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  4. Spallation: what is it and why you should care about it?

Spallation: what is it and why you should care about it?

February 04th, 2021

Authors:   Charles Golub – Market Development Manager – Saint-Gobain Medical Components

                   Heidi Lennon -  Senior Research Engineer – Saint-Gobain R&D - Life Sciences

Peristaltic pumping over compresses the tube in order to form the seal that enables positive displacement of a liquid.  This over compression is referred to as percent occlusion. The occlusion required for peristaltic pumping causes the polymeric material to be exposed to a shear-compression force. Some materials do not perform well under shear and can form micro defects resulting in portions of the tube to come off in the fluid path and/or on the roller assembly. The external spallation can sometimes be confused for a grease or wax like build-up on the pump roller and housing.  A critical consideration that is understated is that the rate of spallation generation as well as the size particulates can vary greatly even within the same family of materials. This means that not all PVC’s will have the same spallation profiles, and the same is true for silicones.

Peristaltic pumping will always have some level of spallation, but it is important to understand the size and amount of spallation that is critical in your specific application.  In some pharmaceutical applications, smaller particles can affect the drugs manufactured, but larger particles can often be easily filtered out.  However, in many medical procedures, larger particles can be more critical since the smaller particles pose less of a threat towards the occurrence of an adverse health event. 

Spallation within medical procedures have been widely studied, but most of the literature published only looks at material classes, not at factors within each material family.  In looking at silicone families there are many different formulations that change things like: durometer, crosslink density, modulus, and even catalyst systems used, all of which will affect how a tube spallates. PVC formulations can be drastically different based on plasticizers used, stabilizers, and types of PVC resins; each of which will result in changes in how they behave. There are so many factors in material formulations that can impact how they wear that for pump manufacturers it is important to partner with a tube manufacturer who has an understanding of this and can work to provide technical support.

If you are looking only at material families for your spallation profile, you may be missing a unique opportunity to balance the pump performance you want with the spallation profile that is critical to your application. Saint-Gobain specializes in formulating solutions to meet your application needs, and if you are interested in having us investigate spallation for your specific application please Contact Us.

Charles Golub - Market Development Manager for Saint-Gobain Medical Components

Charles Golub is the Market Development Manager for Saint-Gobain Medical Components focusing on finding the unmet needs of future customers and providing them with Saint-Gobain’s creative solutions.  Prior to joining the medical marketing team, he spent 12 years in Research and Development and has an expertise in bringing innovative solutions to market. He has technical expertise in polymer materials and blends as well as analytical methods of analyzing them and he holds over a dozen patents.

Heidi Lennon - Senior Research Engineer - Saint-Gobain Life Sciences

Heidi Lennon is a Senior Research Engineer in the Life Sciences group for Saint-Gobain R&D focusing on biopharmaceutical applications. She has spent 14 years specializing in silicone formulations and application testing.  Her current research is specific to silicone tubing in Final Fill drug manufacturing.

About Saint-Gobain

Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in so many industrial applications.

 

Saint-Gobain Performance Plastics' group of businesses gather solutions to save energy, provide protection, improve comfort and sustain the environment for a variety of markets.

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Saint-Gobain’s medical products are distributed exclusively to medical device manufacturers for use in the manufacture, assembly or distribution of their medical devices. Saint-Gobain cannot authorize the sale of its medical products directly to device user facilities (e.g. hospitals, surgery centers, nursing home, clinics, etc.), nor directly to end users (e.g. patients, patients’ caregiver, prescribing physician, nurse, pharmacist, etc.), including distributors serving device user facilities and end users directly. In accordance with every jurisdiction globally, Saint-Gobain’s customers are responsible for determining that any medical device they manufacture and market that incorporates a Saint-Gobain’s medical product, is compliant with each country-specific medical device regulations and has received proper country-specific clearance, certification or registration authorizing the sale of this medical device.


Saint-Gobain’s medical products offer covers:
- Medical Components [21 CFR 820.3(c)], intended for processing or use in the manufacture or assembly of medical devices before the finished medical device is packaged/labeled; Medical Components are intended to be included as part of the finished, packaged, and labeled device [21CFR820.3(c)].
- Finished Devices [21CFR820.3(l)] made on behalf of medical device manufacturers [21 CFR 807.20(a)(2)] under contract-manufacturing agreement. In accordance with the United States’ jurisdiction, Saint-Gobain complies with the FDA’s requirements for contract manufacturers of finished devices.

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