Hospital Pharmacy Isolator (Negative, Recirculation Pressure)

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 HPI model 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.

Alternatively, a negative pressure, total exhaust isolator should be selected.

Model		GPI-4-NS	GPI-6-NS
		Add to Quotes	Add to Quotes
External Dimensions	Without Base Stand	52.8" x 32.3" x 51.9" 1340 x 820 x 1320 mm	76.8" x 32.3" x 51.9" 1950 x 820 x 1320 mm
	With Base Stand (Min)	59.9" x 32.3" x 78.5" 1522 x 820 x 1995 mm	83.9" x 32.3" x 78.5" 2132 x 820 x 1995 mm
	With Base Stand (Max)	59.9" x 32.3" x 88.6" 1522 x 820 x 2250 mm	83.9" x 32.3" x 88.6" 2132 x 820 x 2250 mm
Main Chamber Work Zone		33.1" x 24.0" x 26.4" 840 x 610 x 670 mm	57.1" x 24.0" x 26.4" 1450 x 610 x 670 mm
Pass Through		13.9" x 24.0" x 26.4" 355 x 610 x 670 mm	13.9" x 24.0" x 26.4" 355 x 610 x 670 mm
Work Zone and Interchange Chamber Performance		ISO Class 3 (Class 1, Federal Standard 209E)
Inlet Filter Type		80% efficiency filter
Downflow and Exhaust Filter Type		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 and exhaust filters)
Fluorescent Lamp Intensity		> 950 Lux (> 88 foot candles)
Isolator Construction	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

Maximum Patient Protection and Sterility

Robust construction and enhanced safety features qualify the Hospital Pharmacy Isolator for the most demanding laboratory applications. The isolator is fully assembled and ready to install and operate when shipped.

The combination of downflow and exhaust ULPA filters gives the Pharmacy Isolator a fully integrated envelope for product protection in all configurations.
Advanced mini-pleated supply ULPA filter is tested to >99.999% efficiency for 0.1 to 0.3 micron particulates, significantly better than conventional HEPA filters.
An improved mini-pleat separation technique maximizes filter surface area, improves efficiency and extends filter life over conventional separation.
The ULPA supply filter provides clean air to the work surface in a gentle vertical laminar flow.
Superior air cleanliness of ISO Class 3, 100 times better than competing products.
Laminar (unidrectional) airflow within work zone and pass-thru enables recovery of chamber atmosphere to ISO Class 3 conditions within 3 minutes following a worse-case contamination event. The entire work zone air is changed 20-30 times per minute. Refer to separate information on recovery testing carried out.
Airlock pass-thru ensures work zone remains sterile during insertion and removal of items. Items are inserted into the pass thru, surface decontaminated, the outer pass thru door is closed, while the atmosphere is allowed to purge. Finally, the inner pass-thru vertical door is opened from within the work zone in order to transfer materials into the main work area.
Vertical sliding door between pass-thru and work zone minimizes ingress of particulates from the pass-thru during transfer operations compared with conventional swing door designs.
Optional sharps disposal system enables smoother work flow and minimizes transfers in order to enhance patient protection and sterility. Sharps may be disposed through the work surface into disposal bins while minimizing contamination of the work zone. Interface between sharps disposal bin and isolator is aerosol tight to avoid ingress of contamination during the disposal operation.
Safe-change cuff ring enable glove change with zero risk of contamination.

SentinelTM Microprocessor Control, Monitoring System

The Sentinel™ microprocessor-based control system supervises operation of all cabinet functions. Controls are configurable to meet user requirements. Features of the main control panel include:

Work zone and pass-thru pressure is monitored and displayed on the LCD screen.
Continuous monitoring and display of cabinet laminar (downflow) airflow on large, easy-to-read LCD display.
An optional alarm package is available for users with more sophisticated requirements.

Blower Efficiency

The Hospital Pharmacy Isolator blower system is designed for maximum energy efficiency and minimal maintenance.

Centrifugal, direct-drive, external rotor motors reduce operating costs.
Unique motor/blower orientations minimize noise and vibration.
Built-in solid-state variable speed controllers are infinitely adjustable from Off to Maximum.

