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Isoclean - Compounding Aseptic Containment Isolator (Recirculating)

Isoclean - Compounding Aseptic Containment Isolator (Recirculating)
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Isoclean - Compounding Aseptic Containment Isolator (Recirculating)

Product catalog summary
Main Features
The Esco Isoclean Compounding Aseptic Containment Isolator provides superior air cleanliness with ULPA filters achieving >99.999% efficiency for particles 0.1 to 0.3 microns, ensuring ISO Class 3 air quality. It includes a Sentinel Gold™ Microprocessor for real-time monitoring of airflow and pressures, and a negative pressure work zone for operator protection. The ergonomic design features angled front and oval gloveports for comfort, and safe-change cuff rings for contamination-free glove changes. Available in 1.2 and 1.8 meters models, it offers options like a sharps disposal system and hydraulic height-adjustable stand.
Adjustable Hydraulic Support Stand
The motorized hydraulic stand allows for adjustable work positions, enhancing workflow and minimizing contamination risks. The optional sharps disposal system facilitates safe disposal through the work surface.
Barrier Isolation Systems
These systems provide superior sterility compared to open front devices, suitable for hazardous material compounding. The negative pressure, recirculating model is ideal for hazardous drug compounding, with optional exhaust filters for volatile substances.
Maximum Patient Protection and Sterility
The isolator integrates downflow and exhaust ULPA filters for comprehensive protection. It maintains ISO Class 3 conditions with rapid recovery post-contamination. Features include an airlock pass-thru, vertical sliding door, and optional sharps disposal system.
Ergonomic Enhancements
Designed to minimize operator stress, the isolator includes a sloped front, oval gloveports, and adjustable hydraulic stand. It supports various glove types and provides superior illumination with energy-efficient lighting.
Cabinet Construction
Constructed from pharmaceutical-grade stainless steel, the isolator is easy to clean with no welded joints. It features a single-piece work surface and antimicrobial coating to inhibit bacterial growth.
Sentinel Microprocessor Control System
This system monitors all cabinet functions, displaying pressures and airflow on an LCD screen. It includes optional alarms and password-protected access.
Fan Efficiency
The fan system is energy-efficient, with centrifugal motors minimizing noise and vibration. It includes variable speed controllers for precise airflow management.
Safety and Certification
The isolator meets all safety standards, with each unit factory-tested for electrical safety. It comes with a 3-year warranty, excluding consumables.
Accessories and Options
Available as a bench top unit with various accessories, including electrical outlets, support stands, and UV lamps. The isolator uses ULPA filters for superior filtration compared to conventional HEPA filters.
Standards Compliance
The isolator complies with multiple international standards, ensuring high performance in air quality, filtration, and electrical safety.
Overview: The document provides technical specifications and performance validation details for the Esco Pharmacy Isolator, specifically the Compounding Aseptic Containment Isolator (Recirculating) models HPI-4N and HPI-6N. These isolators are designed to maintain a controlled environment for pharmaceutical compounding.
Specifications:
  • Models: HPI-4N (4 feet) and HPI-6N (6 feet) with options for sharps disposal provisions.
  • Dimensions: Vary based on model and whether a base stand is used. For example, HPI-4N without a base stand measures 1340 x 820 x 1320 mm.
  • Construction: Made from electro-galvanized steel with an antimicrobial powder-coated finish and stainless steel work trays.
  • Filters: Equipped with ULPA filters for downflow, exhaust, and inlet, compliant with EN 1822 (H14) standards.
  • Electrical Requirements: Available in various voltage configurations with specific power and current ratings.
Performance Validation:
  • Air Change Rates: Ensures adequate separation between the main chamber and ambient environment.
  • Dynamic Pressure Test: Confirms pressure adequacy for maintaining differential pressure during operations.
  • Particle Counts: Verifies air cleanliness according to ISO 14644-1 standards.
  • Product Ingress and Egress Tests: Assesses the ability to maintain ISO Class 3 during material transfers.
  • Filter Leak Tests: Validates the integrity of ULPA filters.
  • Recovery Time Test: Measures time to return to ISO Class 3 after contamination events.
  • Operator Comfort Tests: Evaluates noise, light, and vibration levels.
Additional Features:
  • Optional accessories include IV bars, sharps disposal systems, cleaning accessories, and alarm packages.
  • Models can be equipped with carbon filters and thimble exhaust collars.
Conclusion: The Esco Pharmacy Isolator is a robust solution for maintaining a controlled environment in pharmaceutical compounding, with comprehensive testing and validation to ensure performance and safety.
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Catalog excerpts

Isoclean - Compounding Aseptic Containment Isolator (Recirculating)-1

Esco Isoclean Compounding Aseptic Containment Isolator, Compounding Aseptic Containment Isolator (Recirculating) The Premium Solution for Sterile Drug Compounding WORLD CLASS. WORLDWIDE.

