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The Importance of Accurately Measuring the Moisture Content of Plastic Resin in the Molding Process of Medical Devices

The Importance of Accurately Measuring the Moisture Content of Plastic Resin in the Molding Process of Medical Devices
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The Importance of Accurately Measuring the Moisture Content of Plastic Resin in the Molding Process of Medical Devices - 1

Application Note October, 2019 Keywords: Omnimark, Mark 3, Moisture analyzer for medical devices, plastic moisture analysis, ASTM Moisture Plastic resins standard, Moisture testing plastic resin The Importance of Accurately Measuring the Moisture Content of Plastic Resin in the Molding Process of Medical Devices King Snyder1, Dennis Acord1, Evelyn Marschall2 1. Sales Specialist, Moisture Products, Sartorius USA, 2. Product Manager, Moisture Analysis, Sartorius Lab Instruments, Germany Abstract 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 (KF) titration as the applicable standard method. However, a KF titrator is expensive, and testing for moisture requires the use of toxic chemicals so that it can only be used by a trained chemist. A loss-on-drying (LOD) moisture analyzer can be an alternate method for testing moisture in plastic resin, but must be correlated to the KF titration as the measurement principles of both differ. Herein, we show that the Sartorius Mark 3 High Performance Moisture Analyzer correlates well with KF titration standards for a number of plastic resins commonly used in medical device manufacture. The Mark 3 is a recognized ASTM 6980 standard method for testing the moisture content of plastic resin that is a good return on investment for medical device manufacturers because it is easy to use, has low maintenance costs, reduces the risk of rejected parts and customer dissatisfaction, and reduces energy consumption. Find out more: www.sartorius.com

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The Importance of Accurately Measuring the Moisture Content of Plastic Resin in the Molding Process of Medical Devices - 2

Introduction One important variable to monitor and control for during the production of plastic medical device parts is moisture content. Resin manufacturers provide material specification sheets detailing the maximum moisture specification, or the maximum allowable ratio of water in the resin before molding or extrusion. Depending on the resin, maximum moisture specification can vary from 0.20 % to as low as 0.005 % moisture. The manufacturer’s data sheet also provides general guidelines on drying temperature and time for the resin before molding. For instance, a typical drying...

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The Importance of Accurately Measuring the Moisture Content of Plastic Resin in the Molding Process of Medical Devices - 3

Conclusions performed by a trained chemist, using appropriate safety precautions. Therefore, most manufacturers prefer to use alternative methods for moisture testing. Fortunately, 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...

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The Importance of Accurately Measuring the Moisture Content of Plastic Resin in the Molding Process of Medical Devices - 4

Germany Sartorius Lab Instruments GmbH & Co. KG Otto-Brenner-Strasse 20 37079 Goettingen Phone +49 551 308 0 For further contacts, visit Specifications subject to change without notice. Copyright Sartorius Lab Instruments GmbH & Co. KG. Status: 09 | 2020

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