Compounding Aseptic Isolators

Germfree's VersaFlow is a Laminar Flow Compounding Aseptic Isolator and Vertical Laminar Flow Workstation. 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 VersaFlow can also be converted to a Vertical Laminar Flow Workstation (VF) for use in a cleanroom. The complete work area and transfer chamber is bathed by HEPA-filtered air, protecting the product from contamination.

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The most practical, versatile solution for sterile compounding and USP 797 compliance in the hospital pharmacy and cleanroom.

The VersaFlow 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.

Product Specifications

OVERALL DIMENSIONS:

VF-4USP: 64" wide • 31" deep • 79 ½" high
VF-6USP: 88" wide • 31" deep • 79 ½" high

WORK AREA DIMENSIONS:

VF-4USP: 33" wide • 27 ½" deep • 32" high
VF-6USP: 49" wide • 27 ½" deep • 32" high

Designed to fit through standard door openings and elevators.

Germfree's VersaFlow Series: Laminar Flow Compounding Aseptic Isolator and Vertical Laminar Flow Workstation:

Designed to fit through standard door openings and elevators.
All stainless steel construction both inside and out with a pharmaceutical grade finish.
All viewing panels are stainless steel framed Acrylic.
Front viewing panel is top-hinged and self-supporting for easy-access to the work area for cleaning and equipment ingress.
All filter diffuser/guard panels are removable for easy cleaning.
Straight sides and back maximize work area to accommodate the many types and shapes of pharmacy equipment and automated compounders.
All corners in work area, antechamber and work surface are easily accessible and easily cleaned.
2 position adjustable IV bar.

ANTECHAMBER:

Large integrated transfer chamber, located on the left side of unit, protects the work chamber from contamination by continuously bathing the area with HEPA-filtered, unidirectional laminar air.

WASTE REMOVAL:

Trash Tube: 4" diameter tube, flanged for waste bag/container connection and provided with an easily removable seal/stopper to maintain work area containment.
Sharps Tube: 3" diameter tube to facilitate quick drop of the largest syringes and provided with an easily removable seal/stopper to maintain work area containment.
Sharps container Shelf: Fully adjustable; accommodates most commercially available wide-mouth or hinged-top sharps collectors.

SAFETY:

Lock-out handle requiring key for access to work area.
Digital pressure readout with low pressure alarm for work area.
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. Seismic anchors are available.

ERGONOMICS:

Two part sleeve/glove system allows the use of most types and sizes of commercially available gloves for better dexterity and tactility.
Extra large oval gloveports are placed at an ergonomically correct angle to accommodate a wide range of body types and increase range of movement.
Gloveports have a 3" arm rest to enhance operator comfort.
Large viewing panel is set an angle to minimize glare and enhance operator comfort.

FILTRATION:

Full framed, standard-size Minipleat HEPA Filters: 100% of inlet and exhaust air is filtered from both the work area and the antechamber to provide a fully contained environment.
HEPA filters are full coverage and front-loading for easy replacement by a certifier.
A Pre-filter extends the life of the work area supply HEPA filter and can be replaced without tools.

ELECTRICAL:

High capacity motor/blower system with speed control to extend life of HEPA filters.
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.
Voltage = 115 Volt, 60 Hz (220/50-60 Hz also available).
Amperage Rating = 15
Running Amperage = 6 (VF-4USP and VF-6USP) = 7 (VF-64PUSP)