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  • Количество слайдов: 64

• Motivation • Education • Implementation Pharmaceuticals IEC-61508 Implementing a Compliance Program • Motivation • Education • Implementation Pharmaceuticals IEC-61508 Implementing a Compliance Program

Pharmaceuticals Overview Pharmaceuticals Overview

Pharmaceuticals Overview Pharmaceuticals Overview

Pharmaceuticals Overview Pharmaceuticals Overview

• Do you or your company believe in the infallibility of Engineered systems? • Do you or your company believe in the infallibility of Engineered systems? Pharmaceuticals Motivation

• Roche Ireland does not have this delusion • 25 + years operational • Roche Ireland does not have this delusion • 25 + years operational experience • Including some close calls • Reality has motivated out safety culture. Pharmaceuticals Motivation

Much of the rest of this presentation has been generated from training presentations given Much of the rest of this presentation has been generated from training presentations given in Roche Ireland to • Management • Process Engineering • Instrument / Electrical Engineering Pharmaceuticals Education

Need to educate yourself : • Guidelines for Safe Automation of Chemical Processes {CCPS/AICh. Need to educate yourself : • Guidelines for Safe Automation of Chemical Processes {CCPS/AICh. E} • ISA S 84 • Functional Safety, {Smith & Simpson} • IBC conferences • Various WWW resources (exida/ sis-tech etc) Pharmaceuticals Education

• Functional safety of electrical / electronic & programmable electronic safety-related systems. • • Functional safety of electrical / electronic & programmable electronic safety-related systems. • Critical Protective equipment - Safety Instrumented Systems Pharmaceuticals IEC-61508, SOP 973

n Safety requires protection from hazards of different causes (movement, heat, radiation, el. shock, n Safety requires protection from hazards of different causes (movement, heat, radiation, el. shock, etc. ) n “Functional Safety” means protection from hazards due to incorrect functioning. . heat Protection against. . . electrical shock . . . hazards due to incorrect function . . . radiation Pharmaceuticals IEC-61508, SOP 973

• • • Process Engineers: Instrument/Electrical Designers: Mechanical Engineering Commissioning: - Extra Effort • • • Process Engineers: Instrument/Electrical Designers: Mechanical Engineering Commissioning: - Extra Effort Documentation : - Extra Effort Pharmaceuticals IEC-61508 Will Effect:

• • Not legislation Meets ‘Reasonably practicable’ duty Health, safety & welfare at • • Not legislation Meets ‘Reasonably practicable’ duty Health, safety & welfare at Work act, 1989 Have to put in place a compliance program. Pharmaceuticals IEC-61508 is legally vague

ALARP 1 x 10 -4 1 x 10 -6 Negligible risk Figure 65 -1 ALARP 1 x 10 -4 1 x 10 -6 Negligible risk Figure 65 -1 Pharmaceuticals Intolerable region Risk (deaths/year)

• • • As low as reasonably practicable. IEC 61508 based on ALARP • • • As low as reasonably practicable. IEC 61508 based on ALARP concept. ALARP concerns region of risk. Risk is an emotive and irrational thing. Commonly accepted values are: upper limit 1 x 10 -4 deaths per year lower limit 1 x 10 -6 deaths per year Pharmaceuticals RISK Reduction - ALARP

• ISA S 84 life cycle depicted in Fig 65 -3. • ISA • ISA S 84 life cycle depicted in Fig 65 -3. • ISA S 84 focuses on Box 9 of IEC 61508. Pharmaceuticals Safety life cycle - milestone approach

F&G p k-u Diagnostics Alarms, trips & interlocks Pres sure relie f val ves F&G p k-u Diagnostics Alarms, trips & interlocks Pres sure relie f val ves Figure 64 -1 Intrinsic safety ty Bac scs g di stin Bur Alarm handling Pharmaceuticals va y wa ne O n ali Control systems layer Du ESD ig es ed af Active systems layer s il. Fa lv es Passive systems layer

