Raw Material Testing for Safe Implants
Confidence in Raw Material Right from the Start
Final product quality depends on the quality of your raw materials. To prevent device defects and impairment of patient safety, your raw materials must be stable and safe for use. Consequently, raw materials are subject to stringent testing following strict rules according to ISO, USP and EMD.
Check titanium density, analyze moisture of plastics, characterize ceramics and cements in terms of leachables and extractables, test microbial burden of synthetic bone substitutes or define particulate matter of packaging paper. Sartorius solutions help characterize your raw materials to guarantee the specified density and moisture as well as toxicological and microbiological safety.
Medical Devices - General Process Steps
Raw Material Testing Applications for Implants
With the following applications, we are committed to providing you the products you need to characterize and control your raw material:
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
Confirm Purity of Raw 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.
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. Even the smallest deviations can be captured by moisture analyzers.
Sartorius offers robust and reliable solutions to 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
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.
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
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.
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
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.
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
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.
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.