36C24418Q0081-00001006.pdf

LFGI Series Compounding Aseptic Containment Isolator Compounding Aseptic Isolator USP <797> & <800> Compliant

800.888.5357 www.Germfree.com

*proposed

New Design

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 <800> regulations. The operator is provided with a complete barrier from the materials being manipulated by working with a highly ergonomic glove system.

Overall Dimensions:

LFGI-3USP: 54” wide (39” wide at base) x 32” deep x 80” high

LFGI-4USP: 66” wide (50” wide at base) x 32” deep x 80” high

LFGI-6USP: 90” wide (74” wide at base) x 32” deep x 80” high

Work Area Dimensions:

LFGI-3USP: 34½” wide x 24½” deep x 29” high

LLFGI-4USP: 46½” wide x 24½” deep x 29” high

LFGI-6USP: 70½” wide x 24½” deep x 29” high

Sealed Two-Door Airlock: 16” wide x 13½” deep x 14¼” high

Conforms to ANSI/UL STD 61010-1 Certified to CAN/CSA C22.2 STD NO. 61010-1

Negative Pressure Positive Pressure

Room Air Filtered Air

Contaminated Air

External Fluorescent Lighting

1” Stainless Steel Adjustable I.V. Bar with Hooks

Anthropometrically Correct Gloveports with 3” Armrest for Increased Range of Motion

Cleanroom Grade Locking Casters

ClCleanroom-Compliant Prefilter increases the life of the front loading HEPA Filter while reducing particulates inside the cleanroom

Type 316 Stainless Steel Removable Sliding Work Trays for Easy Cleaning

Sliding Work Tray from Antechamber into Work Area

Ergonomic Placement of Sharps and Waste Tubes to Accommodate Different Sized Sharps Containers

Standard Features

Accessories

Stainless Steel 9” x 14” Garbage Can

Additional All Stainless Steel Airlock and Sharps and Waste Tubes

Additional Sleeves

& Options

Sealed Data

Port Passage

Cleaning Handle with Pivoting Head

Lint Free Mop Heads

Rapid Exchange

GRx Glove System

Seismic Anchors

Exhaust Transition

Programmable Electrical

Stand Height Adjustment

800.888.5357 www.Germfree.com

Negative Pressure

Sharps & Waste

Containers

11 Aviator Way, Ormond Beach, FL 32174 * 800-888-5357 Phone * 386-677-1114 Fax * www.Germfree.com

LFGI SERIES

LAMINAR FLOW GLOVEBOX / ISOLATOR

COMPOUNDING ASEPTIC ISOLATOR (CAI)

COMPOUNDING ASEPTIC CONTAINMENT ISOLATOR (CACI)

SECTION I. PERFORMANCE DATA

The Laminar Flow Glovebox/Isolator (LFGI) provides the ultimate in both product and operator protection. The LFGI functions as a Glovebox while operating under negative pressure to meet NIOSH recommendations and as an Isolator under positive pressure to meet USP <797> regulations. HEPA filtered unidirectional (laminar) air bathes the work area to protect the product from contamination and removes any particulate generated by sample manipulation. The operator is provided a complete barrier from materials being manipulated in the work area. The LFGI Series of barrier isolators meet or exceed ISO 14644-1 Class 5 air quality. Each LFGI, before shipping, undergoes rigorous physical testing to assure the unit meets performance requirements as validated. It is required that independent certification be performed before use.

UL Listing # 61010-1.

SECTION II. EQUIPMENT SPECIFICATIONS

-Overall Dimensions:

LFGI-3USP LFGI-4USP LFGI-6USP LFGI-6USP (Dual Airlocks) Width 54” (137.16 cm) 66” (167.64 cm) 90” (228.6 cm) 106” (269.24 cm) Depth 32” (81.28 cm) 32” (81.28 cm) 32” (81.28 cm) 32” (81.28 cm) Height 80” (203.2 cm) 80” (203.2 cm) 80” (203.2 cm) 80” (203.2 cm)

-Work Area Dimensions:

LFGI-3USP LFGI-4USP LFGI-6USP LFGI-6USP (Dual Airlocks) Width 34 ½” (87.63 cm) 46 ½“ (118.11 cm) 70 ½“ (179.07 cm) 70 ½“ (179.07 cm) Depth 24 ½” (62.23 cm) 24 ½” (62.23 cm) 24 ½” (62.23 cm) 24 ½” (62.23 cm) Height 29” (73.66 cm) 29” (73.66 cm) 29” (73.66 cm) 29” (73.66 cm)

-Designed to fit through standard door openings and elevators.

-All stainless steel construction both inside and out with a pharmaceutical grade finish.

-316L Stainless steel work trays slide over one another and are removable to facilitate easy clean up under the work deck.

-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 compounders.

-All corners in work area, antechamber and work surface are easily reached and cleaned.

-Adjustable I.V. Bar with 12 Hooks -Twenty-four (24) month standard Warranty on workmanship and parts.

