MAINTENANCE STRATEGY COURSE ASSESSMENT 2

Student Name: Student Number: Assignment Reference No. Date Submitted: Dave Phelan 7495538 MSTR/July10/1 25/10/10

Question Answer these questions in the form of an essay (2000 - 2500 words) Figure 1 shows a manufacturing process and Figure 2 shows a batch chemical reactor unit within this process. Table 1 shows the life plan for the batch chemical reactor with an indication if the task can be done with the reactor on-line (i.e. working) during a plant shutdown or during a short gap in production between batches which is called a production window. There is a separate Microsoft Excel spreadsheet which gives details of all of the closed maintenance jobs which have been carried out on this reactor unit. This is called Worklist for MSTR Assignment2.xls a) Explain why you would regard this batch chemical reactor as a plant unit. b) Explain your reasons for concluding that this unit is critical for production. c) Extract any user requirements for this designated unit from the plant description. Are there any production windows? d) Extract any corporate requirements for this unit from the plant description. e) Extract any legislative requirements for this unit from the plant description. f) Having described the requirements for this unit, comment on whether you believe any other of the tasks in Table 1 could be completed during a production window in addition to the visual inspection.

g) Comment on whether you think any maintenance tasks are missing h) How do you think this maintenance strategy could be improved?

Answer: 2499 words (word limit 2000-2500)

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Table of Contents
Section 1 - Introduction ........................................................................................ 3

Section 2 Questions 2.1 Explain why you would regard this batch chemical reactor as a plant unit ...... 3-4 2.2 Explain your reasons for concluding that this unit is critical for production ...... 4-5 2.3 Extract any user requirements for this designated unit from the plant description. Are there any production windows? .................................................. 5-7 2.4 Extract any corporate requirements for this unit from the plant description ..... 8-9 2.5 Extract any legislative requirements for this unit from the plant description .... 8-9 2.6 Having described the requirements for this unit, comment on whether you believe any other of the tasks in Table 1 could be completed during a production window in addition to the visual inspection ........................................................... 8-9 2.7 Comment on whether you think any maintenance tasks are missing ............... 8-9 2.8 How do you think this maintenance strategy could be improved ...................... 8-9

Section 3 Conclusions .................................................................................. 9-10

References ...................................................................................................................................................19

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1. Introduction This short essay answers a list of specific questions that pertain to a bulk pharmaceutical manufacturing process (Figure 1) that includes a batch chemical reactor unit (Figure 2). These questions broadly cover a view of the criticality of the reactor, consideration of legislative, corporate and user requirements derived from the plant description, a view of possible opportunities to expand maintenance activities during a production window, and consideration of how the existing maintenance strategy could be improved.

Raw Material Storage

Batch Reactor Unit

Centrifuge Feed Vessel

Centrifuges

Figure 1: Manufacturing Process

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2. Questions

2.1

Explain why you would regard this batch chemical reactor as a plant unit The reactor clearly forms an integral and substantive part of the manufacturing process, itself comprising of a number of sub-level plant assets (e.g. P1) and control loops (e.g. LP steam TI/TIC/CV1). Moubray (1997, Appendix 1) provides guidance on how to develop a plant asset register as a foundation to apply a maintenance management strategy, in his case a reliability centred maintenance (RCM) programme. The ultimate aim of such a programme is to ensure that the physical assets targeted do what the user wants them to do in their present operating context. A list of equipment, vessels, buildings etc. forms the plant asset register and, Moubray asserts, should be constructed as a hierarchy that makes it possible to identify any system or any asset at any level of detail, down to individual components. Moubray recommends (1997 p.81) that the level at which RCM is best applied in a hierarchy, known as the level of indenture, is that which leads to a reasonably manageable number of possible events that could cause a functional failure. Starting too low down in the hierarchy will often lead to too many unhelpful complexities including difficulties dealing with control loops that cross sub-system boundaries and can lead to the same function being analysed multiple times. Equally, starting at the top of the hierarchy may lead to many failure modes being overlooked. Moubray states that identification of the optimum level to apply RCM becomes intuitively obvious with practice (Moubray: 1997,p.86).

