Risk-Based Exposure Assessment and Control Guideline – Free WORD file Download

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The “Risk-Based Exposure Assessment and Control” guideline has been developed to assist Environmental Health & Safety and Engineering professionals in the understanding of the process to be followed when determining potential inhalation/dermal exposure and selection of exposure controls which may be necessary to manage the risk identified.

 

The process begins with a qualitative risk assessment that includes the collection and organization of basic information needed to characterize occupational exposure risk associated with the workplace, workforce, and chemical agents of the process being evaluated.  This information is used to understand the tasks being performed, raw materials and chemicals being used, processes being run, and the controls in place so the potential inhalation/dermal exposure risk ranking can be assigned.

 

The outcome of the qualitative risk assessment will determine whether or not a quantitative risk assessment, requiring the collection of industrial hygiene personal monitoring data, is needed. If the qualitative risk assessment is given a low ranking and the process does not require the use of respiratory protection, the risk assessment and conclusion are documented and filed. However, if the qualitative risk assessment ranking is high or inconclusive, or if respiratory protection is required, a quantitative risk assessment must be performed.

 

The quantitative risk assessment, which includes that collection of industrial hygiene personal monitoring data, is used to determine whether the risk posed by the exposure is acceptable. Several samples must be collected (minimum of three) following validated sampling and analytical methods.  The sample analysis data results must be analyzed using Bayesian or Descriptive statistics and compared to the Occupational Exposure Limit (OEL).  Excursions above the OEL require the use of exposure controls to manage the risk.

 

The primary objective of selecting the exposure control option is to reduce the exposure risk of the workers below the Occupational Exposure Limit.  There are numerous exposure control options in which to choose.  The decision may be to control the airborne contaminants at the source, control the airborne contaminants within the room where the process is located, or rely on personal protective equipment. Whatever control method is selected, industrial hygiene personal monitoring data must be collected to confirm the exposure risk is below the OEL.

 

This guideline can be applied to all chemical risk assessments and exposure control and is applicable to all Johnson & Johnson businesses worldwide. This guideline replaces the former “Controlling Occupational Exposure to Active Pharmaceutical Ingredients (API) and Isolated Process Intermediates (IPI)” standard operating procedure and guideline, which focused primarily on active pharmaceutical ingredients.

Table of Contents

Executive Summary……………………………………………………………………………………………. 2   

Introduction………………………………………………………………………………………………………… 6

 1.1 Purpose of the Document…………………………………………………………………………….. 6

1.2 Team Approach………………………………………………………………………………………………. 6

1.3 New versus Existing Processes………………………………………………………………………… 6

1.4 How to Use the Guideline………………………………………………………………………………… 6

1.5 Need for Documentation Trail…………………………………………………………………………… 6

1.6 Effort Scaled to Risk………………………………………………………………………………………… 7

1.7 The Risk Assessment Process Diagram……………………………………………………………. 7

1.8 Starting the Process………………………………………………………………………………………… 7

1.9 Qualitative Risk Assessment……………………………………………………………………………. 7

1.10 Quantitative Risk Assessment………………………………………………………………………… 7

1.11 Exposure Control Project……………………………………………………………………………….. 8

1.12 Post Control Quantitative Risk Assessment……………………………………………………… 8

2.0 Conducting a Risk-Based Exposure Assessment………………………………………… 10

2.1 Existing or New?…………………………………………………………………………………………… 10

2.2 Qualitative Risk Assessment………………………………………………………………………….. 10

2.2.1 Data Gathering…………………………………………………………………………………………… 10

2.2.2 Basic Information……………………………………………………………………………………….. 11

2.2.3 Product……………………………………………………………………………………………………… 11

2.2.4 Facility………………………………………………………………………………………………………. 12

2.2.5 Process…………………………………………………………………………………………………….. 14

2.2.6 Manufacturing Processes……………………………………………………………………………. 16

2.2.7    Pre and Post Steps in the Process……………………………………………………19

2.2.8 Cleaning……………………………………………………………………………………………………. 19

2.2.9    Assembly & Disassembly of the equipment………………………………………………… 20

2.2.10 Maintenance of Support Utilities…………………………………………………………………. 20

2.2.11 Characterizing the Potential Source of Exposures………………………………………… 20

2.3 Quantitative Risk Assessment………………………………………………………………………… 22

2.3.1 Unacceptable Exposure Risk……………………………………………………………………….. 22

2.3.2 Quantitative Risk Assessment Outline………………………………………………………….. 22 

2.3.3 Statistical Analysis……………………………………………………………………………………… 23

2.4 Tools……………………………………………………………………………………………………………. 23

2.4.1 Risk-Based Exposure Assessment Process (RBEAP)……………………………………. 23

2.4.2 Industrial Hygiene Risk Assessment Forms…………………………………………………… 24

2.5 Conclusion of Quantitative Risk Assessment……………………………………………………. 24

3.0 Engineering & Containment Solutions…………………………………………………………. 25

3.1 Exposure Control………………………………………………………………………………………….. 25

3.1.1 Selecting Exposure Control Options……………………………………………………………… 25

3.1.2 Containment Boundary……………………………………………………………………………….. 27

3.1.3 Hierarchy of Controls………………………………………………………………………………….. 27

3.1.4 Personal Protective Equipment & Personal Hygiene………………………………………. 28

3.1.5 Administrative Controls……………………………………………………………………………….. 29

3.2 Engineering Controls……………………………………………………………………………………… 31

3.2.1 Closed Processes………………………………………………………………………………………. 31

3.2.2 Downflow Booth Considerations…………………………………………………………………… 34

3.3 Facility…………………………………………………………………………………………………………. 41

3.3.1 Laboratory Ventilation Systems Summary…………………………………………………….. 41

3.3.2 Waste Water………………………………………………………………………………………………. 42

3.3.3 Room Layout……………………………………………………………………………………………… 42

3.3.4 Room Envelope………………………………………………………………………………………….. 45

3.3.5 HVAC………………………………………………………………………………………………………… 46

4.0 Forms………………………………………………………………………………………………………….. 50

4.1 Qualitative Risk Assessment form…………………………………………………………………… 50

4.2 Risk-Based Exposure Assessment (RBEAP) form……………………………………………. 51

4.3 Containment Solution Guide template         52

 

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