Occupational Exposure Limit (OEL) categorisations for APIs

Have you already determined your OEL values?
Are you looking for a competent partner for the determination and calculation of OEL values?
Would you like to save time and money to dedicate yourself to more important tasks?

Occupational Exposure Limits (OELs) are an important tool to ensure safety and occupational health of employees in the production of medicinal products and active pharmaceutical ingredients.

For every API, an upper limit on the acceptable concentration in workplace air has to be determined (OEL). For this determination, toxicological and pharmacological properties of the API are analysed and related to preventive measures.

The categorisation of APIs helps to establish adequate safety measures, e.g. control systems, standardised operating processes and safety equipment.

The toxicological experts of our partner Atreiza/Azierta will categorise APIs following a profound scientific evaluation. They are certified according to AETOX (1), EUROTOX (2) und ERT (3).

This is what we need from you to prepare an OEL categorisation:

Our service includes:

• Extensive bibliographic research
• OEL determination according to internationally accepted guidelines
• Categorisation with regard to the specific working conditions according to national requirements or SafeBridge® banding scheme

The result is a high-quality and tailor-made report for your application. The report includes additional comments and suggestions for the safety and health of a specific workplace.

Currently, GMP-Verlag can supply OEL categorisations for all APIs upon request. PDE reports can be determined for these APIs as well (see information about PDE reports).