Sealing solutions are a vital part of nearly every industrial application but this is more important in those applications within the medical and pharmaceutical industries. Original Equipment Manufacturers (OEM) have the responsibility of ensuring that their products meet minimal requirements and so they offer quality and assurance when reducing the risk of cross-contamination.

Aside from keeping contamination levels low, sealing in the medical industry must also complement the mechanical performance and chemical resistance. Therefore, OEMs, should consider certain attributes when choosing a seal manufacturer.

Elastomer Materials

Sealing in the medical industry must be able to show that it is resistant to harmful and toxic materials. They must also be able to handle a wide range of process media, potent active pharmaceutical ingredients and rigorous cleaning routines.

There might be certain qualities required of the elastomeric material, depending on the medical application. Therefore, it is important to choose a seal manufacturer that offers a wide range of materials.

To guarantee chemical resistance, OEMs must prove that all of their medical sealing is manufactured using the highest-quality and highest-performing elastomers. Examples of these elastomer materials that are suitable for medical applications include perfluoroelastomers which are suitable for sealing applications where chemical resistance and high-temperature performance are crucial. Metal detectable elastomers are ideal for containment and controlling contamination.

Across industries, international standards show the quality in the material of a component. Therefore, when choosing sealing components that consist of high-quality, compliant materials you should look for FDA Approval as well as USP Class VI.

To ensure that OEMs adhere to the requirements associated with low contamination levels in medical sealing, they should choose sealing solutions that provide a range of services and engineering capabilities. One of the most significant for both medical and pharmaceutical application is cleanroom manufacturing.

Cleanrooms offer an exceptionally clean environment whereby manufacturers can examine their products, allowing them to ensure that every component that leaves their facility meets all quality standards and contamination levels.

Manufacturers will make and supply sealing solutions for a range of applications that are developed for human consumption which is not just in the medical or pharmaceutical industries but also dairy and food. Therefore, they should be able to demonstrate compliance with the appropriate governing standards that are put in place by the International Standards Organisation.

Contact the NES Sales Team (sales@nes-ips.com) to discuss your Medical and Pharmaceutical sealing needs