Esco Isoclean Pharmacy Compounding Aseptic Containment Isolator (Recirculating), 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 Isoclean Compounding Aseptic Containment Isolator (Recirculating) 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.
- ISO Class 3 workzone
- Superior operator protection
- Fast purging time
- Motorized height stand
- Compliant to USP 797
- 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 are under negative pressure to the room in order to maintain operator protection in case of a breach in the barrier isolation system.
- Robust dual-wall construction. The work zone is 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 or pharmacy environment.
- 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.
Esco's Isoclean Compounding Aseptic Containment Isolator (Recirculating) 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
- Fixed height, available 711 mm (28") or 864 mm (34") - With leveling feet, ±38.1 mm (1.5") (SAL-_ _0) - With casters (SPC-_ _0)
- Telescoping height stand for leveling feet (STL-_ _0), nominal range 660 mm to 960 mm (26"to 37.8")
- Telescoping height stand for casters (STC-_ _0), 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 standing user's work surface height (SHM-_ A0)
Other Options and Accessories
- Anti Blowback Valve
- Electrical outlets
- IV bar, with hooks
- All stainless steel construction
- Sharps disposal system
- Cleaning accessories
- Alarm package
- Exhaust Carbon Filter
- Thimble Exhaust Collar
- Perforated shelf to increase work zone space
- All Stainless Steel Construction
|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 61010-1, Europe
IEC 61010-1, Worldwide