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Business Wire
3 days ago
- Business
- Business Wire
Gore Launches 0.5 mL Silicone-Free GORE® IMPROJECT® Plunger for Ophthalmic Pre-Filled Syringes
NEWARK, Del.--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. ('Gore'), a global materials science company, recently announced the commercial launch of the 0.5 mL silicone-free* GORE® IMPROJECT® Syringe Plunger within its PharmBIO business. The new offering is specially designed for prefilled syringes used in various applications, including ophthalmic intravitreal injections, and complements the GORE IMPROJECT 1 mLL plunger which Gore launched in mid-2018. Gore's 0.5mL plunger, in combination with a silicone-free glass or advanced polymer syringe barrel, enables pharmaceutical companies to achieve what they've been asking for. To reduce risk associated with silicone by enabling its removal from the syringe. Share Conventional pre-filled syringe systems use silicone to provide a seal and act as a lubricant between the barrel and the plunger. However, peer reviewed literature highlights various problems with silicone including elevated subvisible particulate levels, silicone accumulation in the eye resulting in floaters, silicone-induced protein aggregation resulting in immunological responses, and ocular inflammation and increased intraocular pressure (IOP). In addition, silicone-containing syringes have been associated with particle count increases and fatty acid creation over time. The new plunger enabled syringe systems to achieve particulate levels below the limits of the USP<789> subvisible particle standard in testing performed. The plunger is capable of being terminally sterilized and has been shown to provide suitable break loose and glide force (BL/GF) and CCI performance when used in combination with appropriate syringe components and commercial fill and finish processes. 'Gore's 0.5mL plunger, in combination with a silicone-free glass or advanced polymer syringe barrel, enables pharmaceutical companies to achieve what they've been asking for. To reduce risk associated with silicone by enabling its removal from the syringe plunger and barrel,' emphasized Gore Syringe Business Leader, Emily Oliver. To develop this new product Gore worked closely not only with pharma companies, but also CMOs, terminal sterilization companies, machine companies that design equipment for fill operations, and leading syringe barrel suppliers to bring forth the 0.5 mL silicone-free GORE IMPROJECT Plunger for pre-filled syringes. 'We involved key partners to ensure the product meets the needs of stakeholders throughout the value chain including rigorous fill & finish requirements. This is a breakthrough solution for the industry and was designed with the goal of improving patients' lives,' highlights Russ Hornung, Gore Business Development Manager. The GORE IMPROJECT Plunger may enable today's more challenging ophthalmic injections without the need to introduce silicone oil, cross-linked silicone or resin enhanced silicone. With increasing needs for precise, low-volume injections in ophthalmology, gene therapy, and pediatric care, Gore's 0.5 mL prefilled syringe plunger offers a new alternative. Designed for silicone sensitive applications, this innovation underscores Gore's commitment to enhancing patient outcomes and to driving growth in the evolving injectable therapeutics market. PharmBIO enables life improving therapies of our customers through our leading products and commercial capability. In a highly regulated industry marked by economic pressures and drug development and processing challenges, Gore provides technology-driven products and process components designed for safety, efficiency, reliability and productivity. Gore PharmBIO is focused on satisfying the evolving product, regulatory and quality needs of medical device manufacturers, pharmaceutical and biopharmaceutical customers. The products in the Gore PharmBIO portfolio are tested and manufactured under our stringent quality system. W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world's highest peaks to the inner workings of the human body. With approximately 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $5 billion.
Yahoo
13-02-2025
- Business
- Yahoo
Lawsuit Accuses Gore-Tex Maker of "Greenwashing" and Harmful Chemical Use
A law firm has filed a class-action lawsuit against W.L. Gore & Associates — the manufacturers of Gore-Tex — for allegedly misleading consumers about its sustainability and environmental practices while continuing the use of products that contain harmful perfluoroalkyl and polyfluoroalkyl substances (PFAS), also known as 'forever chemicals.'Skiers will be immediately familiar with Gore-Tex, which is the waterproof and breathable fabric membrane that appears in higher-end snow jackets and containing Gore-Tex have become the gold standard for slopeside waterproofing, but they've also drawn concern for their historical use of long-lasting substances break down slowly over time and, according to the Environmental Protection Agency (EPA), have been found in water, air, and human blood due to their widespread industrial humans, exposure to PFAS may lead to several conditions, including negative reproductive effects, certain cancers, and interference with bodily hormones, the EPA reports. The recognition of the PFAS problem has prompted some state bans on clothing containing the substance, and W.L. Gore & Associates now offers a PFAS-free expanded polyethylene (ePE) ePE membrane, according to Gore-Tex Brand, also has a smaller carbon output than its predecessors (Gore-Tex Brand, via fine-print on its website, clarifies that the ePE membrane is 'made without intentionally added [PFAS]; may contain trace amounts').But Hagens Berman, the firm responsible for suing W.L. Gore & Associates, claims the ePE membrane only appears in 'next-generation' products and that the company is still using PFAS while conducting a greenwashing campaign through its marketing and hang tags.'By consistently touting its environmentally friendly products, Gore was under a duty to disclose to Plaintiffs and the other Class members the true character, quality, and nature of the PFAS utilized in its products, including the environmental impact and health risks,' the Hagens Berman complaint reads. In a statement shared with Gear Junkie, W.L. Gore & Associates wrote that it "stands behind its representations, statements and advertisements regarding our commitment to environmental responsibility as well as the performance and safety of our GORE-TEX products.'The class-action lawsuit follows another similar case involving Maryland, which, in December, sued W.L. Gore & Associates for allegedly polluting the environment around 13 of its Elkton-area facilities with the Maryland lawsuit, spokesperson Donna Leinwand Leger told the Associated Press that the company was 'surprised by the Maryland Attorney General's decision to initiate legal action, particularly in light of our proactive and intensive engagement with state regulators over the past two years.'Be the first to read breaking ski news with POWDER. Subscribe to our newsletter and stay connected with the latest happenings in the world of skiing. From ski resort news to profiles of the world's best skiers, we are committed to keeping you informed.
