Sartorius

Sartorius - Your Partner in Medical Device Development, Manufacturing and QC

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 Group

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.

Sartorius Lab Instruments GmbH & Co. KG

Otto-Brenner-Straße 20
37079 Goettingen
Germany
www.sartorius.com

White Papers

Preparation of Standards – Easier than Ever with the Sartorius Cubis® MSA Dosing System

Improving your HPLC Sample Preparation is easier than ever with the Sartorius Cubis® MSA Dosing System. The Cubis MSA individual system with Q-App software automatically corrects the solvent volume to the appropriate value, eliminating the need to reach the precise target weight. At the end of the procedure, the weight of the compound(s) and solvents is used to calculate the verified concentration(s) and the verified volume of the standard prepared.

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.

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.

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.

The Importance of Accurately Measuring the Moisture Content of Plastic Resin in the Molding Process of Medical Devices

Moisture content is an important variable that must be monitored for and controlled during the production of plastic medical device parts. ASTM standard D6869 is the benchmark for measuring the moisture content of plastic resin, and stipulates the use of Karl Fischer titration as the applicable standard method. Herein, we show that the Sartorius Mark 3 High Performance Moisture Analyzer correlates well with Karl Fischer titration standards for a number of plastic resins commonly used in medical device manufacture.

Products & services

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

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.

Microbiological testing solutions for Medical Devices – Discover efficiency, reliability and user-friendliness

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.

Sartorius HPLC sample preparation solutions – Extend the lifetime of your HPLC columns for accurate results

Quality Control of medical devices by HPLC requires robust, reliable sample preparation and streamlined workflows to ensure you get clean, reproducible, interference-free results.

Cubis® balances increase throughput of your weighing processes, while providing premium precision

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.

Minimize the risks in endotoxin testing with smart Sartorius pipetting solutions.

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.

Subscribed

Sartorius - Your Partner in Medical Device Development, Manufacturing and QC