FDA approved electronics

[vicvicvar]

Hi all!

I have a project that will be measuring the humidity and temperature of a raw sugar containers of 1.5 Ton. The sensor is a SHTC3 and will not be in direct contact with the sugar but will be in the surroundings inside an FDA approved case with oppening to measure the humidity and temperature.

My question is, how can I prepare the PCBA so it can comply with FDA standards? Is there a conformal coating that I can apply to the PCB that is FDA approved?

All comments/ideas are welcomed. Thanks.

[jonpaul]

unless the device is to remain in the container and be shipped into the USA, perhaps no requirement.

Conformal coating is for humidity and fungus protection but contains volatile petrochemical solvents.

Contact à spécialiste in GMP, good Manufacturers Practice.

Jon

[SiliconWizard]

If your device is in direct contact with food, there is no way around complying with any regulation it will be subjected to, and not just in the USA.

It's also common sense, not just a legal matter. Do you want to expose food to contaminants?

[jonpaul]

I hope that the OP knows that Omega Engineering and Fischer Scientific among others make temp, humidity and sucrose concentrate meters,and,Sensors,that are,rated,for pharmaceutical and food manufacturer use.

Jon

[Marco]

will not be in direct contact with the sugar

Even when the operators screw up? Which they absolutely will.

Not that I worry what that tiny sensor will do to 1.5 ton of sugar, more the other way around. More used to see sensors in nice solid chunks of stainless steel in threaded holes.

[ejeffrey]

Definitely you should check with an actual expert.  There are a lot of products specifically approved for indirect food contact.  I'm more familiar with stuff like paint, lubricants, and glue but there must be standards for electronics.  You probably also have to worry about other chemicals used in manufacturing such as flux and flux remover.

Another aspect you might need to consider is whether your product needs to be subject to any high temperature cleaning or chemical sanitation process. If the user is going to spray phosphoric acid on your electronics you probably want to plan for that.

[sparkydog]

Don't mess around where liability is concerned. Don't ask a random internet forum how to CYA.

It's one thing if you're doing a personal project where the only person that could sue you is yourself (or maybe a handful of friends and/or family). Since I doubt you're mucking about with 1.5 tons of sugar for a personal project... consult an expert. An expert is a lot cheaper than a lawsuit. If you can't afford an expert, you have no business trying to hot dog a device on your own.

Also, as noted, there is probably an off-the-shelf part that will do what you need.

[kermitfrog]

Do you have to use "food grade" components ? LOL

[Terry Bites]

There's no definitive chemical answer. It probably won't matter what coating you use because they all have evil combustion products.

I'd be thinking about a hermetic container for capturing the exploding pcb fragments and the magic silicone or epoxy smoke.
Minimise the exposed electronics inside the main container and put most of that in the hermetic box. A one pcb solution can make life very difficult.
Spend time writing your way out of the risk of litigation. (I have spent many an hour).
Show that you took reasonable steps to minimise leakage of dangerous contaminants and shrapnel.
File and forget until you get to court.