“The Clinical Advantage”™

CERTIFIED SHIELDED BARRIERLAMINAR FLOW ISOLATOR

PORTABLESHIELDEDISOLATOR

• Small footprint

• Antechamber locatedunder the Isolator

• Large, full-view shielded window

• Designed from the ground upfor a Radiopharmacy

• Stainless Steel, inside and out

• Height adjustable – 10-inch range

• Work sitting or standing withcorrect ergonomics

• USP<797> compliant overcomes expensiveventilation renovations

• Internal IV bar

• Sealed shielded dose calibratorchamber in the work surface

• Fits Atomlab and other dose calibrators

• Use for blood work or other compoundingor drawing requirements

• Mobile, on four heavy-duty locking casters

• Electric outlets in work area

• HEPA air filtration

• Lead shielded (.25" thick) for compoundingsterile radiopharmaceuticals

• ISO Class 5 (Class 100) IsolatorBIO

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PRELIMINARY1-800-224-6339

Int’l 631-924-9000

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The Biodex Germfree ShieldedIsolator provides the ultimate inboth product and operatorprotection. The shieldedisolator functions as a“glovebox” using negativepressure to meet NIOSHrecommendations whilecomplying with USP<797>regulations for use outside acleanroom.

HEPA filtered unidirectional(laminar) air bathes the workarea to protect the product from contamination and removes anyparticulate generated by sample manipulation. The operator isprovided a complete shielded barrier from materials beingmanipulated in the work area. The Biodex Germfree ShieldedIsolator meets or exceeds ISO 14644-1, ISO Class 5 (Class 100) airquality. Each shielded isolator, undergoes rigorous physical testingto assure the unit meets performance requirements as validated. Itis required that independent certification be performed before use.

What is a Barrier Laminar Flow Isolator?In January 2004, USP<797> changed the way facilities thatprepare compound sterile preparations (CSPs) approach theirwork. As the first official and enforceable requirement forCSPs, USP<797> deals with policies and practices forpreparing CSPs. It applies to all facilities that prepare CSPs,including clinics, hospital care units, and main and satellitepharmacies. As facilities that prepare CSPs evaluate and changetheir procedures to meet USP<797> requirements, they arefinding that barrier isolators provide an ideal alternative tomore costly cleanrooms.

According to the Food and Drug Administration, a barrierisolator is “a decontaminated unit supplied with HEPA filteredair that provides uncompromised continuous isolation of itsinterior from the external environment, including surroundingcleanroom air and personnel.”

By installing a certified barrier isolator, one can obtaincleanroom conditions within a contained workspace. Barrierisolators provide a ISO Class 5 (Class 100) environment forproduct preparation, with work occurring inside a closed,pressurized environment accessible only via sealed gloves thatreach into the work area.

A Shielded Glovebox is not a certified barrier isolator. Bychoosing a certified barrier isolator, the requirement for a ISOClass 8 environment is eliminated. A well-designed shieldedbarrier isolator will significantly reduce microbial contaminationand should meet the following minimum standards:

• A unit with unidirectional airflow showers the work zonewith a continuous supply of filtered air that sweepscontaminants out through the air exhaust system.

• Uses negative air pressure to maintain containment ofhazardous substances within the isolator.

• Is easy to clean and disinfect inside and out.• Includes a pass-through system that isolates the interior of theunit from the room when materials are transferred in and out.

• Is made of durable material that is easy to clean, such asstainless steel and high-performance, scratch-resistantlead acrylic.

• Includes height adjusters to make the work environmentas comfortable as possible.

The Biodex Germfree Isolator is an excellent example of awell-designed shielded barrier Laminar Flow Isolator, meetingall of these standards and more:• It is constructed of a single piece of long-lasting stainlesssteel for easy cleaning.

• It includes an air-lock transfer chamber with a ventilationsystem that cleans the air in the chamber up to ISO Class 5(Class 100) quality.

