Solutions for Your Medical Device Processes
Find the Right Products to Ensure Reliable Quality Control in Your Industry
Sartorius' equipment ensures compliance to the most rigorous standards and requirements like GMP, EU 2017/745 MDR, ISO 10993, ISO 13485, USP, JP and EP.
State-of-the-art lab instrumentation constantly delivers accurate, precise and reliable test results. Built-in applications simplify usability while increasing measurement accuracy and precision. Security settings support safe and stable testing processes reducing the probability of human errors and avoiding unnecessary repetitive steps.
Software solutions support your appropriate documentation of procedure and methodology compliant to US FDA 21 CFR Part 11, EU GMP Annex 11 and ALCOA. Seamlessly connectable balances integrate with your user management systems to generate traceable results and enhance your data quality and integrity.
Applications Covered
Evaluate Uniform Dose Delivery Over Time
The accuracy of drug delivery devices is critical to patient safety. Guaranteeing the correct delivery dosage is obligatory for drug delivery systems like insulin-pumps, drug-eluting stents or intrauterine devices (IUD). To avoid failures or variations resulting in over- or underdosing, you must check whether the drug is applied at constant rates over time.
Our weighing solutions are best in class for medical device measurement accuracy for the critical parameters of flow, mass or volume over time:
- Determine weight of smallest sample amounts with highest precision
- Ensure and check exact drug uptake on device
- Fastest stabilization means higher throughput, even in unstable environments
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Your Solution for Dose Accuracy Assessment
Weigh small sample amounts precisely, even in unstable environments with the Cubis® II micro balance. The software solution Interval Print acquires weight values at defined intervals and enables accurate measurement of a sample flow by calculating average weight values over a defined period. Your results are saved to a CSV file and can be easily exported.
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Save Time and Improve Reproducibility
The biological risk of a drug delivery 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. 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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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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Determine Moisture Contents Within Minutes
Raw and packaging materials can vary in their characteristics and hygroscopic properties. However, they need a specific moisture content for optimal processing and to assure the appearance and functionality of the final product.
Sartorius offers robust and reliable solutions to detect and document moisture contents quickly and easily within your routine applications.
- Achieve highest precision, even for very dry samples
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MA160
The MA160 offers high flexibility, making it ideal for use in the widest range of sectors, such as laboratories, incoming goods and production departments.
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Check Smallest Quantities
Extended wear, delivery of drugs, biocompatibility or corrosion resistance - coatings on drug delivery systems provide numerous benefits. To fulfill their function reliably, coatings, protection layers and foils must be picked up uniformly.
Weighing by difference solutions from Sartorius are your best fit to verify that coating systems have applied the exact amount of medical grade polymer or API to an implantable device, such as a DES (Drug Eluting Stent). For reliable, reproducible and straightforward weighing workflows:
- Highest precision for smallest quantities, protected against drafts and electrostatic charges
- Sample holders accommodate differently shaped products
- Full data traceability and integrity
- Compliant to 21 CFR part 11 and EU Annex 11
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Your Solution to Check Coatings, Protection Layers & Foils
Cubis® II Microbalances offer complete digital workflow management while supporting all requirements to achieve 21 CFR part 11 and EU GMP Annex 11 compliance. A stand-alone solution for advanced user management, audit trail, electronic signature and safe data transfer prevents data manipulation. Benefit from easy set-up, simple maintenance and weigh differently shaped products conveniently by choosing the best fitting draft-shield and customized holders. The stainless steel draft shield F protects against drafts and electrostatic charges.
Let the Backweighing QApp guide you through weighing workflows for simple, differential weighing with alphanumeric lot tracking.
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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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Capture and Quantify Smallest Particles
GMP Annex 1 requests that medical devices be scrupulously clean and free of interfering residues. From raw material or environment, clothing, machining and lubricants, particle sources are manifold. Glass, elastomer, hair and other particles can affect biocompatibility and safety as they build an additional surface for microbial growth, or worst case can be released and lodged in a patient's vascular capillary system.
Sartorius’ solutions are designed for capturing particulate matter, reliable optical analysis and accurate quantification:
- Ready-to-use ultrapure, particle-free rinsing water
- Membrane filters with excellent retention rates
- Accurate filter weighing balances, protected against drafts and electrostatic charges
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Your Solutions for Analyzing Particulate Matter
Arium® Pro VF delivers ultrapure water for reliable particle analyzes. The implemented UV lamp ensures excellent breakdown of organics and the integrated ultrafiltration filter provides optimal reduction of particles for reliable optical measurement. Dispense water in the exact quality and quantity required for your analyses, when and where you need it with the New Arium® Smart Station.
Choose Cellulose Nitrate Membranes for precise surface capture and high sample visibility. Surfactants and colloids pass through the membrane filter during filtration, thereby not affecting results. Facilitate accurate weighing of filters with the Cubis® II Ultra-Micro and Micro Balance filter models with the respective QApp. The stainless steel draft shield F protects against drafts and electrostatic charges.
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Reliable Microbial Enumeration
Microbial contamination can be present in raw materials or can be introduced during production. To prevent biofilms, corrosion and hardness deposits, cooling water for machines, autoclaves or instruments for production like lasers, welders, cutters or drills must be hardness‐reduced, deionized and free from bacterial contamination.
Continuous microbiological testing during manufacturing as per ISO 11737-1 is crucial to ensure consistent, reliable product quality and patient safety. Using the right products helps you reduce risks that could impact patient health, lead to unnecessary delays or product recalls.
