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)   
  Isolators

Source:

  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

Other News


Esco Pharma at the 52nd ASHP Midyear Clinical Meeting and Exhibition 2017

Date: Dec 15, 2017


Raising Your Standards with Esco Downflow Booth
Airflow Containment on Its Best

Date: Nov 29, 2017


Bio-decontamination Within
The Efficiency of Esco BioVap™ Inside the Isolators

Date: Nov 28, 2017


Esco Pharma GB exhibited at CPhI and P-Mec in Germany

Date: Nov 08, 2017


Survivor 101: Safe Change Filtration

Date: Nov 07, 2017


The Horror Behind the Gross Art of Sneeze and Cough

Date: Oct 27, 2017


Esco Life Sciences and Healthcare is Strengthening its Core in Biocontainment

Date: Oct 18, 2017


Esco Pharma is at Two Places at Once

Date: Oct 05, 2017


A Perfect Mate

Date: Sep 27, 2017


Nanotechnology: Containment Strategies and Engineering Controls

Date: Sep 26, 2017


It’s more than just being Fragile : How to Handle Potent Formulation?

Date: Sep 25, 2017


Innovative Solutions for the Next Generation: Esco Pharma at ISPE 2017

Date: Aug 30, 2017


How SAFE is your FOOD?

Date: Aug 30, 2017


Nanotechnology in Pharmaceutical R&D: Drug Delivery System

Date: Jul 25, 2017


Inhaled Insulin: Boon or Bane?

Date: Aug 11, 2017


Esco Pharma at High Potent Medicines Conference 2017

Date: Jun 21, 2017


Quality Assurance System

Date: Jun 16, 2017


Defects

Date: Jun 16, 2017


Esco Pharma GB is moving!

Date: May 30, 2017


Esco Pharma at INTERPHEX 2017

Date: Apr 04, 2017


Esco Isoclean® Isolators Aid in a Pharmacy Compounding Facility in Singapore

Date: Mar 17, 2017


Esco Pharma Advancing Aseptic Pharmaceutical Processing with SP Scientific PennTech and ESS Technologies

Date: Jan 26, 2017


Esco joins the biggest pharma event in South Asia!

Date: Nov 28, 2016


Feeling Alienated by Safety?

Date: Dec 01, 2016


Blow-Fill-Seal Technology and Isolators

Date: Nov 22, 2016


How Clean is Clean Enough?

Date: Nov 08, 2016


Be SAFE in Handling High Potency APIs

Date: Oct 26, 2016


Cytotoxic Drugs: Safe Handling in the Workplace!

Date: Oct 17, 2016


Esco isolator finally arrives in the land of the rising sun

Date: Sep 26, 2016


Esco Healthcare exhibits at the 16th ISPE – Singapore Affiliate

Date: Sep 16, 2016


Unidirectional or Turbulent Airflow: Which is best for Sterile Pharmacy Compounding?

Date: Sep 01, 2016


Discover the most diverse compounding pharmacy isolators

Date: Aug 18, 2016


The need for engineering controls in preventing compounding pharmacy mishaps

Date: Jul 19, 2016


Esco at the ASHP in Baltimore!

Date: Jun 23, 2016


Esco at the 2016 PPhA National Convention in Cebu City

Date: Jun 01, 2016


Esco Pharma ships out General Processing Platform Isolator (GPPI) to a client in Canada

Date: Jan 04, 2016


Esco Launches VacciXcell and TapestleRx

Date: Dec 03, 2015


VacciXcell commences the 1st day of exhibition at the Europe Vaccine Congress 2015 in Madrid

Date: Nov 10, 2015


Esco Pharma exhibited concurrently in Pharma Expo Las Vegas and IPEX Packaging Expo in Jakarta

Date: Oct 07, 2015


Esco Pharma partners with UP College of Pharmacy

Date: Jul 09, 2015


Thank you for visiting Esco at ACHEMA 2015!

Date: Jun 26, 2015


Esco at ISPE Exhibition

Date: Jun 09, 2015


Esco Pharma is Proud to Launch its New Range of Containment Isolators

Date: Apr 28, 2015


Esco GB Ltd hosted the 2014 Training at its new premises in Barnsley

Date: Dec 15, 2014


Esco Pharma at ISPE Event in Singapore.

Date: Aug 13, 2014


Esco at INTERPHEX 2014!

Date: Jul 17, 2014