Quality assurance in medical device industry

Transcription

1 LASERS & MATERIAL PROCESSING OPTICAL SYSTEMS INDUSTRIAL METROLOGY TRAFFIC SOLUTIONS DEFENSE & CIVIL SYSTEMS Quality assurance in medical device industry

2 Solutions for medical products Jenoptik is increasingly tackling a two-fold challenge: how do we preserve health in today s globally aging society, and how can we effectively combat chronic disease? Demand for and use of the products and services we supply is increasing among manufacturers of medical technology products. Jenoptik products have become a key driver of development in the life sciences sector and are helping to keep people mobile for life. In this future market, we are a reliable partner in a number of areas of medical technology. Alongside solutions for direct medical use, we also provide systems that enable our customers to ensure their products meet the necessary quality standards and to achieve the required level of process reliability. Lasers & Material Processing Diode lasers and solid-state lasers from Jenoptik s Lasers & Material Processing division have been successfully used in ophthalmology, laser endoscopy and dermatology applications for many years. In addition, the femtosecond laser supplied by the division is used for micro material machining applications, for example the production of medical components such as stents or catheters. Optical Systems The Optical Systems division is a development and production partner for device manufacturers in the fields of medical technology and life sciences. Our optical, micro optical and optoelectronic systems and components facilitate the development of innovative medical technology solutions in areas such as point-of-care diagnostics, endoscopy, biotechnology and pharmaceutical research, microfluidics and therapeutic laser systems. 2

3 Characterized by quality Industrial Metrology The Industrial Metrology division of the Jenoptik Corporation is one of the leading global specialists in high-precision, contact and non-contact production metrology. Our modern, innovative measurement systems are characterized by exceptionally high precision and traceability, and measure geometry, form and surfaces to the tightest tolerance specifications. The systems are easy to operate and enable you to generate full, traceable documentation of product quality. issues promptly so that you can optimize your manufacturing processes improving both quality and profitability. Whether your company needs to flexibly produce components on a small scale, for example endoprostheses, or uses automated series production processes for products such as cannulas, we can provide the quality assurance solutions you need from initial measurements on the production line itself through to final inspections, statistical process control and measuring room checks. We supply solutions for a wide range of measurement tasks to support you in the validation of your processes. These solutions enable you to identify production With our worldwide sales and service network, we are never far away and can offer tailored solutions that take local conditions into account. We are your expert partner for production-based, flexible measurement technology that produces fast, accurate results with full documentation of product quality. 3

4 Precise measurement... Implants* Hip joints Knee joints Shoulder joints Dental implants Dental abutments Osteosynthesis* Bone screws Bone nails Bone plates Spinal fusion Interference screws Invasive products* Cannulas Syringes Endoscopes Trocars Surgical instruments* Bone & dental drills Bone cutters Contra-angle dental handpieces Medical equipment* Components for tomography devices Components for blood glucose meters 4 * Examples of components that can be measured. * Other applications available on request

5 ...with tactile, optical and pneumatic measuring processes Our comprehensive expertise and decades of experience in the field of tactile, optical and pneumatic measurement technology mean you can be confident that our solutions are optimally tailored to your needs. We can work with you to determine a suitable measuring strategy and configure the appropriate system in line with your requirements. In doing so, we take all the important considerations into account, such as the required level of automation and the ability to integrate the measuring process into the production chain Systems for the measurement of: Surfaces Surface parameters 3D topography Contour features Geometry Straightness Facets and cutting edges Tool tips Cannula joining points Angles and radii Diameter and length Thread parameters Form Circularity Cylindricity Example: Measuring a dental implant Fixing screw: Contur, thread, form Dental abutment: Contour, angle, form Dental implant: Roughness, thread, form 5

6 Surface measurement of components such as: acetabular cups femoral components drills femoral head hip stem conus femoral sliding surfaces knee inlay sliding surfaces dental implants Tactile surface measurement systems for a wide range of applications Whether mobile or stationary, manual or automated, for simple or complex measuring tasks, preconfigured or custom-made we will supply you with a measuring system that is tailored to your needs. Our robust and high-precision solutions provide reliable results even in production environments, and are easy to operate via our clearly structured software. Our measurement systems cover the most common measuring processes and can easily be adapted with our wide range of accessories, making them flexible enough to cope with changing measurement conditions. You can tailor your own printed reports to suit your requirements and archive your documents electronically or print them for hard-copy records. Our product range includes systems to measure roughness, contours and topography, plus devices capable of measuring a combination of these parameters. Measurements include roughness parameters, angles, radii, spacing and line forms. HOMMEL-ETAMIC nanoscan 855 measuring station with contour standard Measuring a bone drill with a roughness probe system. 6

