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Sealing machinery proves critical for implant packaging

Patient safety is at the core for Establishment Labs, where packaging equipment and materials are vital to the company’s breast and body shaping implants.

Establishment Labs seals trays of breast implants on a Nelipak Healthcare Packaging NX-T1 machine.
Establishment Labs seals trays of breast implants on a Nelipak Healthcare Packaging NX-T1 machine.

The decision to surgically add or remove a breast implant is a deeply personal one that involves emotional and physical considerations, with safety a paramount factor. Establishment Labs understands that, incorporating patient safety, quality and control in its aesthetic technology product development and innovation.

Based in Costa Rica, Establishment Labs is a global, privately held, medical device and aesthetics company that designs, develops, manufactures, and markets a product portfolio consisting of advanced silicone-filled breast and body shaping implants. Its CE-marked Motiva Implants® employ ultra-high purity medical-grade silicone and are subject to strict quality assurance testing throughout the manufacturing process. The implants are regulated as Class III medical devices.

Downstream packaging machinery and materials serve essential functions, according to Salvador Dada, Establishment Labs’ Chief Operating Officer. In particular, he points to two new NX-T1 medical tray sealing machines from Nelipak Healthcare Packaging.

Establishment Labs began selling implants in late 2010, which are now sold in more than 50 countries worldwide. Dada says, “Our first two families of implants [represented] an improvement [over] current devices in the market. Our third generation is unique, responding to unmet market needs.”

In all, the company produces more than 400 different sizes and shapes of breast and body contour implants. These are sold to hospitals, clinics and plastic surgeons for aesthetic and reconstruction breast enhancement procedures. Dada says, “These are the most innovative and state-of-the-art breast implant in the market. And we have the lowest numbers of complications recorded in the market due to its unique features.”

Specifically, the implants use Puregraft®’s FDA-cleared and CE-Marked technology that provides plastic surgeons with purified fat for reinjection on the sterile field used in hospitals and clinics worldwide. Another feature employed is Divina®, a proprietary 3D imaging technology integrated in consultation and surgical planning to customize implants for aesthetics and reconstruction. All manufacturing facilities are fully compliant with both FDA and ISO applicable standards. (Watch a video of the company’s Motiva Implants® production process.)

Sterile barrier packaging

With 10 manufacturing locations across the U.S., Central America and Europe, Nelipak applies innovative design, development, manufacturing and packaging for implants, which require sterility to remain intact throughout their 5-year validated shelf life. Product must be kept at temperatures between 4°C and 40°C.

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