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BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire,
England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
RBDS Safety Review & Risk Reduction Report
1 RISK ASSESSMENT STRATEGY
RISK IDENTIFICATION
The process of Risk Assessment
combines a series of reviews to RISK ASSESSMENT
identify hazards with a specific risk STRATEGY
classification (low, medium, high and
very high risks) and secondly to apply
a risk reduction process.
The Risk Reduction Process is the
application of standard operating RISK IDENTIFICATION
procedures and/or safety devices (not
relying on the operator) to reduce
medium and high risks to low risk.
Any identifiable “very high risks” stop
the hazard assessment process as
such safety critical equipment design RISK ASSESSMENT
is not appropriate for this type of
assessment which must be replaced
by a higher level HAZOP (Hazard in
Operations) study.
1.1 REVIEWS RISK REDUCTION
A Hazard Review is completed for
equipment and/or processes with
respect to operator safety while
normal (standard) operations and/or RISK ASSESSMENT AFTER
procedures are undertaken. (A RISK REDUCTION
further Risk Review can be completed
to identify risks to product quality i.e. Figure 1 – Equipment risk assessment review structure
compromise the quality of a
Pharmaceutical or Biotechnology
company product.)
1.2 RISK CLASSIFICATION
As a reference for Risk Classification European Monograph EN1050 is used.
The Risk is then clarified numerically based on the factors of severity,
frequency, probability and avoidance. This operation is performed for each
identifiable risk with the numerical classification as follows:
1 to 4 = Low Risk
5 to 7 = Medium Risk
8 to 10 = High Risk
11 to 14 = Very High Risk
Document No: RBDS-009 / Rev. 1 Page 1 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire,
England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
2 RISK IDENTIFICATION
The check list(s) (included) forms a structure for the review and must be
completed as part of the review. These forms are then processed through the
risk analysis matrix to categorise the level of risk.
2.1 CHECK LIST A
Risk Identification stage is completed to review all possible sources of
potential injury or damage to health of operators and personnel in the vicinity
of equipment during operation.
2.2 CHECK LIST B
This Risk Identification stage is for assessment of product quality and security
by review of critical control points (i.e. the risk to product quality from failure
or deviation to out of specification (OOS) limits).
Risk Identification is completed by checklist prompt with a review of listed
items to consider. Both comments on risks and risk production methods are
added to the form.
2.3 RISK ASSESSMENT
Identified risks are processed through the risk analysis estimation form to
categorise (by scoring) risks as low, medium or high.
2.4 RISK REDUCTION
Following risk assessment a process of actions for risk reduction should be
undertaken.
The following actions apply:
• For all LOW RISKS a Standard Operating Procedure (“S.O.P”) should be put
in place or a monitoring programme is required to verify continued
compliance. I.e. At least one additional safe guard, which may rely on the
operator.
• MEDIUM RISKS should be reduced to low risk by two additional safe
guards. One may rely on the operator (S.O.P) but one must be automatic
or a barrier not relying on operator i.e. a) Procedural, b) Risk Reduction by
Design.
• HIGH RISKS should be reduced to low risk by two additional safe guards
both not relying on operators. i.e. Risk Reduction by Design.
2.5 RISK ASSESSMENT AFTER RISK REDUCTION
• Finally after the risk reduction methods/procedures are in place an
assessment is made to verify methods/procedure meet the aim.
Document No: RBDS-009 / Rev. 1 Page 2 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire,
England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
3 Risk identification Checklist A – Operator Safety
3.1 GROUP 1 – RISKS
Equipment Handling
3.1.1 Risks in physical movement/transfer of RBDS equipment in terms of
strain injury to operators and movement (run away) on slopes.
3.1.2 Risks from residual hydrogen peroxide remaining in equipment when
moving/transfer of gas generator.
3.2 GROUP 2 - RISKS
Mechanical Safety
3.2.1 Are there any finger traps on the gas generator or in any connections
made?
3.2.2 Are there any poor ergonomics in use in the gas generator or making
connections that may give rise to strain injury?
3.2.3 In the normal product configuration does the operator have access to
moving parts?
