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Uninterrupted production on a high-speed filling line is a challenge. To help make this easier, West has developed Flip-Off<sup>®</sup> seals. Flip-Off seals are produced with the highest quality aluminum and plastic materials, and the TruEdge<sup>®</sup> manufacturing process.
Artificial Intelligence (AI) and Machine Learning (ML) are considered to be the core pillars of Industry 4.0. Most organizations, including West, have started leveraging the benefits of AI and ML for better resource optimization and an improved customer experience. Our Data Science and AI team is working towards providing AI solutions which can be leveraged at scale for both our internal and external stakeholders.
Recently, there has been discussion in the industry regarding the utility of polymer-based vial containment systems for the storage and transport of gene therapy drug products, which can be performed as low as -80<sup>o</sup>C. Since it is known that all polymers are gas permeable, discussion has centered on whether polymer-based systems can sufficiently restrict ingress of oxygen (during refrigerated storage) and carbon dioxide (during transport on dry ice).
The level of particles in parenteral pharmaceutical formulations is a critical quality attribute. This is no surprise; the clinical consequence of their presence can be very severe, including fatality. In the major pharmacopeia, from the US, Europe, and Japan, there is a specified limit for particles in the final parenteral formulation. Moreover, these pharmacopeia specify two methods for measurement – light obscuration (LO) and microscopic particle count (MPC).
Diane Paskiet, Director Scientific Affairs, will provide an update on the PQRI-PODP working group at the Smithers Rapra Extractables and Leachables conference in Barcelona, Spain on November 10-12, 2014.
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