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Tips and lessons learned - Hydrophilic Coatings

I came into this business two years ago having never even heard of its existence.  Over the last two years I've learned a lot, and continue to do so.  Here are some tips and lessons for you, from my own experience, if you are either selling or looking to license/buy a hydrophilic coating:

Cytotoxicity is a joke, but not a funny one.

ISO 10993-5 gives standards for cytotoxicity testing of materials used in medical devices.  The fact of the matter is that the test is very broad, and totally NOT correlated to what actually occurs in vivo.  Did you know pure water is cytotoxic?  Sure is!  You'll lyse the heck out of a cell culture if you pour pure water on them.... yet we drink water and expose ourselves to it every day.  Nevertheless, your medical device/coated material must pass this test if you want to sell it.

Here's the lesson though:  Just because your material passes the test in one set of conditions, does not necessarily mean it will pass for all of them, especially if something entirely un-related to your coating screws up the results.  When you coat samples for an MEM elution test, make sure you track everything in your process:  what material are your coating vessels made out of?  Your dipping tubes if any?  Your washing apparatus if any?  How do you clean those sprayers?  What kind of gowning do you use in your clean room?  

Validate, validate, validate

OEM's  are used to this.  Contract manufacturers are too.  However, research organizations may not be.  If you make samples for research purposes, you may think to yourself that your process changes with every client and that you are not making GMP materials, so you do not have to validate.  You may even be correct under the law.  However, I can tell you that you should validate your process anyway, and track everything.  For example, even though your process is different for every client, you are still using many of the same supplies, and your suppliers can change or give you new lots of material.  I've seen processes go haywire just because a supplier switched to producing a new lot which was not like the old one.  If you have a validated process, you are at least tracking which samples are created with which supplier lots, and as new lots come in to the supplier you re-validate those to be sure they are the same.  Believe me, stranger things have happened.

How Medical Device Coating Companies Have Fun


I put a little bit of hydrophilic coating on our floor.  Hilarity ensues.

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