3.2.4 During maintenance and re-calibration is the Service Engineer exposed
to unnecessary risks, moving parts, excessive loads?
3.2.5 Are there any trip hazards associated with connections from gas
generator to other equipment?
3.3 GROUP 3 - RISKS
Electrical Safety
3.3.1 Do operators have access, during normal operations, to mains (high)
voltage electrical equipment?
3.3.2 Are Service Engineers exposed to unnecessary risks during
maintenance/re-calibration tasks?
3.3.3 Is there any risk of wetting electrical equipment (a) in normal
operations (b) from other process sources?
3.3.4 Are operators exposed to any electrically heated surfaces (greater than
400C) during normal operations?
3.3.5 Do any electrical leads provide a trip hazard?
Document No: RBDS-009 / Rev. 1 Page 3 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire,
England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
3.3.6 Are any extension cables required to make connections to mains
supply, if so do they present an additional risk?
3.3.7 During power failure does the equipment shut down safely and on
recovery is start up safe? Consider power failure in each mode of
operation:-
Conditioning
Gassing
Aeration
3.3.8 Is there risk of fire or explosion due to electrical energy?
3.4 GROUP 4 - RISKS
Chemicals
3.4.1 Are operators exposed to unnecessary risks during loading of
hydrogen peroxide into gas generator?
3.4.2 Are there any potential residuals of hydrogen peroxide on surfaces
accessible to operators in normal operations?
3.4.3 Are there unnecessary risks to Maintenance engineers from potential
contact with hydrogen peroxide during equipment maintenance/repair?
3.4.4 Can hydrogen peroxide accumulate in pipework/tubing which would
present a risk when removed or accessed by Operators or Maintenance
engineers. Consider accumulation by H2O2 in pump tubing?
3.4.5 Are hydrogen peroxide bottle(s) stored safely and do not present a risk
to operators on handling?
3.4.6 Is a spillage procedure in place for safe recovery under failure/fault
conditions?
3.4.7 Are the necessary warning labels on the equipment as well as on the
supplied bottles of hydrogen peroxide liquid?
3.4.8 Is fault/failure recovery Personal Protective Equipment (PPE) in place for
handling spillage and as required during leakage of hydrogen peroxide
gas?
3.4.9 Can hydrogen peroxide oxidise materials and in the process heat up
materials so auto-ignition can occur?
3.5 GROUP 5 – LEAK INTEGRITY – HYDROGEN PEROXIDE RELEASE
3.5.1 Risk of loss in leak integrity from RBDS equipment
a) Gas leakage
b) Liquid H2O2 leakage
Document No: RBDS-009 / Rev. 1 Page 4 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire,
England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
3.5.2 Risk of loss in leak integrity from a room.
3.5.3 Risk from deviation of pressure (00S) of enclosure when at full
hydrogen peroxide gas concentration
a) High pressure
b) Low pressure
3.5.4 Risk of personnel entering the enclosure during the gassing phase.
3.5.5 Risk of gas penetrating other (adjacent) areas during gassing process
3.5.6 Risk to operator on entering room post decontamination due to high
H2O2 concentration.
3.5.7 Risk to operator during emergency or system failure.
4 Risk Identification Checklist B – critical control points
4.1 GROUP 6 – PROCESS PARAMETERS – CRITICAL CONTROL POINTS
Leak Integrity
4.1.1 Risk to process from gas generator pre filter(s) integrity failure.
Temperature
4.1.2 Risk to process from deviation (OOS) of H2O2 vaporiser temperature
a) Over temperature
b) Under temperature
4.1.3 Risk to process from environmental overtemp
Airflow
4.1.4 Risk to process from deviation (OOS) of gas circulation airflow
a) During conditioning
b) During gassing
c) During aeration (hydrogen peroxide removal)
• Phase one aeration
Hydrogen peroxide Liquid Flow
4.1.5 Risk to process from deviation (OOS) of hydrogen peroxide flow.
a) Flow delivery low to vaporiser
b) hydrogen peroxide bottle runs out before cycle end.