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After consideration of the factors outlined above and in conjunction with personal experience and intuition, the author believes that the batch chemical reactor should be regarded as a plant unit and should be captured as such within the plant asset register.

2.2

Explain your reasons for concluding that this unit is critical for production In any maintenance programme resources will be finite, therefore a quantitative analysis of business impact should be carried out to identify the equipment which has the biggest impact on safety and plant throughput (Wheelhouse: 2010, p.38).

Kelly (2006: p.170) agrees that it is important to rank the identified plant unit according to its impact on production and safety. He bases such rankings on the consequences of unit failure multiplied by the likelihood of unit failure (see Figure 3).

Criticality Ranking Level 1 (high)

Consequential Production Impact Failure immediate causes and an high

Consequential Safety Impact Failure immediate causes an

criticality

and high-

production loss Level X (low) Failure causes no

risk safety hazard Failure causes no

criticality

immediate or potential production loss

safety hazard

FIGURE 3

TYPICAL

CRITICALITY

RANKING

OF

PLANT

UNITS

BASED

ON FAILURE CONSEQUENCES

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Here, in terms of operating context the primary function of the manufacturing process is to produce 13,000 te/year of a bulk pharmaceutical product. At the next level down in the plant asset register hierarchy, the primary function of the batch reactor is to produce 18 tonne of product within the required specification every 10 hours. This equates to 7,222 hours of operation at 1.8 tonne/hour production rate, which, after allowing for the 16-hour annual shutdown, requires that the reactor is available to run for 82.6% of the year. This means that there is 17.4%, or 1525 hours per year of spare reactor capacity. From the process description provided there is no built-in redundancy (i.e. no spare reactor). It is also stated that the centrifuges are the process bottleneck. Therefore, if an unplanned reactor breakdown occurs it wouldnt necessarily immediately impact production. However, a significant amount of reactor downtime may compromise the primary function of the manufacturing process. The centrifuge feed vessel will provide some buffer capacity to safeguard against reactor breakdowns and keep the centrifuges supplied with feed. The amount of buffer capacity available will determine the maximum duration of reactor outage that can be tolerated before plant throughput is adversely impacted. On the other hand, a breakdown on the centrifuges will immediately impact plant throughput.

The author concludes that the reactor unit is clearly critical for production, but it is logical that in a production criticality ranking list the centrifuges might be ranked higher, perhaps as a Level 1, whereas the reactor unit might be ranked slightly lower as a Level 2.

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2.3

Extract any user requirements for this designated unit from the plant description. Are there any production windows?

A user specification requirement (USR) is defined as a description of what the user wants from a unit or system that he believes will deliver a business advantage. The USR should include details of the functionality required of the unit/system, capacities, processing details etc. Functional requirements usually specify what the system is to accomplish rather than how it is to be accomplished.

Here, based on information included within the process description, the USR for the reactor unit includes:

The reactor must be capable of receiving 18 tonne of raw materials from storage (details not specified although pumped fill perhaps via P3 is likely to be required to minimise batch cycle time).

The reactor must be sized to produce an 18 tonne batch of product with a batch cycle time of 10 hours that meets the required product specification.

The reactor must be constructed from materials that are compatible with the chemicals/products used (i.e. no adverse affect on product quality or safety), plus capable to withstand the temperatures and pressures required for the process. It is stated that the reaction materials are benign and do not pose a corrosion concern. The author postulates that a glass-lined vessel is required because it has a smooth, anti-stick surface, is easy to clean, and does not introduce impurities to the process materials.

The pipe-work must be fabricated from stainless steel.

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The reactor must be agitated and jacketed with a LP steam supply to the jacket.

The reactor must be capable of being sealed to fully contain its contents throughout the reaction.

The reactor must be fitted with a temperature control system that has the capability to control the reactor contents through a defined temperature/time profile with a high temperature alarm at 125C. Additionally, the control system must be

configured to protect the glass lined vessel from being damaged by thermal shock. The reactor contents must be transferrable through an automated discharge valve at the base of the reactor to the centrifuge feed vessel via a pump.

