In-Process Control for Implants
Monitor and Control Production Processes
In-process control (IPC) tests are performed at regular intervals to ensure product quality and specifications are met at all stages of production. Continuous testing helps detect manufacturing quality drift and triggers corrective actions on time. Receive assurance throughout the production process.
Sartorius’ solutions support your environmental, contamination and in-process controls to ensure conformity to controlled specifications. Test calcium phosphate materials for moisture content or particulate matter of polymer-based tissues. Check sterility of cochlear implants or perform a weighing step to validate the coating of an interposition implant.
Medical Devices - General Process Steps
In-Process Control Applications for Drug Delivery Systems
With the following applications, we are committed to providing you the products you need to optimize parameters or detect potential contamination at different stages of your process:
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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Determine Moisture Contents Within Minutes
Every material processed during production needs a specific and constant moisture content for optimal processing and functionality of the final product. Even the smallest deviations can be captured by moisture analyzers.
Sartorius offers robust and reliable solutions so you can accurately detect and document lowest moisture contents quickly and easily within your routine applications:
- Measure minimum moisture content down to 0.005 %
- Process up to 4 samples simultaneously
- Achieve highest precision, even for very dry samples
- Compliant to ASTM Standard D6980, ISO 868-7 Annex E
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Economic and Reliable Moisture Content Analysis
Mark 3 HP Moisture Analyzer is the genuine alternative to Karl-Fisher titration because it is easy to use and operates without the need for harmful chemicals. A high-resolution weighing system and special design makes Mark3 HP the perfect solution for precisely analyzing the moisture content of even very dry samples.
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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 nanomaterials. Prior to evaluating reference values like conjugation or encapsulation efficiency, zeta potential and size distribution, a successful purification and concentration of the suspension or dispersion is essential. However, typical separation methods like size-exclusion chromatography and diafiltration require extensive, costly and time-consuming manual handling and subsequent concentration steps.
Sartorius‘ Ultrafiltration Solution moves you one step ahead:
- Perform purification and concentration steps simultaneously and reduce 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) is the fastest RC centrifugal concentrator on the market, providing the best possible recoveries in combination with the Turbo PES. Choose between RC and PES (Polyethersulfone) membranes, whichever is best suited to your molecular target. Ensure highest recoveries in the fastest possible time!
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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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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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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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Optimize Production Processes
Every production process follows a strict set of rules. If those rules are broken, you need to know –the earlier, the better. SIMCA® -online monitors your processes in real-time for a continuous snapshot of operations.
Identify when set parameters change, fix them before they affect production and keep quality consistent. With this level of control, you can maximize efficiency and minimize costs. Enjoy the confidence of high quality in your product and a real boost to your business growth.
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SIMCA®-online
SIMCA®-online monitors your production processes in real-time for a continuous snapshot of operations. Our proprietary multivariate prediction technology gives you early warning of process anomalies that will affect the product. With this real-time process intelligence, your production team can proactively drive the best possible outcomes. And that means you can ensure consistent product quality, maximize productivity and prevent costly re-work or scrapping.
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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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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.