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Most cancer drugs are hazardous. OSHA, NIOSH and USP regulations, enacted to protect healthcare workers from exposure, stipulate the need for safe delivery. Needle-free devices, such as spikes, can help to meet this need. However, traditional spikes used in infusion systems have posed a concern with small drug vials — stopper push-in by spike incidents can occur.
Dr. Xia Zhao, Director of Scientific Insights Lab in Scientific Affairs & Technical Services at West, addressed this issue at the recent PDA Parenteral Packaging Conference in Rome in a presentation entitled:A Case Study to Address a Gap in the Device-to-Vial Interface: Stopper Push-in by Chemo Spikes - An Overlooked Oncology Safety Risk. West’s Scientific Insights Lab is the first to perform an investigation to address the risk of stopper push-in at the device-to-vial interface and to understand the contributing factors. The push-in force threshold was found to vary with spike diameter, stopper material and design. Spike puncture force was determined to be impacted by spike design, surface lubricity, stopper material and design. To prevent a stopper from being pushed into a vial, it is important to consider both the stopper push-in force threshold and spike puncture force.
A three-step quantitative risk assessment was developed to determine stopper and spike compatibility – both of which can be optimized to mitigate risk. Human factors at the user-to-device interface also impact drug transfer. Emphasized was the need for risk mitigation among stopper manufacturers, spike manufacturers, pharmaceutical manufacturers, device manufacturers and hospitals.
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Innovation in manufacturing involves a spectrum of evolution improvements resulting in what West’s partner Daikyo Seiko, Ltd. considers "Absolute Quality." Recent continuous improvement efforts helped Daikyo achieve even higher levels in cleanliness of elastomer products.
<p>The LyoSeal® cap— an all-plastic, instant sealing solution for lyophilized drugs—recently launched at Pharmapack 2017. Plastic seals present a unique opportunity for commercial pharmaceutical manufacturing, as well as for R&D and pre-clinical applications seeking simplified manual capping options (no tools required).</p>
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.
Focused on meeting customer needs in different markets and regions, West offers two types of washed Ready-to-Sterilize (RS) rubber closures: Regional-Washed RS and Westar<sup>®</sup> RS.
Drug products such as biologics, vaccines and products whose chemical and physio-chemical stability depends on temperature put an added emphasis on pharmaceutical manufacturers to ensure proper handling, storage, transportation and dispensing. Maintaining a secure “cold chain” during the storage, handling and transportation of temperature-sensitive drugs, vaccines and blood products not only assures product quality and integrity for the benefit of the patient, but also helps to keep the manufacturer, hospital, pharmacist, physician and nurse in compliance with various laws, regulations, guidelines and codes.
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