The ABCs of manufacturing elastomer medical gaskets

Written by Scott Kelley on February 1, 2016. Posted in Gadget

Elastomer gaskets are mostly used within the engineering and pharmaceutical industry for infusion and injection systems. Their main role is to guarantee the integrity of the medication in primary packaging. Unlike other materials, silicone can withstand lower temperatures and implicitly does not compromise flexibility. Their permeability and flexibility are what ultimately makes them so uniquely suitable for the medical industry. Besides primary packaging, elastomer gaskets can be used for a number of applications, such as basic equipment and even medical devices that are implanted into the patient. Elastomer medical gaskets are capable of meeting a variety of needs and for this reason gasket manufacturers have to constantly adapt their products to different environments. More information about the diverse applications of medical gaskets is available at, but the present article will focus mainly on discussing the fundamentals of the manufacturing process.

The material groups

Elastomer medical gaskets are broadly divided into three categories according to the material:  pharmaceutical rubber, which is actually the most common, silicone and TPE or thermoplastic elastomer. All of these groups have both strengths and weaknesses taking into consideration that elastomer gaskets used for injection and infusion systems have very high requirements. As mentioned before, elastomer gaskets are the most widespread because they offer a very high level of flexibility for medical devices, but more importantly the silicone of the gaskets ensures that the devices are protected against damage from heavy use. Another reason why silicone is mostly used in the medical industry is that it provides protection against electric emissions.

Meeting product-specific requirements

It seems that silicone formulations present the best results when it comes to extraction methods and extraction media. Unlike pharmaceutical rubber and TPE formulations, silicone does not shift. In addition to this, silicone does not trigger allergy symptoms in patients. This is extremely important taking into consideration that about 2 % of the population who has frequent contact with latex are affected by allergy. The good results offered by silicone formulations are attributed to the low number of components, but more importantly to the manufacturing process.

The production process

Pharmaceutical rubber is generally obtained from natural material, but if this is not possible synthetic rubber works just as well. The production process itself takes place outside the clean room and implies harvesting the rubber, preparing it and of course processing it into a finished product. On the other hand, the silicone injection process begins with shaping the gasket element. When it comes to finally incorporating the finished product into the injection or system, it is necessary to ensure that the seal is tight enough. Therefore, seal tightness is tested to make sure that it will withstand environmental conditions.