c) Over fill of vaporiser
Document No: RBDS-009 / Rev. 1 Page 5 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire,
England, SP10 5AA Registered No. 2520270
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4.1.6 Risk to process of cooling fan failures
a) electrical tray cooling
4.1.7 Risk to process of Aeration unit failure / cable failure.
Comms failure
4.1.8 Risk of communication failure & loss of control.
4.2 GROUP 7 – GASSING CYCLE – CRITICAL CONTROL POINTS
4.2.1 Risk of poor gas distribution during gassing cycle
a) Stirrer fan(s) off or failed during gassing of isolator if applicable.
b) Nozzle(s) off or failed during gassing of room if applicable.
4.2.2 Risk to poisoning the catalyst during gassing cycle, from
a) Incompatible chemicals
b) In process coating from process materials
4.2.3 Risk of bio-contamination after gassing cycle due to pre-filter integrity
failure.
4.2.4 Risk of bio-decontamination not being achieved when room surfaces
are out of specification (OOS) limits.
4.2.5 Risk of residual hydrogen peroxide gas remaining after cycle end due
to recesses in room.
Document No: RBDS-009 / Rev. 1 Page 6 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
RISK ANALYSIS
1 to 4 = Low Risk Fig. 2 RISK ESTIMATION TABLE
5 to 7 = Medium Risk
8 to 10 = High Risk
11 to14 = Very High Risk
PROBABILITY
Frequency Unlikely to May occur in
Prob a bility Very likely
Severity occur normal events to occur
1
Infrequent 1 2 3
Severity
2 Frequent
Would distract or give an
operator cause for concern 1 3 4 5 6
1 2
Would cause minor injury
or temporary harm to 1 3 4 5 6 7 8
health and/or may
(increase risk) of 2
2 5 6 7 8 9 10
compromising product
quality
1 7 8 9 10 11 12
Severe 3
Would cause injury or 2 9 10 11 12 13 14
permanent harm to health
and/or compromise 1 1 2 1 2
2
product quality
Avoidance
1 Avoidable
2 Unavoidable
Document No: RBDS-009 / Rev. 1 Page 7 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
sk Ref Stage (1) Stage (2) Commentary Stage (3)
Number Identified Risk Category Protection / Solution
and Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
3.1.1 Risks in physical Score: ____3____ S= 2 The RBDS equipment is Reduce risk by applying risk reduction
Equipment movement/transfer of RBDS F= 1 easy to move and only level 1.
Handling equipment in terms of strain Classification: P= 1 weighs approximately (1) S.O.P – Equipment handling and
injury to operators and Low Risk A= 1 25 kg, run away on a lifting.
movement (run away) on slopes slope is a risk
3.1.2 Risks from residual hydrogen Score: ____5____ S= 2 The hydrogen peroxide Reduce risk to low by applying risk
Equipment peroxide remaining in equipment F= 1 bottle can be removed reduction level 2.
Handling when moving/transferring the Classification: P= 2 but some residual (1) S.O.P – H2O2 Handling.
gas generator. Medium Risk A= 1 liquid remains in the (2) Reverse pump to drain tubes at
tubing. cycle end
Reduce risk by applying risk reduction
3.2.1 Are there any finger traps on the Score: ____3____ S=2 The connections level 1.
Mechanical Gas generator or in connections F=1 between the gas (1) S.O.P. – equipment set-up
Safety made? Classification: P=1 generator and
Low Risk A= 1 distributor nozzle may
cause finger traps
3.2.2 Are there any poor ergonomics in Score: ____1____ S=1 Bending down to Apply risk reduction level (1)
Mechanical use of gas generator or making F=1 load/unload • S.O.P. Equipment Set-up
Safety connections that may give rise to Classification: P=1 H2O2 Bottle. Bottles
strain injury? Low Risk A=1 needs care.
Connections O.K.