Production Windows Production window is defined as a short gap in production between batches, during which it may be possible to carry out asset maintenance tasks. Here, the life plan for the batch reactor unit (ref table 1) indicates that the only activity that could be undertaken during a production window is the weekly visual check on the reactor coupling which takes 5 minutes to carry out. The author suggests that there may be additional production windows if the overall batch cycle is considered. The batch cycle time may be defined as from reactor-empty to reactor-empty. This equates to the time taken to fill the empty reactor with raw materials (fill step) + the 10 hour temperature profile time (reaction step) + the time taken to transfer the entire contents of the reactor to the
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centrifuge feed tank (empty step). As the fill and empty steps have not been defined it is not possible to specify the batch cycle time precisely. However, intuitively the author suggests that some maintenance activities could be carried out on specific items during the fill step (e.g. steam trap), during the reaction step (e.g. P1) or during the empty step (e.g. CV1). The buffer capacity in the

centrifuge feed tank will also effectively create a production window.

2.4

Extract any corporate requirements for this unit from the plant description Corporate requirements include: the need to license the

pharmaceutical product by the FDA and British Pharmaceutical Society; the need for all production and maintenance activities to comply with Good Manufacturing Practice (GMP); the registration of the manufacturing process to the quality standard ISO9002; the need for all company activities to conform to the environmental standard ISO14000; the need for maintenance activities to comply with the company permit-to-work system; in line with company guidelines the reactor must be maintained to achieve a 25 year life and gearboxes maintained to achieve a 15 year life; the facility must be kept wellpainted, clean and tidy for possible visits from pharmaceutical inspectors at any time or visits from key customers.

2.5

Extract any legislative requirements for this unit from the plant description The reactor and the reactor jacket are rated as a pressure vessel and a registered steam receiver respectively and are therefore subject to the Pressure System Safety Regulations (PSSR) 2000 (Lloyds
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British: 2010). The aim of PSSR 2000 is to prevent serious injury from the hazard of stored energy as a result of the failure of a pressure system or one of its component parts.

The Regulations require users to:

establish the safe operating limits of the plant have a suitable written scheme drawn up or certified by a competent person for the examination at appropriate intervals of:

- pressure vessels

-all safety devices

-any pipework which is potentially dangerous

A reactor failure may result in an immediate and high risk safety hazard, therefore the reactor unit should be rated as safety critical (see Figure 3). The reactor and jacket must both be fitted with a certified safety relief valve.

2.6

Having described the requirements for this unit, comment on whether you believe any other of the tasks in Table 1 could be completed during a production window in addition to the visual inspection The author believes that in view of the frequency and duration of the specified tasks in Table 1, that a production window is effectively created by the buffer capacity in the centrifuge feed tank, and that there is 17.4% or 1525 hours/year of spare reactor capacity, that all

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tasks included within Table 1 and all secondary tasks if required could be undertaken during a production window.

2.7

Comment on whether you think any maintenance tasks are missing Maintenance tasks on the reactor system that the author believes are probably missing include:

The integrity of the glass lining on the reactor could be compromised either due to mechanical damage resulting from impact, or by thermal shock caused by heating or cooling the vessel too quickly. A typical maintenance checklist for glass-lined equipment should include: visual inspection of the lining; spark testing for signs of glass-lining failure; glass-thickness readings; inspection of tantalum repair plugs and patches, if installed; vessel nozzle connections; and vessel jacket connections (Goliath: 2007). The inspection frequency may range from once every two years to continuous testing depending on the severity of service or if damage is suspected.

Performance monitoring of the agitator motor and drive (i.e. establish baseline amps being pulled by the agitator motor then instruct operator to check periodically, say 1 / week).

Performance monitoring of the pump motor and drive (i.e. check delivery performance versus pump curve; establish baseline amps being pulled by the pump motor then instruct operator to check periodically, say 1 / week).

Visual check on reactor seals perhaps consider changing out periodically prior to failure.

