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2020-spring-managing-equipment

Managing The Equipment Needs While Designing And Building A Biopharmaceutical Facility

Pharmaceuticals have always been complex products commercialized after years of research and clinical trials.  Launching a new drug requires identifying the root cause of a health problem, determine a strategy to counteract that problem, and execute a research and development strategy.  And if a pharma company is lucky, the clinical trials show the drug is […]

Pharmaceuticals have always been complex products commercialized after years of research and clinical trials.  Launching a new drug requires identifying the root cause of a health problem, determine a strategy to counteract that problem, and execute a research and development strategy.  And if a pharma company is lucky, the clinical trials show the drug is safe and effective, and they can successfully scale it up to manufacturing scale and supply it reliably to the public.

That simplistic overview takes levels of development that all starts with infrastructure.  The modern pharmaceutical research and development space, production facility, or quality testing laboratory is built by incorporating planning, architectural and engineering design, construction management, and execution, and equipment installation and startup.

To successfully startup the equipment needed to facilitate cutting edge research into nad production of biopharmaceutical products at the end of construction, the equipment needs to be defined by the scientists who will use it before anyone ever breaks ground.  The architectural, mechanical, electrical, and plumbing requirements all must be defined so the facility can be properly designed and engineered.  Understanding the overall needs early in the planning phase is critical to successful construction execution, and therefore critical to the eventual installation and startup of that equipment.

The process starts at concept.  A new facility is being built, or a current lab needs remodeling.  The researchers are excited about their new home but need direction to navigate budgetary constraints, help to pick the proper equipment and accessories for their needs, and someone to make sure this is translated to the proper quotes, purchases, and installation activities.  This is where a focused group can help complex projects stay on course.  The equipment management team helps translate the scientific needs of the final laboratory customer, the scientist, into the architectural and engineering requirements of the laboratory design team.   

For example, a researcher may need a microscope.  Seemingly simple enough, it takes up some level of physical space, needs to plug into a wall for a light source, aka have electrical requirements, and that’s pretty much it, right?  Some microscopes, however, are highly sophisticated and require more physical space, heating and cooling, and a computer control and data capture capabilities.  If the unit is used to generate data that may support a company’s FDA submission, there are data integrity and IT requirements that must be met; quickly, the simple gains complexity that all needs to be thoroughly planned for.

Once the equipment has been selected, and laboratory planning has been completed, i.e., there is a defined physical space and utilities on the plan for each piece, the team can help manage the installation aspects of the project.  During construction activities, there are sometimes questions of utility placement; how high should this gas line be, should it be on the right or left of the instrument, how long is the cord?  Ensuring there is an available resource who is knowledgeable about the equipment on hand is critical to this execution stage.

Procurement is up next, and the planning and management of lead times vs. early delivery needs or lack of on-site storage are all considered.  Some projects require early delivery of instrumentation that utilizes a computer in order for groups to validate the software and IT connectivity.  Other projects need to rely on just in time (JIT) delivery due to the lack of storage space on site and concerns over moving sensitive equipment around a construction area.

As installation activities progress, there is the need to manage the vendor access to the construction site and the paperwork they generate.  For a facility performing GMP (Good Manufacturing Practice) work, this includes specific Commissioning, Qualification, and Validation (CQV) activities aimed at ensuring there is proof positive that the equipment has been installed properly and operates correctly. Only once this has been performed and approved by all parties can the equipment, and laboratory in general, be used to perform work.

By connecting all of the various stages of the development of a new laboratory, manufacturing, or quality testing facility, a firm can ensure they are handing off a fully operational project upon turnover.  Genesis AEC (Architects, Engineers, Constructors) has identified the need to manage the laboratory equipment needs of our clients proactively.  We have the technical staff on board to provide support throughout the project lifecycle, thereby guaranteeing project success.  Genesis is committed to delivering facilities for life-saving therapies.

