Whitford Corp.’s Medical Coatings Group Has New Home

Elverson, Pa.-based Whitford Corp., a manufacturer of fluoropolymer coatings for industrial and consumer industries, which recently formed a new Medical Coatings Group dedicated to the supply of fluoropolymer coatings for use on medical devices, has completed construction of the Medical Coatings Group facility at the company’s headquarters.

Validation work has started, and the facility is slated to be fully operational by the end of the third quarter or beginning of the fourth quarter this year. An ISO 13485-compliant quality system has been put in place, according to company officials, who predict that Whitford Medical Coatings will be certified by the end of fourth quarter.

“The importance of product quality is clear. Adhering to the ISO 13485 standard will ensure we are supplying the medical device industry responsibly,” said Dave Willis, Whitford’s president.

The Medical Coatings Group has set in motion a full validation program to ensure it is fulfilling its responsibility to the medical device industry. 
“Device manufacturers know the importance of validation. It’s part of the ISO standard, FDA (U.S. Food and Drug Administration) regulations, and is good practice. Too many coating and chemical-component suppliers have been lax in this sense,” said Greg Lundell, industry manager of medical coatings for Whitford. “We’re going above and beyond what the coating industry is used to, because we believe we have a deeper understanding of the needs of OEM device manufacturers in terms of coating supply than our competitors. Supplier audits will be welcome any time once we’re up and running. We want our medical customers to be able to see for themselves what we’ve done here.”

The medical facility includes new, dedicated equipment, as well as its own quality-control laboratory with management and operations personnel.

“Our aim is to become a global leader in medical-coating supply,” added Lundell. “Having a dedicated facility reinforces our policy of providing exceptional quality and security of supply at a time when many other coating manufacturers are struggling to meet the rising regulatory demands of the medical industry.”