Exposure Control Matrix

TECHNICAL INFORMATION 202-TI-201
EHS Control Matrix series revised

EXPOSURE CONTROL MATRIX Aug 2009
PURPOSE
To assist those designing, developing, procuring or assessing exposure controls for all routine activities
to ensure that the employees operating processes or working nearby are not subjected to concentrations
of hazardous materials at airborne concentrations above their Occupational Exposure Limits (OELs).
SCOPE
The Exposure Control Matrix (ECM) is intended to apply to all solid products, intermediates and raw
materials used and manufactured at all GSK sites, including R&D Chemical Development and
Pharmaceutical Pilot Plants. For laboratories, more specific guidance can be obtained from the GSK
Laboratory Exposure Control Matrix, 1 June 2008.
This ECM does not apply to gases, vapours or liquids. It is intended for use by project engineers
designing new construction projects or upgrading existing facilities, as well as by site production and
EHS and EHM professionals in assessing controls required during handling of hazardous substances.
Warehouses are also within the scope of this matrix if they conduct tasks, such as collection of samples
for quality assurance or disposal that involve hazardous materials.
RELATED GLOBAL EHS STANDARDS
202 EHS Risk Assessment and Management;

601 Process Risk Management;
701 Material Hazard Identification and Communication;
702 Occupational and Environmental Exposure Limits;
703 Chemical Agents;
704 Sensitising Agents.
TABLE OF CONTENTS
1 Introduction 1
2 GSK Occupational Exposure Limits and Occupational Hazard Categories 2
3 Applying the Exposure Control Matrix 4
4 Monitoring of Exposure Control Performance 10
5 Exposure Control Matrices 10
Appendix 1 Template for Item in the Engineering Design Kit 32
Appendix 2 Glossary of Terms 35

1 INTRODUCTION
The Exposure Control Matrix (ECM) aims to:
 provide guidance for the development of exposure control provisions during the design or
modification of facilities, plant or equipment;
 enable recommendations to be made as early as possible during the development and
introduction of new products or as part of product transfer between sites;
 support risk assessments for evaluating exposure control measures in place at GSK;
 provide a methodology for deriving the recommendations on exposure control measures
provided in GSK Safety Data Sheets (SDS);
 identify appropriate engineering control measures that will minimise risk and maintain exposures
below Occupational Exposure Limits (OELs*) or within the hygiene boundaries recommended
for GSK Occupational Hazard Categories (OHC);
 provide a methodology for assessing the exposure control measures in place at contractors’
facilities, for assessing the suitability of equipment prior to acquisition or when performing a due
diligence assessment of a process or facility.
The ECM is intended as guidance to support a number of GSK Global EHS Standards. The
requirements within the ECM are not mandatory but sites are responsible for having sufficient
controls and facilities to maintain employees’ exposure below applicable OELs.
GSK is committed to controlling exposures of employees to hazardous substances. Global EHS

Standard 202 requires that risks shall be controlled, where feasible, according to a hierarchy of
controls whereby engineering controls are the preferred option, followed by work practices and
administrative means. In practice, the control measures chosen are likely to be a combination of
these. Personal Protective Equipment (PPE) should only be used where adequate control cannot
feasibly be achieved otherwise.
PPE, such as gloves, respirators and clothing, should be used where it is not feasible to achieve
complete control by engineered or administrative means or as an interim measure until more
effective controls can be implemented. Certain minimum standards of PPE (e.g. lab coat, safety
glasses, gloves) are suggested for all operations in which chemical substances are handled. The
use of substances with known sensitising (allergenic) properties should invoke consideration of
PPE to minimise the potential for exposure of personnel. The GSK ECM does not, however,
address the use of PPE, as requirements will vary depending on the nature of chemical hazards,
potential for exposure and considerations of current Good Manufacturing Practice (cGMP).
GSK aims to minimise reliance on respiratory protective equipment as the primary control for all
routine activities such as manufacturing and scheduled maintenance activities. However,
respiratory protection and precautions to protect the skin and eyes may be necessary during
unscheduled maintenance, process interventions, emergencies and during process development. It
will also be needed during validation when full confidence in engineered exposure control
measures has yet to be achieved.
This scheme does not replace the need for a full risk assessment of the process or operation. The
ECM specifically targets the control of potential health risks. It does not address physical hazard
characteristics, such as flammability or explosivity, environmental considerations, such as
treatment of effluent or air emissions, or GMP requirements. Additional controls may be required to
address these issues. Process safety and environmental considerations are discussed in their
respective matrices.
* Terms introduced in italics are defined in the glossary in Appendix 2. Click on the link to see these. Scroll back to
the page to return
Exposure Control Matrix Aug 2009

202-TI-201 Page 1 of 37
2 GSK OCCUPATIONAL EXPOSURE LIMITS AND OCCUPATIONAL HAZARD
CATEGORIES
The GSK OEL is a health-based limit, derived solely from health-related data. It is expressed as an
average concentration of a substance present in the breathing zone of a person over a specified
reference period. The OEL’s value is such that there is no evidence, according to current
knowledge, that the substance is likely to have any effect on the health of employees if they are
exposed by inhalation, day after day, to that concentration. GSK Global EHS Standards require
that employees should not be exposed to concentrations of active pharmaceutical ingredients,
isolated chemical intermediates and other process materials above their OELs.
In general, OELs for GSK Active Pharmaceutical Ingredients (APIs) are established at about the
time an API achieves a proof-of-concept decision. However, a preliminary OEL may be assigned
to certain GSK APIs at earlier points in the development process, eg, APIs categorised as OHC-4
may be assigned an estimated OEL prior to first-time-in-human studies. This preliminary OEL
value is to be used only to guide selection of appropriate controls and hygiene monitoring strategy
and will not be fully documented or published within GSK.
The OHC is a number, between 1 and 5, representing one of five ranges of airborne concentrations
(see Figure 1 on page 3). In the absence of an OEL the OHC will be the best estimate of the level
to which exposure to that substance should be controlled to prevent employees from suffering
adverse effects as a result. The OHC for a substance with an OEL is the one whose corresponding
range contains that OEL.
GSK sets OELs or OHCs for APIs, isolated intermediates and other associated process materials
using a standard hazard-evaluation procedure. Further information is provided in the GSK
procedures 702-TI-102 (Establishing GSK Occupational Exposure Categories) and 702-TI-103
(Establishing GSK Occupational Exposure Limits). OHCs and OELs can be found in section 8 of
the SDSs.
Notations of special hazards may accompany GSK OELs or OHCs. These notations are employed
to convey information on serious, often potentially irreversible, health effects (for example,
apparently stochastic effects such as carcinogenesis), indicate groups at special risk following
potential exposure (for example pregnant women), or may indicate routes of exposure for which
extra precautions may be required (for example skin absorption). Additional considerations may be
needed to complement engineering controls when an OEL or OHC is accompanied by one of the
following notations:
 Carcinogen (a suspected or proven human carcinogen);
 Reproductive Hazard (adverse effects on fertility, development or lactation);
 Respiratory Sensitiser;
 Skin Sensitiser (dermal sensitiser);
 Corrosive;
 Skin Absorption (potential for significant contribution to systemic dose).
These controls might include:

 surface swab testing before cleaning outside of engineering controls to understand chemical
migration risk;
 surface swab testing after area housekeeping to verify no migration;
 work clothes contamination checks, safe removal of PPE without skin contamination;
 engineering materials compatibility;
 additional hazards associated with spillage;
 provision of a suitable detoxifying agent e.g. 5% calcium hypochlorite for Topotecan.

202-TI-201 Page 2 of 37
Figure 1 Occupational Hazard Categories
GSK OEL values or other relevant exposure limits for solids in micrograms per cubic metre
< or =5,000 OHC-1
< or =1,000 OHC-2
< or =100 OHC-3
< or =10 OHC-4
Special considerations apply in the planning, design, review and

< or =1.0 implementation – seek specialist assistance from both CEHSS OHC-5
and ETCM.

