Products

IsoSeal Series Positive Pressure Compounding Aseptic Pharmaceutical Isolators

Description

KEY FEATURES

  • superior ergonomic design & styling
  • microprocessor-controlled diagnostic system with 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 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 Positive Pressure Compounding Aseptic Pharmaceutical Isolators are effective laboratory aids in obtaining the optimum control over product quality and meet the needs of pharmacy applications involving aseptic compounding of non-hazardous pharmaceuticals or drugs, preparation of IV solutions and eyedrops, TPN (Total Parenteral Nutrition), ampoule filling and pharmacy routines that require absolute sterility.

DESCRIPTION
The IsoSeal Series Positive Pressure Compounding Aseptic Pharmaceutical Isolator offers a contained, positive pressure work zone with a unidirectional HEPA-filtered airflow to provide aseptic conditions within the work area for product protection.
An effective physical barrier between the operator and the work zone, maintained by an air-tight viewing window prevents contaminants from the outside entering the work area.
The isolator work zone and transfer chamber are maintained at a positive pressure to the room with the work zone pressure slightly more positive 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 easily accessible 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 filtered downflow air is largely recirculated back to the work area through the supply HEPA filter on top of the work zone.
The remaining downflow air is discharged to the laboratory or outside atmosphere after HEPA filtration.

Physical Data & Compliance

COMPLIANCE
Gelman IsoSeal Series Pharmaceutical Compounding Aseptic Positive 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.