Document No: RBDS-009 / Rev. 1 Page 8 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
sk Ref Stage (1) Stage (2) Commentary Stage (3)
Number Identified Risk Category Protection / Solution
and Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
3.2.3 In the normal product Score: ____1____ S=1 Normal configuration Apply risk reduction level (1)
Mechanical configuration does the operator F=1 Does not present risks • S.O.P for pump tube change,
Safety have access to moving parts? Classification: P=1 Changing consumable including instructions for power
When replacing consumable Low Risk A=1 pump Tubes is a risk if off before access.
parts does the operator have pumps on – power
access to moving parts must be off.
3.2.4 During maintenance and re- Score: ____1____ S=1 With gas generator Apply risk reduction level (1)
Mechanical calibration is the Service Engineer F=1 panels open there is • S.O.P Procedures and manuals
Safety exposed to unnecessary risks, Classification: P=1 risk when powered up - must be in place with work taken
moving parts or excessive loads? Low Risk A=1 additional internal out by qualified persons.
guards are fitted.
3.2.5 Are there any trip hazards Score: ____1____ S=1 Only if the power Apply risk reduction level (1)
Mechanical associated with connections from F=1 leads / communication • S.O.P placement of gas generator
Safety gas generator to other Classification: P=1 leads are connected for connection to
equipment? Low Risk A=1 across a means of isolator/enclosure/room.
access (gangway) is
there a risk
3.3.1 Do operators have access, during Score: ____0____ S=0 The equipment is fully No further action is required
Electrical normal operations, to mains F=0 guarded for normal
Safety (high) voltage electrical Classification: P=0 operations
equipment? Not classified A=0
Document No: RBDS-009 / Rev. 1 Page 9 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
sk Ref Stage (1) Stage (2) Commentary Stage (3)
Number Identified Risk Category Protection / Solution
and Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
3.3.2 Are Service Engineers exposed to Score: ____7____ S=3 The equipment Apply risk reduction level (2)
Electrical unnecessary risks during F=1 operates on mains (1) S.O.P – Maintenance/calibration
Safety maintenance/re-calibration tasks? Classification: P=1 voltage and is not Procedures for use by Qualified
Medium Risk A=1 without risk persons
(2) Fit internal guarding where
possible
In normal operations
3.3.3 Is there any risk of wetting Score: ___8____ S=3 the liquid bottles are Apply risk reduction level (3)
Electrical electrical equipment (a) in normal F=1 along side the electrical (1) S.O.P – Equipment set up &
Safety operations Classification: P=1 tray If the equipment operation
(b) from other process sources? High Risk A=2 was exposed to (2) In design, raise high voltage
excessive amount of circuits above bottle where
water there would be a possible.
risk. (3) Provide splash proof covering
3.3.4 Are operators exposed to any Score: ____7____ S=2 Vapouriser will become Apply risk reduction level (2)
Electrical electrically heated surfaces F=2 hot >100°C during (1) S.O.P – handling / equipment
Safety (greater than 400C) during Classification: P=2 systems normal operation
normal operations? And are Medium Risk A=1 operation. Therefore (2) In design use insulation on
operators exposed to cold operator at risk. hot/cold exposed surfaces. Label
surfaces which could cause harm hot surfaces.
to persons
Document No: RBDS-009 / Rev. 1 Page 10 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
sk Ref Stage (1) Stage (2) Commentary Stage (3)
Number Identified Risk Category Protection / Solution
and Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
3.3.5 Do any electrical leads provide a Score: ____8____ S=2 The power & Apply risk reduction level (2)
Electrical trip hazard? F=1 communications leads (1) S.O.P – Power connection
Safety Classification: P=1 would provide a trip (2) By design ensure the lead is long
Medium Risk A=1 hazard if not correctly enough to reach a power point
routed. with the lead on the floor.
3.3.6 Are any extension cables Score: ____4____ S=1 Extension cables should Apply risk reduction level (1)
Electrical required to make connections to F=1 be avoided as they (1) S.O.P – Power connection, without
Safety mains supply, if so do they Classification: P=1 present risk at the extension cables.
present an additional risk? Low Risk A=1 extension connection
plus they can be an Note:- By design socket outlets need
additional trip hazard. to be close to point of use of gas
generator.