202-TI-201 Page 3 of 37
3 APPLYING THE EXPOSURE CONTROL MATRIX
The GSK ECM provides guidance on the design of facilities and processes, in particular in the
selection of engineering and administrative controls so that airborne exposures can be controlled
below the GSK OELs or other exposure limits relevant to the materials to be contained. It does this
under five Exposure Control Approaches (ECAs). The controls provided at the various levels range
from conventional handling practices (ECA-A), for low-hazard materials, to totally enclosed multi
layered isolation processes (ECA-E) for the most hazardous or pharmacologically potent
substances. The requirements for applying each ECA are detailed in section 5.
As part of the process for reviewing technical risk for the Project Investment Proposal (PIP), the
designer or person purchasing the equipment should use the OHC and a process-specific risk
assessment to determine the Exposure Control Approach that is appropriate. The degree of
control achieved in practice depends critically on the adoption of good working practices, the detail
of the design of plant & facilities and regular maintenance. Examination and testing of the control
measures are essential. The Exposure Control Matrix is only a guide and should be used alongside
available test data for similar installations, current best practice and engineering tools.
3.1 Risk Assessment
The process–specific risk assessment should consider such factors as quantities used, the
percentage content of active ingredient, the dustiness of materials and local regulatory
requirements as well as pharmacological and toxicological properties and all potential routes of
exposure including inadvertent release. These general principles are illustrated in Figure 2.
Figure 2: Principles of Risk Assessment
For the Same OHC Band
Less Scale Dustiness Process API

containment Energy content
Gramme Coated tablets Weighing/ 1%
Dispensing
Tablets
Wet Cake Charging/

discharging
Kilogramme Granules 10%
Powders Milling/
sieving
Tonne Micronised 100%
Increased
Containment
F
igure 3 illustrates more explicitly how the scale of an operation might affect the choice of ECA.
Note, though, that this table does not replace the need to complete a risk assessment for the
specific process/product as other factors may be important.

202-TI-201 Page 4 of 37
Figure 3: Indicative relationship between OHC category and ECA for scale of operation
OHC1 Small scale eg. Lab ECA-A
Medium scale eg. Pilot plant ECA-A
Large Scale eg. Manufacturing ECA-A
OHC2 Small scale eg. Lab ECA-A
Medium scale eg. Pilot plant ECA-A ECA-B
Large Scale eg. Manufacturing ECA-B
OHC3 Small scale eg. Lab ECA-A ECA-B
Medium scale eg. Pilot plant ECA-B ECA-C
Large Scale eg. Manufacturing ECA-C
OHC4 Small scale eg. Lab ECA-B ECA-C
Medium scale eg. Pilot plant ECA-C ECA-D
Large Scale eg. Manufacturing ECA-D
OHC5 Small scale eg. Lab ECA-C ECA-D
Medium scale eg. Pilot plant ECA-D ECA-E
Large Scale eg. Manufacturing ECA-E
Small scale would generally apply to quantities below 1kg total material. The percentage active
would need to be taken into consideration. Medium scale would generally apply to quantities in
excess of 1 kg but below 20kg. Quantities above 20kg would generally be regarded as large scale.
The principles can be illustrated by the following examples:

 For operations involving direct handling of single-component powders (e.g. weighing, loading a
granulator/blender and sampling) in kilogram quantities, the ECA needed will often correspond
to the OHC set by GSK (ECA-A for OHC1, ECA-B for OHC2 etc).
 For gram quantities, the ECA will generally be lower. For example, in some situations a fume
cupboard or open fronted bench top enclosure (ECA-C) has been shown to be adequate for
dispensing OHC4 material in a laboratory.
 For operations where the active material is diluted with excipients and may be physically bound
into a matrix (e.g. coating, handling of tablets, capsules or creams), it may be appropriate to
reduce the engineering and administrative measures required, e.g. by one or two Exposure
Control Approaches.
 For milling, particle-size reduction or operations handling large quantities of dusty material a
higher ECA may be required than that indicated by the OHC.

202-TI-201 Page 5 of 37
3.2 Performance
The degree of exposure control achieved in practice depends on

 the detailed design of plant and facilities;
 regular maintenance, examination and testing of the control measures;
 the adoption of good working practices.
Performance will be critically dependent on the operating practices used, and could be 1-2 orders
of magnitude worse than predicted if the working practices advised are not adhered to.
It is important to differentiate between compliance testing and testing for design purposes.
To test the performance of the Engineering design, the airborne concentrations that would be
experienced by an operator using the design have to be measured over the duration of the task
associated with that design. A task duration based measure therefore reflects the intensity of the
exposure experienced by the operator undertaking a specific task.
This differs from a compliance test where an 8 hour time weighted average (TWA) exposure is
used. As the title implies a TWA value averages out all the individual peaks in exposure from
multiple tasks to give an average daily exposure and is therefore a measure of the operator’s
cumulative exposure from all sources over a working day.
For testing the performance of a particular design providing protection to personnel the task
duration measure is therefore more appropriate.
Ideally the OEL for a product will be known and a design can be generated that ensures all test
sample results are predicted to be below the OEL. However, if no information is available on the
product other than OHC band, then the default position for engineering design and control
purposes, is that the arithmetic mean of task duration personal test samples should be below the
middle of the OHC band.
For design purposes, designing “to an OHC band” implies choosing an appropriate Exposure
Control Approach (ECA) that allows the flexibility to enhance the Engineering controls to achieve
performance lower in the band if necessary. If the design is expected to need to meet lower OELs
within an OHC band, this needs to be specified in advance to allow appropriate design from the
outset.
3.3 Application to New Processes
The procedure for designing a new system using the ECM is illustrated in the flow chart in Figure 4
(see next page). The figure also shows an approximate relationship between its steps and the
stages defined in the Project Management Standard.
Once the ECA required for a new plant or process has been defined, consideration should be
given to specifying the infrastructure (e.g. general design concepts, access and egress)
appropriate to a higher level of containment. This would limit future costs of building renovation if
compounds with a higher potency were to be introduced at a later stage. Any such decision
should be based on a business case approved by the appropriate managers.
Exposure measurements, e.g. assessment of exposure controls and work practices, will be
required to confirm that the controls are effective when they are new or after any subsequent
change in the process. They may also be required routinely to ensure that existing controls are
functioning properly. Measurement requirements should be established as part of the risk
assessment process.

202-TI-201 Page 6 of 37
Safety critical items must be identified and appropriate maintenance frequencies established on
automated maintenance systems, for example the RATE system at http://pha.gsk.com (or search
by “Process Hazard Management System” on EHSManager).
The project team should review the final design of engineering controls with a multidisciplinary
input (representing engineering, manufacturing, QA, EHS, EHM, maintenance, etc as appropriate)
to ensure that all aspects of the process, tasks and hazards have been considered.

202-TI-201 Page 7 of 37
Figure 4: Exposure Control Design Flow Chart
PROJECT START
eg New Chemical Entities (NCEs)
EHS inputs:
F Inception
Project investment proposal
 Site Engineering
o Technology Transfer Team (TTT)
 Maintenance
New Product Supply (NPS)
r  Operations
 Quality/Good Manufacturing
Establish Project Design Team to Practice (GMP)
v Identify (Health Effects Review): address exposure control strategy  Employee Health Management
e  hazardous materials (EHM)
 Occupational Hazard Category  Environment, health and safety
r Review process flow
 Engineering Technology and
(OHC) and description
Feasibility
i  Occupational Exposure Limit Capital Management (ETCM)

f (OEL)  Consultants
Approximate correspondence to project stages (as defined in the Project Management Standard)
Confirm process functionality

y Identify best way forward
i
1. Identify unit operations .
n 2. Identify process equipment Apply ECM
g 3. Identify:
Apply OHC to select
Consider other risks
 batch size a preliminary ECA
eg ergonomics, noise, process
 % active/formulation safety and environmental releases
t  dustiness/volatility
h  duration/frequency
Concept design
Conduct a process-specific risk

e 4. Identify cleaning/deactivation assessment
requirements
p Adjust ECA according to the risk

