A cleanroom is a room that has an extremely low concentration of airborne particles. Airborne particles are all particles and substances that float in the air and are usually not visible to the naked eye.
Among other applications, cleanrooms are required in medical research, medical engineering and technology, aseptic processing of medicines in the pharmaceutical industry, and food production. Cleanrooms are equally important for use in semiconductor manufacturing, optics and laser technology, and aerospace technology.
For the manufacture of implants, drug-coated medical devices, pharmaceutical products and sterile medicines and aids for wound care and wound dressing material cleanrooms are a requirement.
ZwickRoell is the first manufacturer of materials testing machines that meet every strict specification for testing in cleanrooms. The zwickiLine materials testing machine was further developed and optimized for these specific requirements. All specifications for cleanrooms class 6 are met in a force range of 0.5 kN to 2.5 kN. In addition, the zwickiLine+ also fulfills the requirements for cleanroom class 5.
The cleanliness classes of the materials testing machines in dynamic operation are confirmed according to DIN EN ISO 14644 1:2016-06; DIN EN ISO 14644-14 and VDI 2083 page 9.1.
All relevant tests can be conveniently performed with the high-performance, flexible and cost-effective zwickiLine testing machine. With its wide range of equipment options, the zwickiLine can fulfill every specification of the above-mentioned areas of application while producing reliable test results.
The obtained results are transferred to the testXpert III testing software program. With the traceability option integrated in the software, the FDA regulations of 21 CFR Part 11 can be fulfilled according to the ZwickRoell whitepaper.
ZwickRoell is not only the ideal partner in cleanrooms, but also in other areas of the medical and pharmaceutical industry.