• All inside surfaces can be easily reached from the glove portsfor daily cleaning. In addition, the low height androller-base frame make the external surface of the isolatoreasy to clean.

CERTIFIED SHIELDED BARRIER LAMINAR FLOW ISOLATOR

Shown antechamber on left and two Sharps Shields on right.

SPECIFICATIONSDimensions:

Overall Dimensions: 38" w x 32.5" depth x 79 " h(96 x 82 x 201 cm)Designed to fit through standard door openingsand elevators.Height Adjustment: 79" – 89" (200.7 x 226 cm)Work Area Dimensions: 32.5" w x 25" depth x 28" h(82.6 x 63.5 x 71 cm)

Viewing window: 30" w x 23" h (76.2 x 58.4 cm), 1.8"(46 mm) thick leaded acrylicConstruction: Stainless steel with a pharmaceutical grade finishLead Shielding: .25" thick (.64 cm) on back, sides,bottom and frontFluorescent Lights: High efficiency; externally mounted tominimize heat build up. Separate lighted power ON/OFF switch.Motor/Blower: High capacity with speed control to extend HEPAfilters life. Separate lighted power ON/OFF switch.Power: 115 VAC, 60 Hz (Optional 220 VAC, 50-60 Hz is available),15 AMP line, running amperage = 6 AMP. Includes ten foot hospitalgrade power cord with molded grounded plug. Sealed outlet in work area.

ANTECHAMBER• Sealed two-door airlock maintains complete environmentalseparation between work area and ambient conditions.

• HEPA filtered purge of trapped airlock air eliminates crosscontamination between the work area and the room during bothmaterial ingress and egress.

FILTRATION• Full framed, standard size mini-pleat HEPAs filter 100% of inletand exhaust air from both the work area and the antechamber toprovide a fully contained environment.

• HEPA filters are full coverage and front loading for easyreplacement by a certifier.

ERGONOMICS• Hydraulic assist height adjusting stand offers a full 10" range,allowing operators to sit or stand comfortably for extendedtime periods.

• Stainless steel sliding tray inside the antechamber airlock thatpulls forward for loading and unloading items into the airlock,eliminating reaching strains. The sliding tray lifts up 7.5" whenthe interior antechamber door is opened.

• Two part sleeve/glove system allows the use of most types and sizesof commercially available gloves for better dexterity and tactility.

• Extra large oval gloveports are placed with bottoms together toprovide an anthropometrically correct configuration thataccommodates a wide range of body types and increases rangeof movement.

• Gloveports have a 3" armrest to reduce operator fatigue.• Large viewing panel is at an angle to reduce glare andoperator strain.

SHARPS CONTAINERS• Two sharps containers in locking shielded holders locatedunder the isolator in individual .25" lead shields.

• Sharps tube is a straight 2.5" diameter tube to facilitate quick dropof the largest syringes with an easily removable shieldedseal/stopper to maintain work area containment.

SAFETY• Lock-out handle requires key for access to work area andsharps containers.

• Digital pressure readout with low pressure alarm for work area.• Inward face velocity is 95-100 LFM at gloveport opening, toprotect operator/product during massive breach of containment.

• Glove changes can be made without breaking containment.• Locking casters are standard, seismic anchors are available.

CLEANING• Front viewing panel is top hinged and self supporting for easyaccess to the work area for cleaning and equipment ingressand egress.

• All filter diffuser / guard panels are removable for easy cleaning.• Straight sides and back maximize work area to accommodate themany types and shapes of equipment and dose calibrators.

• All corners in work area, antechamber and work surface are easilyreached and cleaned.

CONFIGURATION OPTIONS• Overall work area pressure is negativewith the option to externally exhaust.

• Fits Atomlab and other dosecalibrators

WARRANTY• Two years parts; one year labor

190-215 Shielded Isolator

1-800-224-6339Int’l 631-924-9000

www.biodex.comBIODEX