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space requirement


larevalo

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I doubt that you will find any requirement that a laboratory be a certain size, regardless of the type of facility that you serve. What is required by the CFR (a.k.a. cGMPs) and AABB standards is that you have adequate space for the activities performed. What your laboratory needs to do is a thorough assessment of your operations, identify and eliminate waste, create a map of your current and proposed value stream and your current and proposed "spaghetti" diagram. Then, find some paper with grids and lay out your new lab to scale. When properly performed, this process should take no less than 2-3 months. We have tackled this in many of our laboratories by contacting our local NIST Manufacturing Extension Partnership and requesting Lean training.

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I agree with Heather. We did this exact process before moving into our new laboratory 3 1/2 years ago. Planning the new lab's layout and design was the best spent time you can have. We involved our techs and they designed everything - down to the placement of each centrifuge, rack, lamp, computer, etc. And it has all remained in the same place on our countertops since we've moved!

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We designed our current lab several years ago. Management had the final say, and this led to some issues. Some lessons:

1. Go modular if you can, enabling you to move components around as your lab's needs change. We ended up going cheap and hired a cabinet-maker. Beautiful work, but stuck in one place.

2. We had plans for under-shelf lighting. Problem turned out, though, that it's against code to affix lights to movable shelves. So we've got a lot of counter space with poor lighting.

3. Keep an eye on your area to make sure things don't get lost between planning and building. As building progressed I saw that an entire outer wall in my BB had no power outlets! (I needed a dozen or so at that counter.) Make sure to get as many as you can with access to emergency power.

4. If you have the luxery of creating extra counters, spaces etc. do so. They will fill in.

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Make sure you get adequate electrical (including emergency power), plumbing, and computer network. We did OK with power in our new lab, but they totally bypassed me on the plan for plumbing (in spite of frequent requests on my part) and they stole any network capability that we didn't use immediately, which leaves us three years out begging for new connections.

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We just moved into our new space in August. As others have mentioned it is a large task that requires constant attention to the process. As others have stated maximize your power outlets (especially the backup powered ones), overestimate your network connection requirements (there is no such thing as too many network hookups regardless of what I.T. says), and make very sure the HVAC folks understand just how much heat the analyzers we operate generate. The hospital is gearing up for a central monitoring project for temperature and humidity. The thermostats just fitted into each area of the lab will need to be replaced with humidity controls as well (we told them!!). They are still working the bugs out of our HVAC system. We requested modular cabinetry and have "semi-moble" cabinets. The cabinets can be moved, but it will be a process to make any changes. Don't forget countertop colors either. The off-white countertop I specified for blood bank has received more than a few positive comments from the techs when reading gel results. Most immunology kits recomment natural light or incandescent light to read results. Our facility is going incandescent free from an energy standpoint. I compromised on fluorescent lights with a number higher in the K rating that is similar to daylight (it actually is very close to daylight). Consider foot pedal operated or motion detector sinks for hand washing (we love ours). Remember to step back and breathe frequently as it can (and will) be frustrating at times. It is well worth it in the long run as it improves the attitude of the techs when they have a little room to breathe. If you do not perform any PCR or testing requiring "special requirements" keep them tucked in the back of your mind as they may show up regularly in the next few years. Best of luck.

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I doubt that you will find any requirement that a laboratory be a certain size, regardless of the type of facility that you serve. What is required by the CFR (a.k.a. cGMPs) and AABB standards is that you have adequate space for the activities performed. What your laboratory needs to do is a thorough assessment of your operations, identify and eliminate waste, create a map of your current and proposed value stream and your current and proposed "spaghetti" diagram. Then, find some paper with grids and lay out your new lab to scale. When properly performed, this process should take no less than 2-3 months. We have tackled this in many of our laboratories by contacting our local NIST Manufacturing Extension Partnership and requesting Lean training.

Great answer. Also, using an experienced laboratory architect will help. Obviously, there are codes that need to be met as well such as the aisle width, etc.

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A few other thoughts - Go for an open design rather than departments in boxes. Our work areas have countertops on either side, with 3/4 walls between some 6" thick which are open at the top but have columns at either end extending to the ceiling allowing access for power, computer and phone lines. The lines feed into utility strips that run the length of each side of the wall, giving pretty much unlimited access to these facilities. Keep in mind that cupboards under sinks are dead space that you can't store anything in. Make sure drainage for all the sinks is adequate, can handle whatever waste your analyzers produce, and I'll repeat the warning about heat/cold/humidity control. That is by far our biggest issue in our lab.

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