Pharmaceutical and chemical plant manufacturers need to set appropriate occupational exposure limits to assure the health and safety of their workers. Workers employed in chemical and pharmaceutical manufacturing sectors are potentially exposed to active pharmaceutical ingredients, isolated pharmaceutical intermediates and other kinds of chemicals.
Occupational Exposure Limits (OELs) play a critical role in protecting workers from exposure to dangerous concentrations of hazardous materials.
In the absence of useful toxicological information to calculate an OEL, Occupational Exposure Band (OEB) are assigned following a systematic process based on health-effect endpoints to identify potential exposure ranges or categories and to assign a range of airborne concentration levels expected to be protective of worker health.
ToxHub experts have combined experience gained in the pharmaceutical industry, both in occupational toxicology and risk assessment. This allows us to assess occupational health deriving from occupational exposure limits (OEL/OEB), active pharmaceutical ingredients (API) and isolated pharmaceutical ingredients (IPI) in the work environment
Services provided include the following:
- Comprehensive literature search (repeated, reproductive toxicity, genotoxicity / carcinogenesis, etc.) using public and commercial databases and evaluation of biological and chemical hazards; research of pharmacological data and identification of the minimum therapeutic dose.
- For data-poor compounds (i.e IPI) a semi-quantitative case-by-case approach will be followed, assigning the Occupational Exposure Banding (OEB) based on criteria aligned with specific GHS H-codes and categories as allocation of H-statements to hazard groups. In the absence of reliable H-phrases, in silico assessment (QSAR modelling, analogue identifications and read across justification) of toxicological endpoints using commercial tools such as Lhasa and Leadscope is proposed. The ICH M7 approach will be followed for the evaluation of genotoxicity potential. Other endpoints (e.g. skin sensitization) will be evaluated following a step-by-step approach (services provided by partners).
- Definition of a study plan for a full characterization of unknown chemicals according to ECHA directives for hazard classification.
- OEL calculation, or development of OEB approach for the use of non-pharmaceutical chemicals in order to provide rapid screening OEL development for chemicals and provide an exposure-based decision system for modifying OEB recommendations to account for differences in handling procedures.
- Development of written reports and recommendations that document methods for reducing and/or eliminating the onset of occupational injuries and illnesses.