Consultancy Services

Occupational Exposure Limits for Pharmaceutical Ingredients

IOM develops evidence-based Occupational Exposure Limits (OELs) for Active Pharmaceutical Ingredients (APIs), helping pharmaceutical organisations set appropriate controls and protect workers from exposure.

Service overview

Set the right exposure limit to protect your people

Active Pharmaceutical Ingredients (APIs) are designed to have a biological effect. In pharmaceutical manufacturing, employees may handle these substances more frequently or at different concentrations than patients.

An Occupational Exposure Limit (OEL) provides a clear, evidence-based level for managing airborne exposure and protecting worker health. However, not every API has an established OEL, making it difficult to know what level of exposure should be controlled.

IOM reviews the available toxicological and pharmaceutical evidence to develop a scientifically robust OEL, helping you make informed decisions about exposure controls and protect your people.

When this service may be needed

  • A new API is being introduced into manufacturing or development
  • An API does not have an established Occupational Exposure Limit
  • Existing exposure limits or control measures need to be reviewed
  • Evidence is needed to inform containment, ventilation or other exposure controls

INDEPENDENT support

How IOM can help

Our specialists review the available scientific and toxicological evidence to develop an appropriate Occupational Exposure Limit for the API.

The assessment considers the properties and potential health effects of the substance and provides a clear scientific rationale for the recommended limit.

Our assessment includes:

  • Therapeutic use and dose
  • Known adverse effects
  • Relevant toxicological evidence
  • Occupational hazards and exposure considerations
  • Recommended Occupational Exposure Limit and rationale

What the service includes

Review the API, including therapeutic use, dose, adverse effects and drug interactions
Review relevant toxicological information
Assess occupational hazards and exposure controls
Calculate the OEL with clear rationale and recommendations

Discuss your requirements

Get practical advice for your organisation.

Tell us what you need to achieve and your enquiry will be directed to the most appropriate team.

  • Directed to the right team
  • Practical, reliable solutions
  • Confidential and professional
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