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Product category: Air handling: Dust + Fume extraction
News Release from: Hosokawa Micron | Subject: Stott Flexible Compact Isolator
Edited by the Processingtalk Editorial Team on 02 December 2005

Compact isolator and glove box system

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A new plug and play, 'off the shelf' flexible compact isolator and glove box system offers ultra high containment levels, for companies seeking superior levels of product and personnel protection

A new plug and play, 'off the shelf' flexible compact isolator and glove box system from Hosokawa Containment offers ultra high containment levels, to <10nano-g/m3, for companies seeking superior levels of product and personnel protection The cost effective barrier containment solution afforded by the Stott Flexible Compact Isolator (FCI) is ideal for companies undertaking scientific research, bio-technology or pharmaceutical development involving even the finest nano-particles

The FCI is lightweight and portable with the option of either a disposable/flexible plastic canopy or a rigid acrylic canopy fitted to the standard 1m long x 0.6m wide stainless steel base unit to create a contained workstation.

Suitable for a range of small-scale processing applications including laboratory analysis, micronising, drying, packing, product transfer and sampling of high potency compounds, the Stott Flexible Compact Isolator enables both manual and automatic procedures to be carried out with minimal operator exposure.

Containment tests for both powder transfer and dispensing activities were carried out using lactose, to simulate the activities that may be performed in the isolator.

Tests were carried out on two Isolator units.

One with the flexible/disposable canopy and one with the rigid acrylic canopy.

Three individual tests were carried out on each type of Isolator.

A sampling protocol was adopted for the independently-verified airborne containment testing.

This testing complied with the International Society of Pharmaceutical Engineering (ISPE) Standardised Measurement for Equipment Particulate Airborne Concentrations (SMEPAC) committee draft guideline - 'Assessing the Particulate Containment Performance of Pharmaceutical Equipment - A Guide', Version 11.

Standard operating procedures for the handling of active pharmaceutical ingredients.

Before each sample run started, one 1kg batch of lactose was introduced to the Isolator.

The run included the transfer of three, 300g batches of lactose, to separate bags using a metal spoon.

Each bag was tie-wrapped.

All waste was put into a plastic bag and removed from the Isolator via a waste bag docked to the rear bag out port.

Two separate air samples were taken, one background sample and one personal sample from the operators breathing zone.

Personal samples taken during both the flexible plastic canopy and rigid acrylic canopy consistently returned measured lactose levels, over an 8 hour time weighted average, of less than 0.002micro-g.

Background samples taken during the plastic bag canopy tests showed lactose levels over an 8 hour twa, ranging from <0.048micro-g/m3 to 0.15micro-g/m3 and those taken using the rigid acrylic canopy tests, from 0.11micro-g/m3 to 0.21micro-g/m3.

Portable Containment Options.

The ergonomic and flexible design means that the Stott FCI can be easily upgraded as requirements change.

Customers seeking single or short term usage may favour the flexible/disposable canopy option, whilst companies looking for a cost effective containment solution for more arduous applications may choose the rigid acrylic option.

The basic bench-mounted FCI unit can be upgraded with various additional features such as a free-standing base frame, on-board air handling system, CIP system, HEPA filtration and rapid transfer ports, to allow it to be tailored to individual customer requirements.

Although the Stott Flexible Compact Isolator is a standalone contained workstation, several units can be joined together into a multiple configuration, offering a cost effective alternative to a large bespoke static isolator, where investment or usage frequency precludes the purchase of such.

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