Our membrane filtration solutions for standard microbial enumeration protocols per USP <61> facilitate an efficient, accurate detection of potentially pathogenic or spoilage microorganisms:
- Save time with ready-to-use sterile filtration devices
- Minimize the risk of secondary contamination and false positives
- Reliable results
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Simplify Your Microbial Limits Testing Workflows
Single and multi-branch Microsart® Manifolds are easy to clean and are adaptable to various filter device formats to suit your needs. To reduce the risk of secondary contamination, combine manifold with the Microsart® @filter and Microsart® @media system with its integrated adhesive ring in the lid. This effortlessly affixes the membrane and positions it correctly on the agar plate for a touch-free membrane transfer.
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Adapt Your Water to Your Needs
The production of drug delivery systems requires a supply of highly purified water (DI, RO, EDI Ultrapure), which is deionized and free from impurities like bacteria or particles. It feeds lab equipment like washing machines, automatic endoscope re-processors (AERs), steam sterilizers or autoclaves enabling sterile preparation of instruments, parts and assemblies.
Sartorius Water Systems provide ultrapure water for impurity-free and safe operation adapted to your needs:
- Essential quality parameters at a glance
- Touchscreen display and intuitive menu navigation
- Favorites function with direct access for recurring volumes
- Excellent retention rates of impurities
- Bag Tank Technology avoids secondary contamination
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Your Water Supply, When and Where you Need It
Arium® Comfort II delivers ASTM Type 1 ultrapure and Type 2 pure water of the highest quality in one system. The system combines reverse osmosis with EDI and resin technology for optimized impurity-free water quality.
Optimize your endotoxin removal by adding an Arium® CellPlus Ultrafilter to your Arium® Comfort II system.
Dispense ultrapure water, in the exact quality and quantities required for your daily analyses, when and where you need it. To further increase your flexibility, combine the Arium® Comfort II with the Arium® Smart Station dispensing unit.
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Keep Your Microbiological Limits Under Control
Airborne microbes pose a risk of contamination for products and raw materials. Continuous monitoring is a must to evaluate the microbial flora at your manufacturing facility for deviations from norm or undesirable organisms. For clarifying investigations, the verifiable avoidance of product contamination and reliable microbial identification are crucial.
Sartorius’ secure and flexible technology for air sampling by filtration enables accurate and reliable analysis – without the risk of cross-contamination by changing agar plates:
- Be prepared for GMP Annex 1 regulations
- Continuous sample collection with just one filter
- Less intervention/risk of secondary contamination
- Save time (no more frequent changing of agar plates)
- Retain smallest airborne micro-organisms at the most accurate level
- Water-soluble filters assure the best recovery of trapped microorganisms
- Pair traditional growth-based methods with rapid detection methods
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Active Air Monitoring and Sampling for Clean Room Environments
Opt for total safety and convenience using Sartorius MD8 Airscan® technology. Collect samples using a single gelatine membrane filter without compromising the integrity of the clean room. Avoid false positives, especially in Grade A environments where the action limit is set at “zero CFU.” Our proprietary, water-soluble filters retain even the smallest airborne microorganisms with an efficiency of 99.999%, practically ruling out potential false negative results. Focus on other tasks as your air sampler eliminates the need for routine intervention required by other conventional impaction-based samplers.
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Easy and Traceable Counting
Counting individual pieces is time-consuming. Counting on a balance is a fast and automated way to accurately check large numbers of components based on individual weight.
Sartorius balances provide you the weighing capacities you need by ensuring full traceability of data, time-saving workflows and accurate results.
- Ease counting in warehouses, incoming-goods or in production
- Count big quantities of small parts in bulk
- Connect to your ERP
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Count Big Quantities of Small Parts
The large weighing pans of Cubis® II Analytical and Precision Balances provide you the weighing capacities you need. Use the Essential Package Application Counting to calculate the quantity and precise weight of each piece.
The Pharma Software Application Package supports compliance to 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 weight.
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Check Correct Assembly
Sartorius Checkweighing Solutions ensure that complex, but small implants have been assembled completely in QC 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. The fully-modular device can be customized to your specific needs.
- High resolution
- Accommodates differently shaped products
- Full data traceability and integrity
- Document results in compliance with FDA 21 CFR Part 11 & EU GMP Annex 11, USP Chapter 41
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Checkweigh for Error-Proof Packaging
The Cubis® II Analytical and Cubis® II Precision Balances offer completely digital workflow management while supporting requirements for 21 CFR part 11 and EU Annex 11 compliance. A stand-alone solution for advanced user management, audit trail, electronic signature and safe data transfer prevent data manipulation.
Benefit from easy setup and simple maintenance and weigh products with conveniently customized sample holders. On-board QApps guide you through weighing processes, increase measurement accuracy, precision and process safety. The Average Weight control QApp checks if a sample weight is within a specified tolerance.
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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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Your Global Life-Cycle Service Partner
Instrument Service
Ensuring Compliance, Reproducibility and Reliability of Your Results
With our comprehensive range of technical services we support you in regulated and non-regulated labs to ensure regulatory compliance and the highest accuracy of your analytical results. With our certified and accredited services we guarantee the longevity of your equipment and reduce equipment downtime to limit production losses.
We understand the challenges you face as you strive for compliant, reliable, and accurate laboratory data.
We help you to obtain faster and constantly reproducible results with:
- Installation
- System qualification (IQ|OQ)
- Calibration services and certificates
- Preventive maintenance
- Service contracts
- User training