Visual check on pipe-work flanges and joints for leaks, say daily, and consider changing out gaskets periodically prior to failure.

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Visual check of condition of lagging on the reactor jacket, steam and condensate pipe-work.

Check calibration of thermocouple and the performance of the temperature control loop. Replace conductive fluid in the temperature pocket periodically (say every 6 months).

Thickness test pipe-work (establish baseline then check, say annually).

From the completed work-list spreadsheet for the reactor system there have been 10 reactive/breakdown tasks, of which 50% are repeat failures that pertain to the following two issues : Centrifuge P2 mechanical seal replacement:

- on 18/01/1997 (took 3hrs to complete v 2hrs standard) again on 29/03/99 (4hrs actual v 2hrs standard)

- and again on 18/05/99 (2hrs actual v 2hrs standard) Recalibration of reactor T1 temperature sensor

- on 01/09/98 (took 3hrs to complete v 2hrs standard) - and again on 17/04/01 (2hrs actual v 2hrs standard)

It is proposed that T1 be recalibrated annually and that P2 is visually checked for condition and signs of leakage, say weekly.

2.8

How do you think this maintenance strategy could be improved? The author believes that the existing maintenance strategy appears to be quite reasonable as the data provided in the completed work-list indicates that there are a relatively very few breakdown maintenance
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tasks compared with preventive tasks (i.e. 2.9%). However, it is asserted that improvements could be achieved by applying the RCM approach referenced earlier including a rigorous failure mode and effects analysis (FMEA). Use should be made of the equipment history and known failure modes, plus the missing tasks itemised earlier in Question 2.7. The FMEA approach seeks to identify the failure modes that are reasonably likely to cause each functional failure, and to ascertain the failure effects associated with each failure mode (Moubray: 1997, p.53). This should be developed by a cross functional team that includes an operator, fitter, electrical/instrument technician and chemical engineer who ideally know the facility and process well, and have been trained to identify root causes in connection with the analysis of failures. Their combined knowledge and skills coupled with expert advice from vendors where needed should lead to the creation of an effective preventive maintenance programme designed to avoid expensive unplanned breakdowns that could otherwise impact safety or production. The author also strongly advocates the application of total productive maintenance TPM (Plant Maintenance Resource Center: 2010). Some elements of this already exist (e.g. operator first line maintenance routines). Further improvement could be derived from better use of data, KPIs, visual management and industry benchmarking. Operators could also be trained to carry out basic preventive maintenance routines. Application of a structured methodology to effectively manage the workplace, such as 5S, is also advocated as this creates genuine plant ownership amongst the plant team and sets high standards that the team members themselves strive to maintain and improve upon.
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3. Conclusions An analysis of the process description for a bulk pharmaceutical manufacturing process was carried out to identify the key elements of the USR and maintenance strategy for one of its major component parts, namely the batch chemical reactor unit (BCRU). It was concluded that it is appropriate to consider the BCRU as a plant unit within a plant asset register hierarchy, and that it is critical to safety and production within the operating context of the manufacturing process. A number of tasks thought to be missing from the existing maintenance programme were itemised and recommendations were provided to improve the maintenance strategy, principally through the use of FMEA as a core feature of RCM.

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References
Goliath (01 July 2007); Business Knowledge On Demand Maintenance and repair of glass-lined equipment: a customized inspection and maintenance program will minimize operational and performance problems, http://goliath.ecnext.com/coms2/gi_0199-6800697/Maintenance-and-repair-ofglass.html Lloyds British (2010): http://www.lloydsbritishtesting.co.uk/legislation3.php Kelly, Anthony (2006): Strategic Maintenance Planning, Butterworth-Heinemann Moubray, John (1997): Reliability-centred Maintenance, Industrial Press Inc New York Plant Maintenance Resource Center (2010): An Introduction to Total Productive Maintenance (TPM), http://www.plant-maintenance.com/articles/tpm_intro.shtml Wheelhouse, Paul (2010), Maintenance Strategy Study Guide, Manchester Business School MBA

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