Products

IsoSeal Series Negative Pressure (Recirculating) Compounding Aseptic Containment Pharmaceutical Isolators With Primary Containment HEPA Filtration System

Description

KEY FEATURES

  • unique primary containment HEPA filtration system for maximum personnel, product & environment protection
  • superior ergonomic design & styling
  • microprocessor-controlled diagnostic system with audible alarm
  • negative pressure double-wall housings for containment
  • 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 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 IsoSeal Series Pharmaceutical Compounding Aseptic Containment Negative Pressure (Recirculating) Isolators with its unique primary containment HEPA filtration system are designed for compounding of hazardous or potent pharmaceutical compounds, chemotherapy agents and IV mixtures that can be harmful to pharmacy personnel and require both containment and aseptic manipulation.
Gelman IsoSeal Series Negative Pressure (Recirculating) 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.

For applications involving highly volatile hazardous drugs, the IsoSeal Series Pharmaceutical Compounding Aseptic Containment Negative Pressure (Total Exhaust) Isolators should be considered.

DESCRIPTION
The IsoSeal Series Pharmaceutical Compounding Aseptic Containment Negative Pressure (Recirculating) Isolator offers a contained, negative pressure work zone with a unidirectional HEPA-filtered airflow to prevent migration of hazardous contaminants to the environment and to minimize 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 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 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 fans, other internal cabinet components, maintenance technicians and the environment from contamination.
The filtered air is partially recirculated back to the work area through a supply HEPA filter on top of the work zone.
The remaining filtered air passes through an exhaust molecular carbon filter and is totally exhausted to the laboratory or outside atmosphere. The carbon filter removes aerosols, vapours or any gaseous contaminants released within the work zone.
The IsoSeal Series Pharmaceutical Compounding Aseptic Containment Negative Pressure (Recirculating) Isolators have all contaminated ducts and plenums under negative pressure.

 

Physical Data & Compliance


*Total height after mounting on base stand

COMPLIANCE
Gelman IsoSeal Series Pharmaceutical Compounding Aseptic Containment Negative Pressure (Recirculating) Isolators are manufactured under a rigorous Total Quality Management in full compliance with ISO 9001:2008, CETA CAG-001-2005, CETA CAG-002-2006 and USP Chapter 797.