Yahoo
13-02-2025
- Business
- Yahoo
Class Action Lawsuit Filed Against Makers of Gore-Tex
A class action lawsuit has been filed against the makers of Steve Berman and Catherine Gannon have filed a class action, consumer rights, environmental litigation suit in the U.S. District Court for the Eastern District of Washington. The case was filed in court on February 11, 2025, and alleges that W.L. Gore & Associates knowingly sold products that contained forever chemicals, otherwise known as PFAS or perfluoroalkyl and polyfluoroalkyl substances.'Gore has allegedly continued to use these harmful chemicals in its outdoor gear while also seeking to conceal the harms of its use from the public through a greenwashing campaign,' the complaint states. 'Gore promised consumers it was 'Committed to Sustainability' and 'Environmentally Sound' and that its laminates were 'PFC* Free' and reflected 'Responsible Performance' all while continuing to use environmentally harmful PFAS in its manufacturing process.'The suit also alleges that Gore failed to disclose to its consumers that Gore-Tex fabric sheds PFAS into the environment and water supply during use. Those wishing to join the lawsuit should contact Hagens Berman Sabol Shapiro LLP. Gore-Tex is a breathable waterproofing agent that is used by companies across the outdoor industry and beyond. It can be found in gloves, hats, jackets, and outdoor industry has relied on Gore-Tex as its most breathable option for waterproofing for years. In 2021, it was announced that a new PFAS-free version of its Gore-Tex membrane had been created. The lawsuit alleges that the company is still selling goods with the previous chemical makeup, however, and said that the company has relied on 'greenwashing tactics' to market and sell its product to customers.'Gore claims its products represent 'Responsible Performance,' and 'Environmentally Sound' products, which attorneys call empty of January 2025, PFAS-based waterproofing is banned from apparel for sale in both California and New York, according to the New York Times. Theresa McKenney, director of sustainability at Nemo, told the NYT that PFAS chemicals are cheap and perform well, which has made it difficult for the industry to transition away from them on their own. Wearing PFAS gear is unlikely to harm the user, but the harm comes when those chemicals run off of the outerwear and seep into the soil, water, and air, according to Arlene Blum, a biophysical chemist at University of California Berkeley.
Yahoo
30-01-2025
- Health
- Yahoo
Maryland sues manufacturer after making disturbing discovery about the materials used: 'A toxic legacy for generations to come'
When you think of Gore-Tex, you may think of waterproof items like raincoats and outdoor gear. What you might not know is that the chemicals used to make it are harmful, and Maryland is suing W.L. Gore & Associates, the producer of this material, to hold it accountable for the damage the production of Gore-Tex has caused. According to the complaint filed in December "alleges the company polluted the air and water around its facilities with per- and polyfluoroalkyl substances, jeopardizing the health of surrounding communities while raking in profits." The lawsuit says that the company's leaders didn't warn Maryland residents about the risks of living near these facilities in order to avoid liability. It states the company has left "a toxic legacy for generations to come." This isn't the first lawsuit against Gore. A class action suit in 2023 required the company to pay for medical bills, damages, and water filtration systems due to the pollution in Cecil County that happened over decades. "It is unacceptable for any company to knowingly contaminate our drinking water with these toxins, putting Marylanders at risk of severe health conditions," said Maryland Attorney General Anthony Brown. Gore was surprised by the state's lawsuit because of the work it had done to make up for the problems caused. Company spokesperson Donna Leinwand Leger said it had been in "proactive and intensive engagement with state regulators over the past two years." The complaint also demonstrates the links between DuPont and Gore, with Wilbert Gore leaving DuPont in 1958 to start his own company. The suit claims that DuPont has been aware of the adverse health effects since 1961. How often do you worry about toxic chemicals getting into your home? Always Often Sometimes Never Click your choice to see results and speak your mind. Per- and polyfluoroalkyl substances are also known as PFAS or forever chemicals. The Environmental Protection Agency has stated that these chemicals have been used since the 1940s because of their useful properties. Unfortunately, they break down slowly and accumulate in the human body, which is part of the reason they are so harmful. Studies have discovered several adverse health effects that forever chemicals have on humans, with exposure linked to decreased fertility, cancer, developmental issues, and a compromised immune system. While Gore may be trying to do something about the harmful effects, Philip Federico, an attorney representing plaintiffs in the class action and other lawsuits against Gore, said it's "too little, much too late." He added: "It's typical corporate environmental contamination. They're in no hurry to fix the problem." Many companies pretend to take environmental causes seriously while profiting from the harm — a practice known as greenwashing. Many lawsuits have been brought against companies like Gore. Their success varies, but in 2023, 3M announced it would stop making PFAS. In 2023, Congress also proposed the Break Free From Plastic Pollution Act, an extension to bills from 2020 and 2021. It has yet to be voted on. You can use your voice to urge your representatives to take action on the bill. Join our free newsletter for good news and useful tips, and don't miss this cool list of easy ways to help yourself while helping the planet.
