LFGI Series

The Laminar Flow Glovebox/Isolator (LFGI) provides the ultimate in product and personnel protection. Germfree's LFGI functions as a Compounding Aseptic Containment Isolator (CACI) while operating under strong negative pressure to meet NIOSH recommendations. Additionally, the unit functions as a Compounding Aseptic Isolator (CAI) under positive pressure to meet USP 797 (and proposed USP 800) regulations. The operator is provided with a complete barrier from the materials being manipulated by working with a highly ergonomic glove system.
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The ultimate in product and personnel protection for sterile compounding
Germfree’s Compounding Aseptic Containment Isolators use HEPA (High Efficiency Particulate Air) filters to provide the highest level of operator and product protection. The supply HEPA filter provides laminar flow air, which bathes the entire work area. The exhaust HEPA filter handles all air exiting the LFGI. Additionally, two HEPA filters located inside the HEPA Purge Airlock filter the purged air. All filters are rated to remove particulates and aerosols 0.3 micron in size with a minimum efficiency of 99.99%. Particles that are smaller or larger than 0.3 micron are filtered at a greater efficiency.
The LFGI Compounding Aseptic Containment Isolator provides personnel and product protection from particulates, dust, powders and aerosols. Microbiological particulates and aerosols, with the possible exception of prions, are also removed. Operator and product protection from gas and fumes are NOT provided by HEPA filtration, but limited protection from gas and fumes can be provided by venting or ducting. In accordance with the NIOSH alert on the handling of hazardous drugs, the LFGI can be configured for no recirculation and total exhaust of all air exiting the work area. Germfree’s Compounding Aseptic Containment Isolators are designed to meet all USP 797 guidelines for sterile compounding, as well as the regulations for handling hazardous drugs proposed by USP Chapter 800.
LFGI with waste and sharps disposal system for CACI configuration

LFGI with waste and sharps disposal system for CACI configuration

Germfree’s Compounding Aseptic Containment Isolators are ergonomically designed.
Germfree’s Compounding Aseptic Containment Isolators are constructed of high quality all welded stainless steel with a pharmaceutical grade finish. The unit incorporates an integrated height-adjustable stand with locking cleanroom grade casters. The ergonomic, stainless steel sliding tray inside the airlock is designed to eliminate reaching strains. Further, the stainless steel interior work area trays are removable and are designed to slide over one another. This facilitates easy cleanup under the work deck. The extra large oval gloveports incorporate a two-part sleeve/glove system that allows for use of most types and sizes of commercially available gloves. Glove changes can be made while maintaining containment, to enhance personnel protection.

The fluorescent light housing of the Compounding Aseptic Containment Isolator is externally mounted to provide optimum lighting in the work area. The Acrylic viewing panel is encased in a stainless steel frame and set at an angle to reduce glare and enhance operator comfort. The LFGI's system for waste and sharps removal has seals to maintain work area containment. A fully adjustable shelf is included to accommodate most commercially available wide-mouth or hinged-top sharps collectors.
The LFGI Series of Barrier Isolators meet or exceed ISO 14644-1 for Class 5 air quality. Each Germfree Compounding Aseptic Containment Isolator undergoes rigorous physical testing before shipping to assure the unit meets all performance requirements. It is required that independent certification be performed before use of LFGI - Laminar Flow Glovebox/Isolator.
Germfree’s LFGI Series of Compounding Aseptic Containment Isolators provide an advanced solution for compliance of USP 797 sterile compounding requirements as well as the proposed USP Chapter 800 standards for handling hazardous drugs.