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What are Hazardous Drugs?
Hazardous Drugs require careful handling by personnel and others who come in contact with them to minimize the adverse health effects of exposure and reduce contamination of the workplace.
Drugs are classified as hazardous when they possess any one of the following six characteristics:
- Genotoxicity, or the ability to cause a change or mutation in genetic material.(mutagen)
- Carcinogenicity, or the ability to cause cancer in humans, animal models, or
- Teratogenicity, or the ability to cause defects in fetal development or fetal malformation.(teratogen)
- Fertility impairment or reproductive toxicity.
- Serious organ toxicity at low doses in humans or animal models.
- Chemical structure and toxicity profile that mimic existing drugs determined to
be hazardous by the five previous criteria.
Hazardous Drugs may include antineoplastic or cytotoxic agents, biologic agents, antiviral agents, immunosuppressive agents, and drugs from other classes.
What is OEB & OEL?
Occupational Exposure Limits (OELs) is an upper limit on the acceptable air concentration of a hazardous substance in workplace air for a particular substance or group of substances to which workers can be exposed throughout their working lifetime (for 8 hours per day, 5 days a week, for 40 years) without developing adverse health effects.
Occupational Exposure Bands (OEBs) is a mechanism used to precisely assign chemicals into “categories” or “bands” based on their adverse health outcomes and potency considerations. The main purpose of the exposure bands is to make sure that the safety of staff working in pharmaceutical companies is ensured.
Manufacturing and quality control facilities of Alborz Zagros pharmaceutical company, equipped with rigid and flexible isolators, H13 filters in all HVAC and exhausts, and BIBO filter system; complies with OEL5 personnel protection requirements, in association with manufacturing products with hazardous raw materials.