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Forget the App; There’s a Test for That

How many of you have had your blood taken during an annual exam?  That’s right, the yearly blood test.  It’s relatively standard these days to get a report detailing your Complete Blood Count (CBC) that tells you how many red and white blood cells and platelets you have pumping around, and your levels of iron.  […]

How many of you have had your blood taken during an annual exam?  That’s right, the yearly blood test.  It’s relatively standard these days to get a report detailing your Complete Blood Count (CBC) that tells you how many red and white blood cells and platelets you have pumping around, and your levels of iron.  Add to that the standard blood chemistry assays which test for blood urea nitrogen (BUN), carbon dioxide (CO2), creatinine, glucose, and potassium, chloride, and sodium, and you have quite a snapshot of your health.  (Check online for reference levels and what each test tells you; there’s a lot of useful resources.)
What’s relatively new and interesting in the healthcare field, however, aren’t those standard tests that have been around for decades, but the newer, more complex assays.  There are three relatively interesting growth points in the diagnostics industry right now; companion diagnostics, genetic testing, and biomarker tests.
Companion diagnostics were almost forced on the pharma industry, and for good reason. When a pharma giant brings a drug to market, they have to conduct a bunch of clinical trials, eventually including humans.  Throughout the years, the FDA and these companies learned that just because a drug was doing what it was supposed to, that didn’t mean it wasn’t ending up somewhere that was less than ideal.  Or the concentrations were too high or too low for certain people based on their individual metabolism.
The idea of testing for the amount of drug in an individual gained popularity; how much of a drug is in their bloodstream, or liver, or in a cancerous mass.  The FDA soon started requiring testing, and the pharma industry initially partnered with others to make the diagnostic tests.  That is until they realized they could sell the test and the drug; double the income.  Companion diagnostics were born, and now most new drugs are accompanied by a blood test to either screen the patient’s health prior to using the drug, or for levels of the active drug in the body. Those tests are actually a required part of the treatment in some cases.
Genetic testing is well known to individuals with a family history of certain diseases.  A large diagnostics company has a line of genetic screening assays on the market that test for certain genes that predispose you to certain cancers.  Their most popular is for breast cancer and utilizes a specific genetic mutation in the BRCA1 and BRCA2 genes.  If you have the mutation, you’re more likely to get breast cancer at some point during your life than those who do not.  This allows you to drive your own future, and individuals who test positive for the mutations then are urged to undergo more frequent cancer screenings.  Some even opt for a preemptive double mastectomy.  Knowledge, in this case, is innately very powerful.
Biomarker assays take it one step further.  Certain diseases, Alzheimer’s, for instance, are caused by a progressive change that takes place in your body that is not readily visible.  In the Alzheimer’s example, there are a number of proteins that exist in the fluid around our brain that are supposed to be there.  Our own neural cells make these proteins.  Research has shown that individuals who develop Alzheimer’s show a shift in these proteins, specifically in the ratio of one protein to another, that predicts your progression into having the disease.  Yet the only way to positively identify those with the disease is during an autopsy.
That’s exactly how it starts; some research figures out how something affecting our health happens.  Maybe eventually a drug will be developed to reverse or stop the changes that lead to Alzheimer’s.  In the meantime, a test will probably be first on the market to identify people with a higher likelihood of progression.  Then further studies on those people can help determine how we can fix it.
The future of diagnostics in healthcare was cemented years ago, yet innovation keeps pushing the realm of possibility into reality.  Add to that the sheer availability of most tests (they can be ordered online!), and the idea they now have assays that show the overall “age” of your cells (lookup telomere testing), life expectancy is sure to be above 100 before we know it.
This all leaves us with some interesting questions to ask of ourselves.  Do you want to know if that drug or therapy is working correctly?  The answer is most likely yes.  But on the other hand, would you want to know how your health will be in 10 or 20 or 30 years? Would you make any changes in your lifestyle now to possibly live longer or decrease your chances of disease?  Those questions are very personal, and the answers are probably as individualized as we are just being human.

