Products

IsoSeal Positive Pressure (Recirculating) Compounding Aseptic Isolators With Primary Containment HEPA Filtration System

Category:

Description

 KEY FEATURES

  • unique primary containment HEPA filtration system for maximum personnel, product &
    environment protection
  • superior ergonomic design & styling
  • 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 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 / event timer
  • ISO Class 5 (Class 100) air cleanliness work zone for absolute product protection
  • reliability-proven design & performance

 

APPLICATIONS
Gelman IsoSeal Positive Pressure (Recirculating) Compounding Aseptic Isolators with its unique primary containment HEPA filtration system are effective laboratory aids in obtaining the optimum control over product quality and meet the needs of pharmacy applications involving compounding and dispensing of non-hazardous pharmaceuticals or drugs, preparation of IV
solutions and eyedrops, TPN (Total Parenteral Nutrition), ampoule filling, quality controls and pharmacy routines that require absolute sterility.
The IsoSeal Positive Pressure (Recirculating) Isolators with Primary Containment HEPA Filtration System are commonly used for sterility testing of pharmaceutical products before release to market for distribution and use.

 

DESCRIPTION
The IsoSeal Positive Pressure (Recirculating) Compounding Aseptic Isolator with Primary Containment HEPA Filtration System offers a contained, positive pressure work zone to provide aseptic conditions within the work area for product protection.
Unidirectional HEPA-filtered airflow within the work zone minimizes cross-contamination across the work area. An effective physical barrier between the work zone and the environment is maintained by air-tight viewing windows.
The isolator work zone are maintained at a positive pressure to the room with the work area 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 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.

 

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

 

 

 

Specifications

PHYSICAL DATA

COMPLIANCE
Gelman IsoSeal Positive Pressure (Recirculating) Compounding Aseptic 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.