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Quality assurance in the medical and pharmaceutical industry places the highest demands on testing technology in terms of hardware, software, and documentation.

DQ/IQ/OQ - FDA 21 CFR Part 11 - clean room etc. Applications Overview Interesting customer projects Downloads

Name Type Size Download
  • Industry Brochure: medical industry PDF 6 MB
  • Product Information: Traceable and Reliable Test Results in Accordance with FDA 21 CFR Part 11 PDF 1 MB
  • Industry Brochure: Biomechanics PDF 8 MB

Laws regulate the medical and pharmaceutical industry

This industry is heavily regulated by laws and regulations. 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 meets these 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 a test task that 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 engineering 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 engineering 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.

ZwickRoell’s answers to special requirements in the field of medical engineering

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.

DQ IQ OQ Qualification Service
ZwickRoell offers comprehensive solutions and individually tailored documentation for the qualification of your testing system.
to DQ IQ OQ Qualification Service
Traceable test results to FDA 21 CFR Part 11
to Traceability
Automated tests
Automation in the medical industry ✓ Autoinjector ✓ Insulin pens & pen injectors ✓ Syringes ✓ Luer lock connections
to Automated tests
Medium Container for Medical Testing Applications
For biomaterials, the mechanical properties of both regenerative and artificial materials are researched. To reflect the physiological conditions of the body, mechanical tests should be performed in a temperature-controlled fluid bath. ZwickRoell's medium container for medical testing applications enables simulation of an in-vivo environment for tests on fast reabsorbing materials.
to Medium Container for Medical Testing Applications
37°C Temperature Chamber
ZwickRoell's 37°C temperature chambers represent an alternative for more complex temperature chambers if only ambient temperatures up to 37°C need to be controlled. This allows you to use specimen grips you have available.
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Materials testing in clean rooms
With the cleanroom-compatible zwickiLine testing machine
Comprehensive information on ZwickRoell’s clean-room compatible testing machine for materials testing in cleanrooms: √ ISO 14644-1 √ ISO 14644-14 √ VDI 2083 Page 9.1. incl. certificates
to Materials testing in clean rooms

Overview of applications in the medical engineering and pharmaceutical industry

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.
to Therapy Systems
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.
to Catheters and stents
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.
to Biomaterials and clinical research
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.
to Dental Industry
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,
to Biomechanics and Orthopedics
Latex, Rubber, Silicone
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.
to Latex, Rubber, Silicone
Medical textile products
ZwickRoell test fixtures are ideal for the standard-compliant testing of wound dressings, plasters, bandages, suture material, and surgical drapes and garments.
to Medical textile products
Testing of face masks
ZwickRoell provides testing solutions for testing of basic mouth and nose protectors to face masks with filter elements.
to Testing of face masks
Surgical instruments
ZwickRoell has the right testing systems for the testing of surgical scissors, scalpels, forceps, drills, surgical needles, and endoscopes.
to Surgical instruments
Medical packaging
Products from the medical engineering 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.
to Medical packaging

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Interesting customer projects