Products

IsoSeal Series Negative Pressure (Total Exhaust) Compounding Aseptic Containment 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
  • 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 common transfer chamber with HEPA filtration
  • sliding chamber tray for easy access & transfer of product
  • microprocessor-controlled diagnostic system with digital display & audible alarm
  • hourmeter,
  • delayed-automatic-off timer
  • elapsed timer
  • ISO Class 5 (Class 100) air cleanliness work zone and transfer chamber for absolute product protection
  • reliability-proven design & performance

 

APPLICATIONS
Gelman IsoSeal Series Negative Pressure (Total Exhaust) Compounding Aseptic Containment 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 IsoSeal Series Negative Pressure (Total Exhaust) Compounding Aseptic Containment 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 highly volatile 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 Isolator offers a contained, negative pressure work zone to prevent migration of hazardous contaminants to the environment.
Unidirectional HEPA-filtered airflow within the work zone minimizes cross-contamination.
An effective physical barrier between the operator and the work zone, maintained by an air-tight viewing window provides personnel protection.
The work zone is maintained at a negative pressure to the room with the transfer chamber pressure slightly more negative than the work area.
Operations in the isolator are carried out through rubber gloves attached to large diameter glove ports, ergonomically located for greater operator arms movement.
The main viewing window with the glove ports attached, is hinged along the top and may be fully opened for cleaning, loading and unloading of auxiliary equipment.
The transfer chamber is equipped with an external door to the outside and an inter-chamber vertical sliding door to the work area. The inter-chamber door allows operator to introduce or remove items from the work area 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.
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.
HEPA-filtered entry / exit transfer chamber with prefilter provides sterile entry / exit of product from the work area.
The air from the transfer chamber blends with the contaminated work area air in a sump beneath the work surface and is filtered by a primary containment HEPA filter located below the work area. The filter arrests all the particulates released within the work zone, thereby protecting fan, other internal 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 isolator or return to the laboratory.
An exhaust Terminal Fan Module can be installed when the building exhaust system is inadequate to overcome the static pressure of the isolator.

 

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

 

 

Specifications

PHYSICAL DATA

COMPLIANCE
Gelman IsoSeal Series Negative Pressure (Total Exhaust) Compounding Aseptic Containment Isolators with Primary Containment HEPA Filtration System 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.