Implants – R&D and Process Development
Quality control begins in the design phase, and accurate production processes must be established to ensure continuous manufacturing of compliant and consistent products. Our solutions help you understand and anticipate risks associated with materials, achieve quality goals and satisfy Quality by Design (QbD) requirements. Create competitive products, de-risk projects and increase success rates, accelerate time-to-market and adhere to guidelines.
Medical Devices - General Process Steps
R&D and Process Development Applications for Implants
You are committed to improving mechanical and biocompatibility characteristics of implant materials for better patient experiences. We are committed to providing the products you need to ensure premarket approval. Consider the following applications:
Measure Liquids, Pastes and Solids – Precisely, Accurately and With Full Regulatory Compliance
Coatings, 3D inks, plastics, metals - guaranteeing the specified density of raw materials is crucial for stability and safety of drug delivery systems. Deviations due to impurities or poor quality may have profound effects on the final product’s performance.
Our solutions are tailored to the needs of density applications. Durable, high-performance balances and pycnometers, integrate with user management systems to generate traceable results, for precise and reproducible density calculation.
- Check density of solids, liquids and pastes with one balance, even highly viscous or solid materials with densities in excess of 3 g/cm3
- Increase measurement precision and process safety
- Document results compliant to 21 CFR Part 11 & EU GMP Annex 11, USP Chapter 41
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Confirm Purity of Materials
Cubis® II analytical balances are designed for high-performance weighing and offer completely digital workflow management following the US FDA data integrity principles (ALCOA). On-board QApps contribute to correct usage by guiding through weighing processes, increasing measurement accuracy, precision and process safety.
The Pharma Software Application Package supports compliance with 21 CFR Part 11 and EU GMP Annex 11, USP Chapter 41 and includes features like user management, digital signatures, audit trail and USP minimum weigh.
Simply combine the Density Kit YDK03MS and you can determine additional key physical property characteristics like specific gravity or density on solids, liquids and even pastes.
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Maximum Recovery in Minimum Time
ISO 10993-1 requests a safety evaluation and risk assessment to exclude potential harmful effects of constituent materials, as for nanomaterials. Prior to evaluating reference values like conjugation or encapsulation efficiency, zeta potential and size distribution, successful purification and concentration of the suspension or dispersion is essential. However, typical separation methods like size-exclusion chromatography and dialysis require subsequent concentration steps and extensive manual handling that is time-consuming and costly.
Sartorius Lab Ultrafiltration solutions move you one step ahead:
- Perform purification and concentration steps simultaneously, reducing manual handling time
- Highest recovery in the fastest possible time
- Save consumable costs
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The Fastest of Its Kind
Vivaspin® Turbo 15 RC (Regenerated Cellulose Membrane) is the fastest RC centrifugal concentrator on the market. Vivaspin® Turbo devices are designed to provide the best possible recoveries.
Choose between RC and PES (Polyethersulfone) membranes, whichever is best suited to your target. Ensure highest recoveries in the fastest possible time!
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Save Time and Improve Reproducibility
The biological risk of an implantable device is directly linked to its surface properties and the complexity of its constitutive components. Assessing the composition of materials and their ability to release extractables and leachables is standard in evaluating biocompatibility. FTIR, MS, ICP-MS or GC require robust, reliable sample preparation and streamlined workflows to ensure clean, reproducible, interference-free results.
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.
- Fast, simple and economical
- Fully automated preparation of standards
- 21 CFR Part 11 & EU GMP Annex 11, USP Chapter 41 compliant records
- Filtration solutions with low retention volumes and maximal recoveries
- Minimum leachables or extractables
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Your Solutions for Analytical Testing
Ultrapure Lab Water Systems Arium® Mini Plus UV with Unique Bag Technology produce ASTM Type 1 ultrapure water for analytical buffer and sample preparations. Minimize chemical ion interference and take TOC levels down to a minimum to ensure consistent baselines and avoid background noise in chromatograms.
Simplify your buffer and sample preparation with the Cubis® MSA Dosing System with Q-App Software for automation and documentation of 100% comparable standards. Documentation of your test procedures is compliant to 21 CFR Part 11.
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Insight into Active Biological Processes in Real-Time
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.
Sartorius’ Incucyte® Live-Cell Analysis Systems are ideally suited to perform non-invasive monitoring under stable culture conditions and quantitative live-cell imaging and analysis in real-time:
- Visualize and quantify cell behavior around the clock
- Time-lapsed, kinetic measurements in long-term
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Incucyte® Cytotoxicity Assay
Incucyte® Cytotox Dyes, in combination with the Incucyte® Live-Cell Analysis System, kinetically measure dynamic changes in cell membrane integrity to quantify cytotoxicity over multiple days. The Incucyte® Cytotoxicity Assay provides real-time measurements of cell death in response to treatments, pharmacological agents or environmental factors and can be used to determine biocompatibility.
While not CFR 21 compliant, the Incucyte® Live-Cell Analysis System is ideal for research and development studies across multiple drug delivery applications such as oncology, immune-oncology, immunology or neuroscience.
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Develop Complex Formulations
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 product development. Predict the properties of untested formulations based on the properties tested and reduce the number of experiments you need to do to find the most promising product for your purposes, saving time and money.
- Significantly reduce experimental costs
- De-risk projects and increase success rates
- Make the most of valuable samples, raw materials and human resources
- Accelerate progress and time-to-market while keeping within budget
- Achieve quality goals and satisfy Quality by Design (QbD) requirements
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Design of Experiments Software That Accelerates Progress
MODDE® does a lot more than ordinary Design of Experiments (DOE) software. Its built-in guidance and quality measures ensure users make the best experimental choices, so you get the most relevant and effective outcomes. MODDE® is designed to help experimentalists get DOE right from the start.
MODDE® provides optimization by a guided workflow wizard that helps scientists and engineers intensify processes, reduce waste and optimize process output using a top-notch approach to mitigate risks.
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Instrument Service – Better Performance for Your Devices
Service life cycle management is a critical element when purchasing your equipment. Proper life cycle management starts with the installation of the equipment and basic user training, which is followed by routine preventative maintenance visits. These services will increase the longevity of the unit, while reducing downtime and limiting product lost.