Nudelman ChemTox
Consulting
Occupational Health Categorization (OHC) and Health-Based Exposure Limits (HBEL)
Occupational exposure limits (OELs) and acceptable daily exposure (ADE) limits for APIs and isolated intermediates
Occupational Exposure Limits (OELs)
This service involves establishing safe exposure limits for workers handling active pharmaceutical ingredients (APIs) and intermediates during manufacturing. Key activities include:
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Evaluating the toxicological and pharmacological properties of the API or intermediate, such as potency, genotoxicity, and systemic toxicity.
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Conducting risk assessments to determine safe airborne concentrations for occupational settings.
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Establishing OELs tailored to protect worker health, ensuring compliance with regulatory and industry standards.
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OEL assessments are critical for minimizing occupational risks and ensuring the safety of workers in pharmaceutical and chemical production facilities.
Acceptable Daily Exposure (ADE) Limits
This service focuses on defining health-based thresholds for APIs and intermediates to prevent cross-contamination in multiproduct manufacturing facilities. Key components include:
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Calculating ADEs based on clinical safety data or non-clinical toxicology studies.
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Considering specific endpoints like reproductive toxicity, genotoxicity, carcinogenicity, and immunotoxicity in the assessment.
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Ensuring ADE values align with regulatory requirements.
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These assessments help manufacturers implement robust cleaning validation protocols, manage risks of cross-contamination, and maintain product safety.