The new Capintec CAP-Cell® Isolator is designed to provide an ISO Class 5 (Class 100) clean air environment to meet the new and more stringent requirements of USP <797> for aseptic sterile compounding.

This shielded negative pressure recirculating isolator is the ideal system for compounding and dispensing injectable Nuclear Medicine radiopharmaceuticals. The unit incorporates a sealed glove box and interchange chamber, with 1/8 inch (optional ¼ inch) of lead shielding to front door, sides, and floor. Additional shielding on front face provides a full ¼ inch lead body shield. The sealed isolator also eliminates the costly requirement for placement in an exterior ISO Class 7 (Class 10,000) clean room. The standard system uses HEPA filtered air with partial recirculation and room air exhaust. This feature eliminates the need for HVAC hookup and reduces operating costs. Optional external exhaust accessories are available for HVAC hookup if desired. The model has a fully hinged front panel to allow easy access for cleaning and equipment placement. The sealed interchange chamber allows the user to transfer materials without compromising the air quality of the primary cell.

SPECIFICATIONS

• Isolator:

• Sealed glove box design with sealed interchange chamber
• Unit shall maintain ISO Class 5 (Federal Standard 209E Class 100) within workzone and interchange chamber
• Negative pressure, with sufficient interchange chamber pressure differential to maintain sterility in glove box
• Interchange door is interlocked to prevent inadvertent opening when outer door is open
• Two removable work trays with cove corners for main and interchange chambers
• HEPA filter for supply air protected by non flammable perforated metal diffuser
• HEPA filter seal is spring loaded Neoprene
• Partial re-circulating or total exhaust choice
• Externally mounted fluorescent lighting
• Hospital grade duplex outlet on back wall with drip proof cover
• Hinged front face, ergonomically slanted at 10° from vertical
• 16 GA, Type 304 stainless steel liner with reinforced U channels
• Top/Front filter removal access without disassembly of control panel
• Two 8 inch diameter glove ports
• Two circular nitrile rubber gloves
• Two circular nitrile rubber sleeves
• Three position IV bar with six hooks
• Key locks included on external front face

• Shielding/Base

• Viewing window: 1/2 in. of 4.8 g/cm3 leaded glass, 25 in. wide x 7 1/2 in. height
• 1/8 in. lead shielding on base, back and sides (optional 1/4 in.)
• 1/8 in. lead shielding on hinged front panel excluding glove ports and viewing window
• 1/4 in. lead body shield in center of front panel
• Base penetrations are sized for sharps container and flush mount dose calibrator chamber
• 1/8 in. lead shielding for sharps container (Optional 1/4 in.)
• Articulating arm for calibrator readout mounted on base
• Exterior steel cosmetic panels painted epoxy enamel
• Heavy duty base support-adjustable height with 10 in. range
• Height adjustment to center of glove port-42 1/2 in. to 52 1/2 in.

• Electrical/Control Panel

• Exhaust interlock to prevent positive pressure workzone and interchange
• Centrally located control panel for adjustable airflow and lights
• Airflow adjustment via solid state motor voltage regulator
• Fuses located in control panel
• Two minihelic gauges
• Meets UL requirements for U.S. and Canada for electrical safety
• UL/UL-C Listed 115 V, AC 60 Hz, 6 Amps (220V/50 Hz option)
• 12 ft. Hospital Grade Power Cord
• Exhaust rate 65 CFM (110CMH) @ 0.1in. w.g. (external exhaust option only)

• Installation

• Unit is designed for customer installation
• Disassembled unit will fit through standard 36 in. doorway
• Base adjustment must be set before placing shielded glove box

• Options

• Thimble kit for external exhaust
• Additional lead shielding (1/4 in. total) on sides, floor, and sharps shield

ITEM MEASUREMENTS

• Overall Dimensions: 51.5" w x 31" d x 80.5"- 90.5" h (130.8 x 78.7 x 204.4 - 229.9 cm) , depending upon adjustable base setting
• Workzone Dimensions: Main Cell 35.25" w x 23.25" d x 27.375" h (89.5 x 59 x 69.5 cm)
• Interchange Chamber Dimensions: 14.125" w x 24" d x 27.375" h (35.8 x 60.9 x 69.5 cm)
• Interior sliding door: 18" w x 8.5" h (45.7 x 21.6 cm)
• Weight: 1/8" 1,200 lbs. (.3175 cm 544 kg), 1/4" option 1,600 lbs. (.635 cm 725.7 kg)

ITEM NUMBERS

CAP-Cell® with 1/8" lead............................................................... 5530-3140

CAP-Cell® with 1/4" lead............................................................... 5530-3141

OPTIONAL ACCESSORIES

CRC®-25R Dose Calibrator ........................................................... 5130-3215

2 Gallon Chemotherapy Sharps Containers ................................. 0660-0022

Nitrile Rubber Gloves (25 Pair): Small ......................................... 5500-0006

Nitrile Rubber Gloves (25 Pair): Medium..................................... 5500-0007

Nitrile Rubber Gloves (25 Pair): Large......................................... 5500-0008

Nitrile Rubber Gloves (25 Pair): X-Large..................................... 5500-0009

Nitrile Rubber Sleeves..................................................................... 5500-0004

Glove Port Clamps........................................................................... 5500-0003

CRC®-55tR Dose Calibrator.......................................................... 5130-3234