Note: This information becomes
assessment
e the basis for the User
Requirement Specification
r (URS) If an existing facility, assess it
Identify general control
f requirements
using Self Assessment
Questionnaire (SAQ)
o
r
Check the Engineering Design Kit
m Identify appropriate control
(EDK) or Pre-engineered Solutions
a Set up local group to address technologies/equipment
or both
Scheme design
n needs
c No Are suitable
controls available?
e Search for or develop equipment
Yes
o Design review or HAZOP or both Finalise and approve design Standard layouts
f
Detailed
design
Specify and procure equipment,

Standard specifications
e including performance guarantee
x
Construction
i Confirm performance of control Outputs from

equipment at vendor site by means Engineering Technology Forum (ETF) &
s of Factory Acceptance Test (FAT) Sourcing Group Management (SGM)
t
i
Commissioning
Install and commission

and handover
n equipment, conducting, eg: Common

Review and update chemical risk
g assessment
Installation Qualification (IQ) Standard Operating Procedures
Performance Qualification (PQ) (SOPs) and training
Operational Qualification (OQ)
T Confirm performance of control

Validation
equipment at GSK by means of

Submit new EDK
Site Acceptance Test (SAT) and
ongoing performance monitoring

202-TI-201 Page 8 of 37
3.5 Application to Existing Processes
The principles for assessing existing plant are covered in 703-TI-102 (Chemical Risk Assessment).
This is supplemented by a tool for assessing an existing facility called the ECM Self-assessment
Questionnaire (202-TI-202). This Self-assessment Questionnaire (SAQ) is designed to assist in
the assessment of the Exposure Control Approach (ECA) provided by the controls selected for or
applied to a given process or working environment. The SAQ can be used:
 to assess a facility prior to the introduction of:
 a new product;
 a new raw material;
 a raw material in a new physical form;
 new process;
 to assess a contractor or contract manufacturer;
 when performing a due diligence assessment of a process or facility;
 as part of a Request for a Proposal (RFP) to manufacture.
It may be advantageous to establish a team to complete the evaluation. Team members may
include the EHS Manager and representatives from the Maintenance, Engineering, Manufacturing
and Quality Assurance departments. If a team is not used, the results of the evaluation should be
discussed with appropriate facility functions.
A separate evaluation should be completed for each process area in which manufacturing activities
take place. For example, each suite and area dedicated to compression, milling, dispensing,
kegging etc. will require its own evaluation.
In order to select the controls required it is necessary to:

 identify all actual and potential sources of emission;
 identify those sources of emission that could contribute to exposure, including through
inadvertent releases, and determine the relative contribution of each such source;
 note any relevant characteristics of each emission (e.g. rate, initial velocity) and whether each is
continuous or intermittent (if intermittent, how frequent);
 observe work methods and workers’ interactions with each emission source (particularly the
proximity of the workers’ breathing zones to the emission);
 estimate potential for exposure by other routes (e.g. skin contact via surface contamination)
 consider potential for migration of contamination to other areas
Documents in the Engineering Design Kit (EDK) series provide recommended exposure control
designs for specific unit operations. Appendix 1 shows the structure and generalised content of a
typical entry in the EDK. Entries describing actual equipment can be found on the GMS
Engineering Home Page (website) under the Technical Library tab (also accessible via myEHSS).

202-TI-201 Page 9 of 37
4 MONITORING OF EXPOSURE CONTROL PERFORMANCE
The control measures described in the matrix should enable sites to achieve compliance with GSK
OELs and other relevant exposure limits after taking due account of the risks and operational
factors identified in section 3.
The guidelines contained in this document need ongoing verification. This can be achieved by a
programme of personal monitoring using validated sampling and analytical methods and specific
sampling strategies. Measurement of the performance of new control measures and many existing
control measures will continue to be required to improve the reliability of the information in these
guidelines.
The results of any exposure measurements should be made available to CEHSS on request to
enable the “good practice” to be updated where appropriate to reflect sites’ actual experience.
Details of the equipment installed should also be entered on a form such as that in Appendix 1
(Engineering Design Kit) and submitted to CEHSS/GMS Engineering via myGSK.
It may be that some existing installations do not appear to match the guidance given in the tables of
this ECM. It is not a requirement to change existing installations if appropriate data exists to
demonstrate that the controls in place are effective. However, opportunities to reduce risk by
improving engineering controls and reducing reliance on operational factors should be considered
as part of continuous improvement
Further information about personal sampling requirements can be found in the GSK Technical
Information documents in the 703-TI-100 series (Chemical Agents).
5 EXPOSURE CONTROL MATRICES
Matrices for the topics listed below appear on the following pages:
 Engineering controls:
 Table 1 Containment page 11
 Table 2 Local Exhaust Ventilation page 13
 Table 3 General/Room Ventilation page 16
 Table 4 General Design Concepts page 19
 Procedural controls:
 Table 5 General Controls Achieved by Good Practice page 23
 Table 6 Access and Egress page 25
 Table 7 Adverse Events and Emergencies page 26
 Table 8 Maintenance and Cleaning page 27
 Table 9 Training page 30
 Table 10 Exposure Monitoring page 31

202-TI-201 Page 10 of 37
Table 1 Containment
Exposure Control Approach A Exposure Control Approach B Exposure Control Approach C Exposure Control Approach D Exposure Control Approach E
 Good Manufacturing  Good Manufacturing  Good Manufacturing  Good Manufacturing  Good Manufacturing
Practice (GMP) should be Practice (GMP) should be Practice (GMP) should be Practice (GMP) should be Practice (GMP) should be
adopted. adopted. adopted. adopted. adopted.
 No special engineering  Specialist advice should be

containment is required. sought for OELs at or
below 1.0 micro gram per
cubic meter and for OHC5
new products where an
OEL has not yet been set.
 Open handling should be  Open handling is not  Open handling is not  Open handling is not
limited to small quantities. recommended. permitted. permitted.
Generally not suitable for
OHC 4 and 5 materials.

202-TI-201 Page 11
 Partial enclosures, e.g.  Down-flow booths (fitted  Plant and equipment  Plant and equipment
down-flow booths, should with barriers or shower needs to be totally needs to be totally
be used to house plant and curtains), enclosed enclosed. enclosed.
equipment where material transfer systems Unit processes should be Unit processes should be
appropriate. (e.g. split butterfly valves, housed in dedicated rooms housed in dedicated rooms
flexible liners or inflatable or segregated areas. or segregated areas.
heads), or glove-boxes The use of glove-boxes, Operations should be
may be needed. Proper isolators, enclosed close coupled to avoid
ergonomic design is material transfer systems materials transfers outside
essential. or other devices that the enclosure.
ensure containment is The use of multiple
mandatory. compartment glove-boxes
to protect transfer ports,
measures within the glove-
box to reduce the dust
challenge, enclosed
material transfer systems
or other devices that
ensure containment are
mandatory. Consideration
should be given to the use
of manipulators and/or
robotics.
 Partial enclosures, process  Partial enclosures, process  Enclosures, process  Enclosures, process
vessels and containers vessels and containers vessels and containers vessels and containers
should be maintained should be maintained need to be maintained need to be maintained
under negative pressure to under negative pressure to under negative pressure to under negative pressure to
prevent leakage. prevent leakage. prevent leakage. prevent leakage. Pressure
cascades to be used for
multi compartment glove-
boxes.
  Equipment should be  Equipment needs to be  Equipment should be

designed to be Wash in designed to be Wash in designed to be Clean in
Place. Place place

