'Audit Trail' Compliant
• Option to decontaminate with H2O2
• Electronic control system for automatic adjustment of basic operating modes managed by Siemens PLC
• Colour touchscreen control
• Jacket material: stainless steel AISI 304
• Chamber material – AISI 316L with a thickness of 3.00 mm
• Polished surface finish, Ra < 0.6 μm
• Inlet filtration HEPA H14 - 'A' Class cleanlinnes
• Easy-to-clean inner and outer surfaces
• Sliding trays in Airlock for easy material transfer (applicable with airlock)
• Oval holes with gloves for improved material handling
• Laminar flow 0.45 m/s ±20%
• Positive pressure mode

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 - it is 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.

he HVAC system allows for the formation of positive pressure in the interior of the isolator. This function is mostly used in case of a failure - compromised leak-proofness - and helps protect products. In order to prevent damage to the equipment caused by insufficient pressure a pneumatic valve is used. This protective function prevents the pressure from dropping further, protecting the technology from damage.

Standards

• Temperature and humidity sensor - Rotronic - Used for monitoring critical parameters or/and to control a decontamination process. Rotronic is an accurate and high-quality product resistant to hydrogen peroxide vapors.
• Velocity sensor for laminar flow - Schmidt
• Pressure sensor with analog 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.
• Cross-bar for hanging rack

Options

• Steritest Symbio ISL - Located on the right portion of the chamber´s worktop.
• H2O2 decontamination - This isolator can be sterilized with vaporised hydrogen peroxide. vapors are generated by an additional external device – Puriter (hydrogen peroxide vapor generator).
• Wire trays & accessories - The rear panel can be fitted with wire trays and hangers made from AISI 316L stainless steel.
• Glove Holder -For positive pressure isolators not in operation so that the gloves do not extrude into the space in front of the isolator. For isolators where sterilization with a hydrogen peroxide vapor generator is used.
• Power supply sockets for additional equipment - Sockets are placed on the rear wall of the isolator. Sockets are operable from the control display. Sockets available in all country variants.
• Pass-through chamber K2
• Sliding tray
• Connecting clamp for Puriter and H2O2 distribution nozzle
• Humidity and temperature measuring sensor - Rotronic
• Schmidt speed sensor for laminar flow
• Equipped for microbiological monitoring – DN 1 clamp
• Equipped for ISO kinetic sensing unit – DN 10 clamp

Safety Features

• Pressure fuse - The pressure fuse serves as a safety element indicating increased pressure in the chamber. In the event that the assigned pressure in the chamber is exceeded a pneumatic flap valve is opened and the pressure value is decreased without deterioration of internal atmosphere.
• Safety glass - We use tempered safety glass for the front windows and ports of our equipment. This glass has improved mechanical properties and is durable. When damaged it forms small chunks which reduce the risk of injury from cuts.
• Safe replacement of sleeves - Our glove / sleeve flanges have two grooves. The first for sealing the glove and the second for an o-ring. This design conforms to standard procedure for the safe replacement of gloves.