Airflow

"Blue Box" ULPA-Filtered Air
"Red Box" Unfiltered / Potentially contaminated Air
"Green Box" Room Air / Inflow Air

Ambient air is pulled through the inlet pre-filter and 80% efficient filter located on top of the isolator. The pre-filter traps large size particles to extend the life of the 80% efficient filter.
Air from the top inlet and from work zone is pulled by the fan, which creates positive pressure on the plenum that creates downflow. Work zone pressure is always higher than the pass-thru, to prevent contaminants from entering the work zone through the pass-thru.
The ULPA downflow filter creates a laminar and particle-free ISO Class 3 environment inside the isolator to protect the work material inside the main chamber and pass-thru.
Air from the work zone and pass-thru is quickly purged out by the fan to keep the area clean. The fan pulls approximately 90% of the purged air back to the plenum and after passing through the ULPA downflow filter again, it is re-circulated back to the work and pass-thru. The high rate of airflow re-circulation helps to prolong filter life.
Approximately 10% of the recirculated air is exhausted through an ULPA filter to prevent heat build-up inside the isolator. This exhausted air is replenished by ambient air coming from the top inlet pre-filter and 80% efficient filter.

Safety and Certification

All components used in products meet or exceed all applicable safety requirements.
Each cabinet is individually factory tested for electrical safety.
Documentation specific to the cabinet serial number is maintained on file.

Warranty

The Pharmacy Isolator comes with a 3-year warranty excluding consumable parts and accessories. Contact your local sales representative for specific warranty details.

Accessories and Options

Hospital Pharmacy Isolator is available as a standard bench top unit. Additional accessories are available for further enhancement.

Electrical outlet, ground fault, North America
Electrical outlet, Euro/Worldwide
Fixed height, available 711 mm (28") or 864 mm (34")
- With leveling feet, ±38.1 mm (1.5") (SAL)
- With casters (SPC)
Telescoping height stand for leveling feet (STL), nominal range 660 mm to 960 mm (26"to 37.8")
Telescoping height stand for casters (STC), nominal range 660 mm to 880 mm (26" to 34.6")
- Adjustable in 25.4 mm (1") increments
Infinitely adjustable hydraulic stand, with casters elevates to seating or standing work surface height (SHM)
Other Options and Accessories
IV bar, with hooks
All stainless steel construction
Sharps disposal system
Cleaning accessories
Alarm package
Perforated shelf to increase work zone space

Validated Performance

Comprehensive design qualification and factory acceptance tests are performed on the Esco Hospital Pharmacy Isolator.
Filter Leak Tests verify the integrity of the ULPA filters as-installed.
Downflow Velocity Tests verify adequate laminar air flow velocities and air change rates in the main chamber and pass-thru.
Dynamic Pressure Test determines if main chamber and pass-thru pressures are adequate to aid in providing separation between the main chamber and ambient environment. Glove-pull’s are simulated to ensure differential pressure is maintained during actual operation.
Particle Counts (Air Cleanliness Tests) verify air cleanliness in accordance with ISO 14644-1 criteria for both the main chamber and pass-thru.
Product Ingress and Egress Tests determines if the isolator work zone can maintain ISO Class 3, during material transfers with no wait or purge time during the transfer process, when used outside an ISO Class 7 cleanroom, as per USP 797.
Recovery Time Test determines the amount of time the main chamber takes to recover to ISO Class 4 after an event such as a full window opening or large scale contamination.
Gauntlet Breach Test determines product protection in case of a glove failure.
Operator Comfort Tests include noise, light and vibration.

Standards Compliances	Cabinet Performance	Air Quality	Filtration	Electrical Safety
Standards Compliances	CETA CAG-001-2005, USA CETA CAG-002-2006, USA USP Chapter 797, USA	ISO 14644.1, Class 3, Worldwide JIS B9920, Class 3, Japan JIS BS5295, Class 3, Japan US Fed Std 209E, Class 1 USA	EN-1822, Europe IEST-RP-CC001.3, USA IEST-RP-CC007, USA IEST-RP-CC034.1, USA	EN 61010-1, Europe IEC 61010-1, Worldwide