Sartorius Solutions for Medical Device Development, Manufacturing and Quality Control

Get Reliable Results Every Time While Improving Your Productivity

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Maximum productivity and accuracy are critical success factors in Medical Devices development, manufacturing and quality control. However, you need to be completely confident that you can trust your results all the way through your manufacturing process.

Let Sartorius save you time and increase your throughput by helping you control the quality of your Medical Devices, to produce results you can really rely on.

Introducing our customized 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 enable you to streamline time-consuming, labor-intensive and potentially error-prone manufacturing processes, as well as quality control your workflows.

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Get Consistently High Quality Results Compliant to ASTM Standard D6980 with Sartorius Moisture Analysis Solutions for Plastics

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Sartorius offers convenient 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.

We have decades of experience and in-depth knowledge on moisture content analysis of plastic resins and have optimized our instruments to meet our customers’ 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 customized settings for your plastic samples.

Mark 3 HP Moisture analyzer for plastics

Sartorius Mark 3 HP is the perfect solution for plastic moisture content analysis in medical device manufacturing. Its optional modular add-ons provide the best solution for every measuring task.

Its 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.

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Boost Productivity and Get Reliable Results With Cubis®

Cubis® Balances Increase Throughput of Your Stent Weighing, While Providing Premium Precision

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Peak performance weighing and back-weighing solutions for drug substances and excipients, as well as controlling the amount of coating on drug eluting stents – makes Sartorius Cubis® balances the perfect choice for stent manufacturers in the Medical Devices industry.

Even for tiny amounts of drug substances, Cubis® balances ensure high throughput, boosting your productivity via fast stabilization times, regardless of the stent size or weighing conditions you’re using. You can rely on 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 (ERP) system. Additionally, Cubis Q-Apps software offers you a range of options to use balance and process weighing data even more efficiently. And if your stent manufacturing and quality control processes have to fulfil specific criteria, we can customize our Sartorius weighing solutions to match your needs.

Discover Cubis® – the right balance between precision and productivity

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Extend the Lifetime of Your HPLC Columns for Accurate Results Every Time

Save Time and Improve Reproducibility With Sartorius HPLC Sample Preparation Solutions

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Quality Control of Drug Eluting Stents by HPLC requires robust, reliable sample preparation and streamlined workflows to ensure you get clean, reproducible, interference-free results. Sartorius supports you with simple, time-saving solutions for preparing your HPLC samples, as well as analyzing the content and purity of drug substances and excipients such as polymers for stents. This means your fully validated sample processing procedures can perform with robustness and reliability.

Small improvements from quality product selection can produce a significant impact on testing and is the simplest way to create the best results.

Check out the straightforward steps and optimized solutions to help you achieve accurate, reproducible results:

  • Preparation of Buffers and Dilution of Samples
  • Preparation of standards
  • Accurate Pipetting
  • Reliable Filtration

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Efficient, Reliable, User-friendly Microbiological Testing Solutions for Medical Devices

Product Safety Means Patient Safety - Confidence in Medical Device QC Testing

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Medical devices can improve the quality and even extend a patient’s life. In an increasingly 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.

Check out how we can help you meet regulatory requirements in your microbiological testing:

Air Monitoring solutions

  • Discover Continuous Active Air Monitoring solutions for Clean Room environments and be prepared for Annex 1 regulations.

Water and bioburden testing solutions

  • Streamline your workflows and simplify your microbiological testing with user-friendly Sartorius consumables and equipment for microbial enumeration.

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Continuous Microbial Air Monitoring in Clean Room Environments

Be prepared for Annex 1 regulations and download our application note.

Learn how to benefit from implementing continuous microbial air monitoring to entire manufacturing and quality control process of your medical devices.

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Ultrapure Water for HPLC Analysis

The quality of a solvent is often decisive for the reliability of an HPLC analytical run, as the presence of trace contaminants during gradient elution can result in “ghost or phantom peaks.”

Deionized or distilled water still contains considerable quantities of organic substances, which can cause ghost peaks.

Water of the quality required for HPLC can be either purchased from various manufacturers or produced on site by employing a water purification system. This application note evaluates such a system as an alternative to commercially sold ultrapure water for the preparation of high-purity eluents for HPLC analysis.

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Advanced Compliance for Use in Regulated Sectors

Sartorius Cubis® II balance is designed to follow US FDA data integrity principles that require data to be accurate, legible, contemporaneous, original, and attributable (ALCOA).

The Cubis® II balance, with pharma package, contains all the technical controls to support compliance with common regulations. Full compliance can be achieved with additional procedural controls and systems for long-term data storage.

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