202-TI-201 Page 12
Table 2 Local Exhaust Ventilation and Extracted Air
 Local Exhaust Ventilation  LEV needs to be applied at  LEV should be used in  LEV is not appropriate for  LEV is not appropriate for
(LEV) is recommended. source to capture conjunction with other this approach, since total this approach, since total
contaminants from open or control measures as a containment is required. containment is required.
semi-enclosed operations. means of removing
material incidentally
released.
 The relative position of the  The relative position of the  The relative position of the  Glove-boxes should be at a  Glove-boxes should be at a
LEV with respect to the LEV with respect to the LEV with respect to the negative pressure to the negative pressure to the
dust generation zone dust generation zone dust generation zone room they are in. Controls room they are in. Controls
should be fixed should be fixed. should be fixed. should be in place to should be in place to
maintain this and alarm with maintain this and alarm with
a leaking glove. a leaking glove.
 Recirculation of air from  Recirculation of air from  Recirculation of air from  Recirculation of extracted air  Recirculation of extracted
LEV systems is not “built in” fixed pipework “built in” fixed pipework is not permitted. air is not permitted.
permitted unless HEPA LEV systems is not LEV systems is not
filters are used. permitted. permitted.
 However recirculation of  However recirculation of

air from down-flow booths air from down-flow booths
and mobile LEV units is is permitted, provided
permitted, provided double double HEPA filters are
HEPA filters are fitted. fitted

202-TI-201 Page 13
 Extracted air should be  Extracted air should be  OHC4/5 - extracted air  OHC4/5 - extracted air
 OHC3 - extracted air
passed through a suitable passed through a suitable should be passed through a should be passed through a
should be passed through
air-cleaning system prior to air-cleaning system prior to double HEPA filter before double HEPA filter before
a single HEPA filter before
emission to atmosphere. emission to atmosphere. being exhausted outside the being exhausted outside
being exhausted outside
building. the building.
the building.
 Suitable pre-filters should be  Suitable pre-filters should
 OHC4/5 - extracted air
used to extend the life of the be used to extend the life of
should be passed through
HEPA filter i.e. F9 or the HEPA filter i.e. F9 or
a double HEPA filter
cyclone with filters. cyclone with filters.
before being exhausted
outside the building.
 Suitable pre-filters should

be used to extend the life
of the HEPA filter i.e. F9 or
cyclone with filters.
 OHC3, OHC4, OHC5 or  OHC3, OHC4 and OHC5 -  OHC3, OHC4 and OHC5 -
 OHC3, OHC4, OHC5 or
sensitisers - filters should filters should be of a “safe- filters should be of a “safe-
sensitisers - filters should
ideally be of a “safe- change” type that enables change” type that enables
ideally be of a “safe-
change” type that enables their removal and their removal and
change” type that enables
their removal and replacement without replacement without
their removal and
replacement without contaminating the operator contaminating the operator
replacement without
contaminating the operator or the workplace. or the workplace.
contaminating the operator
or the workplace.
or the workplace.
 All the ductwork inside the  All the ductwork inside the  All the ductwork inside the  Ductwork should be  Ductwork must be
building should, wherever building should, wherever building needs to be under dedicated. All the ductwork dedicated. All the ductwork
feasible, be under negative feasible, be under negative negative pressure (e.g. inside the building needs to inside the building needs to
pressure (e.g. achieved by pressure (e.g. achieved by achieved by a fan on the be under negative pressure be under negative pressure
a fan on the roof). a fan on the roof) unless roof) unless protected by (e.g. achieved by a fan on (e.g. achieved by a fan on
protected by an air- an air-cleaning device. the roof). the roof).
cleaning device.

202-TI-201 Page 14
 The air-cleaning device  The air-cleaning device  The air-cleaning device  The air-cleaning device  The air-cleaning device
should be located close to should be located close to should be located close to must be located close to the must be located close to
the process to prevent the the process to prevent the the process to prevent the process to prevent the the process to prevent the
contamination of exhaust contamination of exhaust contamination of exhaust contamination of exhaust contamination of exhaust
ductwork. ductwork. ductwork. ductwork. ductwork.
 Where positive-pressure  Where positive-pressure  Where positive-pressure

ductwork inside the building ductwork inside the ductwork inside the
cannot be avoided, an building cannot be building cannot be
appropriate filter should be avoided, an appropriate avoided, an appropriate
placed on the upstream filter should be placed on filter should be placed on
side of the fan. the upstream side of the the upstream side of the
fan. fan.

202-TI-201 Page 15
Table 3 General/Room Ventilation
 Negative air pressure  Negative air pressure  Negative air pressure  Negative air pressure  Negative air pressure
conditions must be conditions must be conditions must be conditions must be conditions must be
maintained relative to the maintained relative to the maintained relative to the maintained relative to the maintained relative to the
adjacent clean corridor in adjacent clean corridor in adjacent clean corridor in adjacent clean corridor in adjacent clean corridor in
the working area. the working area. the working area. the working area. the working area.
 Suitable air locks should  Suitable air locks should  Suitable air locks should  Suitable air locks should  Suitable air locks should
be incorporated to prevent be incorporated to prevent be incorporated to prevent be incorporated to prevent be incorporated to prevent
migration of contaminants. migration of contaminants. migration of contaminants. migration of contaminants. migration of contaminants.
 Supply air should be  Supply air should be

 Supply air should be  Supply air should be  Supply air should be
introduced and introduced and
introduced and introduced and introduced and
contaminated air extracted contaminated air extracted
contaminated air extracted contaminated air extracted contaminated air extracted
at appropriate rates. at appropriate rates.
at appropriate rates. at appropriate rates. at appropriate rates.
 Consideration should be
given to the use of
showers within negative air
locks to prevent movement
of airborne powders out of
the operating area in the
event of an equipment
breach.

202-TI-201 Page 16
 Where primary protection is  Where primary protection is  Where primary protection is  Where primary protection is  Where primary protection is
provided by engineering provided by engineering provided by engineering provided by engineering provided by engineering
containment at source so containment at source so containment at source so containment at source so containment at source so
that operators can routinely that operators can routinely that operators can routinely that operators can routinely that operators can routinely
work in the area without work in the area without work in the area without work in the area without work in the area without
respiratory protective respiratory protective respiratory protective respiratory protective respiratory protective
equipment, then room air equipment, then room air equipment, then room air can equipment, then room air equipment, then room air
can be recirculated. can be recirculated. be recirculated. can be recirculated. can be recirculated.
 Recirculation will not be Subject to consideration of Subject to consideration of In this instance the following In this instance the following
appropriate where certain any other materials used in any other materials used in criteria must be met: criteria must be met:
other materials such as the area such as solvents; the area such as solvents;
1. Double HEPA filters must 1. Double HEPA filters must
solvents are also present. general room ventilation air general room ventilation air
be provided on the return be provided on the return
can be recirculated if: can be recirculated if:
 General room ventilation ductwork. ductwork.
air may be filtered and 1. Double HEPA filters must 1. Double HEPA filters must
2. One HEPA will be terminal 2. One HEPA will be terminal
recirculated as appropriate be provided. be provided.
at the room boundary, and the at the room boundary, and the
for the manufacturing or 2. One filter will be on the 2. One filter will be on the other one will be in the other one will be in the
packaging environment. return ductwork as close as return ductwork as close as recirculated ductwork in the recirculated ductwork in the
practicable to the source of practicable to the source of plantroom. plantroom.
contaminant. The other filter contaminant. The other filter
3. The terminal filter will be 3. The terminal filter will be
will be on the supply air will be on the supply air
changed within the room, and changed within the room, and
handing unit. handing unit.
the central unit will be safe the central unit will be safe
3. OHC3, OHC4, OHC5 or 3. OHC3, OHC4, OHC5 or change. change.
sensitisers - filters should sensitisers - filters should
4. Provision for 100% once 4. Provision for 100% once
ideally be of a “safe-change” ideally be of a “safe-change”
through air should be provided through air should be provided
type that enables their removal type that enables their removal
for an emergency situation. for an emergency situation.
and replacement without and replacement without
contaminating the operator or contaminating the operator or The decision to recirculate The decision to recirculate
the workplace. the workplace. must be subject to must be subject to
consideration of any other consideration of any other
4. A bag filter will provided 4. A bag filter will provided
materials used in the area materials used in the area
before the return HEPA before the return HEPA
such as solvents. such as solvents.
Where suitable primary Where suitable primary
If suitable primary If suitable primary
containment cannot be containment cannot be
containment cannot be containment cannot be
achieved, specialist EHS achieved, specialist EHS
achieved, the room ventilation achieved, the room ventilation
advice should be sought. advice should be sought.
air must not be recirculated. air must not be recirculated.
Criteria 1, 2 and 3 must still be Criteria 1, 2 and 3 must still be
applied. applied.

