Pharmaceuticals

Safeguarding Workers and Your Business with Active Pharmaceutical Ingredient (API) Occupational Exposure Limit (OEL) Documents 

To help keep workplaces safe IOM can help by creating and updating Active Pharmaceutical Ingredient (API) Occupational Exposure Limit (OEL) documents. These essential documents help ensure worker safety, regulatory compliance and keep businesses running. They are used extensively in the pharmaceutical manufacturing and biotechnology sectors. 

Realise the Benefits of API OEL Documentation 

Ensuring Worker Safety and Regulatory Compliance 

Hazardous workplace exposures cause thousands of illnesses every year. Our API OEL documents are  key to keeping your workers safe and meeting stringent regulatory requirements. By adhering to Control of Substances Hazardous to Health (COSHH) regulations, you not only ensure legal compliance but also avoid costly penalties and fines. 

Worker Health & Wellbeing 

API OELs protect worker health by providing clear guidelines, assuring safety, improving work environments, and increasing job satisfaction. OELs reduce the risk of acute and chronic illnesses which can reduce worker anxiety.  

Boosting Efficiency and Reducing Costs 

Safe workplaces with healthier employees translate into higher productivity. Workers protected from hazardous exposures are less likely to fall ill, reducing absenteeism and creating a more efficient and productive workforce. Workplace illnesses from exposure to hazardous substances amount to millions in costs annually. Preventing worker accidents and ill health linked to API exposure can lead to substantial cost savings including lower healthcare expenses, decreased employee replacement costs, and reduced expenses from workplace incidents. 

Key Features of API OEL Documents 

Our API OEL documents are comprehensive and include: 

• Threshold Limit Values: Specifying maximum allowable concentrations over an 8-hour workday. The OEL is based on 1% of the therapeutic dose, taking into account inhalation. 
• Substance Description: Summarising the substance, chemical properties, and precautionary statements. 
• Animal and Human Studies: Detailing toxicity, carcinogenicity, reproductive toxicity, and clinical pharmacology. 
• Summary Table: Presenting acute and repeated toxicity, OELs, side effects, contraindications, and drug interactions. 

The IOM Process 

 Leveraging a diverse range of scientific expertise, the IOM's approach encompasses the following key steps: 

1. Toxicological Review: We thoroughly examine and present available data for the substance and related compounds. 
2. Identification of Health Endpoints: Our experts pinpoint the primary health concerns linked to the substance. 
3. Presentation of Health Impacts: We present potential acute and chronic health effects from exposure to the substance. 
4. Dose-Response: We detail the lowest toxic effects dose, no observed effects levels, and therapeutic doses, providing a comprehensive understanding of reactivity. 
5. Vulnerable Populations: We identify individuals at heightened risk, such as asthmatics and those of childbearing age. 
6. Expert Evaluation: Our experts exercise judgment to determine if a 1% margin of therapeutic dose is sufficient for protection, accounting for various factors and uncertainties in the assessment. 

This approach ensures a thorough evaluation of the substance's impact on health, laying the foundation for setting an OEL. 

Invest in API OEL documents from the Institute of Occupational Medicine, and you not only ensure the health and safety of your workers but also benefit from legal compliance, increased efficiency, reduced costs and business continuity.  

Join us in creating a safer, more productive workplace in your organisation.