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The pharmaceutical industry has established categorization systems to help manage exposure and contamination risks.Most process handling for potent compounds is designed for closed operations to provide primary containment through the equipment, and secondary measures are taken in the design of heating, ventilation, and air conditioning (HVAC) systems and airlocks.As a result, many new facilities have implemented enhanced control measures for both a primary (where the product is exposed) and a secondary (where the product has been packaged in a nal form but has not received secondary packaging for nal shipment) containment.
The pharmaceutical industry has established categorization systems to help manage exposure and contamination risks. A typical pharmaceutical company has either a four- or ve-band system. For each band, guidance is provided on engineering control measures to be implemented to mitigate exposure risks. Some international regulatory agencies have expressed concern over certain therapeutic drug classes, for example, antibiotics, specically penicillin; these agencies have therefore demanded a dedicated facility for the production of this antibiotic. Other drug classes, such as cytotoxic compounds, also require dedicated or segregated facilities, depending on the market distribution and regulatory authority. The discovery and registration of drugs that include potent compounds have been on the rise. As a result, many new facilities have implemented enhanced control measures for both a primary (where the product is exposed) and a secondary (where the product has been packaged in a nal form but has not received secondary packaging for nal shipment) containment. Most process handling for potent compounds is designed for closed operations to provide primary containment through the equipment, and secondary measures are taken in the design of heating, ventilation, and air conditioning (HVAC) systems and airlocks.
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