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FDA Investigates Failure-Prone Plastic Syringes Made in China
Agency recommends avoiding use of plastic syringes manufactured in China as it evaluates quality issues resulting in leakage and breakage.
FDA reported on Nov. 30 that it is evaluating plastic medical syringes made in China for potential device failures, such as leakage and breakage.
The agency said in a statement issued on Thursday that it has received information about quality issues associated with several China-based manufacturers of syringes. It is currently collecting and analyzing data on plastic syringes made in China that are used to inject or withdraw fluids into and from the body. The investigation does not involve glass or pre-filled syringes or those used for oral or topical applications, FDA noted.
The investigation was launched as FDA became aware of quality issues related to recent syringe recalls, medical device reports, and various complaints. “Quality issues reported have included leaks, breakage, and other problems after manufacturers made changes to the syringe dimensions. These quality issues may affect the performance and safety of the syringes including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps,” said FDA in the announcement.
While it conducts its evaluation, FDA recommends that Chinese-made syringes that fit this description not be used. “If you only have syringes manufactured in China, then continue to use them as needed until you are able to use alternative syringes and closely monitor for leaks, breakage, and other problems,” the agency added.
Medtech giant BD immediately followed up on the safety notice by posting a press release on its website stating that this does not apply to any of its syringes. “Essentially all plastic syringes BD provides to the US healthcare system are manufactured in the United States in Nebraska and Connecticut,” said BD Medication Delivery Solutions President Eric Borin. "BD . . . is ready to increase production to help supply those providers who currently purchase syringes impacted by the FDA communication,” he added.
Likewise, the world’s largest manufacturer of plastic insulin syringes, embecta, said that it manufactures all of its syringes at a facility in Nebraska and, therefore, is not affected by the FDA safety communication.
Resin Price Report: End-of-Year Discounts Begin to Appear
PP drops another penny, and it would not be surprising to see PE resin contracts peel off $0.03/lb, according to the PlasticsExchange.
By PlasticsToday Staff
Thanksgiving week was short but sweet at the PlasticsExchange trading desk. The spot resin market had a solid showing: Supplies continued to improve as a relatively heavy flow of polyethylene (PE) and polypropylene (PP) off-grade railcars materialized. Prime packaged resin remained scarce, however.
The resin clearinghouse reported that a limited number of buyer inquiries hit its spot marketplace the week of Nov. 20, but that most realistic offers met with success. Some deals were for normal monthly customer orders; others were for urgent truckload deliveries required for processing over the long holiday weekend. For last-minute orders, availability and quick service trumped price; buyers with more patience have been seeking super sharp prices to entice their purchase orders. Some sellers acquiesced and chased the low-ball bids to reduce inventories as the year comes to a close. PE producers have been lowering their export prices to stay competitive on the global market, as well, which has added to the bearish sentiment.
PE trading picks up
PE trading was a bit brighter than expected, as some processors sought ready-to-ship supplies ahead of the holiday. Prime PE prices at the PlasticsExchange trading desk held steady, although some nicely discounted railcars became available. The two recent force majeures have been lifted by Nova and CPChem; however, the market has not been flooded with material as producers, in general, appear to be cautious with reactor rates to prevent burdensome inventories from developing.
PE contracts roll flat, at best
Despite the average $0.03/lb price increase nominated for November, the market has lost its upward momentum and larger buyers have been clamoring for a decrease. PlasticsExchange analysts believe that PE contracts will roll flat, at best, and said they would not be surprised to actually see $0.03/lb peel off. Domestic demand has been rather poor in November, as resellers and processors have generally been reducing their resin positions, which is typical for the fourth quarter. Direct exports will remain robust through the end of the year, according to the PlasticsExchange, as North American producers enjoy a cost advantage compared to most of their international counterparts. Nevertheless, incremental export sales have slowed as buyers try to drive prices lower.
PP resin prices lose another cent
The PP market fared fairly well during the holiday-shortened week, reports the PlasticsExchange, as buyers picked away at offers that came with reduced pricing. Overall PP levels dipped another penny, led lower by easing feedstock costs.
Demand for PP copolymers has been solid — supply remains relatively scarce— while homopolymers, especially off-grade resins, have been plentiful.
PP processors had been limiting their volume purchases as they attempt to avoid peak pricing. Unless another round of polymer-grade propylene (PGP) disruptions come into play, this leg of the cycle, indeed, seems to have topped out in November. It also appears that PP producers have reacted quickly to the lackluster demand this month and cut operating rates further, which placed unneeded PGP back into the spot market, helping to cap the monomer rally.
Nonetheless, November PP contracts remain in position for a mild increase because of the cost spike earlier in the month. Any further upstream production issues could easily sway this market again, since PP inventories throughout the supply chain are still considered tight, notes the PlasticsExchange.