3.3.7 During power failure does the Score: ____7____ S=2 Interruption of the Apply risk reduction level (2)
Electrical equipment shut down safely and F=1 gassing process at any (1) S.O.P – Fault/failure recovery
Safety on recovery is start up safe? Classification: P=2 stage would be a non (2) On power failure system to fail
Consider power failure in each Medium Risk A=2 validated cycle. safe and cycle abort. Operators
mode of operation: Additionally if H2O2 is should be made aware of fault
Conditioning: Gassing: Aeration present there are condition. There must be a safe
additional risks to recovery method/procedure.
operators.
Document No: RBDS-009 / Rev. 1 Page 11 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
sk Ref Stage (1) Stage (2) Commentary Stage (3)
Number Identified Risk Category Protection / Solution
and Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
3.3.8 Is there risk of fire or explosion Score: ____5____ S=2 The gas generator must Apply risk reduction level (2)
Electrical due to electrical energy. F=1 be constructed of (1) S.O.P – Electrical safety tests.
Safety Classification: P=1 materials that do not (2) No combustible materials. Multi
Medium Risk A=1 present risk or earthing and earthed power
support combustion. supply.
3.4.1 Are operators exposed to Score: ____5____ S=2 The hydrogen peroxide Apply risk reduction level (2)
Chemical unnecessary risks during loading F=1 bottle has a vented top (1) S.O.P – Use of PPE (personal
Hazard of gas generator? Classification: P=1 fitted when loading to protective equipment) plus
Medium Risk A=1 gas generator hence a spillage procedure
bottle dropped By design ensure the bottle is
presents risk. always fully supported and easy
to load.
3.4.2 Are there any potential residuals Score: ____6____ S=2 The bottle pick up Apply risk reduction level (2)
Chemical of hydrogen peroxide on F=1 coupling presents a (1) S.O.P – Pump tube changing +
Hazard surfaces accessible to operators Classification: P=2 risk. The pump tubes PPE.
in normal operations? Medium Risk A=1 during replacement (2) By design use self-sealing
present a risk couplings.
3.4.3 Are there unnecessary risks to Score: ____6____ S=2 During parts change of Apply risk reduction level (2).
Chemical maintenance engineers from F=1 any of the H2O2 liquid (1) S.O.P - for all H2O2 parts change
Hazard potential contact with hydrogen Classification: P=2 circuits engineers are at (2) By design ensure H2O2 can be
peroxide during equipment Medium Risk A=1 risk. drained from system before parts
maintenance/repair? change
Document No: RBDS-009 / Rev. 1 Page 12 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
sk Ref Stage (1) Stage (2) Commentary Stage (3)
Number Identified Risk Category Protection / Solution
and Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
3.4.4 Can hydrogen peroxide Score: ____6____ S=2 If the pump tubes are Apply risk reduction level (2)
Chemical accumulate in pipework/tubing F=2 disconnected in wrong (1) S.O.P – Pump tube changing /
Hazard which would present a risk when Classification: P=1 sequence H2O2 can maintenance procedures
removed or accessed by Medium Risk A=1 become trapped and (2) Use of personal protective
operators or maintenance spill out on final equipment (PPE) gloves and safety
engineers. Consider disconnection. glasses.
accumulation by H2O2 in pump
tubing.
3.4.6 Are hydrogen peroxide bottle(s) Score: ____7____ S=2 Bottle of H2O2 must be Apply risk reduction level (2)
Chemical stored safely and do not present F=2 stored to suppliers (1) SOP – Handling H2O2/Storage.
Hazard a risk to operators on handling? Classification: P=2 recommendations. Any (2) Bottle storage to meet COSHH
Medium Risk A=1 residual H2O2 on the requirements for laboratory safety
outside of a bottle in handling/storing hazardous
would present a risk to chemicals.
operators
3.4.7 Is a spillage procedure in place Score: _____6___ S=2 With open bottles of Apply risk reduction level (2)
Chemical for safe recovery under F=2 hydrogen peroxide (1) S.O.P – Spillage Procedure
Hazards failure/fault conditions? Classification: P=1 handled during bottle (2) Operator use of PPE (Personal
Medium Risk A=1 loading procedure – a Protective Equipment, gloves and
fault/failure recovery safety glasses.
