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Market trends toward home use and patient self-administration of drugs used to treat chronic conditions (e.g., multiple sclerosis, rheumatoid arthritis and autoimmune) have made prefillable syringe systems an ideal choice for single-dose drugs. Prefilled syringe systems for vaccines, pharmaceuticals and biopharmaceuticals offer convenient, fixed dosing and are adaptable to automated injection devices.
For patients, use of a prefilled syringe system has the potential to minimize microbial contamination and reduce medication dosing errors. The syringe systems offer ease of use and enhanced convenience for those who require frequent dosing, and when combined with an auto-injector system, can provide a more portable drug delivery system.
Plungers that fit 1mL long staked needle syringes were originally developed for a manual injection action. As customer requirements for higher quality and patient need for self-injection with auto-injectors have evolved, demand for a high-quality plunger rose. Using QbD principles, West developed its NovaPure® components for prefillable syringe systems to provide high reliability for breakloose and glide force, dimensional accuracy and consistency, sub-visible and visible particulate control, and low parts-per-million (ppm) defect attributes.
The optimized functional and dimensional performance for NovaPure plungers provides improved rate of injection times and consistency when used in conjunction with 1mL long staked needle syringes and an auto-injector system.
The 1mL long NovaPure plunger followed a development lifecycle program, which used a Quality Target Product Profile (QTPP) to establish Critical Quality Attributes. As the product – which included risk-based design inputs,Finite Element Analysis (FEA) modeling, data generation on multiple concepts, and final product performance verification with glass barrels from multiple suppliers of a 1mL long glass staked needle syringe – was developed, the QTPP served as a guideline to assure that targeted performance characteristics, including breakloose and glide force were met.
<p><em>Part 2 of the Good Supply Practices Series</em></p><p><em>West is pleased to welcome guest blogger Dr. Marla Phillips, Director,</em><em> Xavier University. This is the second installment in a four-part series on supply chain management.</em></p><p>In my previous blog, I mentioned the three overarching themes that need to be addressed to help ensure the integrity of the materials supplied throughout the pharmaceutical and medical device supply chains through the development of Good Supply Practices (GSPs).</p>
Our communities continue to face challenging circumstances related to COVID-19, and West is working hard to support our customers, our teams and our neighbors. Business as usual is changing, and we all struggle to understand what business as usual looks like now and what it means for each of us.
West’s location in Jurong, Singapore celebrated 40 years of operations and announced an inauguration of the newly advanced facility last month. This site’s updates will improve manufacturing efficiency for the future of containment for injectable medicines. Last month, Eric Green, CEO and President, customers, and other West executives attended the festivities and ribbon cutting.
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
The answer is – it depends. Your Technical Customer Service (TCS) representative can help you decide. Butyl rubber, derived synthetically from petrochemicals, is a copolymer of isobutylene, and to a smaller extent, isoprene. Subsequent halogenation results in a halobutyl rubber – typically bromobutyl or chlorobutyl.
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