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
In the prefilled syringe system, the plunger is in contact with the drug product during administration and the drug storage period, which may last up to two years and can affect the long-term stability of the drug product.
Interactions between a drug product and its packaging can have a significant impact on the purity of a drug and the safety of patients. With drug impurities and degradation among the primary causes of drug recalls, management and control of associated risks should dominate product development and manufacturing processes. The selection of the right plunger for a prefilled syringe system is therefore an important consideration for the pharmaceutical and biopharmaceutical industry.
Fluorpolymer films (such as the FluroTec® barrier film coating) provide an effective barrier against organic and inorganic extractables, minimizing the interaction between the drug and the plunger while maintaining the plunger’s seal integrity. These film coatings can reduce the leaching of extractables into the drug product. Further, FluroTec barrier film reduces absorption and adsorption of the drug product, an important benefit for maintaining the full strength and shelf life of most drugs. In addition, the low surface energy of the film provides lubricity without the need for silicone oil, eliminating one source of particulate contamination.
West flurpolymer film-coated plungers are designed according to the ISO 11040 requirements for glass dimensions part 4, and are available in: 0.5 mL, 1 mL long, 1-3 mL, 5 mL and 10 mL formats; additional sizes and configurations are availed on request. FluroTec film coated plungers have been on the pharmaceutical market for 25 years, with a high number of registrations in the overall worldwide pharma market. Fluorpolymer coated plungers have become a standard for many drug products, especially in the biological field, and are typically easily processed.
New generations of plungers with FluroTec coating were developed over the last five years to answer ever-increasing quality and regulatory requirements and market trends toward home administration that may require different application formats, such as auto injectors. Functionality profiles for auto injector applications have different requirements. All these requests have been addressed by developing a new generation of plungers, NovaPure® plungers.
Contact us to speak with a Technical Customer Service representative to learn more about the benefits of fluorpolymer coated plungers.
NovaPure® and FluroTec® are registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
West has recently converted its Elastomer Formulation Drug Master Files (DMFs) to an electronic (eCTD) format.
As part of the 2010 West without Borders campaign, employees in West’s Exton, Pa., headquarters raised funds to aid Canine Partners for Life (CPL), an organization dedicated to training service dogs, home companion dogs and residential companion dogs to assist individuals who have a wide range of physical and cognitive disabilities. One of the many bonuses to working with the organization was an opportunity to name one of the service dogs. After a vote, the name “Star” was chosen.
As advancements in pharmaceutical technology increase in the use of automated injection systems for health care treatment, traditional glass vials, syringes and cartridges must withstand higher automated delivery forces and pressures. The fragile nature and dimensional variability in wall thickness of glass components may lead to breakage, which presents challenges to automatic administration systems.
Considering the world of commercial transparent polymers, Daikyo Crystal Zenith® cyclic olefin polymer (COP) clearly stands out – having very good resistance to oxygen/water and compatibility with drug product (it comprises only carbon and hydrogen). Other transparent polymers may suffer limitations, in one or more ways. For example, poly(vinylidene chloride) has outstanding resistance to oxygen/water, but lacks compatibility; sterilization can result in release of HCl. For parenteral drug products, polymer-based containment/delivery systems have many advantages compared to glass.
For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.
English
Chinese