Figure 65 -3 1 Conceptual process design 2 Perform process HAZAN & risk assessment Figure 65 -3 1 Conceptual process design 2 Perform process HAZAN & risk assessment 3 Apply Category 0 protection systems to prevent hazards & reduce risk No 4 Are any Category 1 protection systems required? 5 Define target safety integrity levels (SIL) 6 Develop safety requirements specification (SRS) 7 Conceptual design of active protection systems & verify against SRS 8 Detailed design of protection system 9 & 10 Installation, commissioning and pre-start-up acceptance testing 11 Establish operating & maintenance procedures 12 Pre-start-up safety review 13 Protection system start-up, maintenance & periodic testing yes 14 Modify protection system? 15 Decommission system End Pharmaceuticals Start

• First Stage of realisation of high-integrity safety instrumented systems • Modified PHA • First Stage of realisation of high-integrity safety instrumented systems • Modified PHA • Feeds into SRS • Based on good process data & good process judgement. Pharmaceuticals Process Engineering

• • • Carius Tube test for decomposition Pressure Dewar Calorimetry Understanding of • • • Carius Tube test for decomposition Pressure Dewar Calorimetry Understanding of Exotherms Knowledge of onset temperatures {Chilworth} Pharmaceuticals Process Chemistry

• Good process judgement. • Hazop • Margins of safety Pharmaceuticals Process Engineering • Good process judgement. • Hazop • Margins of safety Pharmaceuticals Process Engineering

• Reactant being transferred in from Reactor 1 without agitation could accumulate & • Reactant being transferred in from Reactor 1 without agitation could accumulate & react in a sudden, violent manner. • Reactor 2 Inlet valve 205 should OPEN only if agitator ON Pharmaceuticals Hazard identification, Interlock Identification

• Simplified Technique. • MIL Std 882 Pharmaceuticals Hazard identification, Interlock Identification • Simplified Technique. • MIL Std 882 Pharmaceuticals Hazard identification, Interlock Identification

• Consequence of this is overpressure, loss of batch, over-temperature, possible destruction of • Consequence of this is overpressure, loss of batch, over-temperature, possible destruction of vessel. • 1 week downtime to recover. • Fatality or Serious injury unlikely. • Critical • (C 2) Pharmaceuticals Consequences

• Building is continually occupied • (F 2) Pharmaceuticals Occupancy factor • Building is continually occupied • (F 2) Pharmaceuticals Occupancy factor

• There is quite a good chance of an operator observing that something • There is quite a good chance of an operator observing that something is going wrong & intervening successfully. • (P 1) Pharmaceuticals Manual Avoidance factor

• • • Likely to occur once every 5 years. Occasional The process • • • Likely to occur once every 5 years. Occasional The process is DCS automated. DCS is not a SIS – no SIL rating. DCS control reduces frequency of Unmitigated Demand. • (W 2) Pharmaceuticals Unmitigated demand rate.

C 1 F 1 C 2 F 2 Start C 3 C 4 F C 1 F 1 C 2 F 2 Start C 3 C 4 F 1 F 2 Most risk EN 954 Approach P 1 P 2 W 3 W 2 W 1 x 0? 1 1 x 0? 2 1 1 3 2 1 3 3 2 4 3 3 x 2? 4 3 Pharmaceuticals Least risk

Pharmaceuticals Pharmaceuticals

Pharmaceuticals Roche Consequences Pharmaceuticals Roche Consequences

Pharmaceuticals Roche ‘unmitigated’ demand rate. Pharmaceuticals Roche ‘unmitigated’ demand rate.

• Second Stage of realisation of high-integrity safety instrumented systems • Modified Instrument • Second Stage of realisation of high-integrity safety instrumented systems • Modified Instrument design • Modified Instrument Commissioning • Feeds into SRS Pharmaceuticals Instrument / Electrical Design

Hazard reduction factor HRF PFD (fractional) Availability A (fractional) 1 >101 10 -1 to Hazard reduction factor HRF PFD (fractional) Availability A (fractional) 1 >101 10 -1 to 10 -2 0. 9 to 0. 99 10 -5 to 10 -6 2 >102 10 -2 to 10 -3 0. 99 to 0. 999 10 -6 to 10 -7 3 >103 10 -3 to 10 -4 0. 999 to 0. 9999 10 -7 to 10 -8 4 >104 10 -4 to 10 -5 0. 9999 to 0. 99999 10 -8 to 10 -9 Demand mode of operation Table 65 -1 Continuous mode Failure rate (failures per hr) Pharmaceuticals Safety integrity level SIL

