Why isolators are still preferred when handling HPAPIs?

By Esco Healthcare 27 October, 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:

Engineering Controls: Balancing Cost and Containment Hazard by P. Richards
Occupational Exposure Banding by A. George
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.

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