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Quality Management Systems for Medical Device Manufacturing and Supply Companies

In general, manufacturing is manufacturing; just make a thing.  When talking about a medical device, a “thing” that could affect human health, there’s more to think about than your production line, though. Quality management systems…really exciting stuff, I know.  Typically, poorly understood and unpopular subjects with fast-moving entrepreneurs, they are usually thought to be blockades […]

In general, manufacturing is manufacturing; just make a thing.  When talking about a medical device, a “thing” that could affect human health, there’s more to think about than your production line, though.

Quality management systems…really exciting stuff, I know.  Typically, poorly understood and unpopular subjects with fast-moving entrepreneurs, they are usually thought to be blockades to market entry or hoops you need to jump through.   Unfortunately, these systems are also necessary evils in the world of medical device manufacturing and supply, and sometimes just good business practice.

Okay, so what is a quality management system?  According to the definition, “A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.”  Simplified, it’s making sure what you make meets your client’s needs and keeps them happy.  Seems simple enough, right?  But mention FDA inspections, audits, and potential jail time for the owner or principals of a company, and people get nervous.

I’ve been in the medical device manufacturing and supply industry my entire career and have found that many people really struggle with quality management systems and implementation.  I think it may be out of fear of doing the wrong thing, but this stuff is pretty straightforward and can even be easy. And you should never fear the audit or the inspection…although jail time is a different story!

Really, the key to implementing a QMS is understanding your needs in the scope of your business model and how it’s most easily conveyed to your employees.  If I were manufacturing a pen, for instance, a couple of bins of parts in front of a worker with a diagram of how those parts fit together may be enough.  Machining a small, highly specific part with multiple pieces, like a stent, however, requires a more thorough document describing the nuances of the process; a simple diagram may not be so appropriate.

For medical device manufacturers or supply companies, there are generally two guidelines for your QMS: FDA 21 CFR part 820 and ISO 13485 (google the acronyms for a good time).  Both FDA and ISO 13485 give an outline of what you, as a medical device manufacturer, need in your QMS.  That said, the FDA regulations and ISO standards are open to interpretation as to how they apply to your company and process.

Basically, you need to have control over how you manufacture, starting with raw materials all the way through your product labeling for your customer. You also need to troubleshoot issues and prevent bad products from reaching the market (doesn’t everyone?). Not a wholly unreasonable proposition.

For a raw material supplier, for which I have worked for two (one supplying highly technical raw materials, one supplying a commodity type product), the ISO standard is for you.  Unfortunately, there is another caveat depending on your business model.  Certainly, the FDA regulations are not your concern, but supplying parts is different from manufacturing a final device.

On the one hand, if you specifically want to target device manufacturers, complying with the 13485 standards is a great selling point / marketing tool.  It can make it easier for certain companies to use you as a supplier as well, and any chance to remove a blockade to sales is just good business sense.  It is also expensive to set up and maintain, which can lead to premium pricing for your products.

Conversely, if you are making a more commoditized product, ISO 9001’s general QMS standards for manufacturing (think making refrigerators, paint, HVAC systems, pens, etc.) are enough.  Even a manufacturer of a medical device wants to go to the lowest bidder.  Although your product was never intended for use in a device, the device manufacturer has to control their supply; the onus is on them, not you.   ISO 9001 is also cheaper and easier to maintain, allowing you to stay competitive with price.

In order to manufacture, market, and sell a final medical device, whether a tongue depressor, hip replacement, or blood test, you need to establish a QMS that meets all of the regulations defined in 21 CFR part 820.  There’s no getting around this one; the FDA has to be involved if you want to be a device manufacturer.

To determine your path, just evaluate your overall business model.  Solicit the opinions of your potential customers, but always do what’s best for your company’s particular situation. It’s not one size fits all when it comes to a QMS, and it’s a complicated business.
If you need an outside opinion, shoot me an email. I’d be happy to help.

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