Negative Pressure Hospital Pharmacy Isolator

Barrier isolation system provide inherently superior sterility compared to open front clean air devices such as laminar flow clean benches and Class II biological safety cabinets. USP797 guidelines specify that isolators may be situated in an area subject to less severe environmental controls compared with open front clean air devices.

When used as part of a system that includes operator aseptic technique training, process validation, expiration setting, product quality maintenance after the CSP leaves the pharmacy, isolators are a cost-effective solution especially for lower-volume pharmacies. They reduce operating and renovation costs, take up less space, and are easier to maintain.

The negative pressure, recirculating isolator is suitable for work involving hazardous materials, antineoplastic, or cytotoxic compounding applications. The work zone and pass-thru interchange are under negative pressure to the room in order to maintain operator protection in case of a breach in the barrier isolation system.

When hazardous drugs compounded have the potential to volatilize, the negative pressure, recirculating isolator should be ordered with the optional exhaust activated carbon filter and / or externally vented.

Product Description

Streamline® Pharmacy Compounding Aseptic Containment Isolator, provides a safe and clean environment for compounding of hazardous, sterile drug preparations in compliance with USP 797* criteria.

Barrier isolation system provides inherently superior sterility compared to open front clean air devices such as laminar flow clean benches and Class II biological safety cabinets. USP797 guidelines specify that isolators may be situated in an area subject to less severe environmental controls compared with open front clean air devices.

When used as part of a system that includes operator aseptic technique training, process validation, expiration setting and product quality maintenance after the CSP leaves the pharmacy, isolators are an effective solution especially for lower-volume pharmacies. They reduce operating and renovation costs, take up less space, and are easier to maintain.

The Streamline® Compounding Aseptic Containment Isolator is suitable for work involving hazardous materials, antineoplastic, or cytotoxic compounding applications. The work zone and pass-thru interchange are under negative pressure to the room in order to maintain operator protection in case of a breach in the barrier isolation system.

* United States Pharmacopoeia (USP), Chapter 797(1), enacted January 1, 2004, presents the first enforceable standards for sterile compounding. Following years of patient safety recommendations and professional guidelines, the intent of USP 797 is to set forth the procedural and practical requirements for safe compounding of sterile preparations. The Chapter’s requirements are applicable in all practice settings where sterile preparations are compounded.

Key Benefits:

  • ISO Class 3 workzone
  • Superior operator protection
  • Fast purging time
  • Motorized height stand
  • Compliant to USP 797
Part NumberGPI-4-NSGPI-6-PS
External Dimensions
(WxDxH)
Without Base Stand - 52.8" x 32.3" x 51.9"

With Base Stand (Min) - 59.9" x 32.3" x 78.5"

With Base Stand (Max) - 59.9" x 32.3" x 88.6"
Without Base Stand - 76.8" x 32.3" x 51.9"

With Base Stand (Min) - 83.9" x 32.3" x 78.5"

With Base Stand (Max) - 83.9" x 32.3" x 88.6"
Main Chamber Work Zone (WxDxH)33.1" x 24" x 26.4"57.1" x 24" x 26.4"
Pass Through (WxDxH)13.9" x 24" x 26.4"13.9" x 24" x 26.4"
Work Zone and Interchange Chamber PerformanceISO Class 3 (Class 1, Federal Standard 209E)ISO Class 3 (Class 1, Federal Standard 209E)
Downflow and Exhaust Filter and Inlet Filter TypeULPA filter with integral metal guards and filter frame gaskets; fully compliant with EN 1822 (H14) and IEST-RP-CC001.3 requirements (each cabinet has individual downflow, exhaust filters and inlet filters.)ULPA filter with integral metal guards and filter frame gaskets; fully compliant with EN 1822 (H14) and IEST-RP-CC001.3 requirements (each cabinet has individual downflow, exhaust filters and inlet filters.)
Typical Filter Efficiency>99.999% for particle size between 0.1 to 0.3 micron>99.999% for particle size between 0.1 to 0.3 micron
Fluorescent Lamp Intensity> 950 Lux (> 88 foot candles)> 950 Lux (> 88 foot candles)
Isolator ConstructionMain Body -1.2 mm (0.05") 18 gauge electrogalvanised steel with white oven-baked epoxy antimicrobial powder-coated finish

Work Tray - 1.5 mm (0.06") 16 gauge stainless steel, type 304, with 4B finish

Side Walls - 1.2 mm (0.05") 18 gauge stainless steel, type 304, with 4B finish
Main Body -1.2 mm (0.05") 18 gauge electrogalvanised steel with white oven-baked epoxy antimicrobial powder-coated finish

Work Tray - 1.5 mm (0.06") 16 gauge stainless steel, type 304, with 4B finish

Side Walls - 1.2 mm (0.05") 18 gauge stainless steel, type 304, with 4B finish