Cleanliness Validation Analyzed in CERAM White Paper

CERAM, an independent expert in materials testing, analysis and consultancy for the medical devices sector, published a white paper on cleanliness and cleaning process validation.

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The paper, which has been written by Dr. Chris Pickles, Head of Surface Science at CERAM, looks at guidance on cleanliness validation from regulatory bodies, such as the Federal Drug Administration (FDA), and compares the different analytical methods that are available to validate cleanliness and cleaning processes.

The issue of cleanliness validation is an important one for all medical device manufacturers; failure to comply with specific cleanliness validation procedures, set out by bodies such as the FDA, will result in the product not being allowed to enter the market or being recalled. The problem for manufacturers is that regulations do not stipulate how cleanliness should be validated, just that residue limits should be set and then documentation provided to show that these limits have not been exceeded.

“Choosing a cleanliness validation method can be confusing and time-consuming for manufacturers,” said Chris Pickles. “We've compared different validation methods: direct surface analysis, residue analysis and gravimetric analysis, in order to give companies the tools they need to select the method that is right for their product.”

The white paper can be downloaded for free at www.ceram.com/medical

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