The J&J Risk Based Exposure Assessment Process
IH & Containment Conference
Rome, May 14-16, 2013
Janssen Campus Belgium
Michel Vangeel
Principal Expert Industrial Hygiene & Ergonomics
[email protected]ONE TEAM Making the Difference for Patients WORLDWIDE
Risk Based thinking
Risk drives the decision, Where we were yesterday?
hazard is considered Former J&J guidelines
Prioritize activities, use of recommended containment
resources and future specifications and controls based
investments based on risk on OEL and Toxicity levels API.
Risk Based thinking assumes Where we are Today?
that
Recommends containment
Consider realistic scenarios
specifications and controls based
Integrates approach with QA, on risk. Introduction of Risk
engineering and manufacturing
Based Exposure Assessment
Relies on facts and data in the Process (RBEAP) and Risk
decision making process
Based Exposure Assessment
Without Risk Based Thinking Control Guideline (RBEAC)
Infinite resources will be required
to achieve objectives.
The J&J Risk Based Exposure Assessment Process May, 14th 2013 2
2
Risk Based Exposure Assessment Process (RBEAP)
Tool created by cross functional team, IH Steering Team
Janssen Supply Chain
Process to systematically assess inhalation exposure risks
of activities with Active, Pharmaceutical Ingredients and
solvents
Tool introduced step-by-step in Pharmaceutical Production,
Chemical Production and R&D (training program, metrics)
Team Approach: Use of stakeholders, involvement
operations.
The J&J Risk Based Exposure Assessment Process May, 14th 2013 3
Risk Based Exposure Assessment Process (RBEAP)
Provides a lean, systematic and pragmatic methodology to;
Identify the chemical hazards for each unit operation
Identify priorities for air sampling based on those products that
have the potential to generate the highest airborne particulate
concentration.
Organize the data so that Similar Exposure Groups can be
established.
Communicate results to employees, medical and management
using a transparent format.
Understand future IH air sampling needs and managing changes,
ie impact of introducing new products.
RBEAP is used to understand exposure risks to be able to
make data driven decisions to prioritize containment projects
The J&J Risk Based Exposure Assessment Process May, 14th 2013 4
Risk Based Exposure Assessment Process
Six Steps
1.Create a
Unit Operation
Inventory
Periodic re-sampling 2. Identify
6. Periodic Batch Size, % active
according to specified Risk Factors ingredient or quantity, etc
Re-Sample
criteria Compounds Solvents – Vapor Pressure,
temperature
5.Analyze & 3. Prioritize Assign High, Medium or
Analyze using Bayesian
Statistics Communicate compounds UO Low risk to prioritize
Data sampling activities
4.Personal
Sampling if
required Based on the qualitative risk
assessment and respiratory
protection requirement.
The J&J Risk Based Exposure Assessment Process May, 14th 2013 5
Risk Based Exposure Assessment Process
Create inventory of Unit Operations
Powder Handling Unit
Sampling
complete
reference
last IH RBEAP
Location Unit Operations SEG Risk report date APF1 APF2 APF3A APF3B APF4 Remarks
API1 toevoegen uit container/müllerdrum
G120/221 operator
zeefinstallatie PZE2
H IHG09-059 12.02.2010 50 50 1000 NA NA
API2 aftappen in container/müllerdrum
G120/021 operator
zeefinstallatie PZE2
H IHG09-059 12.02.2010 50 50 1000 NA NA
API3 demonteren zeefinstallatie PZE2 voor
G120/021-221 omsteller
reiniging H IHG09-059 12.02.2010 50 50 1000 NA NA
API4 toevoegen uit container/müllerdrum
G120/201 operator
zeefinstallatie PZE3 - klein batch
H IHG08-088 12.02.2010 50 50 1000 1000 10000
G120/019-219 API5 Aandocken cannisters SVA toren 1&2 operator
L IHG09-017 12.02.2010 1 1 1 1 1
G120/019 API6 aftappen zakjes - SVA toren 1&2 operator
L IHG08-081 12.02.2010 1 1 1 1 1
API7 wisselen toevoegcontainer/müllerdrum
G120/217 operator
maalmolen PMA1/PMZ1
H IHG09-056 11.02.2010 50 50 1000 NA NA
API8 wisselen opvangcontainer/müllerdrum
G120/017 operator
maalmolen PMA1/PMZ1
H IHG09-056 11.02.2010 50 50 1000 NA NA
G120/017 API9 controle maalmolenhuis PMA1/PMZ1 operator
H IHG09-056 11.02.2010 1 50 50 NA NA
API10 demonteren maalmolen PMA1 voor
G120/017-217 omsteller
reiniging H IHG09-056 11.02.2010 50 1000 1000 NA NA
API11 wisselen
G120/218 toevoegcontainer/müllerdrum maalmolen operator
PMA2 H IHG10-024 03.05.2010 50 50 50 NA NA
API12 Toevoegen via zakkenstorttrechter
G120/218 operator
PMA2 H IHG08-048 11.02.2010 50 1000 1000 NA NA
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Document all information
for each Unit Operation
General Information
Active compounds involved
Selection compound greatest
potential airborne exposure
Respiratory protection required
(based on analysis below)
Document results personal sampling
Analysis of the IH sample data
for ‘worst case’ compound
Risk Based Exposure Assessment Process
Conclusion
Former Approach
Not Risk Based.
Beyond Compliance
More resources and IH Costs.
(Need to sample for each API and process)
IH method required for every chemical
Sampling criteria were hazard based
Current Approach
Risk Based
Full regulatory compliance
Sampling criteria based on worst case scenario
Eliminates need to have IH method each API
Cost avoidance with resources and air sampling
Supports new product introduction, sourcing decisions and product transfers
Streamlining medical surveillance, All IH information in one document
Generates statistical data to drive risk based decisions investments
One format to share and communicate results (Internal + Ext)
The J&J Risk Based Exposure Assessment Process May, 14th 2013 8
Thank You
Janssen Campus Belgium
Michel Vangeel
ONE TEAM Making the Difference for Patients WORLDWIDE
