Overview

Occupational Exposure Limit

Calculating occupational exposure limit (OEL) value (not mandatory for Pharma manufacturing unit, but occupational exposure values (OEVs) are still established by the manufacturing units for pharmaceuticals, in-order to assure safety of workers at work place) Establishing occupational exposure bands (OEBs). We at Maven can provide these working procedures with ease.

The OEL calculation has been recommended by Occupational Safety and Health Administration (OSHA) and several other Agencies including American Conference of Governmental Industrial Hygienists (ACGIH), National Institutes of Occupational Safety and Health (NIOSH), Japan Society for Occupational Health (JSOH) and European Chemical Agency (ECHA)

API Categorization

Making a judgement about the risks to employees starts with scientific assessments, animal studies and clinical trials that are done by the drug developers, giving an insight into the potential hazards and the dose–response effects. Risk assessment experts use their professional judgment to interpret this data and generate critical effect risk-based values, including OELs and occupational exposure bands (OEBs). These assessments allow a manufacturing facility and its management team to put engineering and industrial hygiene strategies in place to control and minimize the risk of exposure. As well as training, these will include containment and personal protective equipment (PPE) strategies.

API Categorization is based on:

1. Bibliographical search to review all the relevant information related to the API

2. OEL Determination following international and widely accepted Guidelines

3. Categorization for the specific work conditions of any laboratory according with the Safebridge banding or National Requirements Scheme.

Advantages: