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.
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 or visit our website, where you can also download the qualification certificates.