Read the full Market Update, including news about PGP pricing and energy futures, on the PlasticsExchange website.
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‘Robo-molded’ Fuel Tank Scores Product of the Year Award
The Association of Rotational Molders recognized the fuel tank and Gemstar’s robotic rotational molding technology, a precision process that reportedly achieves elevated levels of tolerance and design freedom for hollow products.
A specialized fuel tank manufactured using Robomold rotomolding technology has earned the Association of Rotational Molders (ARM) 2023 Product of the Year award. Gemstar Manufacturing’s fuel tank features an anti-spill funnel in the filler spout in order to comply with EPA guidelines, which was displayed in the entry sample via a cutaway that revealed the internal features of the tank.
The fuel tank employs Hostaform POM RF polyacetal resin from Celanese to deliver toughness and rigidity, temperature resistance, wear resistance, and low fuel permeation, while Gemstar’s Robomold robotic rotational molding technology provides precision repeatability necessary for highly specialized custom parts. Robomold technology is said to produce tighter tolerances, design flexibility, and high control compared with traditional rotational molding.
The EPA/CARB-compliant tank is molded in a precise process that allows for optimization of material and reduction of processing time by up to 50% compared to the industry average (27% for the fuel tank). A nearly endless array of fuel types can be accommodated, and the streamlined design is realized through a single-layer solution, contrary to other options on the market.
Robomold technology achieves high tolerances with precision-distributed heat and material control for consistent plastic part repeatability and optimized strength-to-weight ratios. The technology reportedly allows for design flexibility, including the ability to layer different compounds and coatings into finished parts. In-house tool design is also critical for controlled and focused heat to specific areas on the funnel feature, thereby achieving improved threading and accounting for changes in wall thickness.
Nestlé Puts Resources Into Plastics Recycling
The CPG giant is investing $8.8 million in the facility.
By PlasticsToday Staff
A new plastic recycling plant is set to open in Durham, North England, with a significant investment from Nestlé UK and Ireland.
Impact Recycling will open the new facility to process hard-to-recycle flexible plastics, typically used in food packaging, into pellets which can be used to make new flexible products such as postbags and refuse bags.
Nestlé will provide Impact Recycling with a £7 million ($8.8 million) loan to get its process off the ground, and with a grant from Innovate UK, the site is set to be operational in late summer 2024.
“I am thrilled to be joining forces with Impact Recycling and helping fund this new plant in Durham," said Sokhna Gueye, head of Packaging at Nestlé UK & Ireland. " At Nestlé, we are dedicated to ensuring our packaging can have multiple lives and doesn't end up as waste in landfill. Supporting innovative technologies like this is just one of the many steps we are taking towards achieving this goal."
The innovative process, known as Baffled Oscillation Separation System, or BOSS, sorts the waste plastics by spinning them in water, meaning that different materials either sink or float, depending on their density. This makes it easier to take the correct materials to be recycled.
When open, the site will have the capacity to take 25,000 tonnes of the plastic and produce the pellets, which can be used to replace virgin plastic films in construction and agriculture, as well as or to make bin bags. This means the facility has the potential to recycle more than the amount of flexible plastic packaging Nestlé UK and Ireland places on the market.
Packaging such as KitKat wrappers, Purina pet food pouches, Rowntree confectionery sharing bags, and Nestlé Cereal bags will be collected from major supermarket collection points so they can be recycled.
“We are delighted to partner with Nestle on this initiative to develop a 25,000-tonne commercial recycling plant for post-consumer flexible plastic. Without the funding from Nestlé this development would not have been possible, said David Walsh, CEO of Impact Recycling. “Through this funding, Nestlé demonstrates its unwavering commitment to innovation and the pursuit of sustainable solutions for plastic packaging.”
MORE WEEKLY NEWS
➡️ Single-Use Autoinjector Line Meets Sustainability Goals with Renewable Feedstock: The bio-based styrene acrylic co-polymer from Ineos Styrolution is used to manufacture the device housing.
♻️ Chemical Recycling Just Isn’t Feasible: From an energy perspective, breaking down plastics into their components to make the same plastics is fundamentally unsound.
🗞 Fiber-reinforced Polyamide for 3D Printing Boasts Low Moisture Absorption: Compounder Lehvoss partners with Evonik to develop compound that also addresses safety concerns involving carbon microfibers.
🩺 New Kid on the Medtech Contract Manufacturing Block: Evevo says it is committed to serving emerging medical device companies in the Minneapolis ecosystem.
👉 AdvaMed Joins National Campaign to Improve Supply-Chain Performance: The Biden Administration has launched a strategy to bring medical products and other necessities into the hands of more Americans more quickly.
🏅 CAE Technology Pioneer Receives Lifetime Achievement Award: The award was presented to Kevin Pageau, who developed one of the first warp analysis tools for injection molding, among other achievements, at the SPE Automotive Innovation Awards gala.