|The Model Z2.5 Zwicki universal testing machine can be configured to perform syringe testing.|
From CGMP guidelines to FDA regulations, a plethora of standards and directives governs how medical device manufacturers must test, validate, and qualify their products. However, meeting these standards is no easy feat for many OEMs. Luckily, that task is made easier using testing equipment provided by Zwick USA (Kennesaw, GA).
No newcomer to the testing industry, Zwick USA is the U.S. affiliate of Zwick Roell AG (Ulm, Germany), a veteran materials testing firm. Zwick Roell's history dates to 1920, when Roell & Korthaus was formed. In 1992, the company merged with Zwick, a machine builder founded in 1937. Along the way, the growing corporation picked up several other entities, including Toni Technik, the French company Acmel Labo, the German company GTM, and the Austrian company Messphysik.
Used in R&D, production, and QA and QC applications--not to mention in testing institutes and training centers--Zwick USA offerings include instruments and systems, as well as services, for testing medical products. "With more than 20 years of experience in testing medical products, Zwick combines two distinct disciplines: medical engineering and plastic and metal materials testing," says Robert Donohue, Zwick USA's sales manager. "Our move into the medical realm represented a natural evolution of our testing systems. We went from testing materials to testing medical devices and packaging."
To accommodate the needs of OEMs, Zwick offers testing systems and services for virtually every branch of medical device manufacturing. In the area of clinical research, its machines are used to test human, animal, and artificial materials, including human and animal bones. In the field of therapy systems, it provides equipment for testing hypodermic needles, tubes and guidewires, catheter components, luer-lock connections, and cannulae. As for the biomaterials sector, it offers biaxial machines for mechanical testing of natural and artificial tissues, tensile test machines for artificial tissue, and testing scaffolds for bone-replacement applications.
Drawing from this spectrum of products, the company will take advantage of MD&M Midwest to exhibit the Model Z2.5 Zwicki universal testing machine configured for syringe testing. It will also display the latest version of its testXpert II software, which includes video synchronization and expanded traceability for FDA 21 CFR Part 11 compliance. With this product, Zwick is the only major manufacturer to offer a single software platform for materials testing systems, according to Donohue.
"In the last four years alone, the company's orders in the medical field have doubled," Donohue remarks. "The reason for this is that safety requirements occupy an even more prominent position in medical technology than in most other industries, simply because the products have a direct influence on human beings." To meet these requirements, testing is required at every step of the way, from development to production and packaging. "While enabling manufacturers to pay due attention to legal requirements and relevant standards," Donohue says, "we help them to meet the most important requirement: minimizing risks for patients and users."