{"id":44480,"date":"2017-11-10T15:51:00","date_gmt":"2017-11-10T19:51:00","guid":{"rendered":"https:\/\/caireadydev1.wpenginepowered.com\/life-sciences\/cai-the-most-important-thing-that-you-dont-think-affects-you\/"},"modified":"2025-06-21T17:55:08","modified_gmt":"2025-06-21T21:55:08","slug":"the-most-important-thing-that-you-dont-think-affects-you","status":"publish","type":"post","link":"https:\/\/caiready.com\/life-sciences\/blog\/the-most-important-thing-that-you-dont-think-affects-you\/","title":{"rendered":"The Most Important Thing That You Don\u2019t Think Affects You!"},"content":{"rendered":"

\"BioPharm<\/span><\/p>\n

<\/p>\n

CAI has been working from a comprehensive model called the Chemistry of<\/span> F<\/span>ull <\/span>S<\/span>cale Operations<\/span> <\/span>(FSO) for the past several years.<\/span> <\/span>This model helps to tie together the many disparate aspects of a major Pharmaceutical<\/span> capital<\/span> project, and provides the user a framework in which to view the many el<\/span>e<\/span>ments that all need to be brought to<\/span>gether<\/span> to create a successful project.<\/span> <\/span>Thes<\/span>e<\/span> include the usual suspects of C&Q, design, procurement<\/span>,<\/span> and regulatory strategy.<\/span> <\/span>All of which must be executed <\/span>to<\/span> have a <\/span>successful<\/span> project.<\/span> <\/span>However, there is one work stream, that is too <\/span>f<\/span>requ<\/span>ently<\/span> overlooked, or viewed only as a m<\/span>i<\/span>nor <\/span>adjunct<\/span> to the \u201cmai<\/span>n\u201d<\/span> drivers above.<\/span> <\/span>I<\/span>gnoring this element<\/span> <\/span>may create a very undesirable react<\/span>i<\/span>on.<\/span> <\/span>What is this leg?<\/span> <\/span>The <\/span>Asset Management & <\/span>Reliability<\/span> (<\/span>A<\/span>M&R<\/span>)<\/span> aspect of your project.<\/span> <\/span><\/p>\n

A<\/span><\/span>M&R is frequently overlooked, especially at the beginning of a project, simply beca<\/span><\/span>u<\/span><\/span>se it can be.<\/span><\/span> Why worry about PMs and <\/span><\/span>periodicities<\/span><\/span>, <\/span><\/span>spare parts<\/span><\/span>,<\/span><\/span> <\/span><\/span>or installing vibration monitoring equipment at the beginning of the project<\/span><\/span>?<\/span><\/span> Why worry abou<\/span><\/span>t<\/span><\/span> it during the heart of the project when you are struggling through the <\/span><\/span>c<\/span><\/span>ommi<\/span><\/span>s<\/span><\/span>sioning and startup<\/span><\/span>?<\/span><\/span> It is not on the crit<\/span><\/span>ical<\/span><\/span> path, we can get<\/span><\/span> to the coveted licensure without 95% of that work<\/span><\/span>-stream <\/span><\/span>being accomplished, and even operate for ye<\/span><\/span>a<\/span><\/span>r<\/span><\/span>s <\/span><\/span>wit<\/span><\/span>h<\/span><\/span>out ever actually doing all the tasks that can make up this area.<\/span><\/span> No wonder it is so of<\/span><\/span>t<\/span><\/span>en overlooked or put aside. But the <\/span><\/span>team<\/span><\/span> <\/span><\/span>does <\/span><\/span>this at <\/span><\/span>their<\/span><\/span> <\/span><\/span>own peril.<\/span> <\/span> <\/span><\/p>\n

Why <\/span><\/span>wor<\/span><\/span>r<\/span><\/span>y<\/span><\/span> about <\/span><\/span>A<\/span><\/span>M&R?<\/span><\/span> Because thinking ab<\/span><\/span>o<\/span><\/span>ut this ea<\/span><\/span>r<\/span><\/span>ly and often, and making <\/span><\/span>A<\/span><\/span>M&R strategy part of the very fabric of your project<\/span><\/span> from the earliest inception, can pay huge dividends in the long run.<\/span><\/span> No, it will probably not drive down your capital costs, nor will it shorten your time to licensure, but it can provide long<\/span><\/span>–<\/span><\/span>term <\/span><\/span>benefits<\/span><\/span> in the form of equipment reliability, operational cost savings, training cost savings, increased operational up time, decreased spare part costs, ease of maintenance<\/span><\/span>,<\/span><\/span> and increased reliability. In short, all the things the <\/span><\/span>long-term<\/span><\/span> owner and maint<\/span><\/span>ainers <\/span><\/span>of the facility will care about, and <\/span><\/span>that can <\/span><\/span>make your facility more cost competitive. <\/span><\/span> <\/span><\/p>\n

