Nelipak Healthcare Packaging Sealing Machinery Chosen for ...
Establishment Labs ultimately decided to replace its existing sealing equipment with Nelipak’s NX-T1 machines. The company now uses two of Nelipak’s sealing machines within a Class VII clean room just prior to sterilizing the implants in their primary package. The Results.
Sealing machinery proves critical for implant packaging
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.
Sealing Machinery Proves Critical for Implant Packaging
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.
Medical packaging with Makrofol® helps to protect breast implants
Makrofol® medical grade film: clear, tough, sterile, and rigid packaging for breast implants. Breast implants require rigid packaging that is transparent, exceptionally impact-resistant and highly sterile.
Implant Packaging Solutions - UPPI
UPPI’s implant packaging solutions will exceed your need for a package that surpasses your sterility specifications, product protection and ease of use.
What You Need to Know About the New FDA Breast Implant ...
ABCS surgeons are in favor of the FDA’s efforts to ensure patients have the information they need to make informed decisions regarding implant-based breast augmentation. Breast implant manufacturers have until the end of November 2021 to comply with these new requirements.
‘Black Box’ Warning on Breast Implants: What It Means | RUSH
The U.S. Food and Drug Administration requires some drugs and medical devices to carry black box warnings to alert health care professionals and consumers about serious risks associated with the products. As of last month, the FDA requires saline-filled and silicone gel-filled breast implants to include these warnings.
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.
Breast implants: US regulator issues “black box” warning and ...
The US Food and Drug Administration has placed a black box warning—its highest level of caution—on breast implant packaging, and it now requires manufacturers and surgeons to use a checklist to ensure that patients make informed decisions about using the devices. 1
High-value breast implants demand high standards in packaging
A breast implant packaging solution must be able to cope with high-temperature autoclave steam sterilization that removes all residues. It must also be resistant to impacts and possess a transparency that allows for careful optical inspection of the implant prior to unpacking.