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OEL & API Categorization

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Overview

Occupational Exposure Limit (OEL)

Calculating occupational exposure limit (OEL) values is essential to ensure worker safety, even though it is not mandatory for pharmaceutical manufacturing. Establishing occupational exposure bands (OEBs) helps maintain safe working conditions. MAVEN provides expert guidance and working procedures for OEL determination.
OEL calculation is recommended by OSHA, ACGIH, NIOSH, JSOH, and ECHA.

API Categorization

API categorization assesses risks to employees based on scientific studies, animal data, and clinical trials. Expert toxicologists interpret this data to generate critical effect risk-based values including OELs and OEBs.
This allows manufacturing facilities to implement containment, PPE strategies, and training programs.
API Categorization is based on:
  • Bibliographical search of all relevant information related to the API
  • OEL determination following international and widely accepted guidelines
  • Categorization according to specific laboratory conditions using Safebridge banding or national schemes

Advantages

  • Multidisciplinary team of expert toxicologists with hands-on experience in in vitro and in vivo studies
  • Toxicologists accredited by EUROTOX, AETOX, DABT, ERT, and FELASA
  • Global delivery of 770+ PDE Reports, 340+ OEL Reports, and 150+ combined PDE & OEL Reports
  • Swift turnaround time for end-to-end toxicology risk assessment reports
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