LFGI-R (RADIOPHARMACY ISOLATOR):

• Achieve USP <797> compliance without expensive pharmacy ventilation renovations.
• ISO Class 5 (Class 100) LFGI Series Isolator does not require an ISO Class 8 cleanroom.
• 1/4" lead shielding for protection while compounding sterile radiopharmaceuticals.
• Fits Atomlab and other dose calibrators.

SAFETY:

• Lock-out handle requires a key to access the work area.
• Digital pressure gauge with audible and visual low pressure alarm.
• Inward face velocity is 95-100 linear feet per minute at gloveport opening to protect operator/product during potential glove loss.
• Glove changes can be made without breaking containment.
• Locking casters are standard.
• Each Shielded Isolator undergoes rigorous physical testing to assure the unit meets performance requirements. Independent certification is required before use.

FILTRATION AND EXHAUST:

• 100% HEPA filtration of supply and exhaust air from both the work area and the antechamber to provide a fully controlled and contained environment.
• Long lasting HEPA filters are full coverage and front loading for easy replacement by a certifier.

ERGONOMICS:

• Hydraulic assist height adjusting stand offers a full 10" range variance allowing operators to sit or stand comfortably for extended time periods.
• Stainless steel sliding tray inside the airlock pulls forward for loading and unloading items into the airlock to eliminate reaching strains.
• Two part sleeve/glove system allows the use of most types and sizes of commercially available sterile gloves for better dexterity and tactility.
• Extra large oval gloveports are placed with bottoms together to provide an anthropometrically correct configuration that accommodates a wide range of body types and increases range of movement.
• Gloveports have a 3” arm rest to enhance operator comfort.
• Large viewing panel is set at an angle to reduce glare and enhance operator comfort.

CONFIGURATION OPTIONS:

• Work area differential pressure is negative with the option to exhaust to the outside.
• Fits Atomlab and other dose calibrators.

ELECTRICAL:

• High capacity motor/blower system with speed control to extend HEPA filter life.
• Ten foot hospital grade power cord with molded grounded plug.
• Sealed outlet in work area.
• Separate lighted power ON/OFF indicator switches for blower and lighting.
• High efficiency, standard sized fluorescent lights are externally mounted to minimize heat build-up and allow for replacement outside of containment.
• Voltage = 115 Volt, 60 Hz (220v/50-60 Hz also available).
• Amperage Rating = 15
• Running Amperage = 6

ANTECHAMBER:

• Sealed two-door airlock maintains complete environmental separation between the work area and the laboratory.
• HEPA filtered purge (air change) of airlock air eliminates cross contamination between the work area and the room during both material ingress and egress.

SHARPS AND WASTE DISPOSAL:

• A sharps container is located under the isolator surrounded by individual ¼” lead shields.
• Sharps tube is a straight 2 ½” diameter tube to facilitate quick drop of the largest syringes.
• The tubes are provided with easily removable shielded seals/stoppers to maintain work area containment.

EQUIPMENT SPECIFICATIONS:

• 1/4” Standard Lead Shielding located in the back, sides, bottom, and front of the work area.
• All stainless steel construction both inside and out with a pharmaceutical grade #4 finish - lead is encapsulated between the interior and exterior stainless steel panels.
• Front viewing panel is top hinged and self supporting for easy access to the work area for cleaning and equipment ingress.
• Straight sides and back maximize work area to accommodate the many types and shapes of equipment and dose calibrators.
• All corners in work area are seamless; antechamber and work surface are easily reached and cleaned.
• Large 46mm thick leaded acrylic viewing window.

FEATURES:

AIRFLOW:

Compounding Aseptic Containment Isolators:
USP 797 Regulations for Compounded Sterile Preparations

USP 797 applies to the diverse range of facilities that prepare
Compounded Sterile Preparations

General Standards for USP 797 Compounding Aseptic Containment Isolators:

• Unidirectional airflow showers the work zone with a continuous supply of filtered air that sweeps contaminants out through the air exhaust system.
• Negative air pressure maintains containment of hazardous substances within the isolator
• Easy to clean and disinfect inside and out
• Pass-through system that isolates the interior of the unit from the room when materials are transferred in and out
• Made of durable materials (stainless steel, glass, and high-performance, scratch-resistant plastics)
• Includes height adjustors to make the work environment ergonomic