Best-Fit Solutions for Medical Device Quality Control
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Best-Fit Solutions for Medical Device Quality Control

Solutions for Medical Device Manufacturers Pave Your Way to Market by Controlling Quality with Smart and Robust Solutions Best-fit solutions assist you through the entire development and production process to fulfill biocompatibility, cleanliness, safety and packaging standards. Benefit from precision weighing solutions, ultra-pure water systems and our expertise in filtration, topped with Data Analytics software for straightforward and reliable quality control. With over 150 years of trusted service and proven innovation, quality and reliability, Sartorius can help you bring your...

Explore the Process Steps for Ensuring Reliable Quality Controls Quality control starts in the design phase and continues through the whole product life cycle. It is vital activity for successful commercialization, assuring the consistent and compliant manufacturing of life enhancing products. The quality of the final product hinges on the quality of the raw materials. To prevent device defects and impairment of patient safety, your raw materials must be stable and safe for use. Solutions for your applications: Density Check of Solid Material & Liquids Nanoparticle Concentration Gravimetric...

Check Coatings – Applications of Correct Amounts Density Check of Solid Material & Liquids Gravimetric Dose Accuracy Assessment Weighing by difference solutions from Sartorius are your best fit to verify that coating systems have applied the exact amount. For reliable, reproducible and straightforward weighing workflows: Coatings, 3D inks, plastics, metals guaranteeing the specified density of raw materials is crucial for stability and safety of devices. Deviations may have profound effects on the final product’s performance. The accuracy of drug delivery devices is critical to patient...

Counting with Reference Weight Error-Proof Packaging Moisture Determination of Medical-Grade Plastics Counting individual pieces is timeconsuming. Counting on a balance is a fast and automated way to accurately check large numbers of components based on individual weight. Sartorius Checkweighing Solutions ensure that complex, but small medical device systems have been assembled completely and that no part is missing - before and after packaging. The readability of balances will be determined by the weight of the smallest component in the finished product assembly. Raw and packaging...

Analytical Characterization Particulate Matter Analysis - Biocompatibility The biological risk of a medical device system is often directly linked to its surface properties. Assessing the composition of materials and their ability to release extractables and leachables is standard in evaluating biocompatibility. Sartorius provides user-friendly sample prep tools for Chemical Characterization per ISO 10993-18. Time-saving solutions for preparing samples for content and purity analysis produces robust and reliable sample processing procedures: Fully automated preparation of standards with...

Microbial Water Testing & Bioburden Nanoparticle Concentration - Separation Microbial contamination must be evaluated in water, raw materials and prior to sterilization of medical devices. Membrane Filtration is the method of choice for the evaluation of microbial contamination of liquids such as purified water or rinsing fluids used during the manufacturing process. Microbial air monitoring is a must to evaluate the microbiological flora at your manufacturing facility for deviations from norm or undesirable organisms. ISO 10993-1 requests a safety evaluation and risk assessment to exclude...

Data Analytics Cytotoxicity testing is a standard biocompatibility test to evaluate toxicity levels or irritancy potential of the drug delivery system or material. According to ISO 10993-5, the quantitative MTT Assay involves the incubation of cultured mammalian cells in contact with a device and/or extracts to determine biological response. When it comes to evaluating the chemical properties of a formulation, data analytics streamlines the process. MODDE® Design of Experiments (DOE) software lets you select the most influential ingredients for a new formulation and focus on these in...

Contract Manufacturing & Integration Learn More: Build on a reliable partnership with customized solutions tailored to your individual requirements Process Automation Ready-to-Use Filtration Devices & Membranes Customized Components Let our solutions provide support where practical, repetitive processes such as check weighing, dispensing or filling are best handled by automated systems. Automation in production enables high-throughput, fast turnaround times, reduced errors and increased reproducibility: Sartorius supplies customers with a wide variety of microporous flat membrane filters in...

Additional Medical Device Solutions Free Handbook: Achieve Optimal Weighing Performance with Cubis® II High-Resolution Balances Medical Device manufacturers need the most reliable weighing results. The Cubis® II platform provides a completely configurable, high-performance portfolio of both lab weighing hardware and software to meet your expectation on the highest level. External environmental influences or improper handling can lead to inaccurate results or poor weighing performance, which are not caused by the balance. To ensure high accuracy during weight measurements and excellent...

Perform Reliable Testing of Endotoxin Levels on Medical Devices with Smart Pipetting Solutions Tacta® Mechanical Pipettes Effortless pipetting thanks to ergonomic design Volume lock for reliable pipetting results Easy calibration and adjustment Picus® Electronic Pipettes Accurate and precise pipetting results Fully electronic operation and easy to use Light weight pipette for superior pipetting ergonomics Low Retention Tips Optimal sample recovery Purity certified - Sartorius pipette tips are tested for endotoxin content with a limit of 100 times lower than the regulatory requirement Octet®...