The Most Important Thing That You Don’t Think Affects You!

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CAI has been working from a comprehensive model called the Chemistry of Full Scale Operations (FSO) for the past several years. This model helps to tie together the many disparate aspects of a major Pharmaceutical capital project, and provides the user a framework in which to view the many elements that all need to be brought together to create a successful project. These include the usual suspects of C&Q, design, procurement, and regulatory strategy. All of which must be executed to have a successful project. However, there is one work stream, that is too frequently overlooked, or viewed only as a minor adjunct to the “main” drivers above. Ignoring this element may create a very undesirable reaction. What is this leg? The Asset Management & Reliability (AM&R) aspect of your project. 

AM&R is frequently overlooked, especially at the beginning of a project, simply because it can be. Why worry about PMs and periodicities, spare parts, or installing vibration monitoring equipment at the beginning of the project? Why worry about it during the heart of the project when you are struggling through the commissioning and startup? It is not on the critical path, we can get to the coveted licensure without 95% of that work-stream being accomplished, and even operate for years without ever actually doing all the tasks that can make up this area. No wonder it is so often overlooked or put aside. But the team does this at their own peril.  

Why worry about AM&R? Because thinking about this early and often, and making AM&R strategy part of the very fabric of your project from the earliest inception, can pay huge dividends in the long run. No, it will probably not drive down your capital costs, nor will it shorten your time to licensure, but it can provide longterm benefits in the form of equipment reliability, operational cost savings, training cost savings, increased operational up time, decreased spare part costs, ease of maintenance, and increased reliability. In short, all the things the long-term owner and maintainers of the facility will care about, and that can make your facility more cost competitive.  

How and why. By thinking about how you intend to operate and maintain your facility early in the design process, you can develop and then incorporate cost saving measures into the earliest requirements of the facility, utilities. and process equipment. And as is so frequently the case, the more thought surrounding problems in existing facilities, the easier it will be to avoid those pitfalls in the new one. But solutions must be designed into the facility. Deciding you need vibration sensors after the facility is built is a good idea, but now each AHU, pump, and motor must be shut down, have sensors installed, and wiring strung in a built facility. How much easier it would be to have that all done as part of new construction or even from the skid vendor.  

So, what are some of the AM&R items that should be considered prior to the first URS being written?

Here are several major categories:  

  1. What is the planned/needed operational up time for the facility, and how often do you want to shut down? Annually, Bi-Annually, or even a 3year rotation?  
  2. Around what equipment do you want to standardize? One can argue the merits of different pumps and motor vendors and optimize for each application, but by standardizing as much as possible on specific valve types instruments, pumps, motors, agitators, etc., you reap a host of rewards. 
  3. What equipment reliability technology do we want to have installed?   

Below are some considerations for each of the above.  

Shutdown periodicity. By determining this early, system design can be optimized to support the operational needs of the facility. Given that shutdowns are the single biggest contributor to plant downtime, and a single annual shutdown can reduce yearly output by 25% or more, moving to a multiyear periodicity can clearly add to the bottom line. However, going multiple years requires extra thinking about equipment and systems. Some equipment simply cannot be run two years without a shutdown. In that case, it is much easier to install redundancy during design, than after the facility is built. Additionally, selection of components should be based on expected life cycle. It does no good to plan to shut down Bi-Annually but to have elastomers that must be changed annually. Components and plans need to match.  

Equipment standardization. While every engineer wants to optimize his/her design, and get the perfect components, it is almost always better to compromise and standardize to the maximum extent possible on component selection. Even going to corporate global standards if possible. The advantage of only having to train your technicians to a single type of pump seal or a single motor vendor is obvious. How much easier to have to only stock spare parts for 5 different size pumps, and not 5 sizes from 3 different vendors! Not only can the spare parts inventory be reduced, but the availability of critical spares can be increased. 

Technology. A few years ago, I had to add several days to a planned shutdown to allow the shutdown and IR (infra-Red) inspection of switchgear. This is an important and necessary PM requiring us to shutdown each piece of electrical switchboard, establish the requisite safety area, and re-energize the gear with the door open to allow inspection. Now think of how much time could be saved, if some forward thinking engineer had specified that all of our switchgear come with installed IR windows, allowing the inspection to occur more frequently and with no interruption of power required.   

For these reasons, and more, your AM&R strategy, while easily overlooked, should be an important part of your planning and specification effort. Reach out to our Global Director of AM&R by clicking the button below. 

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