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In a traditional Life Sciences facility, anything that touches or even comes close to touching the product typically gets the full validation workup. Once validation is completed, the system is typically placed under tight change control to ensure no system modifications jeopardize efficacy or safety. The industry has been moving further and further to what is referred to as a risk based approach.
The simplistic interpretation is looking at the highest risk areas and focusing a substantial amount of effort to ensure they are correct and tightly controlled. Lower risk areas involve spending an adequate amount of time making sure things function properly without going overboard. Unfortunately, many organizations spend the same amount of time and money expended on indirect impact systems and parameters as on direct impact systems and associated parameters. Take one real world example: the lowly keyboard and mouse.
How many times have you seen someone document in a design spec that the operator station has a 104 key PS/2 keyboard and 2 button PS/2 mouse? Say the mouse broke, and you purchased one with a track wheel in addition to the two buttons, and it is USB instead of PS/2. Oh the horror! Now we have a deviation that could take the same amount of paperwork during IQ as finding a critical alarm that was not enabled properly. Does this sound logical? Or even worse, after the system is qualified, the mouse breaks and you cannot locate a 2 button PS/2 mouse. Now you have a change control, a design spec update, a qualification test, etc. Let's take this approach and apply it to environmental conditioning and monitoring.
A typical setup includes an air handling unit with ductwork distributing filtered, conditioned air to clean spaces. We control the discharge temperature, pressure, and possibly the humidity depending on the application. The next stop is the rooms. But before you get to the rooms, you will go through a VAV or simple coil to fine tune the temperature in the room. Finally, in the room we will monitor humidity, temperature, and differential pressure relative to adjacent spaces. Now consider what measurements are actually critical to ensuring the product will meet all quality specs. Does the discharge pressure of the air handler matter? If your room to room DP's are ok then what does the pressure matter? What about the discharge temperature? If the temperature in the room is ok, is the temperature coming out of the air handler critical? Don't get me wrong, you can waste a lot of energy or make a space very hard to maintain if you don't control at appropriate values at the unit itself, but those values are truly incidental to the actual conditions in the room.
What if we took an approach where we only qualified the space monitoring in the rooms themselves and treated the balance of the system as a somewhat less qualified system, perhaps just commissioned? Let's take this one step further and have a completely separate PLC or entirely separate software stack for monitoring space conditions. Now we can very easily draw the line between qualified and commissioned.
There are two real costs to calling something a qualified system: First is the initial purchase cost which encompasses engineering, documentation, installation, and testing. Then, there is the hidden cost of the additional change control burden. How much flexibility would you have around improving energy usage or general system efficiency if we could make modifications to the air handler without the added burden of change control for a qualified system? We've seen a number of customers implement an approach similar to this where they validate space condition monitoring and just commission the air handler unit itself. Unfortunately, everything is typically on the same controller, so when it comes change control time, it can be a difficult fight to convince the review board that you want to change the code in the controller, but it won't affect the environmental monitoring.
Do you have a new facility under construction? Are you working on up-fitting a new suite? Maybe you want to upgrade your air handler controls but the anticipated validation cost and schedule is a deal breaker. Let's talk to see if we can find some new solutions to your age old problems.