Be SAFE in Handling High Potency APIs

By Esco Healthcare 26 October, 2016

A significant proportion of new drugs under development contain high potency active pharmaceutical ingredients (HPAPIs). The market of HPAPIs is increasing, with expected growth in the global arena of about $17.8 billion by 2018. However, due to its inherent cytotoxicity, HPAPIs present handling challenges.

What are HPAPIs?

Highly potent active pharmaceutical ingredients, also known as HPAPIs, are defined as:

1. A pharmacologically active ingredient or intermediate with biological activity at approximately 150 µg/kg of body weight or below in humans (daily therapeutic dose at or below 10mg)

2. An active pharmaceutical ingredient or intermediate with an occupational exposure limit (OEL) at or below 10µg/m³ of air as an 8-h time-weighted average

3. A pharmacologically active ingredient or intermediate with high selectivity and/or with the potential to cause cancer, mutations, developmental effects, or reproductive toxicity at low doses

4. Or, by default, a novel compound of unknown potency and toxicity

Reference:

PharmTech, 2008. High-Potency APIs: Containment and Handling Issues. Available from: http://www.pharmtech.com/high-potency-apis-containment-and-handling-issues

What are the 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

Containment Approach and Risks

Containment Design

Contain at the Source
Avoid technique-dependent systems
Containment is a holistically engineered control system
Minimize the number of transfers
Design below the occupational exposure limit
Plan for ergonomics, cleaning, sampling, waste material compatibility
Provide redundancy/ secondary containment
Engineer out the reliance on PPE

What are the options for containment?

Many types of equipment are used for design containment approaches for hazard and risk associated with handling HPAPIs, such as:

Glove Box / Isolation Technology	Ventilated Enclosures and Local Exhaust	Powder Weighing Hoods	Vertical Process Trains

Intermediate Bulk Containers	Special Valves	Glove Bags	Vacuum Transfers

Barrier isolators are the most common equipment for contained handling of potent materials such as HPAPIs.

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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