Esco Isoclean Pharmacy Compounding Aseptic Isolator, provides a safe and clean environment for compounding of non-hazardous, sterile drug preparations and IV admixtures in compliance with USP 797* criteria.
Barrier isolation system provides inherently superior sterility compared to open fronted 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 fronted 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 Isoclean Pharmacy Compounding Aseptic Isolator is suitable for work involving non-hazardous materials. The work zone and pass-thru interchange are under positive pressure to the room in order to maintain sterility in case of a breach in the barrier isolation system. Negative pressure models should be selected for antineoplastic or cytotoxic compounding applications.
*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
• Fast purging time
• Motorized height stand
• Compliant to USP 797
Features
•ULPA filters with a typical efficiency of 99.999% at 0.1 to 0.3 microns provide superior ISO Class 3 air cleanliness, 100 times better than competing products.
•Sentinel Gold™ Microprocessor controller supervises all functions and monitors airflow and pressures in real-time.
•Work zone and pass-thru interchange are under positive pressure to the room in order to maintain sterility in case of a breach in the barrier isolation system.
•Airlock pass-thru interchange ensures main work zone remains sterile during insertion and removal of items.
•Robust dual-wall construction. All positive pressure work zones are surrounded by negative pressure plenums at the sides and back. Unique Esco Dynamic Chamber™ plenum surrounds filter seals with negative pressure.
•Ergonomically angled front and oval gloveports improve reach and comfort.
•Safe-change cuff rings permit glove changes with zero risk of contaminating the work zone.
•One piece work zone liner with no crevices is easy to clean.
•Esco Isocide™ antimicrobial coating on all painted surfaces minimizes contamination.
•Sharps disposal system and hydraulic height-adjustable stand are available as options.
Models
Model No. |
External
Dimensions (mm) |
Internal
Dimensions (mm) |
Airflow
Velocity (Inflow) |
Airflow
Velocity (Downflow) |
Electrical |
HPI-4P1 |
1522 x 820 x 1995 |
main chamber: 840x610x670 |
- |
0.28(m/s) /
55(fpm) |
220-240V,AC, 50Hz,1ø |
HPI-4P2 |
110-120V,AC, 60Hz,1ø |
HPI-4P3 |
220-240V,AC, 60Hz,1ø |
HPI-6P1 |
2132 x 820 x 1995 |
main chamber:1450x610x670 |
- |
0.28(m/s) /
55(fpm) |
220-240V,AC, 50Hz,1ø |
HPI-6P2 |
110-120V,AC, 60Hz,1ø |
HPI-6P3 |
220-240V,AC, 60Hz,1ø |
Accessories
Esco's Isoclean Pharmacy Compounding Aseptic Isolator is available as a standard bench top unit. Additional accessories are available for further enhancement.
Electrical Outlets and Utility Fittings
•Electrical outlet, ground fault, North America
•Electrical outlet, Euro/Worldwide
Support Stands
•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 accommodate a sitting or a standing user's work surface height (SHM)
Other Options and Accessories
•IV bar, with hooks
•All stainless steel construction
•Sharps disposal system
•Cleaning accessories
•Alarm package
•All Stainless Steel Construction
Certification
STANDARDS COMPLIANCE |
CABINET PERFORMANCE |
AIR QUALITY |
FILTRATION |
ELECTRICAL SAFETY |
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 |
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