procedure must be in
place
Document No: RBDS-009 / Rev. 1 Page 13 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
sk Ref Stage (1) Stage (2) Commentary Stage (3)
Number Identified Risk Category Protection / Solution
and Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
3.4.8 Are the necessary warning labels Score: ____6____ S=2 Warning labels must be Apply risk reduction level (2).
Chemical on the equipment as well as on F=2 fitted so that operators (1) S.O.P – Check warning labels in
Hazards the supplied bottles of hydrogen Classification: P=1 are constantly made place
peroxide? Medium Risk A=1 aware of risks. (2) Fit warning labels in clear and
visible places – country specific.
3.4.9 Is fault/failure recovery Personal Score: ____6____ S=2 As a minimum gloves Apply risk reduction level (2).
Chemical Protective Equipment (PPE) in F=1 and goggles should be (1) S.O.P – Spillage, leakage procedure
Hazard place for handling spillage and as Classification: P=2 available. It is (2) PPE – Gloves and goggles - Face
required during leakage of Medium Risk A=1 recommended in mask with 40:1 reduction
hydrogen peroxide liquid? addition to have a face
mask (charcoal filter
type) available
3.4.10 Can hydrogen peroxide oxidise Score: ____5___ S=2 The exothermic (heat) Apply risk reduction level (2)
Chemical materials and in process heat up F=1 reaction is an issue on (1) S.O.P – Materials selection for
Hazard materials so that auto-ignition Classification: P=1 finely divided materials. gassing.
can occur? Medium Risk A=1 It is important materials (2) By design ensure system has no
used do not support combustible materials.
combustion.
Document No: RBDS-009 / Rev. 1 Page 14 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
Risk Ref Stage (1) Stage (2) Commentary Stag (3)
Number Identified Risk Category Protection / Solution
and Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
3.5.1 Risk of loss in leak integrity from Score: ____3____ S=2 The gas generator is Apply risk reduction level (1)
Leakage RBDS equipment (a) Gas leakage F=2 located within the room • S.O.P gas generator leak tests
- H2O2 (b) Liquid H2O2 leakage Classification: P=2 and hence any leakage
Release Medium Risk A=1 will be contained within
the gassing enclosure
3.5.2 Risk of loss in leak integrity from Score: ____7____ S=2 Doors and openings in Apply risk reduction level (2)
Leakage a room if applicable. F=2 room are not generally • S.O.P room sealing
- H2O2 Risk of leakage into an adjacent Classification: P=2 leak tight as they rely • Install room gas analyses to
Release area (room) with access to Medium Risk A=1 on controlled air automatically stop gassing if
operators leakage and pressure detected in adjacent areas
differential protection
3.5.3 Risk from deviation of pressure Score: ____3____ S=2 If the room HVAC were Apply risk reduction level (1)
Leakage (OOS) of enclosure when at F=1 started the room could • S.O.P. - leak detection
- H2O2 optimum hydrogen peroxide gas Classification: P=1 positively pressurise
Release concentration Medium Risk A=1
a) High pressure
b) Low pressure
Document No: RBDS-009 / Rev. 1 Page 15 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
Risk Ref Stage (1) Stage (2) Commentary Stag (3)
Number Identified Risk Category Protection / Solution
and Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
3.5.4 Risk of personnel entering the Score: ____7____ S=3 As a room is a normally Reduce risk by applying risk reduction
Leakage enclosure during the gas phase F=1 accessible area there is level (2)
- H2O2 Classification: P=1 a risk that people may 1. S.O.P. on Room Sealing &
Release Medium Risk A=1 try to enter during distribution of warning signs
gassing. 2. Locking / sealing of all accesses to
area during gassing
3.5.5 Risk of gas penetrating other Score: ____3____ S=2 If the room has an air Reduce risk by applying risk reduction
Leakage (adjacent) areas during gassing F=1 handling system which level (1)
- H2O2 process Classification: P=1 is located in another 1. S.O.P. on room sealing &
Release Low Risk A=1 area or feeds other monitoring of equipment
areas which cannot be
isolated then the risk of
leakage exists.
