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Isoclean® Pharmacy Compounding Aseptic Isolator

Solutions for USP <797> Compliance Picture
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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 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 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

 

ULPA ISOCIDE

  • 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.
Model No. External
Dimensions (mm)
Internal
Dimensions (mm)
Airflow
Velocity (Inflow)
Airflow
Velocity (Downflow)
Electrical
HPI-4P2
1522 x 820 x 1995
main chamber: 840x610x670
-
0.28(m/s) /
55(fpm)
110-120V,AC, 60Hz,1ø
HPI-6P2
2132 x 820 x 1995
main chamber:1450x610x670
-
0.28(m/s) /
55(fpm)
110-120V,AC, 60Hz,1ø
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
Solutions for USP <797> Compliance Airflow

  • Ambient air is pulled through the inlet pre-filter and 99.999% efficient filter located on top of the isolator. The pre-filter traps large size particles to extend the life of the 99.999% efficient filter.
  • Air from the top inlet and from the work zone is pulled by the blower, which creates positive pressure on the plenum that creates downflow. The proprietary plenum design ensures that more air goes to the work chamber, making it have a greater positive pressure at a specified magnitude than the transfer chamber to prevent outside contaminants from entering the work chamber through the transfer chamber.
  • The ULPA downflow filters create a laminar and particle-free ISO Class 3 environment inside the isolator to protect the work material inside the main chamber and transfer chamber.
  • Air from the work chamber and transfer chamber 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 the ULPA downflow filter again, it is re-circulated back to the work and transfer chambers. The high rate of airflow re-circulation helps to prolong the filter life and reduces the chance of ambient contaminants to enter the work chamber.
  • Approximately 10% of the purged air is exhausted through an ULPA filter to prevent heat build-up inside the isolator that can be detrimental to drug compounding. This exhausted air is replenished by ambient air coming from the top inlet pre-filter and 99.999% efficient filter.

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