How and why.<\/span><\/span><\/strong> By thinkin<\/span><\/span>g<\/span><\/span> about how you intend to operate and maintain your facility early in the design process, you can develop<\/span><\/span> and then incorporate cost saving measures into the earliest requir<\/span><\/span>e<\/span><\/span>ments of the facility<\/span><\/span>, utilities<\/span><\/span>.<\/span><\/span> and process equipment.<\/span><\/span> And as is so <\/span><\/span>frequently<\/span><\/span> the case, the more <\/span><\/span>though<\/span><\/span>t <\/span><\/span>surrounding<\/span><\/span> <\/span><\/span>problems in existing <\/span><\/span>f<\/span><\/span>acilit<\/span><\/span>i<\/span><\/span>es, the easier it will be to avoid those pitfalls in the new <\/span><\/span>one<\/span><\/span>.<\/span><\/span> But <\/span><\/span>solutions <\/span><\/span>must<\/span><\/span> be <\/span><\/span>d<\/span><\/span>esigned<\/span><\/span> into the facility.<\/span><\/span> Deciding you need vibration sensors after the facility is built is a good idea, but now each AHU, pump<\/span><\/span>,<\/span><\/span> and mot<\/span><\/span>o<\/span><\/span>r <\/span><\/span>must <\/span><\/span>be shut down, have sensors installed<\/span><\/span>,<\/span><\/span> and wiring strung in a buil<\/span><\/span>t<\/span><\/span> facility.<\/span><\/span> How much easier it would be to have that all done as part of new construction<\/span><\/span> or even from the skid vendor.<\/span> <\/span> <\/span><\/p>\n

So<\/span><\/span>,<\/span><\/span> what are some of the <\/span><\/span>A<\/span><\/span>M&R items that should<\/span><\/span> be considered prior to the first URS being written?<\/span><\/span><\/p>\n

Here are several major <\/span><\/span>categories<\/span><\/span>:<\/span> <\/span> <\/span><\/p>\n

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

    Below<\/span><\/span> <\/span><\/span>are<\/span><\/span> some considerations for each of the above. <\/span><\/span> <\/span><\/p>\n

    Shutdown periodicity.<\/span><\/span><\/strong> By determin<\/span><\/span>in<\/span><\/span>g this early, system design can be optimized to support the operational needs of the facility.<\/span> <\/span>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 <\/span><\/span>can <\/span><\/span>clearly <\/span><\/span>add to the bottom <\/span><\/span>line<\/span><\/span>.<\/span><\/span> However,<\/span><\/span> going multiple years requires extra thinking about equipment and systems.<\/span><\/span> Some equipment simply cannot be run two years without a shutdown.<\/span><\/span> In that case, it is much easier to install redundancy during design, than after the facility is built.<\/span><\/span> Additionally, selection of components should be base<\/span><\/span>d<\/span><\/span> on expected life cycle.<\/span><\/span> It does <\/span><\/span>no good to plan to shut down Bi-Annually but to have elastomers that must be chan<\/span><\/span>ged<\/span><\/span> annually.<\/span><\/span> Comp<\/span><\/span>o<\/span><\/span>nents and plans need to match.<\/span> <\/span> <\/span><\/p>\n

    Equipment standardization.<\/span><\/span><\/strong> 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.<\/span><\/span> Even going to corporate global standards if possible.<\/span><\/span> T<\/span><\/span>he advantage of only having to train your technicians to a single type of pump seal<\/span><\/span> <\/span><\/span>or a single motor vendor<\/span><\/span> is obvious<\/span><\/span>.<\/span><\/span> How much easier to have to only stock spare parts for 5 different size pumps<\/span><\/span>, and not 5 sizes from 3 different vendors!<\/span><\/span> Not only can the spare parts inventory be reduced, but the availability of <\/span><\/span>critical spares <\/span><\/span>can <\/span><\/span>be<\/span><\/span> increased<\/span><\/span>.<\/span><\/span> <\/span><\/p>\n

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

    For these reasons, and more, your <\/span><\/span>A<\/span><\/span>M&R strategy, while easily overlooked, should be an important part of your planning and specification effort.<\/span><\/span> Reach out to our Global Director of AM&R by clicking the button below.<\/span><\/span> <\/span><\/p>\n

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