• SIL value is measure of quality of protection system, end to end. • SIL value is measure of quality of protection system, end to end. • System has to be designed, specified, built and maintained to that standard. • Proof testing at regular intervals • Conformance assessment for safety systems Pharmaceuticals Equipment implications

• • Simplified Equation ISA-TR 84. 00. 02 -2002 Part 2 Equation B. • • Simplified Equation ISA-TR 84. 00. 02 -2002 Part 2 Equation B. 34 – Rare event approximation “Adequate” for SIL 1 or 2, where the plant is well controlled, well maintained, understood process, conservative engineering with good mechanical integrity Pharmaceuticals PFD Calculation

• MTBF = Mean (Average) time between failures • Information provided by vendor. • MTBF = Mean (Average) time between failures • Information provided by vendor. • MTBF = 86 Years Pharmaceuticals PFD Calc. Motion Sensor

Failures can be • fail to danger (Falsely shows agitator moving)or • fail to Failures can be • fail to danger (Falsely shows agitator moving)or • fail to safe (Falsely shows agitator stopped) • Aim of good design is to maximise fail to safe, minimise fail to danger. The failure mode split is the percentage in the fail to danger category. • Failure mode split =. 1 (SA estimate) Pharmaceuticals PFD Calc. Motion Sensor

• Proof test interval = 1 year (8760 hours) • Time between re-tests • Proof test interval = 1 year (8760 hours) • Time between re-tests of the interlock. • Need to be genuine tests Pharmaceuticals PFD Calc. Motion Sensor

• 86 years * 8760 hours/year = 753, 000 (MTBF in hours) • • 86 years * 8760 hours/year = 753, 000 (MTBF in hours) • = 1/ MTBF = 1. 30 E-6 failures per hour • FMS =. 1 • Proof test = 1 year (8760 hours) • PFD(SS) = 1. 30 E-6 *. 1 * (8760/2) • PFD(SS)=. 0006 Pharmaceuticals PFD Calc. Motion Sensor

• MTBF = 4 Years • Failure mode split =. 4 • Proof • MTBF = 4 Years • Failure mode split =. 4 • Proof test interval = 1 year (8760 hours) = 1/ MTBF = 2. 87 E-5 failures per hour PFD(B 6) = 2. 87 E-5 *. 4 * 1 * (8760/2) • PFD(B 6)=. 0500 Pharmaceuticals PFD Calc. Barrier 6

• MTBF = 100 Years • Failure mode split =. 01 • Proof • MTBF = 100 Years • Failure mode split =. 01 • Proof test interval = 1 year (8760 hours) = 1/ MTBF = 1. 14 E-6 failures per hour PFD(R 5) = 1. 14 E-6 *. 01 * (8760/2) • PFD(R 5)=. 00005 Pharmaceuticals PFD Calc. Relay 5

• MTBF = 10 Years • Failure mode split =. 9 • Proof • MTBF = 10 Years • Failure mode split =. 9 • Proof test interval = 1 day (24 hours) = 1/ MTBF = 1. 14 E-5 failures per hour PFD(MB) = 1. 14 E-5 *. 9 * 1 * (24/2) • PFD(MB)=. 001242 Pharmaceuticals PFD Calc. Main Barrier

• MTBF = 10 Years • Failure mode split =. 4 • Proof • MTBF = 10 Years • Failure mode split =. 4 • Proof test interval = 1 day (24 hours) = 1/ MTBF = 1. 14 E-5 failures per hour PFD(SOL) = 1. 14 E-5 *. 4 * 1 * (24/2) • PFD(SOL)=. 00006 Pharmaceuticals PFD Calc. Solenoid

• MTBF = 10 Years • Failure mode split =. 2 • Proof • MTBF = 10 Years • Failure mode split =. 2 • Proof test interval = 1 day (24 hours) = 1/ MTBF = 1. 14 E-5 failures per hour PFD(VA) = 1. 14 E-5 *. 2 * 1 * (24/2) • PFD(VA)=. 00003 Pharmaceuticals PFD Calc. Valve & Actuator

• • PFD(VA)=. 00003 PFD(SOL)=. 00006 PFD(MB)=. 00124 PFD(R 5)=. 00005 PFD(B 6)=. • • PFD(VA)=. 00003 PFD(SOL)=. 00006 PFD(MB)=. 00124 PFD(R 5)=. 00005 PFD(B 6)=. 0500 PFD(SS)=. 0006 PFD =. 052 => SIL 1 Pharmaceuticals PFD Calc. Overall

