1. RBEAP Risk Based Exposure Assessment Process

2. RBEAP Objectives
Lean, simple, systematic and pragmatic methodology for assessing and documenting risks to APIs
Prioritize operations that require air sampling and document the decision logic
Reduce waste that can be generated by random sampling ad hoc decisions
Assist with managing risks associated with handling APIs..…errors on side of safety
Process aligned with &J Corporate standards including the requirement for statistical analysis of IH data and establishment of SEGs
Provide a format to share and communicate results/conclusions with JNJ sites, employees, management and OH

3. RBEAP - Six Step Process
Develop an inventory of unit operations
Assign a risk rating to the unit operation (H, M, L)
Weighing – H, Compression – M, Coating - Low
Identify risk factors for process
Batch size, % API, solid vs liquid, etc
Classify the API/Product as H, M or L for exposure potential…..
Sampling conducted for H
Note: The decision is not driven by the hazard
Conduct personal air-sampling
Analyze and communicate the data
Periodic re-sampling after there is a change of process, procedures, APIs/products

4. RBEAP Inventory

5. RBEAP
General Information – unit operation, process description, photos Active compounds involved
Selection compound greatest potential airborne exposure Respiratory protection required (based on analysis below)
Analysis of the IH sample data for ‘worst case’ compound

6. Benefits of RBEAP Risk based Efficient use of resources
Consistent approach for prioritizing sampling
Provides a reasonable approach for characterizing risk using a minimal number of samples
Can conduct sampling when there is no validated IH method available
Will help understand impact of new or transferred products
Uses of objective scientific data to characterize risks
Ensuring that the require PPE is aligned with the IH data……..data driven decision making process
Meaningful basis for establishing self directed dashboard objectives
Actual vs. estimate budgets for IH sampling and analysis can be calculated
Achievable!!!