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Compliance Corner: Investigator Gives 7 Tips To Ensure Device Cleanliness, Cleaning Validation

 
• By Shawn M. Schmitt

The US FDA’s Tom Peter offers advice, from determining a company’s “worst-case device” to identifying contaminants that work their way into the manufacturing process – and more.

The word compliance on a notebook.

It’s essential that original equipment manufacturers (OEMs) that use contract firms to make their products thoroughly communicate their expectations around device cleanliness – and the same goes for the contract firms.

So says Tom Peter, an investigator with the US Food and Drug Administration.

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