202-TI-201 Page 17
 Contaminated exhaust  Contaminated exhaust  Contaminated exhaust

ducts passing through the ducts are not acceptable ducts are not acceptable
building need to be and need to be designed and need to be designed
maintained under negative out. out.
pressure.
 Restrictions on access to  Restrictions on access to  Access to exhaust points  Access to exhaust points
exhaust points may be exhaust points may be needs to be restricted to needs to be restricted to
necessary. necessary. authorised personnel. authorised personnel.

202-TI-201 Page 18
Table 4 General Design Concepts
 Differential pressure  Differential pressure  Differential pressure  Differential pressure  Differential pressure
gauges must be provided gauges must be provided gauges must be provided gauges must be provided gauges must be provided
across all critical bag and across all critical bag and across all critical bag and across all critical bag and across all critical bag and
HEPA filters. High and HEPA filters. High and low HEPA filters. High and low HEPA filters. High and low HEPA filters. High and low
low limits must be limits must be indicated on limits must be indicated on limits must be indicated on limits must be indicated on
indicated on the gauge. the gauge. the gauge. the gauge. the gauge.
 In addition to the above, a  In addition to the above, a  In addition to the above, a  In addition to the above, a
differential pressure signal differential pressure signal differential pressure signal differential pressure signal
(e.g. 4-20mA) must be (e.g. 4-20mA) must be (e.g. 4-20mA) must be (e.g. 4-20mA) must be
provided and monitored provided and monitored provided and monitored provided and monitored
continuous by the building continuous by the building continuous by the building continuous by the building
management system (if management system (if management system (if management system (if
available), with alarm available), with alarm available), with alarm available), with alarm
limits. This does not need limits. This does not need limits. This does not need limits. This does not need
to be validated. to be validated. to be validated. to be validated.
 Self-closing doors should  Self-closing doors should  The working area around  Isolation of the working  Isolation of the working
be fitted to processing be fitted to processing the process may need to area by means of airlocks area by means of air
rooms or bays. rooms or bays. be isolated from other for materials and airlocks for materials and
areas, with access for personnel is essential. personnel is essential.
personnel and materials
via airlocks.
 Surfaces should be easily  All surfaces in the work  All surfaces in the work  All surfaces in the work  All surfaces in the work
cleanable. area should be smooth area should be smooth area should be smooth area should be smooth
and non-porous for easy and non-porous for easy and non-porous for easy and non-porous for easy
cleaning. Materials cleaning. Materials cleaning. Materials cleaning. Materials
selected for these surfaces selected for these surfaces selected for these surfaces selected for these surfaces
should be resistant to the should be resistant to the need to be resistant to the need to be resistant to the
decontaminating agents decontaminating agents decontaminating agents decontaminating agents
that will be used. that will be used. that will be used. that will be used.

202-TI-201 Page 19
 Operations need to be
segregated (e.g., with
partitions or barriers)
and/or conducted to
prevent the spread of
contamination.
 Rooms should be  Rooms should be  Rooms should be  Rooms should be  Rooms should be
designed and designed and constructed designed and constructed designed and constructed designed and constructed
constructed using using materials and using materials and using materials and using materials and
materials and solutions to solutions to achieve solutions to achieve solutions to achieve solutions to achieve
achieve minimal air minimal air leakage. minimal air leakage. minimal air leakage. minimal air leakage.
leakage.
 A suitable test (smoke or  A suitable test (smoke or
pressure) should be pressure) should be
conducted to confirm the conducted to confirm the
required standard. required standard.
 An FMEA study/review  An FMEA study/review (or  An FMEA study/review (or  An FMEA study/review (or  An FMEA study/review (or
(or similar) should be similar) should be similar) should be similar) should be similar) should be
undertaken to consider undertaken to consider undertaken to consider undertaken to consider undertaken to consider
and identify the risks and and identify the risks and and identify the risks and and identify the risks and and identify the risks and
mitigation strategies. mitigation strategies. mitigation strategies. mitigation strategies. mitigation strategies.

202-TI-201 Page 20
 Washing facilities should  Washing facilities should  Locker rooms and showers  Locker rooms and showers
be adjacent to the area. be adjacent to the area. should be: should be:
 adjacent to the area but  adjacent to the area but

isolated with airlocks and isolated with airlocks and
de-robing facilities for the de-robing facilities for the
removal of protective removal of protective
clothing; clothing;
 provided with washing and  provided with washing and

storage facilities. storage facilities.
 Potentially contaminated  Potentially contaminated

shower water and shower water and
decontamination liquids decontamination liquids
may need to be collected may need to be collected
for treatment prior to for treatment prior to
disposal. disposal.
 Ancillary units such as  Ancillary units such as

decontamination facilities decontamination facilities
may need to be located may need to be located
within the enclosed plant between the enclosed
area. plant area and locker and
shower rooms.
 Materials should be
transported to remote  Materials should be
laboratories in robust and transported to remote
sealed containers. laboratories in robust and
Additional protection such sealed containers.
as a plastic liner or glove Additional protection such
bag should be used if the as a plastic liner or glove
outside of the container bag must be used if the
may be contaminated. The outside of the container
laboratory should be may be contaminated. The
equipped to receive laboratory must be
contaminated containers. equipped to receive
contaminated containers.

202-TI-201 Page 21
 Design should minimise  Design should minimise  Design should minimise

ledges, horizontal surfaces ledges, horizontal surfaces ledges, horizontal surfaces
and inaccessible areas and inaccessible areas and inaccessible areas
where dust may collect. where dust may collect. where dust may collect.
 Non-essential equipment  Non-essential equipment  Non-essential equipment

and piping should be and piping should be and piping should be
excluded from the work excluded from the work excluded from the work
area. area. area.
 Utilities should be  Utilities should be  Utilities should be

accessible from outside accessible from outside accessible from outside
the contained area. the contained area. the contained area.

202-TI-201 Page 22
Table 5 General Controls Achieved by Good Practice
 Eating, drinking, smoking  Eating, drinking, smoking or  Eating, drinking, smoking  Eating, drinking, smoking  Eating, drinking, smoking
or applying cosmetics are applying cosmetics are or applying cosmetics are or applying cosmetics are or applying cosmetics are
prohibited in the work prohibited in the work area. prohibited in the work prohibited in the work prohibited in the work
area. area. area. area.
 Work uniforms may not be  Work uniforms may not be  Work uniforms may not be  Work uniforms may not be  Work uniforms may not be
worn outside the facility or worn outside the facility or worn outside the facility or worn outside the facility or worn outside the facility or
taken home. taken home. taken home. taken home. taken home.
 Procedures need to be in  Procedures need to be in  Procedures need to be in  Procedures need to be in  Procedures need to be in
place and implemented to place and implemented to place and implemented to place and implemented to place and implemented to
prevent or control prevent or control exposure prevent or control prevent or control prevent or control
exposure of ancillary or of ancillary or contract exposure of ancillary or exposure of ancillary or exposure of ancillary or
contract workers (e.g., workers (e.g., laundry contract workers (e.g., contract workers (e.g., contract workers (e.g.,
laundry workers) to raw workers) to raw materials, laundry workers) to raw laundry workers) to raw laundry workers) to raw
materials, intermediates intermediates and products. materials, intermediates materials, intermediates materials, intermediates
and products. and products. and products. and products.
 Health Surveillance needs  Health Surveillance needs  Health Surveillance needs  Health Surveillance needs  Health Surveillance needs
to be conducted as to be conducted as specified to be conducted as to be conducted as to be conducted as
specified in the SDS or in the SDS or the specified in the SDS or the specified in the SDS or the specified in the SDS or the
the documentation documentation supporting documentation supporting documentation supporting documentation supporting
supporting the allocation the allocation of the OEL or the allocation of the OEL the allocation of the OEL the allocation of the OEL
of the OEL or OHC. OHC. or OHC. or OHC. or OHC.

