A large percentage of medical or pharmaceutical items are produced in clean rooms in which the concentration of airborne particles is maintained at the required low level. EN ISO 14644 describes the requirements for clean rooms and associated clean-room areas.
Different classifications are allocated to clean rooms according to the size and number of particles present (see graphic).
The Fraunhofer Institute for Production Technology and Automation (IPA) in Stuttgart has carried out cleanliness tests and clean-room suitability tests on zwicki-Line universal testing machines.
As a result of these tests, zwicki-Line materials testing machines may be used in clean rooms with Class 7 air cleanliness to DIN EN ISO 14644-1.
Medical components are mostly produced under air cleanliness Classes 8 and 7, meaning that zwicki-Line materials testing machines can be used directly in these production areas or in associated testing areas.
For more demanding clean-room requirements such as those found in the pharmaceutical industry, Zwick can supply a specially adapted clean-room edition of the zwicki-Line which may be used in clean rooms with Class 6 air cleanliness to DIN EN ISO 14644-1.
If you would like more information please contact us at info@zwickroell.eu or visit our website at www.zwick.com where you can also download the qualification certificates.
PDF Qualification certificate for Class 6 air cleanliness
PDF Qualification certificate for Class 7 air cleanliness
About the Zwick Roell Group
Zwick Roell Group customers benefit from more than 150 years of experience in the manufacturing of high quality testing systems. Zwick is the global leader in static testing and is experiencing significant growth with its dynamic test systems. A financially strong and family run business, its innovative product developments, diverse product range, and global support provide tailored solutions targeted specifically at the needs of both Research and Development and Quality Assurance customers. Serving more than 20 industry sectors with 960 employees, via manufacturing facilities in Germany, regional headquarters in Atlanta, Georgia, USA and Singapore, as well as offices in 56 countries worldwide, the brand name Zwick is a guarantee of the highest quality and support. For more information see: www.zwick.com
Zwick Roell
Zwick GmbH & Co KG
August-Nagel-Str. 11, D-89079 Ulm
Tel: +49 (0)7305-10-0
Fax: +49 (0)7305-10-200
Email: info@zwickroell.eu
www.zwick.com