Moisture Analysis and Determination for Medical-Grade Plastics

Product Safety Means Patient Safety - Get Consistently High Quality Results Compliant to ASTM Standard D6980 with Smart Sartorius Moisture Analysis Solutions

Innovation in medical devices is often dependent on the development of the polymers and resins used in their manufacture; the inherent flexibility and low cost make polymers and resins the ideal material for many medical solutions, from stents, pacemakers, or catheters to prosthetic limbs and much more. 

Patient safety must come first; therefore, resins used for medical devices are subject to stringent analysis because the quality of the final product depends the quality of the raw materials. In particular, the moisture content and potential moisture absorption of the raw material has a significant impact on the appearance and functionality of the final product.

Consistent monitoring and quality control are critical success factors in Medical Device manufacturing. This starts in the design phase and remains critical during the processing of the resins through to the injection molding phase. To obtain high-quality end products, the moisture content of the resins used to create them must lie within narrow tolerances, being neither too moist, nor too dry; either situation would have a negative impact on the resulting product. Therefore, plastic resins require monitoring and control of moisture levels or moisture absorption before the injection molding process and during pre-drying processes, if such are used. 

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How to Accurately Measure the Moisture Content of Plastic Resin?

Moisture content is an important variable that must be monitored for and controlled during the production of plastic medical device parts. ASTM standard D6869 is the benchmark for measuring the moisture content of plastic resin, and stipulates the use of Karl Fischer titration as the applicable standard method. Herein, we show that the Sartorius Mark 3 High Performance Moisture Analyzer correlates well with Karl Fischer titration standards for a number of plastic resins commonly used in medical device manufacture.

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Smart Solutions to Determine Moisture Content in Polymers and Resins

Medical grade polymers can vary in their characteristics and hygroscopic properties, and so each type of polymer needs a specific moisture content for optimal processing. Typical plastics used for safe and effective medical solutions include: 

• Polysulfone | PS

• Polyethersulfone | PES

• Polyethylene PE

• Polyurethane | PU

• Polypropylene | PP

• Polyurethane | PUP

• Polycarbonate | PC

Even the smallest deviation in the specified moisture level may cause device defects and could compromise patient safety. Sartorius offers smart solutions and services to determine even the lowest moisture content in polymers and resins within minutes, offering technicians a simple workflow that guarantees reliable and accurate results and stable testing processes. We have decades of experience and in-depth knowledge on moisture content analysis of plastic resins and have optimized our instruments to meet our customers’ special needs. Our expertise and library of 30,000 settings for different plastic resins offer easy and reliable moisture analysis solutions for all your plastic raw materials. We can supply you with an instrument with customized settings for your plastic samples.

Mark3 HP Moisture Analyzer | The Choice of the Medical Device Industry

Sartorius Mark 3 HP is the perfect solution for plastic moisture content analysis in medical device manufacturing. The Mark 3 HP Moisture Analyzer operates on the principle of loss on drying. The instrument finalizes on a programmed rate of weight change compared to the actual initial weight of the sample over a programmed window of time, and it features a built-in temperature and weight calibration function to ensure advanced moisture analysis.

The Genuine Alternative to Karl-Fisher Titration

The Mark 3 HP is a flexible moisture analyzer system for labs and production facilities. Its optional modular add-ons provide the best solution for every measuring task. Its high-resolution weighing system and special design make the Mark3 HP the perfect solution for precisely analyzing the moisture content of even very dry samples. This feature makes Mark 3 a genuine alternative to Karl-Fisher titration because it is an easy-to-use, without using harmful chemicals. Learn more about the versatility of Mark 3 in plastic applications. 

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Discover the Benefits of Mark 3 HP Moisture Analyzer:

  • Economical and reliable alternative to the Karl-Fischer titration and drying oven methods
  • Intuitive operation – With a learning curve of a few minutes
  • Easy-to-use, single button operation 
  • Robust and fast; optimal for routine operation
  • Multi-module operation enables parallel measurements of up to 4 different samples on one single device
  • An extensive range of security settings guarantees reliable results and 100% traceability
  • The Mark 3 conforms to ASTM standard D6980

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Sample Testing Services - The Convenient and Reliable Way to Obtain Correct Results

Complex medical device production processes and products place high demands on fast, reliable, and highly precise moisture analysis. Moisture Analysis Individual is an innovative concept that exactly meets these requirements with the moisture analyzer Mark 3. Our application specialists support you to create a customized, reliable and traceable method with the highest possible comparability to your reference method. If needed, our application labs can support you further and use your sample for comparative measurements. Just start measuring – with the simple touch of a button.

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Datasheet: Mark 3 HP Moisture Analyzer — Modular Infrared Moisture Analyzer with Quartz Radiator

PDF | 384.5 KB

Datasheet: Mark 3 Moisture Analyzer — Application Examples — Plastic

PDF | 151.9 KB

Datasheet: Moisture Analysis Individual — The Convenient and Reliable Way to Obtain Correct Results

PDF | 467.8 KB

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