ISO 13485 Certification Not a "Huge Leap" for Biochemicals Maker

American Bioanalytical Inc. recently announced that it has received ISO 13485:2003 certification. The company supplies biochemicals and reagent products for molecular diagnostics and personalized medicines, among other life science applications.
When determining whether to seek ISO 13485 certification, Wayne Gagnon, vice president of American Bioanalytical, says that the already ISO 9001 certified firm did a gap analysis and found that the additional certification wasn’t a huge leap. “Our customers were looking for ISO 13485 certification, so it just made sense,” he says.

For years, American Bioanalytical has been using mobile cleanrooms to ensure purity throughout most of its filling, packaging, and kitting operations. “It became apparent to us years ago that to protect the purity of our products, we needed to protect them from the ambient environment,” says Gagnon. “So we have mandated a high-quality standard for particle control. While rated Class 10,000, we actually operate them at Class 1000. Most people are surprised that we do so much in cleanrooms, since we are a small operation.”

To achieve ISO 13485 certification, Gagnon reports that the company did need to invest significantly in software and other technology to document traceability, particularly at the lot-specific level. “For water, for instance, we now certify that every lot is nuclease-free,” he explains.

The company is now dual certified, Gagnon adds. “Achieving these certificates validates our commitment to quality and strengthens our ability to compete in this global marketplace,” he stated in a press release.

American Bioanalytical currently fills anywhere from 500 to 10,000 bottles per run using “fairly low technology,” says Gagnon, but given steady growth over the past few years, the company is planning to bring in automated filling and capping equipment. “We are also anticipating adding a larger analytical lab and additional manufacturing capacity.”