Products

Besaire Isoseal Series Negative Pressure (Total Exhaust) Compounding Aseptic Containment Pharmaceutical Isolators with Primary Containment HEPA Filtration System

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Description

KEY FEATURES

  • unique primary containment HEPA filtration system for maximum personnel, product & environment protection
  • superior ergonomic design & styling
  • microprocessor-controlled diagnostic system with digital display & audible alarm
  • all stainless steel work zone construction with radiused & crevice-free corners
  • spacious work zone interior
  • smooth opening/closing pneumatically controlled viewing window
  • large diameter glove ports ergonomically located for greater operator arms movement
  • spacious sterile entry / exit stainless steel common transfer chamber with HEPA filtration
  • sliding chamber tray for easy access & transfer of product
  • ISO Class 5 (Class 100) air cleanliness work zone and transfer chamber for absolute product protection
  • UNI-FLO LAF system for improved performance & cost savings
  • ZERO-LEAK airflow system for enhanced safety
  • reliability-proven design & performance
  • ultra-quiet,low vibration operation
  • low maintenance & operating costs

 

APPLICATIONS
Gelman Besaire IsoSeal Series Negative Pressure (Total Exhaust) Compounding Aseptic Containment Pharmaceutical Isolators with its unique primary containment HEPA filtration system are designed for compounding of highly volatile hazardous drugs or potent pharmaceutical compounds, chemotherapy agents and IV mixtures that can be harmful to pharmacy personnel and require both containment and aseptic manipulation.
Gelman Besaire IsoSeal Series Negative Pressure (Total Exhaust) Compounding Aseptic Containment Pharmaceutical Isolator is an effective laboratory aid in providing total protection for

  • all personnel and environment from any aerosols, particles or vapours which may be liberated in the preparation, manipulation and dispensing of hazardous drugs.
  • drug products so that they are prepared or dispensed in an environment free from particulates including biological matter.
  • maintenance and testing personnel from exposure to the residue of drug products which may contaminate cabinet filters, mechanical components and other surfaces.

DESCRIPTION
The IsoSeal Series Negative Pressure (Total Exhaust) Compounding Aseptic Containment Pharmaceutical Isolator offers a contained, negative pressure work zone to prevent migration of hazardous contaminants to the environment. Uni-directional HEPA-filtered airflow within the work zone and transfer chamber minimizes cross-contamination across the work area.
An effective physical barrier between the operator and the work zone, maintained by an air-tight viewing window provides personnel protection and prevents contaminants from the outside entering the work area.
The isolator work zone and transfer chamber are maintained at a negative pressure to the room with the work zone pressure slightly more negative than the transfer chamber.
Operations in the isolator are carried out through rubber gloves attached to large diameter glove ports, ergonomically located for greater operator arms movement. The viewing window with the glove ports attached, is hinged along the top and may be fully opened for cleaning, loading and unloading of pharmacy equipment.
The common transfer chamber is equipped with an external door to the outside and an inter-chamber vertical sliding door to the work zone. The inter-chamber door allows operators to introduce or remove items from the work zone while maintaining the internal aseptic conditions.

OPERATION
Ambient air is drawn in through an intake prefilter on top of the isolator and is introduced to the work area through a supply HEPA filter which comprises the top of the work zone.
HEPA-filtered vertical airflow free from airborne contaminants is projected downwards over the work surface to create an ultra-clean ISO Class 5 (Class 100) air cleanliness work area for aseptic work and product protection.
The downflow air blends with the contaminated work area air in a sump beneath the work surface and passes through a primary containment HEPA filter located below the work zone. The filter arrests all particulates released within the work zone, thereby protecting fan, other internal cabinet components, maintenance technicians and the environment from contamination.
The filtered air is totally discharged to the outside atmosphere via a dedicated facility exhaust system after being treated by a final exhaust HEPA filter, without recirculation in the cabinet or return to the laboratory.
The IsoSeal Series Negative Pressure (Total Exhaust) Compounding Aseptic Containment Pharmaceutical Isolators have all contaminated ducts and plenums under negative pressure.

 

MICROPROCESSOR CONTROL
Microprocessor-controlled diagnostic system with digital display & audible alarm

 

Specifications

PHYSICAL DATA
*Total height after mounting on base stand

COMPLIANCE
Gelman Besaire IsoSeal Series Negative Pressure (Total Exhaust) Compounding Aseptic Containment Pharmaceutical Isolators are manufactured under a rigorous Total Quality Management in full compliance with ISO 9001:2015, CETA CAG-001-2005,
CETA CAG-002-2006 and USP 797 / USP 800.