Pharmaceuticals ∑ PFD = 10% SIL 1 Limit PFD Mapping Valve Barrier Overall ∑ Pharmaceuticals ∑ PFD = 10% SIL 1 Limit PFD Mapping Valve Barrier Overall ∑ PFD = 1% SIL 2 Limit Relay Logic Barrier Instrument

• Elements in series: USYS Ui 62 -16 Elements in parallel: USYS Ui • Elements in series: USYS Ui 62 -16 Elements in parallel: USYS Ui -17 • Common cause failure: SYS = IND + . MAX -18 • Voting systems: UKOON n. Uk -19 • For more complex systems – Fault Tree Analysis using ISA-TR 84. 00. 02 -2002 Part 3. • “Probabilistic Risk Assesment” – Henley, E J Pharmaceuticals PFD Calc. Issues

• Roche have decided that valve & actuator may be shared for SIL • Roche have decided that valve & actuator may be shared for SIL 1 only. • SIS & BPCS share barrier, solenoid, actuator & Valve. This is not recommended • Solenoid has local SMO, which might be OK for normal operation, but not for SIS. Pharmaceuticals Design issues

Pharmaceuticals Design issues Pharmaceuticals Design issues

• #####-# type barrier not recommended (TTL Logic switching – independent energy source) • #####-# type barrier not recommended (TTL Logic switching – independent energy source) • No clear indication on loop sheet or in field of safety critical nature of instruments Pharmaceuticals Design issues

• Design of periodic re-test method is the instrument designers responsibility. • This • Design of periodic re-test method is the instrument designers responsibility. • This would help facilitate periodic testing • Loop sheet to indicate safety critical nature of instruments Pharmaceuticals Design issues

• SIS to actuate solenoid in panel, which controls air supply to Shutoff • SIS to actuate solenoid in panel, which controls air supply to Shutoff Valve & Control Valve • High energy panel mount solenoid, not IS pilot operated solenoid => more ‘suitable’ for SIS • Control Valve should have positioner suitable for SIS Pharmaceuticals Improvement suggestions

Pharmaceuticals Loop sheet modifications Pharmaceuticals Loop sheet modifications

• IQ / OQ + Proof testing of the safety function • Validation • IQ / OQ + Proof testing of the safety function • Validation of the retest method • Loop sheet to indicate safety critical nature of instruments • Field marking Pharmaceuticals Commissioning Aspects

• Supplier might have correctly designed safety Engineering. • That does not mean • Supplier might have correctly designed safety Engineering. • That does not mean it reaches standard. • Modified Instrument/Electrical design • Modified Instrument/Electrical Commissioning • Feeds into SRS Pharmaceuticals Machine / Package Design

• • E Ex d motor – Surface temperature limits Variable Speed Drive. • • E Ex d motor – Surface temperature limits Variable Speed Drive. Never below 10 Hz Always with Thermistor Protection Pharmaceuticals Machine / Package Design

Pharmaceuticals Machine / Package Design Pharmaceuticals Machine / Package Design

Thermistor Relay Pharmaceuticals Machine / Package Design Thermistor Relay Pharmaceuticals Machine / Package Design

Pharmaceuticals Maintenance • Vital part of ensuring safety function remains intact. • Will have Pharmaceuticals Maintenance • Vital part of ensuring safety function remains intact. • Will have to retest interlocks on a periodic basis. • Will need to follow methods set out during Instrument/Electrical design stage. • Care required in effecting changes to the loop when in use.

• Document which brings together the design thread. • Started by the Process • Document which brings together the design thread. • Started by the Process Engineering group • Continued by the Instrument / Electrical engineering group • Reviewed by Safety Engineering group. • Live document until pre-start safety review. Pharmaceuticals Safety Requirements Spec

• Different way of thinking Defence in Depth Layers of Protection • Risk • Different way of thinking Defence in Depth Layers of Protection • Risk Analysis • Basic Statistics • Fault Tree Analysis Pharmaceuticals New skills

Pharmaceuticals 6 June 1967 Pharmaceuticals 6 June 1967

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Pharmaceuticals Pharmaceuticals

Pharmaceuticals Pharmaceuticals