Maximum productivity and accuracy are key success factors in medical devices development, manufacturing, testing and quality control. However, you need to be completely confident that you can rely on your results all the way through your medical device process.
Sartorius enables you to save time and increase your throughput by helping you control the quality of your Medical Devices, to produce results you can really trust.
Introducing Sartorius solutions into your Medical Devices manufacturing and QC processes will not only improve your productivity, but also ensure full compliance to the most rigorous standards and requirements. Sartorius solutions help you to streamline time-consuming, labor-intensive and potentially error-prone manufacturing processes, as well as quality control of your workflows.
Sartorius Cubis® balances are the perfect choice for the medical devices industry e.g. for stent manufacturers. Discover the high performance weighing and back-weighing solutions for drug substances and excipients, as well as controlling the amount of coating on drug eluting stents. Even for tiny amounts of drug substances,
Cubis balances ensure high throughput, boosting your productivity via fast stabilisation times, regardless of the stent size or weighing conditions you're using. You can trust the precise weighing results and high-speed processing of all critical parameters.
Thanks to their flexible, seamless connectivity, Cubis balances are easily integrated into any process and system. Moreover, Cubis Q-Apps software offers you a range of options to use balance and process weighing data even more efficiently. If your manufacturing and quality control processes have to fulfill specific criteria, we can customise our Sartorius weighing solutions to match your needs.
Discover Cubis - the right balance between precision and productivity.
Quality control of medical devices by HPLC requires robust, reliable sample preparation and streamlined workflows to ensure you get clean, reproducible, interference-free results. Sartorius provides you with simple, time-saving solutions for preparing your HPLC samples. This means your fully validated sample processing procedures can perform with robustness and reliability.
Small improvements from quality to product selection can produce a significant impact on testing and is the simplest way to create the best results.
Sartorius offers easy and optimised solutions to help you achieve accurate, reproducible results:
1. Preparation of buffers and dilution of samples
2. Preparation of standards
3. Accurate pipetting
4. Reliable filtration.
Medical devices usually improve the quality and even extend a patient's life. In a complex regulatory landscape, continuous microbiological testing during manufacturing is crucial to ensure consistent, reliable product quality and more importantly, patient safety. With our established expertise in microbiological quality control, Sartorius enables you to achieve accurate, reproducible results for in-process and final release microbiological testing. We provide medical device manufacturers with fully compliant membrane filtration solutions, ideal for use in water, bioburden and sterility testing, as well as active air monitoring for clean room and production environments.
Meet the regulatory requirements in your microbiological testing with:
Sartorius provides you with smart solutions and services to determine even the lowest moisture content in polymers and resins within minutes, offering technicians a simple workflow that guarantees reliable and accurate results and stable testing processes. Sartorius has decades of experience and knowledge on moisture content analysis of plastic resins and we have optimised our instruments to meet your special needs. Our expertise and library of 30,000 settings for different plastic resins offer easy and reliable moisture analysis solutions for all your plastic raw materials. We can supply you with an instrument with customised settings for your plastic samples.
Sartorius Mark 3 HP is the perfect choice for plastic moisture content analysis in medical device manufacturing. Its optional modular add-ons provide the best choice for every measuring task. The high-resolution weighing system and special design make the Mark3 HP the perfect solution for precisely analyzing the moisture content of even very dry samples. This feature makes Mark 3 a genuine alternative to Karl-Fisher titration because it is an easy-to-use, without using harmful chemicals.
Endotoxins can cause a risk to patient safety. Even a low endotoxin concentration in the blood stream can produce inflammation in the human body; therefore, preventing endotoxin exposure to your patients is important.
To prevent patient exposure to endotoxins, frequent and reliable testing for endotoxin levels on medical devices is required. The LAL method, is one such reliable test method used to guarantee patient safety and the risk-free use of medical devices. An alternative method is the recombinant Factor C (rFC) assay that is completely animal-free. Sartorius enables you to get consistently reliable endotoxin testing results with purity-certified pipette tips and smart pipetting solutions.
The Sartorius Group is a leading international partner of biopharmaceutical research and the industry. With innovative laboratory instruments and consumables, the Group's Lab Products & Services Division concentrates on serving the needs of laboratories performing research and quality control at pharma and biopharma companies and those of academic research institutes. The Bioprocess Solutions Division with its broad product portfolio focusing on single-use solutions helps customers to manufacture biotech medications and vaccines safely and efficiently. Currently, more than 8,800 people work at the Group's approximately 60 manufacturing and sales sites, serving customers around the globe.