3.5.6 Risk to operator on entering Score: ____3____ S=3 If the sensor within the Reduce risk by applying risk reduction
Leakage room post decontamination due F=1 room fails there is a level (1)
- H2O2 to high H2O2 concentration Classification: P=1 risk to the operator on 1. S.O.P. on Room entry & cycle run to
Release Low Risk A=1 entry to the room. include secondary monitoring
Document No: RBDS-009 / Rev. 1 Page 16 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
Risk Ref Stage (1) Stage (2) Commentary Stag (3)
Number Identified Risk Category Protection / Solution
and Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
3.5.7 Risk to operator during Score: ____8____ S=3 If the operator has Reduce risk by applying risk reduction
Leakage emergency or system failure F=1 cause to enter the room level (3)
- H2O2 Classification: P=1 during a gassing cycle • By design operate equipment from
Release High Risk A=1 to correct an outside of the enclosure
emergency there is a • By design equipment automated
risk to the operator. action to shut down if operator
control lost
• S.O.P. on Personnel Protection
Equipment including breathing
apparatus
4.1.1 Risk to process from gas Score: ____5____ S=2 The generator is in the Apply risk reduction level (2)
Leakage generator pre-filter(s) integrity F=1 room and so will not • S.O.P filter changes and routine
- H2O2 failure Classification: P=1 induce contamination. monitoring.
Release Medium Risk A=1 If the R2 unit’s filter • By design allow routine pre-filter
fails then there is a risk change and integrity test.
of contamination.
Document No: RBDS-009 / Rev. 1 Page 17 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
Risk Ref Stage (1) Stage (2) Commentary Stag (3)
Number Identified Risk Category Protection / Solution
and Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
4.1.2 Risk to process from deviation Score: ____8____ S=3 Over temperature may Apply risk reduction level (3)
Process (OOS) of H2O2 vaporiser F=1 trip the power. Under • By design automatically monitor
Parameter temperature Classification: P=2 temperature may not temperature and control liquid
Deviation a) Over temperature High Risk A=2 vaporise H2O2with risk flow.
b) Under temperature of explosion in extreme • By design employ thermal cut-outs
concentration and • S.O.P. on cycle failure and
(OOS) temperature equipment recovery
conditions
4.1.3 Risk to process from deviation Score: ____7____ S=2 During any cycle phase Apply risk reduction level (2)
(OOS) of gas circulation airflow F=1 (OOS) deviation would Automatically
a) During conditioning Classification: P=2 compromise gassing • S.O.P. Equipment calibration
b) During gassing Medium Risk A=2 cycle efficacy and • By design automatically monitor
c) During aeration (hydrogen associated product and control airflow
peroxide removal) quality
• Phase one aeration
• Phase two aeration
Document No: RBDS-009 / Rev. 1 Page 18 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
sk Ref Stage (1) Stage (2) Commentary Stage (3)
Number Identified Risk Category Protection / Solution
and Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
4.1.4 Risk to process from deviation Score: _____8___ S=3 Failure of any part of Apply risk reduction level (3)
Process (OOS) of hydrogen peroxide flow F=1 the of the hydrogen Automatically
Parameter a) Flow delivery low to vaporiser Classification: P=2 peroxide flow delivery • Monitor performance of H2O2 liquid
Deviation b) hydrogen peroxide bottle High Risk A=2 would compromise the flow
runs out before cycle end gassing cycle and • Abort the gassing cycle in event of
c) Over fill of vaporiser potentially the product (OOS) deviation in H2O2 flow A) + B)
+ C)
• S.O.P. H2O2 Circuit calibration
4.1.5 Risk to process of cooling fan Score: ____6____ S=2 Cooling fan failure Apply risk reduction level (2)
Process failures F=1 would allow the system • S.O.P. Equipment calibration
Parameter a) Electrical tray cooling fan Classification: P=1 to overheat and may • Abort cycle for any (OSS) deviation
