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:

  • Name and address of the company
  • Name of the API

 

 Request your quote now!

 

Information to print:   OEL categorisation - request for quote    List of available APIs


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, Maas & Peither can supply OEL categorisations for more than 1,600 already available APIs and new APIs upon request. Further reports will be available shortly. PDE reports can be determined for these APIs as well (see information about PDE reports).

Contractor in accordance with EU GMP Guide Chapter 7: Azierta Contract Scientific Support Consulting S.L., Vía de las Dos Castillas 33, Edificio 7-h, 28224 Pozuelo de Alarcón (Madrid), Spain


Pricing:

  • OEL categorisations for available APIs:
    500.00 EUR net per API
  • OEL categorisations for APIs not yet available:
    price available upon request
     

List of available APIs

If you order a PDE report and an OEL categorisation together, you will receive both reports at the following prices:

  • Combination of PDE report and OEL categorisation for available APIs:
    800.00 EUR net per API
  • Combination of PDE report and OEL categorisation for APIs not yet available:
    price available upon request

Why can we offer OEL categorisations for such a competitive price?

Our partner Azierta is the market leader in Spain for the preparation of toxicological assessments and employs approximately 15 toxicologists for the preparation of PDE reports, OEL categorisations or elemental impurities risk assessments. These are also successfully used by the industry in other European countries (e.g. Germany, Switzerland, Italy, Belgium) and have been accepted by the authorities.

 

Our customers say:
"... many thanks for the professional support in this matter"
"... we appreciate the constructive collaboration with the colleagues from Azierta very much"
"... summarised very nicely"
"... we will be happy to come back to you in comparable situations"
"... worked out perfectly"


Do you need reports for other APIs?

We can also prepare OEL categorisations for APIs not included in the list of available APIs.
We will be pleased to prepare a specific offer for you.


Please contact us:

Cynthia Schulz

Phone: +49 7622 6668670
E-Mail: cynthia.schulz@gmp-verlag.de

 

 Request your quote now!