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Main 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 negative pressure to the room in order to maintain operator protection in the event 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™...

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Vertical Pass Thru Door Horizontal Tray The vertical pass-thru door prevents ingress of contamination into the work zone during transfer procedures. The built-in electrical interlock prevents both doors from being opened at the same time. The horizontal tray prevents operator fatigue during transfer procedures. Optional Sharps Disposal System Airlock Pass-thru The airlock pass-thru ensures work zone remains sterile during insertion and removal of items. Optional sharps disposal system enables smoother work flow and minimizes transfers in order to enhance patient protection and sterility. Sharps...

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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. Maximum Patient Protection and Sterility • The combination of downflow and exhaust ULPA filters gives the Esco Pharmacy Isolator a fully integrated envelope for product and operator protection in all configurations. Product, Operator and Environment Protection Esco Isoclean Compounding Aseptic Containment Isolators...

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Work zone, interchange pressures and downflow velocity are continuously measured and displayed. Integrated true airflow sensor is temperature compensated for improved accuracy. Color coded indicator lamps display green for fan operation; blue for fluorescent lights and electrical outlet; and orange for AUX function ON . Password-protected administration can be set to restrict access to main menu. Enlarged, multi-line digital read-out with alpha-numeric display indicates all input, status and alarm functions. Optional audible and visual alarms warn of unsafe conditions such as low chamber pressure....

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Compounding Aseptic Containment Isolator (Recirculating) Exhaust ULPA filter Supply ULPA filter Ambient air is pulled through the inlet pre-filter located on top of the Isolator. The pre-filter traps larger particles and extends the life of the supply ULPA filter. Air from the top inlet and from work zone is pulled by the main fan, which creates positive pressure on the plenum that creates downflow. The work zone and pass-thru interchange are under negative pressure to the room. ULPA-filtered air Unfiltered / potentially contaminated air Room air / Inflow air The ULPA downflow filter creates...

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Glove Change Procedure Step 1 Normal operating condition glove and sleeve inside the isolator. Pull glove and sleeve outside the isolator. Twist sleeve and tie-up the sleeve with tie/band. Remove glove. Place new glove into the sleeve. Fold glove over cuff ring and install spring. Release tie/band. change rates in the main chamber and pass-thru. • IV bar, with hooks • Sharps disposal system • Cleaning accessories • Alarm package • Exhaust carbon filter • Thimble exhaust collar • Perforated shelf to increase work zone space Validated Performance Comprehensive design qualification and factory acceptance...

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Model HPI, Compounding Aseptic Containment Isolator (Recirculating) Technical Specifications Pharmacy Solutions • Compounding Aseptic Containment Isolator (Recirculating)

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Model HPI-6N_-_ (3 Gloves) 1. Esco Sentinel™ microprocessor control system 6. Pass-thru, hinged outer door 2. Hinged front window 7. Electrical outlet Retrofit Kit provision (2 single outlet on the right side of work area) 3. Oval glove ports 8. Exhaust ULPA filter 4. Hydraulic height adjustable base stand with casters (optional) 9. Intake ULPA filter 16. Pass-thru, inner door, vertical sliding 10. Carbon filter (optional) 5. Sharps / garbage disposal system (optional) 17. Removable paper catch 18. UV lamp retrofit kit provision (optional) 14. Downflow ULPA filter

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General Specifications, Compounding Aseptic Containment Isolator (Recirculating) Model Nominal Size Without Base Stand External Dimensions (W x D x H) With Base Stand (Min) With Base Stand (Max) Main Chamber Work Zone (W x D x H) Work Zone and Interchange Chamber Performance ISO Class 3 (Class 1, Federal Standard 209E) 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.) Downflow and Exhaust Filter and Inlet Filter Type Typical Filter Efficiency...

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Biological Safety Products Containment / Pharma Products Ductless Fume Hoods / Carbon Filtration General Purpose Scientific Equipment Industrial Lab Equipment In-Vitro Fertilization Products PCR Products Pharmacy Products Lab Animal Research Products Lab Thermostatics Products Lab Ventilation / Chemical Fume Products / Lab Furniture Powder Handling Products Biological Safety Cabinets • Cytotoxic Safety Cabinets • Laminar Flow Clean Benches • Pharmacy Isolators Esco Technologies, Inc. • 2940 Turnpike Drive, Units 15-16 • Hatboro, PA 19040, USA Toll-Free USA and Canada 877-479-3726 • Tel 215-441-9661...

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