Final Release Testing for Drug Delivery Systems
Every classified medical device, whether auto-injector, insulin pump, nasal spray or transdermal patch, must meet relevant safety, efficacy and quality standards, such as ISO 10993 or 11607. Every lot requires tests to ensure each implant is free of contaminants. Error-free assembly, conforming to controlled tolerances, is necessary to avoid malfunction.
Check density, moisture, dose accuracy as well as biocompatibility and bioburden. Identify early irregularities, prevent device defects and ensure your finished products are stable and safe for use. Sartorius solutions support your final release testing to demonstrate compliance with regulatory guidelines.
Medical Devices - General Process Steps
Final Release Testing Applications for Drug Delivery Systems
With the following applications, we are committed to providing you the products you need to validate your devices are safe for the patient and to guarantee the efficiency of the active ingredients:
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
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.
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
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.
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 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
Drug delivery system packaging must provide a secure barrier to preserve the product until use. To avoid microbial contamination, friction or oxidation, the influence of moisture on packaging material like nylon, plastic, paper or cardboard has to be tested. It is mandatory to capture even the smallest deviations in moisture for assuring the appearance and functionality of the final product.
Sartorius offers robust and reliable solutions, so you accurately detect and document moisture contents quickly and easily within your routine applications:
- Compliant to ASTM Standard D6980, ISO 868-7 Annex E
- Measure minimum moisture content down to 0.005 %
- Process up to 4 samples simultaneously
- Achieve highest precision, even for very dry samples
- Comply with EN 868 for sterile barrier systems
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.
Reliable Microbial Enumeration
Finished products must be free from microbial contamination to ensure consistent, reliable product quality and safety as per ISO 11737-1. Any undetected presence of microorganisms may cause unnecessary delays or product recalls. Prior to final sterilization and packaging, bioburden testing is carried out to determine the population of viable microorganisms on or in the product. Post sterilization, it can demonstrate the integrity of the sterilization process and sterility assurance during shelf life.
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
- Touch-free membrane transfer
Simplify Your Microbial Limits Testing Workflows
Single and multi-branch Microsart® Manifolds are easy to clean and rinse, provide reliable and reproducible results and are adaptable to various filter device formats to suit your individual needs.
To reduce the risk of secondary contamination, the Microsart® @filter combined with the 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. No liquid remains after filtration.
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
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.
Save Time and Improve Reproducibility
The biological risk of a drug delivery system is often directly linked to its surface properties. Assessing composition of materials and their ability to release extractables and leachables is standard to evaluate biocompatibility. FTIR, MS, ICP-MS and GC require robust, reliable sample preparation and streamlined workflows to ensure you get clean, reproducible, interference-free results.
Sartorius’ tailored equipment provides user-friendly sample prep tools for Chemical Characterization per ISO 10993-18. Time-saving solutions for preparing your samples, as well as analyzing content and purity, let you perform sample processing procedures with robustness and reliability.
- 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 & Arium® Pro UV produce ASTM Type 1 water for your preparation of buffers and sample dilutions. Minimize chemical ion interference and move TOC levels to a minimum to ensure consistent baselines, reduce ghost peaks and avoid background noises in chromatograms.
Benefit from automated preparation and documentation of 100% comparable standards with the Cubis® MSA Dosing System with Q-App Software. Documentation of test procedures compliant to CFR21 Part 11.
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.