Deviation Medium Risk A=2 over time cause cycle resulting in system overheating
failure. Would also
cause electrical tray not
to be bio-
decontaminated
4.1.6 Risk to process of Aeration unit Score: ____2____ S=1 If aeration units fail to Apply risk reduction level (1)
Process failure / cable failure F=1 start, the gas contained • S.O.P. Equipment set-up and test
Parameter Classification: P=1 within the enclosure
Deviation Medium Risk A=2 will not leak but will
present a risk to the
operator on removal
Document No: RBDS-009 / Rev. 1 Page 19 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
Risk Ref Stage (1) Stage (2) Commentary Stage (3)
Number Identified Risk Category Protection / Solution
And Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
Apply risk reduction level (1)
4.1.7 Risk of communication failure & Score: ____2____ S=1 Comms failure would • S.O.P. Equipment set-up and test
Comms loss of control F=1 cause loss of
failure Classification: P=1 equipment control,
Low Risk A=2 cycle will abort
4.2.1 Risk of poor gas distribution Score: ____8____ S=3 Effective gassing cycles Apply risk reduction level (3)
Product during gassing cycle F=1 rely on good gas • S.O.P Equipment set-up and test
Quality - a) Stirrer fan(s) off or failed Classification: P=2 distribution • Preferred digital signal to start
Gassing during gassing of isolator if High Risk A=2 from gas generator
Cycle applicable • Minimum – Supervisor confirms
Deviation b) Nozzle(s) off or failed during start
gassing of room if applicable • Minimum – Supervisor confirms
continued operation at end of
cycle
4.2.2 Risk to poisoning the catalyst Score: ____5____ S=2 All catalysts can be Apply risk production level (2)
Product during gassing cycle, from F=1 poisoned so risks must • S.O.P – use of compatible materials
Quality - a) Incompatible chemicals Classification: P=1 be considered in processes
Gassing b) In process coating from Medium Risk A=1 • Protect catalyst with pre-filter
Cycle process materials
Deviation
Document No: RBDS-009 / Rev. 1 Page 20 of 21 BIOQUELL (UK) LTD
BIOQUELL (UK) Ltd, 34 Walworth Road, Andover, Hampshire, England, SP10 5AA Registered No. 2520270
Tel: + (44) (0)1264 835835 Fax: + (44) (0)1264 835836
S – SEVERITY F - FREQUENCY P – PROBABILITY A - AVOIDANCE
Risk Ref Stage (1) Stage (2) Commentary Stage (3)
Number Identified Risk Category Protection / Solution
And Low, Medium, Risk Reduction Method
Group High Risk from Reduction Level (1) S.O.P
Analysis Reduction level (2) S.O.P. + Safety
Device
Reduction Level (3) Two Safety Devices
4.2.3 Risk of biological contamination Score: ____0____ S=0 After cycle, rooms is Apply risk reduction level (1)
Product after gassing cycle due to HEPA F=0 bio-decontaminated so • S.O.P – Routine filter integrity
Quality - filter integrity failure Classification: P=0 no bio-agents can be testing
Gassing Medium Risk A=0 drawn into the room as • Routine pre-filter replacement and
Cycle equipment already in. test. If filter at risk of damage
Deviation provide second backup pre-filter
4.2.4 Risk of biological Score: ____5____ S=2 If surfaces are ‘soiled’ Apply risk reduction level (2)
Product decontamination not being F=1 contaminated or • S.O.P – cleaning – pre-gassing
Quality - achieved when room surfaces are Classification: P=1 over/under • Studies – pre-gassing surface
Gassing out of specification (OOS) limits Medium Risk A=1 temperature the temperatures
Cycle gassing cycle efficacy • Define boundaries of temperature
Deviation will be compromised deviation
4.2.5 Risk of residual hydrogen Score: ____4____ S=2 Stagnant areas within Apply risk reduction level (1)
Product peroxide gas running after cycle F=1 the room present • S.O.P – equipment set-up
Quality - end due to recesses in room Classification: P=1 possible residual
Gassing Low Risk A=1 hydrogen peroxide
Cycle pockets and hence risk
Deviation to operators
Document No: RBDS-009 / Rev. 1 Page 21 of 21 BIOQUELL (UK) LTD
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