202-TI-201 Page 23
 Protective clothing needs  Protective clothing needs to  Protective clothing needs  Personnel need to remove  Personnel need to remove
to be removed on exit be removed on exit from the to be removed on exit from protective clothing on exit protective clothing on exit
from the area area. the area. from the area. Shower to from the area. Shower to
be used if contamination be used if contamination
suspected. suspected.
 Use of disposable  Use of disposable

protective clothing is protective clothing is
generally preferred to that generally preferred to that
of reusable clothing. of reusable clothing.
Where reusable protective Where reusable protective
clothing is worn, it is clothing is worn, it is
essential to have essential to have
appropriate procedures in appropriate procedures in
place to prevent or control place to prevent or control
exposure of ancillary or exposure of ancillary or
contract workers (e.g., contract workers (e.g.,
laundry workers) to raw laundry workers) to raw
materials, intermediates materials, intermediates
and products. and products.
 Batch paperwork needs to  Batch paperwork needs to  Batch paperwork needs to  Contamination of batch  Contamination of batch
be protected from be protected from be protected from paperwork needs to be paperwork must be
contamination. contamination. contamination. avoided. Appropriate avoided. Appropriate
controls to achieve this controls to achieve this
include electronic data include electronic data
transmission. Paperwork transmission Paperwork
systems using plastic systems using plastic
envelopes or boxes which envelopes or boxes which
are wipe clean need to be are wipe clean need to be
verified by swab testing. verified by swab testing.

202-TI-201 Page 24
Table 6 Access and Egress
 Only authorised personnel  Only authorised personnel  Only authorised personnel  Strict control of access to  Strict control of access to
wearing appropriate wearing appropriate clothing wearing appropriate the working area is the working area is
clothing and protective and protective equipment clothing and protective essential. Only authorised essential. Only authorised
equipment (e.g. lab coat, (e.g. lab coat, safety equipment (e.g. lab coat, and trained personnel and trained personnel
safety glasses, gloves) glasses, gloves) may enter safety glasses, gloves) wearing appropriate clothing wearing appropriate clothing
may enter the working the working area. may enter the working and protective equipment and protective equipment
area. area. (e.g. lab coat, safety (e.g. lab coat, safety
glasses, gloves) may enter glasses, gloves) may enter
this area during operations. this area during operations.
 Only equipment and  Only equipment and  Only equipment and

supplies necessary for job supplies necessary for job supplies necessary for job
activities should be taken activities should be taken activities should be taken
into the working area. into the working area. into the working area.
 Doors with interlocks may  Doors with interlocks are  Doors with interlocks are
be needed for materials needed for materials needed for materials
airlocks and locker rooms. airlocks, locker rooms and airlocks, locker rooms and
decontamination areas. decontamination areas.
 Emergency exit routes  Emergency exit routes  Emergency exit routes may
should be considered for should not pass through not pass through general
general work areas. work areas.
 an emergency inside the
contaminated area where
the operator may be
significantly contaminated.
 an emergency outside of
the work area where the
operator in this area is not
significantly contaminated.

202-TI-201 Page 25
Table 7 Adverse Events and Emergencies
 Normal site procedures for  Normal site procedures for  Specific procedures need  Specific procedures need  Specific procedures need
emergencies and adverse emergencies and adverse to be devised and to be devised and to be devised and
events apply. events apply. implemented for dealing implemented for dealing implemented for dealing
with emergencies and with emergencies and with emergencies and
adverse events, e.g. adverse events, e.g. adverse events, e.g.
breaches of containment, breaches of containment, breaches of containment,
fires inside and outside the fires inside and outside the fires inside and outside the
area. area. area.
 Spilled materials need to be  Spilled materials need to be  Spills need to be cleaned  Spills must be cleaned up  Spills must be cleaned up
cleaned as soon as possible. cleaned as soon as up as soon as possible by as soon as possible by as soon as possible by
possible. personnel wearing personnel wearing personnel wearing
appropriate protective appropriate protective appropriate protective
equipment. equipment. equipment.
 All contaminated waste needs  All contaminated waste  All contaminated waste  All contaminated waste  All contaminated waste
to be bagged before removal needs to be bagged before needs to be bagged before needs to be bagged before needs to be bagged before
from the area. removal from the area. removal from the area. removal from the removal from the
enclosure. enclosure.
 Wherever possible,  Exercises must be  Exercises must be

exercises should be undertaken to ensure undertaken to ensure
undertaken to ensure practicability and practicability and
practicability and effectiveness of the effectiveness of the
effectiveness of the procedures. procedures. (This includes
procedures. an emergency outside of
the area as well as inside
the area).
 Additional containment  Additional containment

may be needed for use in may be needed for use in
the event of a catastrophic the event of a catastrophic
loss, e.g. fire, explosion, loss, e.g. fire, explosion,
over-pressurisation, over-pressurisation,
contaminated fire-water. contaminated fire-water.

202-TI-201 Page 26
Table 8 Maintenance and Cleaning
 PPE, including Respiratory  PPE, including  PPE, including Respiratory  It is essential to have and  It is essential to have and
Protective Equipment (RPE), Respiratory Protective Protective Equipment follow specific procedures, follow specific procedures
may be needed when Equipment (RPE), may be (RPE), may be needed including use of PPE or (method statements)
equipment is opened for needed when equipment when equipment is opened RPE, if required, when including the use of PPE
maintenance and cleaning. is opened for for maintenance and equipment is opened for or RPE if equipment is
maintenance and cleaning. maintenance, e.g. opened for maintenance.
cleaning. replacement of filter
elements. Design should minimise the
need to open the enclosure
for maintenance, features like
hot glove change, full clean
ability from outside the
enclosure .
Submerged and/or wet

methods must be fully
utilised.
 Equipment should be  Equipment should be  Equipment should be  Equipment needs to be  Equipment needs to be
designed for easy designed for easy designed for easy designed for easy designed for easy
maintenance. maintenance. maintenance, with access maintenance, with access maintenance, with access
from outside the from outside the from outside the
containment. containment. containment.
 Cleaning by brush-sweeping  Cleaning by brush-  Surfaces should be  Surfaces need to be  Surfaces need to be
is prohibited. Vacuum sweeping is prohibited. cleaned using vacuum accessible for cleaned accessible for cleaned
systems or other dust-free Vacuum systems or other systems fitted with HEPA using HEPA vacuum using HEPA vacuum
cleaning methods should be dust-free cleaning filters prior to wet mopping. systems and wet systems and wet
used instead. methods should be used mopping/wiping. Chemical mopping/wiping.
instead. decontamination may be Chemical
necessary. decontamination may be
necessary.

202-TI-201 Page 27
 Use of Wash in Place  Use of wash in place is  Use of Clean in Place

equipment is essential. equipment is essential.
recommended
 Alarms or performance  Alarms or performance  Alarms or performance  Alarms or performance  Alarms or performance
indicators required for any indicators required for any indicators required for any indicators required for any indicators required for
control equipment should be control equipment should control equipment should control equipment must be any control equipment
maintained in accordance be maintained in be maintained in maintained in accordance must be maintained in
with the recommended accordance with the accordance with the with the recommended accordance with the
preventive maintenance recommended preventive recommended preventive preventive maintenance recommended preventive
schedule. maintenance schedule. maintenance schedule. schedule. maintenance schedule.
 Engineering controls  Engineering controls  Engineering controls  Engineering controls need  Engineering controls
including LEV need to be: including LEV need to be: including LEV need to be: to be: need to be:
 visually checked every week;  visually checked every  visually checked every  high wear components
week; week; visually checked daily or  High wear components
 maintained in accordance before a batch if use is less visually checked daily or
with manufacturers’  maintained in accordance  maintained in accordance frequent; before a batch if use is
specifications; with manufacturers’ with manufacturers’
less frequent;
specifications; specifications;  controls visually checked
 examined and tested at least weekly;
annually.  examined and tested at  examined and tested at  Controls visually checked
least annually. least annually.  maintained in accordance weekly;
with manufacturers’
specifications;  maintained in accordance
with manufacturers’
 examined and tested at
specifications;
least annually;
 Critical safety items defined  examined and tested at
and part of a validated least annually;
maintenance systems.
 Critical safety items
defined and part of a
validated maintenance
systems.

