Considerations for setting occupational exposure limits for novel pharmaceutical modalities.

The high toxicity and uncertainty of exposure uptake efficiencies means that other activities that may lead to exposure to trace levels of residues, such as might occur during manual cleaning of contaminated equipment, may be significant, and the potential and mechanisms for equipment and containers to become contaminated on exposed external surfaces should also be assessed. 3.5.7 Occupational exposure banding guidance recommendation Occupational exposure banding recommendations are based on the inherent hazards associated with exposures to each component of the ADC manufacturing process.

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