RBEAP Risk Based Exposure Assessment Process RBEAP Objectives

RBEAP Risk Based Exposure Assessment Process

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

RBEAP - Six Step Process 1. Develop an inventory of unit operations • Assign a risk rating to the unit operation (H, M, L) • Weighing – H, Compression – M, Coating - Low 2. Identify risk factors for process • Batch size, % API, solid vs liquid, etc 3. 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 4. Conduct personal air-sampling 5. Analyze and communicate the data 6. Periodic re-sampling after there is a change of process, procedures, APIs/products

RBEAP Inventory

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

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!!!