202-TI-201 Page 28
 Contaminated liquid and  Contaminated liquid and  Contaminated liquid and  Contaminated liquid and  Contaminated liquid and
solid wastes, including solid wastes, including solid wastes, including solid wastes, including solid wastes, including
residuals, contaminated residuals, contaminated residuals, contaminated residuals, contaminated residuals, contaminated
equipment and clothing, equipment and clothing, equipment and clothing, materials, need to be materials, need to be
need to be categorised and need to be categorised need to be categorised bagged and categorised bagged and categorised
disposed of as described in and disposed of as and disposed of as and disposed of as and disposed of as
the Pollution Control Matrix. described in the Pollution described in the Pollution described in the Pollution described in the Pollution
Control Matrix. Control Matrix. Control Matrix. Control Matrix.
 Integrity testing is required  Integrity testing is required  Integrity testing is required  Integrity testing is
after each HEPA filter after each HEPA filter after each HEPA filter required after each HEPA
change. change. change. filter change.
 Where double HEPA are

installed, each filter must
be integrity tested
individually.
 Duct isolation may be  Duct isolation may be  Duct isolation is required  Duct isolation is required
needed during filter needed during filter during filter changes. during filter changes.
changes. changes.
 Where feasible, tools  Where feasible, tools

should be dedicated and if should be dedicated and
necessary stored in the if necessary stored in the
operational glove-box or operational glove-box or
securely in the operating securely in the operating
area. area.
 All tools that have to be  All tools that have to be

removed from the area removed from the area
need to be need to be
decontaminated before decontaminated before
removal. removal.

202-TI-201 Page 29
Table 9 Training
 Induction training needs to  Induction training needs to  Induction training needs to  Induction training needs to  Induction training needs to
outline the theoretical outline the theoretical outline the theoretical outline the theoretical outline the theoretical
aspects of the work, aspects of the work, aspects of the work, aspects of the work, aspects of the work,
including hazards, risks and including hazards, risks and including hazards, risks including hazards, risks including hazards, risks
controls relevant to the controls relevant to the and controls relevant to and controls relevant to and controls relevant to
workplace. The training workplace. The training the workplace. The the workplace. The the workplace. The
needs to include a review of needs to include a review of training needs to include a training needs to include training needs to include
the SDSs and the the SDSs and the review of the SDSs and practical (i.e. hands-on) practical (i.e. hands-on)
procedures for hazard procedures for hazard the procedures for hazard aspects of the work and a aspects of the work and a
communication, communication, communication, review of the SDSs and review of the SDSs and
emergencies (including emergencies (including emergencies (including the procedures for hazard the procedures for hazard
evacuation), maintenance evacuation), maintenance evacuation), maintenance communication, communication,
and cleaning. and cleaning. and cleaning. emergencies (including emergencies (including
evacuation), maintenance evacuation), maintenance
and cleaning. and cleaning.
 The competence of the  The competence of the  The competence of the  The competence of  The competence of
operator should be operator should be operator needs to be operators in following operators in following
validated. validated. validated. SOPs for effective use of SOPs for effective use of
controls must be observed controls must be observed
and documented. and documented.
 Regular refresher training is  Regular refresher training is  Regular refresher training  Regular refresher training  Regular refresher training
needed. needed. is needed. is needed. is needed. This may be
before each campaign for
infrequent manufacture.
 Processing with placebo  Processing with placebo  Processing with placebo

materials should be materials should be materials should be
undertaken to assess the undertaken to assess the undertaken to assess the
effectiveness of the effectiveness of the effectiveness of the
training. training. training.

202-TI-201 Page 30
Table 10 Exposure Monitoring
 Exposure measurements  Exposure measurements  Exposure measurements  Exposure measurements  Exposure measurements
may be needed, in may be needed, in need to be undertaken, in need to be undertaken, in need to be undertaken, in
accordance with the accordance with the accordance with the accordance with the findings accordance with the
findings of the chemical findings of the chemical findings of the chemical of the chemical risk findings of the chemical
risk assessment, to risk assessment, to risk assessment, to assessment, to validate the risk assessment, to
validate the effectiveness validate the effectiveness validate the effectiveness effectiveness of the validate the effectiveness
of the exposure controls. of the exposure controls. of the exposure controls. exposure controls. of the exposure controls.
 Only validated methods  Only validated methods  Only validated methods  Only validated methods may  Only validated methods
may be used (for may be used. may be used. be used. Only approved may be used. Only
chemicals with an OEL > laboratories may be used. approved laboratories may
2,000 μg m-3; gravimetric be used.
methods are acceptable).
 The required frequency of  The required frequency of  The required frequency of  The required frequency of  The required frequency of
routine monitoring is routine monitoring is routine monitoring is routine monitoring is routine monitoring is
determined by the risk determined by the risk determined by the risk determined by the risk determined by the risk
assessment. More assessment. More assessment. More assessment. More assessment. More
information about how to information about how to information about how to information about how to information about how to
assess this is given in assess this is given in 703- assess this is given in 703- assess this is given in 703- assess this is given in 703-
703-TI-103 (Air Sampling TI-103. TI-103. TI-103. TI-103.
Strategies).
 Wipe samples should be  Regular wipe samples

taken from the working area must be taken from the
outside of the enclosure working area outside the
during normal operation enclosure during normal
from identified high risk operation from identified
locations before cleaning to high risk locations before
aid risk assessment of build cleaning to aid risk
up or migration of assessment of build up or
contamination. migration of contamination.
Note: In addition to any requirements for occupational hygiene measurements, consideration needs to be given to any health surveillance that may
be necessary. This should be included as part of the risk assessment process.

202-TI-201 Page 31
APPENDIX 1 TEMPLATE FOR ITEM IN THE ENGINEERING DESIGN KIT
Engineering Design
Kit
Design Kit No. Project Title Rev Date

EDK?? Engineering Control Guidelines x Day/month/year
For
Chemical & Pharmaceutical Compound Exposures
ENGINEERING DESIGN KIT STATUS – (HIGHLIGHT STATUS)

GSK OPERATIONAL VENDOR / THEORETICAL
CONTROL EQUIPMENT PHOTO / DRAWINGS

{insert photo or engineering detail drawing} {insert photo or engineering detail drawing}
UNIT OPERATION DESCRIPTION

e.g. milling, sieving, compression, dispensing, charging, kegging
ROUTINE OPERATION / PROCESS DESCRIPTION
e.g. brief description or process activities
SUPPORT / NON – ROUTINE OPERATION / PROCESS DESCRIPTION
e.g. cleaning, maintenance, decontamination
DESIGN FEATURES
e.g. glove box, air lock, negative pressure, RTP docking, double HEPA, LEV, etc
CONTROL DEVICE UNIT COST £ {insert cost} YEAR {insert year}
OCCUPATIONAL HAZARD CATEGORY (OHC) & EXPOSURE CONTROL APPROACHES

(ECA) DESIRED
CHEMICAL/API
(Link to SDS)
CHEMICAL OCCUPATIONAL HAZARD OHC – {insert OHC}
CATEGORY & RANGE {insert lower } g / m3
{insert upper} g / m3
3
CHEMICAL OEL (µg / m ) {insert OEL} g / m3
RISK ASSESSMENT-BASED CONTROL ECA – {insert ECA}
APPROACH DESIRED2
(Link to ECM)
OCCUPATIONAL HYGIENE (OH) AIR SAMPLING RESULTS3

NUMBER OF BREATHING ZONE/ {insert quantity}
PERSONNEL SAMPLES
RANGE OF RESULTS {insert lower } g / m3 – {insert upper} g / m3
MEAN OF RESULTS {insert data} g / m3
EXPOSURE CONTROL APPROACH ECA – {insert ECA}
ACHIEVED

