Occupational Exposure Limit (OEL) categorisations

Toxicological classification of 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 partners will categorise APIs following a profound scientific evaluation. They are certified according to AETOX (1), EUROTOX (2) und ERT (3).

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).

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

Name and address of the company
Name of the API

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.

Our customers are saying:

... many thanks for the professional support in this matter"

"... sehr schön zusammengefasst"

"... we will be happy to come back to you in comparable situations"

"... worked out perfectly"

"... we appreciate the constructive collaboration with the colleagues from Azierta very much "

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Type of assessment *

PDE Report

OEL Report

Elemental Impurities Risk Assessment

Organic Impurities

Mutagenic Impurities

Environmental Risk Assessment (ERA)

API / Product / Contamination *

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Comments, questions, suggestions

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Last Name *

Company *

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Cynthia Schulz

cynthia.schulz@gmp-verlag.de +49 (0)7622 66686-70

OEL Categorisation | Sample Document

Why do you need OEL categorisations? 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.Our service includes extensive bibliographic researchOEL determination according to internationally accepted guidelines Categorisation with regard to the specific working conditions according to national requirements or SafeBridge® banding scheme This is what we need from you to prepare a quote Company name and address Name of the API

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