COMPOUNDING ASEPTIC ISOLATORS

Germfree's line of USP <797> and NIOSH compliant Compounding Aseptic Isolators.

LFGI (Laminar Flow Glovebox/Isolator)

 

The Laminar Flow Glovebox/Isolator provides the ultimate in product and personnel protection. The LFGI functions as a Compounding Aseptic Containment Isolator (CACI) while operating under a strong negative pressure to meet NIOSH recommendations and as a Compounding Aseptic Isolator (CAI) under positive pressure to meet USP <797> regulations. The operator is provided a complete barrier from materials being manipulated by working outside of the work environment through a glove system.

The Laminar Flow Glovebox/Isolator uses HEPA (High Efficiency Particulate Air) filters to provide the highest level of personnel and product protection. These filters are the laminar flow supply HEPA filter, which filters all air passing over the entire work area, and the exhaust HEPA filter that filters all air exiting the Laminar Flow Glovebox/Isolator. Additionally, there are two HEPA filters located inside the HEPA Purge airlock that 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%. These filters are even more effective at removing particulates both larger and smaller than 0.3 microns.

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The Laminar Flow Glovebox/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. Personnel 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. The LFGI can be configured to meet the recommendation for no recirculation and total exhaust of all air exiting the work area made by the NIOSH alert on the handling of hazardous drugs. Glove changes can be made while maintaining containment, there by furthering personnel protection.

The LFGI is constructed of quality all welded stainless steel with a pharmaceutical grade finish. The unit comes standard with an integrated manual height adjusting stand with locking cleanroom grade casters. The stainless steel sliding tray inside the airlock pulls into the work area eliminating reaching strains. The interior stainless steel work area trays slide over one another and are removable to facilitate easy cleanup under the work deck. The extra large oval gloveports incorporate a two-part sleeve/glove system that 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 viewing panel is encased in a stainless steel frame and is at an angle to reduce glare and operator strain. The unit comes standard with a waste and sharps removal system with seals to maintain work area containment. A fully adjustable sharps container shelf is included to accommodate most commercially available wide mouth or hinged top sharps collectors. For further information on standard features and additional options please refer to the unit specification sheet.

 

VERSAFLOW SERIES

The VersaFlow Compounding Aseptic Isolator (CAI) offers the highest level of product protection by providing vertical unidirectional (laminar) flow HEPA filtered air to the complete work environment. The unit functions as an Isolator while operating under positive pressure to meet USP <797> regulations. The VersaFlow can also be converted to a Vertical Laminar Flow Workstation for use in a cleanroom.

 

The VersaFlow (CAI) is 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 better than ISO Class 5 particulate-free environment. Particulates generated by manipulations are continuously removed, maintaining ISO Class 5 or better conditions when operational. All air entering the VersaFlow is twice filtered, once by the pre-filter then by the supply HEPA filter.

The VersaFlow is constructed of 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 that 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 at an angle to reduce glare and operator strain. The unit comes standard with a waste and sharps removal system with seals to maintain work area containment. A fully adjustable sharps container shelf is included to accommodate most commercially available wide mouth or hinged top sharps collectors. For further information on standard features and additional options please refer to the unit specification sheet.

 

 

 

 

 

 

 

 

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