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NX-T1 Medical Tray Sealing Machines for Implant Packaging
Time: 2018-02-04
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. 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.
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 seals trays of breast implants on a Nelipak Healthcare Packaging NX-T1 machine.
Establishment Labs began selling implants in late 2010, which are now sold in more than 50 countries worldwide. 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. 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.
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. Although material specifications are considered proprietary, the implants are protected within a polycarbonate rigid tray with a zone-coated DuPont Tyvek® lidding, and a product label. Nelipak provides the trays while the Tyvek is sourced through Oliver Healthcare Packaging.
Before using the Nelipak NX equipment, Establishment Labs used sealing equipment from a different vendor. In searching for additional equipment, the company evaluated various suppliers, eventually visiting Nelipak’s Cranston, RI facility to “test drive” the NX-T1 tabletop tray and blister heat sealers. “The main reason for the switch was the technological features the Nelipak equipment provides,” explains Dada. “Specifically, the digital controls, the ability to upload the data into cloud-based systems, the one-piece flow configurability, the zone-seal feature, and the regulations Nelipak adheres to in building its machines.”
Establishment Labs uses two of the machines within a Class VII clean room just prior to sterilizing the implants in their primary package. The Nelipak machines are user-friendly, allow for easy parts changeover and require little maintenance. There is good spare part availability. The service is a highlight and the cost is acceptable. 
As the company increases production volumes, more equipment will be required—at least two new machines within the next 10 months, according to Dada. The ability to increase future production volume makes sense given the optimistic forecasts for the global implant market. According to a Persistence Market Research report, “Breast Implants Market: Global Industry Analysis and Forecast, 2016-2024,” the breast implant market will reach a value of over $1.48 billion by the end of 2024.
With its combination of Nelipak sealing machinery and sterile barrier materials, Establishment Labs is positioned to take advantage of the growing implant market, and maintain its focus on patient safety.
Source: Pack World