202-TI-201 Page 32
Engineering Design
Kit

For
PRODUCT CHARACTERISTICS
BATCH SIZE {insert quantity} kg
% ACTIVE IN BLEND {insert percentage} %
DUST CHARACTERISTIC4 (L / M / H) {insert classification}
CRITICAL TRAINING/WORK PRACTICE RECOMMENDATIONS

TRAINING: e.g. containment devices dependent on correct use and work practices.
VALIDATION: e.g. both GMP/exposure control compliance.
CLEANING/DRYING: e.g. impact on plant operation cycle times and utilisation.
MAINTENANCE/TESTING: e.g. routine maintenance/testing of containment compliance.
LESSONS LEARNED/GENERAL REMARKS

1. knowledge sharing
GSK INFORMATION
LOCATION: {insert building & site}
PROJECT REFERENCE: {e.g. Project No. / Name)
P & ID No.: {insert process P & ID number}
Tag / ID No.: {insert process Tag / ID number}
CONTACT NAMES
ENGINEERING: {insert name}
{insert GSK Net telephone}
OCCUPATIONAL HYGIENE: {insert name}
{insert GSK Net telephone}
PROCESS EQUIPMENT VENDORS

{insert equipment name and tag / ID No.}
{insert vendor name}
{insert vendor address}
{insert vendor telephone}
{insert vendor fax}
{insert vendor web site}
CONTROL EQUIPMENT VENDORS

{insert equipment name and tag / ID No.}
{insert vendor name}
{insert vendor address}
[insert vendor telephone}
{insert vendor fax}
{insert vendor web site}

202-TI-201 Page 33
Engineering Design
Kit

For
NOTES:
1. The use of the information in this Engineering Design Kit does not replace the need to perform a
Chemical Risk Assessment for the particular operation being evaluated.
2. If the ‘ECA’ differs from the ‘OHC’ requirements, state reasons in ‘REMARKS’ box.
3. The air sampling results do not reflect the protection factor provided by respiratory protection
equipment that may have been used.
4. See Glossary

202-TI-201 Page 34
APPENDIX 2 GLOSSARY OF TERMS
Clean-in-place  Used to describe a system and any process equipment it contains that is
designed to facilitate decontamination without the need to dismantle it or
remove any item from it.
ECA  Exposure Control Approach – a set of measures designed to achieve

exposure levels within a defined band when used in conjunction with a
process-specific risk assessment.
EHS  Environment, Health and Safety.
Exposure  The collection and analysis of air samples to measure the amount of a
measurements chemical in the air typically collected from the employee’s breathing zone to
enable personal exposure to be assessed.
HEPA filter  High-efficiency Particulate Air filter – a type of filter used to remove
contaminants from an air-flow; the usual criterion is that it should collect at
least 99.97 of 0.3 µm particles of particulate matter. The matter used to test
the filter may be sodium chloride or thermally generated aerosol of
dioctylphthalate (DOP), which gives particles of that size.
Hierarchy of controls  The requirement under Global EHS Standard 202 to select controls to
minimise the overall EHS risk by:
 eliminating or substituting materials, agents, conditions or activities with the
potential to cause harm, wherever feasible;
 where the potential for harm cannot be eliminated, using all feasible
engineering measures to control the risks;
 establishing administrative and other control measures to minimise any
remaining risk.
 PPE may be used to control residual risks only when all the above
approaches have reduced the risk to the greatest extent feasible.
LEV  Local Exhaust Ventilation – an industrial ventilation system that captures and
removes contaminants emitted from a process at or near their source.
OEL  Occupational Exposure Limit – the maximum airborne concentration of a

substance to which personnel may be exposed without adverse health
effects, expressed as an average concentration measured over a defined
period of time.
OHC  A GSK banding system designed to classify compounds based on the health
hazards; the least hazardous are classified as OHC-1; the most hazardous
as OHC-5.
PPE  Personal Protective Equipment – any specialised clothing or equipment worn

by an individual designed to provide protection against specific hazards. In
the context of the ECM it generally means respirators, gloves or chemical
protective clothing.

202-TI-201 Page 35
Primary control  The principal method used to control exposures, which should in itself limit
employees’ exposures to hazardous substances to an acceptable level. In
practice, it may be prudent to add Secondary controls to provide protection
depending on the assessed risk that the primary control could fail.
Routine activities  Activities and tasks that are conducted as part of normal work operations
under normal, foreseen conditions.
RPE  Respiratory Protective Equipment – any device that will effectively protect
the respiratory system from inhalation of hazardous airborne substances. It
typically includes a face piece and mechanism to provide clean or filtered air
to the user.
Secondary control  A means of controlling residual risks in the event of failure of a Primary
control to provide adequate protection. For example, a glove-box may
provide adequate control of exposures during handling of a hazardous
powder and thereby be considered a Primary control. Operating it inside
the secondary control of a down-flow booth provides protection in the event
of leakage in one of the gloves.
Wash in Place  Used to describe a system and any process equipment it contains that is
designed to facilitate gross decontamination without the need to dismantle it
or remove any item from it. Wash in place may be followed by hand
cleaning, wiping or dismantling for deep cleaning and swab sampling before
use on another product.

202-TI-201 Page 36

Exposure Control Matrix

Uploaded by

Copyright:

Available Formats

Exposure Control Matrix

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Exposure Control Matrix

Uploaded by

Copyright:

Available Formats

TECHNICAL INFORMATION 202-TI-201

EHS Control Matrix series revised

RELATED GLOBAL EHS STANDARDS

202 EHS Risk Assessment and Management;

Appendix 1 Template for Item in the Engineering Design Kit 32

Appendix 2 Glossary of Terms 35

GSK is committed to controlling exposures of employees to hazardous substances. Global EHS

Exposure Control Matrix Aug 2009

These controls might include:

Exposure Control Matrix Aug 2009

< or =5,000 OHC-1

< or =1,000 OHC-2

< or =100 OHC-3

< or =10 OHC-4

Special considerations apply in the planning, design, review and

Exposure Control Matrix Aug 2009

3.1 Risk Assessment

Figure 2: Principles of Risk Assessment

For the Same OHC Band

Less Scale Dustiness Process API

Wet Cake Charging/

Exposure Control Matrix Aug 2009

OHC1 Small scale eg. Lab ECA-A

Medium scale eg. Pilot plant ECA-A

Large Scale eg. Manufacturing ECA-A

OHC2 Small scale eg. Lab ECA-A

Medium scale eg. Pilot plant ECA-A ECA-B

Large Scale eg. Manufacturing ECA-B

OHC3 Small scale eg. Lab ECA-A ECA-B

Medium scale eg. Pilot plant ECA-B ECA-C

Large Scale eg. Manufacturing ECA-C

OHC4 Small scale eg. Lab ECA-B ECA-C

Medium scale eg. Pilot plant ECA-C ECA-D

Large Scale eg. Manufacturing ECA-D

OHC5 Small scale eg. Lab ECA-C ECA-D

Medium scale eg. Pilot plant ECA-D ECA-E

Large Scale eg. Manufacturing ECA-E

The principles can be illustrated by the following examples:

Exposure Control Matrix Aug 2009

The degree of exposure control achieved in practice depends on

3.3 Application to New Processes

Exposure Control Matrix Aug 2009

Exposure Control Matrix Aug 2009

i  Occupational Exposure Limit Capital Management (ETCM)

Confirm process functionality

Conduct a process-specific risk

p Adjust ECA according to the risk

Specify and procure equipment,

i Confirm performance of control Outputs from

Install and commission

n equipment, conducting, eg: Common

T Confirm performance of control

equipment at GSK by means of

Exposure Control Matrix Aug 2009

In order to select the controls required it is necessary to:

Exposure Control Matrix Aug 2009

5 EXPOSURE CONTROL MATRICES

Exposure Control Matrix Aug 2009

 No special engineering  Specialist advice should be

Exposure Control Matrix Aug 2009