Available to the laboratory team at Gore's Putzbrunn site for performing a range of mechanical tests is a zwickiLine materials testing machine with a nominal load capacity of 500N. The characteristic values from tensile and ball burst tests on textiles are channeled directly into product development. The machine is also used for 3-point flexure tests on various components.
The employment of this testing machine in a regulated environment makes qualification necessary. For this Gore relies on ZwickRoell's experienced qualification team.ZwickRoell has generated qualification documentation tailored to the machine for Design Qualification (DQ), Installations Qualification (IQ) and Operational Qualification (OQ) in accordance with GAMP 5 and the current guidelines. Qualification was carried out on-site at the customer's premises by a specially trained ZwickRoell service engineer. This on-site qualification includes numerous tests concerning installation and operation. The results of these tests are documented individually. During Operational Qualification the emphasis is on the software, with traceability and electronic signatures being checked through numerous tests, as well as individual demands on user management.
"The commissioning of our materials testing machine and performance of IQ/OQ by ZwickRoell were completed to our utmost satisfaction. The employee who came to us impressed through his expertise and willingly went into individual questions during the briefing and operator instruction," commented Isabel Willim, laboratory engineer at Gore.