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Health  Based Exposure Limit

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1

Permitted Daily Exposure (PDE) / Acceptable Daily Exposure (ADE)

PDE is the maximum daily amount of a substance, including impurities, that a patient can be exposed to without significant health risks.

2

Occupational Exposure Limit (OEL)

Occupational Exposure Limit (OEL) Assessment: This process entails a thorough examination of

airborne chemical exposure within the workplace to establish safe thresholds for the protection of

employees.

3

Occupational Exposure Banding (OEB) 

Occupational Exposure Banding (OEB) is a risk-based approach used to categorize chemical compounds based on their potential health hazards in the workplace. It helps establish safe handling practices when Occupational Exposure Limits (OELs) are not available.

4​

Maximum Allowable Carryover (MACO)

 Maximum Allowable Carryover (MACO) is the maximum acceptable level of residual contamination from one product that can be carried over to the next product in shared manufacturing equipment. It is a critical parameter in Cleaning Validation to ensure patient safety and product quality.

Topic Walkthrough

What is Permitted Daily Exposure (PDE)?

PDE is the maximum daily amount of a substance, including impurities, that a patient can be exposed to without significant health risks. ​ 

Is PDE the same as an Acceptable Daily Intake (ADI)?

They are similar, but PDE is specific to pharmaceuticals, while ADI is used more broadly in food and environmental safety.