Sartorius

Medical Device Manufacturing and Quality Control

Otto-Brenner-Straße 20, 37079 Goettingen, Germany



Sartorius provides products and services to medical device manufacturers, with a focus on quality control (QC) to enable time-saving and increased throughput throughout the medical device process.

Introducing Sartorius into medical device manufacturing and QC processes can improve productivity, ensuring full compliance with the most demanding standards and requirements.

Our solutions help clients to streamline time-consuming, labour-intensive and potentially error-prone manufacturing processes, as well as quality control of the workflow.

Weighing and back-weighing systems for pharmaceuticals

Sartorius Cubis® provides high-performance weighing and back-weighing solutions for drug substances and excipients and controls the amount of coating on drug-eluting stents.

Even for small amounts of drug substances, Cubis balances ensure high throughput, boosting productivity via fast stabilisation times, regardless of the stent size or weighing conditions.

Cubis balances have flexible, seamless connectivity, easily integrated into any process and system. Furthermore, Cubis Q-Apps software offers a range of options to use and process weighing data efficiently. Our weighing solutions can also be customised to meet specific customer requirements.

High-performance liquid chromatography sample preparation solutions

Medical device QC by high-performance liquid chromatography (HPLC) requires robust and reliable sample preparation, as well as streamlined workflows to ensure clean, reproducible, interference-free results.

Sartorius provides simple, time-saving solutions for preparing HPLC samples to ensure fully validated sample processing procedures can perform with robustness and reliability.

Minor improvements from quality to product selection can produce a significant impact on testing and is the simplest way to create the best results during the preparation of buffers and dilution of samples and preparation of standards, as well as accurate pipetting and reliable filtration.

Microbiological testing solutions for medical devices

Medical devices typically improve quality and can extend a patient’s life. In a complex regulatory landscape, continuous microbiological testing during manufacturing is crucial to ensure consistent, reliable product quality and patient safety.

With our reputable proficiency in microbiological QC, we assist clients in achieving reliable and reproducible results throughout the process and during final release microbiological testing.

We deliver fully compliant membrane filtration solutions, which are optimal for use in sterility, water and bioburden testing, as well as active air monitoring for production and cleanroom environments.

Moisture analysis solutions for plastics

Sartorius provides smart solutions and services for determining moisture content in polymers and resins within minutes to offer technicians a simple workflow that guarantees reliable and accurate results, as well as stable testing processes.

Our expertise and library of approximately 30,000 settings for different plastic resins offer smooth and reliable moisture analysis solutions for all plastic raw materials. We can also supply instruments with customised settings for plastic samples.

Sartorius Mark 3 HP is an ideal choice for plastic moisture content analysis on medical device manufacturing. Its optional modular add-ons provide the most suitable option for each measuring task.

The high-resolution weighing system and unique design allow precise analysis of moisture content on even the driest of samples.

Regular endotoxin testing with smart pipetting solutions

To prevent patient exposure to endotoxins, routine testing for endotoxin levels on medical devices is required. Limulus amebocyte lysate (LAL) method is a positive test method used to guarantee patient safety and risk-free use of medical devices.

An alternative method we use is the recombinant Factor C (rFC) assay, which is entirely animal-free. We enable consistently reliable endotoxin testing results with purity-certified pipette tips and smart pipetting solutions.

About Sartorius

Sartorius is a leading international partner of biopharmaceutical research. With innovative laboratory instruments and consumables, our lab products and services division focuses on serving the needs of laboratories performing research and QC at pharmaceutical and biopharmaceutical companies, as well as those of academic research institutes.

With its broad product portfolio focusing on single-use solutions, our bioprocess solutions division helps clients to manufacture biotech medications and vaccines safely and efficiently.

More than 8,800 individuals currently work across approximately 60 manufacturing and sales sites worldwide.

Sartorius Lab Instruments GmbH & Co KG

Otto-Brenner-Straße 20

37079 Goettingen

Germany

+49.551.308.0 +49.551.308.3289 www.sartorius.com