Drug Delivery Systems for Safe, Effective Active Ingredient Monitoring
Competence in Quality Control - From Development to Production
Today’s healthcare relies on drug delivery systems like nasal spray, drug-eluting stents, autoinjectors, inhalers or Transdermal Drug Delivery System (TDDS) for the targeted delivery or controlled release of active ingredients. A balanced interplay between active compounds, packaging and administration devices for combination products is critical.
As a manufacturer, your task is aligning formulation requirements and patient/ user need with Quality-by-Design and production. MDR article 117 requirements for combination products and assessing dose accuracy by Ph. Eur. 2.9.27 or USP <905> must be embedded in your risk management strategy.
Stringent QC is a key factor for successful commercialization of drug delivery systems. It offers the potential to de-risk projects, increase success rates, significantly reduce costs, and accelerate time-to-market. Deviations or fluctuations can be detected in time to avoid higher production costs, downtimes, or product recalls.
Quality Control solutions from Sartorius help your products reach their full potential.
Explore the Process Steps for Ensuring Reliable Drug Delivery Systems QC
Medical Device Manufacturing Workflow
R&D and Process Development
Novel drug delivery systems are diverse but share one goal: accurate, precise, and reproducible delivery of therapy in a controlled manner. It all starts in the design and development phase.
Discover R&D and Process Development solutions for your application:
- Density Check of Solid Material & Liquids
- Nanoparticle Concentration
- Gravimetric Dose Accuracy Assessment
- Chemical Characterization - Biocompatibility
- Cytotoxicity - Biocompatibility
- Data Analytics
Raw Material Testing
The quality of the final product depends on the quality of the raw materials. To ensure device performance and patient safety, your raw materials must be stable and safe for use and meet stringent ISO, USP, EP, ChP, JP, and ARTG testing standards.
Discover the Raw Material Testing solutions for your application:
- Density Check of Solid Material & Liquids
- Moisture Determination of Raw Material
- Particulate Matter Analysis
- Chemical Characterization - Biocompatibility
- Microbial Water Testing & Bioburden
In-Process Control
In-process quality control tests are performed at regular intervals to verify product quality and specifications at every stage of production. Evaluate correct dose delivery for transdermal patches, auto-injectors, syringes, or nasal sprays. Test inhalers for moisture content or particulate matter before filling with the active drug. Check the sterility of drug-eluting stents or perform a weigh test to validate the antimicrobial coating of a catheter.
Discover the In-Process Control solution for your application:
- Check Coatings – Application of Correct Amounts
- Moisture Determination
- Nanoparticle Filtration of Liquids - Concentration – Detection
- Particulate Matter Analysis
- Dose Accuracy Assessment
- Continuous Microbial Air Monitoring
- Rinsing & Sterile Preparation
- Data Analytics
- Counting with Reference Weight
Final Release Testing
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. To avoid malfunction, tests are required to ensure each drug delivery system is free of contaminants or assembly errors and conforms to controlled tolerances.
Discover the Final Release Testing solutions for your application:
- Check Coatings Application
- Error-Proof Packaging
- Density Check of Solid Material & Liquids
- Moisture Determination of Packaging Material
- Microbial Testing: Bioburden & Sterility
- Gravimetric Dose Accuracy Assessment
- Chemical Characterization - Biocompatibility
Featured Products
Cubis® II Microbalance
Weighing by difference solutions are your best fit to verify coating systems have applied the exact amount of medical grade polymer or API.
Arium® Comfort II Ultrapure Water System
Sartorius Water Purification Systems provide ultrapure water for impurity-free and safe operation
Microsart® @filter
Membrane filtration solutions for standard microbial enumeration protocols facilitate accurate detection of potentially pathogenic or spoilage microorganisms.
Featured Resources
Frequently Asked Questions
An ultra-microbalance with a scale interval of 0.1 μg and maximum weighing capacity offers a resolution in 21 million steps. In weight units, this is fine enough to measure a weight of 1 g of a total mass of 21 tons.
This high resolution provides ideal support for measuring the smallest sample weights below 1 mg within one part per thousand.
Read the White Paper: The Perfect Microbalance for Every Application
ASTM 6980 states that a loss-on-drying (LOD) moisture analyzer can be an alternate method for testing moisture in plastic resin. LOD moisture analyzers measure weight loss to determine the moisture content of a sample.
Because they cannot distinguish between weight loss from water and weight loss from other volatiles being driven off by heating the sample, ASTM 6980 requires that test methods on an LOD analyzer are developed to correlate to the ASTM 6980 Karl Fischer titration standard.
Read the Application Note: The Importance of Accurately Measuring the Moisture Content of Plastic Resin in the Molding Process of Medical Devices
Watch our bubble point video and see how easy you can verify the filters integrity.
Nanotechnological solutions are commonly combined with Medical Devices to help drugs reach their target. Tangential flow filtration (TFF) enables simple diafiltration while maintaining a constant sample volume and can easily be placed under sonication to prevent aggregation.
Typically choose a MWCO 1/3 the size of the target molecule MW. Supplier options advertising 1/2 may have a pore matrix that is too “tight”, those advertising 1/6 may be too “loose”. Sartorius membranes have a porosity specified to offer the the best concentration values for all sample types, in combination with our widest range of membrane materials.
Explore Nanoparticles**
Professional training is a very good option to improve pipetting skills. Especially when working with viscous, volatile, or liquids with low surface tension proper technique will increase the quality of results significantly. Ask your pipette provider if they offer training courses.
In addition to being able to pipette more accurately and precisely, proper training can save you time and promotes ergonomical working habits.