We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
The U.S. Food and Drug Administration recently issued a draft guidance, “Glass Syringes for Delivering Drug and Biological Products: Technical Recommendations to Supplement International Organization for Standardization (ISO) Standard 11040-4 (Draft).” The document relates to issues encountered with glass Luer lock syringes when connecting to Luer fittings, including needles, needle-free Luer connectors, adapters and transfer units.
Issues such as breakage, detached needles, jammed IV lines, or syringe tip cracking and breaking have prompted the FDA to issue new recommendations and potential solutions to avoid delays in the administration of a medication. In extreme situations, including medical emergencies, such delays may potentially result in harm to the patients. Because of this, FDA has recognized that compliance to ISO 11040-4 alone does not ensure that glass syringes can be connected effectively, and requires supplemental tests to help ensure patient safety.
The FDA also recommends:
-the use of a bonded or staked needle with appropriate sharps protection for intramuscular or subcutaneous injections
-glass syringes designed with specific internal dimensions to ensure connectivity
-new designs for dedicated dual connections between the syringe and connecting devices
West offers a variety of packaging and delivery solutions that can help to ensure effective delivery, including the Daikyo Crystal Zenith® syringe systems, passive and active safety systems for staked and Luer lock syringes, needle-free administration systems, and collaborative development solutions for combination products.
Partnering with West early in the drug development process will help to ensure that challenges of packaging, delivery and administration can be overcome through the use of innovative design, high-quality materials and/or novel polymers that meet or exceed the FDA recommendations for connectivity. Contact West today to discuss your delivery requirements.
In an effort to treat more complex diseases, the injectables market has seen high-value molecules dominate clinical pipelines. As modern molecules continue to gain market share, it is becoming the norm for drug manufacturers to plan containment system compatibility earlier in their drug development process due to the sensitivities of their complex molecules. With packaging systems becoming an integral part of the drug development and research process, a challenge drug manufacturers face is the plentitude of choice.
Join West’s Graham Reynolds as he presents the keynote at Pharmapack North America. Graham will present, “<em><strong>Understanding the regulations and safety concerns surrounding injectables to overcome inherent design challenges” </strong>on </em>Wednesday, May 23, 2012 at 1:50 pm. The conference will be held at the Pennsylvania Convention Center, Philadelphia, PA on May 22-23.
In a previous <a href="/blog/2012/may/lifecycle-planning"><span style="text-decoration: underline;">post</span></a>, my colleague Fran DeGrazio discussed lifecycle planning and the use of a single material for packaging components from development through commercialization. There has been a great deal of innovation around drug container materials. Although glass has been the traditional material of choice for drug containment, it has significant limitations including breakage, glass particulate, visual quality and functional performance.
Traditionally, drugs and biologics have been sold in vials. Utilizing a vial system requires the use of a syringe or other transfer device to withdraw the medication from the vial and facilitate delivery directly to the patient or to an IV bag for subsequent administration to the patient. These steps can result in errors, spills, contamination, or other mishaps. A simplified approach for administration has been to package the drug or biologic as a <a href="/blog/2022/january/importance-of-prefilled-syringe-packaging-in-market">pre-filled syringe</a> combination product. Drug administration is then made easier because the syringe is both the containment system and the delivery system such that the drug can be directly injected into a patient or into an IV bag port.
The global injectable drug market sees an ever-increasing adoption of high-value biologic drug products. More than half of today’s 20 top selling injectables are biologics, and many of them are delivered in a prefilled syringe. Even though glass syringes are predominantly used for primary containment of parenterals, the (bio)pharmaceutical industry continues to cope with certain limitations associated with glass prefilled systems.
English
Chinese
