Choosing medical device seals

Medical & pharmaceutical original equipment manufacturers (OEMs) must ensure products surpass minimal requirements, offering quality and assurance against cross contamination and the risk of medical environments.

Aside from low contamination levels, successful medical sealing must also demonstrate mechanical performance and chemical resistance. Finding sealing suppliers that can meet those standards is critical.

Whether a medical application requires diaphragms, O-rings, gaskets, lip seals, or custom parts, the right sealing solution expert will help OEMs identify the key elements to consider in medical seals.

Elastomers

Medical sealing must demonstrate resistance to harmful and toxic chemicals – withstanding process media, potent active pharmaceutical ingredients (APIs), and aggressive cleaning regimes.

Depending on the medical application, certain qualities may be required of a seal’s elastomer, so it’s important to choose a sealing manufacturer with a variety of available materials.

To ensure chemical resistance, OEMs must also certify that their medical sealing is manufactured from the highest performing elastomers and the highest qualities.

Novotema engineers use specially-developed elastomer materials manufactured by sister company, Precision Polymer Engineering, with properties suitable for medical sealing applications:

Perlast – Perfluoroelastomers for sealing applications requiring chemical resistance, high temperature performance
Detectaseal – Metal detectable elastomers for containment, contamination control

Quality assurance

International standards assure quality in a component’s material. When selecting sealing components look for:

• Food & Drug Administration (FDA) approval
• United States Pharmacopeia (USP) Class VI approval

In addition to material compliance, look for partners that maintain full batch traceability throughout the entire manufacturing process with the availability of BS EN ISO 10204 certification.

Cleanroom manufacturing

For low contamination levels in medical sealing, OEMs should opt for sealing solutions that offer a wide range of services and engineering capabilities. Perhaps the most significant for medical applications – cleanroom manufacturing – allows manufactures to closely examine products to ensure that each component leaves the facility without compromising quality standards, including contamination levels.

It is imperative that a manufacturer and supplier of sealing solutions demonstrate compliance with appropriate governing standards set by the International Standards Organization (ISO).