In many ways, manufacturing a medical device is like cooking up a great meal. It starts with selecting the right ingredients (materials), then following a recipe (design) to put everything together in proper order.
Consider the gaskets in medical devices and equipment. Within this small component are several materials sandwiched together in a precise manner. In this article, we’ll look at the typical layers required to make this type of medical-grade gasket, as well as some important material considerations.
Medical gaskets in genderless aseptic connectors
Genderless aseptic connectors use identical ends instead of male and female ends. Two genderless connectors fit together to create a fluid-tight and sterile connection, even in a non-sterile environment. Compared to traditional gendered connectors, genderless aseptic connectors offer several benefits, including being easier to use, improving patient care, and reducing the risk of misconnection.
Layers and materials of medical gaskets
To achieve a high level of functionality, genderless aseptic connector gaskets are often made of at least six material layers.
Assembly release liner – In most cases, the gasket is manufactured separately from the rest of the connector. A release liner, typically made from polyester, protects the underlying adhesive layer. When the gasket is ready for assembly, the release liner is removed to expose the adhesive, which is then applied to the plastic body of the connector. The main consideration for this layer is easy, clean removability.
Differential adhesive for permanent bond – Differential adhesive is required when you’re bonding dissimilar substrates. For disposable aseptic connectors, one side of this layer is typically acrylic adhesive with permanent bonding strength for assembly, and the other is silicone adhesive to bond to the sealing material.
Sealing material – The most common sealing material for connectors (and many medical devices) is silicone. Silicone foam can be cut into virtually any shape, not just circles.
Differential adhesive for temporary bond – On the other side of the silicone foam is another layer of differential adhesive. However, this time you’ll usually want a low-tack removable adhesive to complement the silicone adhesive.
Removable membrane – A film, typically made from PET, covers the opening of the sealing material and is a key feature that helps the connector preserve sterility. After two genderless connectors are attached in a medical setting, the films (one of each connector) are pulled out. This exposes the openings of the gaskets (now adjoined), creating a water-tight seal and flow path. As an option, a sterilization indicator can be printed on the film so users can easily verify the component has undergone a sterilization method, such as gamma ray or steam.
Outside liner – A top liner is placed on the removable membrane. This layer helps with placement and can include printed graphics on the outside portion. Since the gasket will likely go through a sterilization process, key considerations for the liner materials are temperature resistance, durability, and autoclavability.
Manufacturing custom gaskets and seals
As you can see, there are numerous layers and considerations that go into making the gasket for a genderless aseptic connector. We should also mention that this is just the typical configuration – gaskets can be customized based on your application. But going back to the cooking analogy, it’s crucial that you get the ingredients perfect, which is one reason it’s beneficial to work with an advanced outsourced manufacturing partner.
At Tapecon, we have the materials expertise to help you select the optimal materials for your disposable aseptic connector. We’re also experienced and equipped to handle complex multi-layer components such as custom silicone foam gaskets. Talk to the Tapecon team about producing your medical device components in our FDA-approved facility in Buffalo, New York.
Let’s make something great
With over 100 years of manufacturing experience, Tapecon works with product teams to solve challenges, create products, and enhance lives. Learn more about our gasket and filtration componentsapplications.