OEL & API CATEGORIZATION
Establish the link between Occupational Exposure Limits and safety measures.
Manufacturing pharmaceutical products that are safe to use for patients is always a priority. At the same time, it’s important to guarantee the health and safety of the staff involved in the manufacturing process. It is therefore necessary to determine an upper limit for any hazardous substance in the workplace air which employees can be exposed to over a given period – usually eight hours per day, five days per week – without suffering any immediate or long-term consequences.
When you know this Occupational Exposure Limit (OEL), it can be used to implement the proper containment strategies accordingly. In addition to preventing occupational illness from too high an airborne concentration of a certain API in the workplace, adequate preventive measures also help to avoid cross-product contamination.
The link between OELs and safety measures, such as engineering control, standardized work processes and safety equipment, is established by API categorization. After analyzing the properties of APIs we’re able to divide and place them into categories that best describe their toxicity and potency. Since we determine a set of corresponding safety measures for each category, the steps that have to be taken for each API can be clearly identified.
To craft a high quality and specially tailored written report, our team of certified toxicology experts performs a scientific-based evaluation, consisting of:
- bibliographic research to review all relevant information related to the respective API
- OEL determination following international and widely accepted guidelines
- API categorization customized for the specific work conditions of your laboratory, in accordance with the applicable national requirements or SafeBridge® banding scheme.
Our reports provide you with additional comments and recommendations to ensure health and safety in your particular workplace.