- Operator/User Manual

Antechamber- -Sealed two-door airlock (16” W x 13 ½” D x 14 ¼” H) maintains complete environmental separation between work area and ambient conditions.

-HEPA filtered purge of trapped airlock air eliminates cross contamination between the work area and the room during both material ingress and egress.

Waste Removal- -Trash tube is a 4” diameter tube, flanged for waste bag/container connection and provided with an easily removable seal/stopper to maintain work area containment. (Stainless trash can is available) -Sharps tube is a straight 2 ½” diameter tube to facilitate quick drop of the largest syringes and provided with an easily removable seal/stopper to maintain work area containment.

-Fully adjustable sharps container shelf accommodates most commercially available wide mouth or hinged top sharps collectors. (Examples BD Part # 305610 and 305491)

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/product during massive breach of containment.

-Glove changes can be made without breaking containment.

-Locking casters are standard, seismic anchors are available.

Ergonomics- -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 into the work area eliminating reaching strains.

-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 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 reduce operator fatigue.

-Large viewing panel is at an angle to reduce glare and operator strain.

-Integrated foot rest.

Configuration Options- -Overall work area pressure can be either positive or negative and can be altered in-place by a certifier.

-Antechamber can be left or right handed or can be installed on both sides.

-Waste and sharps removal tubes can be left or right handed or can be installed on both sides.

-Three available exhaust options that can be factory set or changed by a certifier in-place.

Filtration- -Full framed standard size minipleat HEPAs filter 100% of inlet and exhaust air 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 Prefilter extends the life of the work area supply HEPA filter and can be replaced without tools.

Electrical- -High capacity motor/blower systems with speed control to extend HEPA filters 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.

-Voltage = 115 Volt, 60 Hz (220/50-60 Hz also available).

-Amperage rating- 15

Exhaust- -Clean air plenum is external to the work area.

-Constructed to allow for optional outside venting of exhaust air.

-Constructed to allow for 2 exhaust options that can be factory set or changed by a certifier in-place -Venting is not required for operation but is optional.

LFGI-3USP LFGI-4USP LFGI-6USP LFGI-6USP (Dual Airlocks) Exhaust Static Total Exhaust

Up to 2 inches w.c.

(depending on configuration)

Up to 2 inches w.c.

(depending on configuration)

Up to 2 inches w.c.

(depending on configuration)

Up to 2 inches w.c.

(depending on configuration)

Exhaust Connection Total Exhaust

CFM

8” OD Flexible duct

8” OD Flexible duct

8” OD Flexible duct

8” OD Flexible duct

Voltage/Phase 115/1 115/1 115/1 115/1 Average Running Amps

6 6 7 7

Weight uncrated

525 lbs (238.14 kg) 625 lbs (283.5 kg) 825 lbs (374.21 kg) 975 lbs (442.25 kg)

Shipping Weight

700 lbs (317.51 kg) 950 lbs (430.91 kg) 1200 lbs (544.31 kg) 1350 lbs (612.35 kg)

SECTION III. OPTIONAL EQUIPMENT AND ACCESSORIES-

(CONSULT YOUR SALESPERSON FOR PRICING)

LFGI-A33B

LFGI-A33TGOS

Two-Part Butadyl/Hypalon Sleeves 3 Groove Ring for Two-Part Glove/Sleeve with 4 O-Rings

LFGI-A83 Stainless Steel Garbage Can (9” x 14”) (attaches to side of unit to catch waste from discharge tubes)

LFGI-A12x Exhaust Transition Piece LFGI-A85S Stainless Steel Cleaning Handle LFGI-A51D Sealed Port in Side Panel for passage of data cables.

LFGI-A85M Lint Free Cleaning Mop Heads (Pkg 4)

LFGI-A80x Ergonomic Task Chair with Anti-Bacterial, Anti-Microbial Vinyl Covering Available in 5 colors:

Black, Charcoal, Navy, Teal or Wine

LFGI-A8E Electrical Height Adjustment LFGI-ADVD Operator Training DVD LFGI-SEISMIC Seismic Anchors, set of 2

LFGI-A33GRX

LFGI-A24

LFGI-A402C

GRx Rapid Exchange Glove System

Additional Pair of Stainless Steel Discharge tubes with seals Additional 2 Door HEPA Purge Stainless Steel Airlock with Sliding Tray -adds 16” (40.64 cm) to overall width of unit

LFGI-TCC In-Service Training and Set Up by factory Representative and Extended Warranty Program.

Upgrade of original warranty coverage to include labor cost and (1) additional year of extended warranty covering including parts and labor. Also includes (1) Isolator Training DVD, (1) Stainless Steel Cleaning Handle and (24) cleaning mop heads, (2) pairs of smooth Butadyl/ Hypalon isolator sleeves,

(3) cans of Stainless steel exterior shine,

(12) pre-filters

SECTION IV. UNIT DIAGRAMS

LFGI-3USP

LFGI-4USP

LFGI-6USP

LFGI-6USP DUAL

11 Aviator Way, Ormond Beach, FL 32174 * 800-888-5357 Phone * 386-677-1114 Fax * www.Germfree.com