new laboratory in germany meets highest cleanroom standard

Originally opened in March 2016, the STERIS Laboratories facility in Radeberg, Germany offers testing support and validation aligned with ISO11137 – including aging, bioburden, endotoxin, environmental and sterility tests for medical device and pharmaceutical Customers.

The laboratory addition was part of a recent warehouse expansion at the Radeberg site which already offers gamma and electron beam services. It was designed so that Radeberg would be able to offer “one-stop shop” for sterilization and validation services.

“Our state-of-the-art Radeberg facility is already starting to support Customer testing needs and is helping medical device Customers reduce the time and expense of validation and routine supply of product to market by linking the microbiological laboratory team with the established expertise of our local operations and technical teams,” said Gerold Quilitz, AST and Laboratories Managing Director in Radeberg.

In October, the Laboratory achieved a premier good manufacturing practice (GMP) certification, allowing STERIS to further support medical device manufacturers in Austria, Germany, Poland and Switzerland. It is the only facility in the German state of Saxony with the most stringent GMP class A in a class B environment classification and supports future opportunities in the Saxony pharmaceutical market.

“We acquired ISO13485 approval in February, which is required to test medical devices,” said Mark Botting, director of global laboratories. “By expanding the license to GMP we can now test pharmaceutical products. Excellent laboratory leadership by Saskia Faassen, Laboratory Manager, has enabled the project to advance successfully.”

The next step in lab accreditation is ISO 17025, which is scheduled for completion in the first half of 2017.