LFGI SERIES Radiopharmacy Isolator
All Stainless Steel Lead Shielded Compounding Aseptic Containment Isolator
The Germfree Shielded Isolator provides advanced product and personnel protection while compounding sterile radiopharmaceuticals. Our Shielded Isolator functions as a Glovebox while operating under negative pressure to meet NIOSH recommendations. Additionally, the unit complies with USP regulations for operation outside of a cleanroom.
Unidirectional Laminar Airflow System Maintains
ISO Class 5/Class 100 air Under Dynamic Conditions
HEPA filtered unidirectional (laminar) air bathes the work area to protect the product from contamination and removes any particulates generated by sample manipulation. The unit has 1/4″ lead shielding for protection while compounding sterile radiopharmaceuticals. Users are completely shielded from materials being manipulated in the work area.
Performance Tests are Validated to the CETA
Compounding Isolator Testing Guide | CAG-002-2006
Germfree’s Radiopharmacy Isolator meets or exceeds
ISO 14644-1 Class 5 (Class 100) air quality under dynamic conditions. The LFGI Series Isolator does not require an ISO Class 8 cleanroom. The unit fits Atomlab and other dose calibrators. Each Shielded Isolator undergoes rigorous physical testing to assure the unit meets performance requirements.
Leasing Options: Contact us about leasing USP 797 Compounding Equipment.
- LFGI-R: 36″ wide ・ 34″ deep ・ 79.5″ high
Work Area Dimensions:
- LFGI-R: 34″ wide ・ 24″ deep
Designed to fit through standard door openings and elevators.
LFGI-R (RADIOPHARMACY ISOLATOR):
Performance Tests are Validated to the Requirements of the CETA Compounding Isolator Testing Guide|CAG-002-2006
- Achieve USP 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.
- Lock-out handle requiring key for access to work area.
- Digital pressure gauge with audible and visual low pressure alarm.
- Inward/Outward Face Velocity is 95-100 linear feet per minute at gloveport opening to protect operator and product in the event of a breach of containment.
- 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.
- 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.
- Work area differential pressure is negative with the option to exhaust to the outside.
- Fits Atomlab and other dose calibrators.
- 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
- 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 1/4″ lead shields.
- Sharps tube is a straight 2″ 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.
- 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.
RADIOPHARMACY ISOLATOR FEATURES:
AIRFLOW PATTERNS FOR RADIOPHARMACY ISOLATORS
Compounding Aseptic Containment Isolators: USP 797 Regulations for Compounded Sterile Preparations
USP 797 provided the first official and enforceable requirements for preparing CSPs -Compound Sterile Preparations. USP 797 is the U.S. Pharmacopeia’s (USP) Revised General Chapter for Pharmaceutical Compounding Sterile Preparations. According to the organization these requirements set “practice standards to help ensure that compounded sterile preparations are of high quality”. Chapter fundamentally changed the way that facilities that prepare compounded sterile preparations approach their work.
USP 797 applies to the diverse range of facilities that prepare Compounded Sterile Preparations
Chapter applies to all facilities that prepare CSPs. This includes hospital and health-system pharmacies that prepare compounded sterile preparations including main hospital pharmacy operations and satellite pharmacy units. USP 797 also applies to clinics, hospital care units as well as other facilities that handle the compounding of sterile preparations. As facilities change their procedures to meet USP 797 requirements, they are finding that barrier isolators can provide an ideal alternative to a more costly cleanroom.
The Food and Drug Administration states that a barrier isolator is: “a decontaminated unit supplied with HEPA filtered air that provides uncompromised continuous isolation of its interior from the external environment, including surrounding cleanroom air and personnel.” Installing a Compounding Aseptic Containment Isolator provides cleanroom conditions within a contained workspace. Compounding Aseptic Containment Isolators provide an ISO Class 5 (Class 100) environment for product preparation, with work occurring inside a closed, pressurized work space, accessible only via a sealed gloves system.
GENERAL STANDARDS FOR USP 797 COMPOUNDING ASEPTIC CONTAINMENT ISOLATORS:
Germfree’s Compounding Aseptic Containment Isolators are an ideal solution for providing a clean work environment in the pharmacy industry when compounding sterile preparations.
As there no true uniform industry standards for manufacturing isolators, there are significant design differences among manufacturers. A well-designed isolator that will significantly reduce microbial contamination should meet a range of minimal standards. Germfree’s Radiopharmacy Shielded Isolators meet or exceed these standards: