GERMFREE

Compounding Aseptic Isolators

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. Product SpecificationsPrint Page Request More Information Germfree_LFGI_all-sizes-new-logo 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.

VersaFlow Series

Germfree's VersaFlow(tm) is a Laminar Flow Compounding Aseptic Isolator. The VersaFlow provides the most practical and versatile solution for I.V. compounding in the hospital pharmacy and cleanroom. While operating under positive pressure, the VersaFlow functions as a Compounding Aseptic Isolator (CAI) to meet USP 797 regulations. The complete work area and transfer chamber is bathed by HEPA-filtered air, protecting the product from contamination. Product SpecificationsPrint Page Request More Information Versaflow Series The most practical, versatile solution for sterile compounding and USP 797 compliance in the hospital pharmacy and cleanroom. The VersaFlow(tm) Compounding Aseptic Isolator (CAI) offers the highest level of product protection by providing vertical HEPA-filtered air to the complete work environment. This unidirectional laminar flow air removes any particulates generated by sample manipulation. Germfree's VersaFlow barrier isolators meet or exceed ISO 14644-1 Class 5 air quality. The unit functions as an Isolator while operating under positive pressure to meet USP 797 regulations. The VersaFlow compounding barrier isolators are designed for the handling of materials in a sterile working environment. The work area is continuously bathed with positive pressure ISO 5/Class 100 vertical laminar flow air that has passed through a High Efficiency Particulate Air (HEPA) filter. This filter removes organisms and particulates 0.3 micron in size with an efficiency of 99.99%. The laminar flow principle consists of moving individual streams of unidirectional, ultra-clean air along parallel lines with minimal turbulence. The HEPA filter is positioned in the top of the work area and is protected by a removable, perforated metal diffuser. The unit utilizes a full width and depth supply HEPA filter above the work surface which provides a particulate-free environment exceeding ISO Class 5. Particulates generated by operator manipulations are continuously removed. All air entering the VersaFlow is twice filtered, initially by the pre-filter, subsequently by the supply HEPA filter. The VersaFlow is constructed of high quality, all-welded stainless steel with a pharmaceutical grade finish. The unit comes standard with an integrated stainless steel stand with locking cleanroom grade casters. The interior stainless steel work area trays are removable to facilitate easy cleanup under the work deck. The extra large, oval gloveports incorporate a two-part sleeve/glove system which allows for the use of most types and sizes of commercially available gloves. The fluorescent light housing is externally mounted to provide optimum lighting into the work area. The Acrylic panel is encased in a stainless steel frame and is set at an angle to minimize glare and enhance operator comfort. The VersaFlow’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. Please see our full line of Sterile Compounding and Pharmacy Equipment. Versaflow-Mini-KSweb Countertop VersaFlow(tm) Germfree’s VersaFlow Countertop (VF-CTUSP) is ideal for adding a Compounding Aseptic Isolator when additional space is limited. Additionally the unit is useful for low volume Sterile IV Compounding operations. Practical for facilities with space constraints Small footprint Designed for compatibility with existing casework