7 nanoscan 855 A diamond tip runs over the surface and simultaneously measures both roughness and contour. Example application: Acetabular cups Surface roughness is a crucial factor in hip replacements, affecting both the fusion of the bone on the outside of the joint and the level of friction between the acetabular cup and the femoral head on the inside. Exceptional surface quality directly influences the service life of the prosthesis and therefore the long-term health of the patient. Requirements for surface roughness vary depending on the surface material used. Measured parameters: Roughness, Ra Waviness Radius [µm] 0,14 µm 0,10 System highlights: Long traverse length High-precision resolution Low measurement force of 0.6 mn Roughness and contour measurement in one process The surface of the acetabular cup can be measured to EN ISO standards using the HOMMEL-ETAMIC nanoscan 855 combined roughness and contour measuring system. The Ra value is measured to the tightest tolerance specifications. 0,00-0,10-0,20 Max: 0,06 µm Min: -0,08 µm R23,0454 Länge: 1,2658 mm Ra 0,01 µm 7

8 Geometry and form measurement on components such as: dental implants dental abutments cover screws bone screws pedicle screws bone drills cannulas syringes Optical shaft measurement systems for flexible measurement of geometry and form Optical measurement technology allows you to measure your components quickly and precisely. The systems are also highly flexible and can be easily adapted for new measurement tasks. Our shaft measurement systems excel in production environments because the technology and quality of the systems are optimally tailored to the specific requirements of applications in these areas. These systems also provide highly reliable measuring tool capability over long periods. They can be used as SPC measuring stations in both offline and automated applications within the production chain, and as a customized solution for specific requirements. Our product range includes optical measurement systems to determine dimensions, form and position, as well as geometrical parameters on shaft-type workpieces. For example, users can measure the straightness, facets and joining points of cannulas, the form of cutting edges and tool tips, angles and radii, diameters, lengths and thread parameters HOMMEL-ETAMIC opticline C305 with test shaft Measuring a bone cutter, dental abutment and cannula. 8

9 opticline C305 Cameras optically scan the part and capture its contours in a matter of seconds. Example application: Dental abutment A healthy smile is an appealing feature, so any lost teeth are usually replaced with perfectly fitting implants. A geometrically precise implant that complies exactly with specified tolerances aids the healing process and promotes the well-being of the patient. High precision is crucial during the manufacture of dental abutments because these components need to be a perfect fit on the implant as well as the crown. The optical shaft measurement systems in the HOMMEL-ETAMIC opticline C-series can be used with a range of different clamping devices, allowing you to measure a wide range of implants as part of your flexible production processes. Measured parameters: Diameter Length Angle Radii Profile form Cylindricity Radial run-out Concentricity System highlights: Repeatable, non-contact measurement Flexible use Simple programming High resolution High measuring speed The systems are used for statistical process control (SPC) in implant production and for operator-controlled inspections in the production environment. They provide measurement results of all key features within seconds, without operator input and with full documentation of the results. 9

10 Geometry and form measurement on components such as: hip stem conus acetabluar cups femoral heads cannulas Pneumatic measuring systems for fast geometry and form measurements Our pneumatic measurement systems are extremely robust and reliable. These characteristics make them exceptionally well-suited to testing components that are manufactured and processed in the toughest production conditions. Each system comprises the measuring equipment itself, a converter, an interface and an evaluation unit to display results graphically. They are used for manual measurements and in semi or fully automated measuring stations on the production line and in the measuring room, both for complete inspections and random sampling. Thanks to the pneumatic principle that we apply, no special maintenance processes are required simply cleaning the measuring equipment is sufficient. Depending on the dimensions of the workpiece, the measuring range and the surface structure, the nozzle type used with the measuring equipment varies. Measurements can include length, spacing, diameter and simple form characteristics. HOMMEL-ETAMIC vega evaluation unit with measuring spindle for measuring an acetabular cup Pneumatic measuring spindle with handle. Measuring spindle to measure an acetabular cup. 10

11 AG100 The internal diameter is determined in a non-contact process using direct-blow nozzles. Example application: Femoral components To ensure that a prosthetic hip joint is able to move around securely and fluidly in the socket, the femoral component must be positioned securely on the stem. Tight tolerances are therefore crucial for an accurate fit. HOMMEL-ETAMIC AG100 measuring spindles pneumatically measure the cone angle and internal diameter of a femoral head on two levels. Measured parameters: Angle Diameter System highlights: No knowledge of measurement technology required Low qualification requirements Fast and precise Repeatable measurements ø Operating the system is easy: the femoral component is simply placed on the measuring spindle. Within a few seconds, the operator can see whether the component is within the required tolerances. B The measuring spindles can be used at all stages of production and are characterized by their ease of use and calibration. ø1 ø2 A α 11

12 Head Office Jenoptik Industrial Metrology Germany GmbH Alte Tuttlinger Straße VS-Schwenningen Germany Phone: Close to you. Group companies in: Germany France Switzerland Spain Czech Republic USA Mexico Brazil China Singapore South Korea India Affiliates and representation worldwide: Please contact us: Copyright JENOPTIK Industrial Metrology Germany GmbH. All rights reserved. Subject to change without notice. The photos may show options and are not legally binding /2014