Why isolators are still preferred when handling HPAPIs?

Oct 27, 2016

Inherent risks associated with HPAPIs

Highly-potent active pharmaceutical ingredients (HPAPIs) show effects at much smaller doses. Unintentional exposure to these agents could potentially result in undesirable effects on operators.


Handling challenges for HPAPIs

Handling HPAPIs is different from other active pharmaceutical ingredients. Specialized containment is required to protect workers, facilities, and environment from HPAPIs. Moreover, as applied to other pharmaceuticals, product protection from contamination and losses is also required.

Worker Protection   Product Protection   Environment Protection


Type of Containment Options


Band Category OEB 1 OEB 2 OEB 3 OEB 4 OEB 5
OEL (μg/m3) 10,000 to 1,000 1,000 to 100 100 to 50 50 to 10 10 to 1 1 to 0.1 0.1 to 0.01
Equipment / Containment Systems Local Exhaust Ventilation  
      Crossflow booth
  Downflow Booths  
  Cone Valves  
Split Butterfly Valves (SBV)     
SBV with Air Extraction     
SBV with Washing   
Rapid Transfer Ports (RTP)   


  1. Engineering Controls: Balancing Cost and Containment Hazard by P. Richards
  2. Occupational Exposure Banding by A. George
  3. Potent Product Process and Facility Design by S.C. Singhai


Why choose isolator then?


Benefits of Isolators

  • Minimized exposure to operator
  • Lowest cross contamination
  • Smaller contact surface area
  • Minimal energy requirements
  • Material handling without exposure
  • Ideal for aseptic processing
  • Localized inert gas environment is possible
  • Suitable for OEB 4 and 5 potent materials

Contamination and Containment


Source: Potent Product Process and Facility Design by S.C. Singhai


Esco is a world leader in Containment and Cleanroom Technologies

Esco provides containment systems for the manufacture and handling of HPAPIs. Our equipment are compliant with cGMP and other international standards, and provide comprehensive operator, product, and environment protection.


Our Products

Aseptic Containment Isolator (ACTI) General Processing Platform Isolator (GPPI)







Weighing and Dispensing Containment Isolator (WDCI) Containment Barrier Isolator (CBI)


For more information, contact us at:

Tel: +65 6542 0833

Fax: +65 6542 6920

Email: csis.pharma@escoglobal.com

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