Medical and Pharmaceutical Industry

Quality assurance in the medical and pharmaceutical industry places the highest demands on materials testing in terms of hardware, software, and documentation.
Testing solutions for the medical engineering and pharmaceutical industry

The medical and pharmaceutical industry is heavily regulated by laws and regulations. That is why safety requirements are even more stringent than in most other industries—because these products, from pen injectors and implants to sterile packaging, directly impact humans. Quality control that fulfills stipulated requirements comprises not only development, production, and packaging of medical and pharmaceutical products in compliance with the legal framework and applicable standards, but must also minimize risk to patients and users.

ZwickRoell offers the right solutions for mechanical and technological tests in the medical and pharmaceutical industries. We offer a flexible, modular system of machines, specimen grips, and software to equip your lab efficiently and economically, saving you time and money. The extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopedics and biomaterials. There isn't any test task we can't handle.

An ever-increasing demand is placed on software used in the medical and pharmaceutical industries to document the traceability of completed actions. These demands are met by the Expanded Traceability (as per FDA 21 CFR Part 11) option available for ZwickRoell's testXpert III testing software, optimally supporting the operator with test tasks.

A significant element of process validation in the medical and pharmaceutical industries is the technical review of individual plant and devices. This qualification is also required for ZwickRoell materials testing systems used in the medical and pharmaceutical industries, because systems are subject to various legal requirements (for example, under Medical Devices Directive 93/42/EEC or regulations such as FDA 21 CFR Part 11 and EU GMP Guideline Annex 11). ZwickRoell provides support for customers in the DQ, IQ and OQ qualification stages for materials testing systems in the form of comprehensive, individually tailored qualification documentation in accordance with GAMP5 and current guidelines, and during the actual on-site qualification procedure.

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Testing Requirements in the Medical Device Industry

ZwickRoell has all the tools needed to meet requirements of the medical device industry—from clean room requirements, DQ IQ OQ qualification, Expanded Traceability for test results, and systems for climate and temperature testing.

Therapy Systems

Therapy systems are drug delivery systems and injection devices with which drugs and pharmaceutical products can be administered in outpatient, hospitalized, and private situations. They include, among others, hypodermic syringes, injection needles, cannulae, infusion systems, pen injectors, and autoinjectors.

Catheters and Stents

Stent implants are becoming more and more common in the treatment of cardiovascular diseases. The stent is pushed through the artery just past the narrow passage with the help of a guide wire and a catheter and is then released. This stent is a thin mesh tube. It is cut from a tube by a laser or woven out of wire. Catheters are used for minimally invasive surgical procedures. Their use and functionality continues to grow, requiring complex component testing.

Biomaterials and Clinical Research

In the field of biomaterials, research examines the mechanical properties of both regenerative and artificial materials. In the field of clinical research, basic research is carried out primarily on human, animal, and replacement materials. Characteristic values, which provide information on the post-operation healing process or when new drugs are used, are determined.

Dental Industry

In the dental industry, materials (ceramics and metals), composite materials, and adhesive bonds are tested, and the fatigue strength of dental implant systems is determined.

Biomechanics and Orthopedics

Biomechanics involves the functions and structures of the musculoskeletal system and the movements of biological systems. Orthopedics involves the diagnosis and treatment of diseases, injuries, abnormalities, and functional disorders of the musculoskeletal system. Medical products that are tested include orthopedic implants, osteosynthetic implants, and prostheses, which support or replace physiological functions.

Latex, Rubber, and Silicone Products

Testing of baby bottle seals, pacifiers, condoms, diaphragms, rubber gloves, masks, protective covers, seals, plugs, tubes, toothbrushes, and contact lenses for their elastic characteristics, non-toxicity, and hygiene.

Textile Medical Products and Instruments

ZwickRoell has the solutions you need to test textile medical products, such as wound dressings, adhesive plasters, surgical textiles, and sutures and drapes for patients, as well as medical instruments, such as scissors, endoscopes, drills, knives, forceps, hooks, etc.

Medical Packaging

Products from the medical and pharmaceutical industry must be packaged safely, and product safety must also be guaranteed for products that are stored for a long period of time.