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Material characterization is an important part of the selection process of containment/delivery systems for parenteral drug products.
A key aspect of material characterization is understanding extractable elements as potential leachables - an aspect that has gained more attention recently, resulting from the publication of new guidance documents:
These guidances provide clear direction for testing for elemental impurities in drug products, API’s and excipients. However, no clear guidance exists for examining elemental impurities in containment/delivery systems. This issue was addressed in the recent webinar (see it here):
Elemental Impurities: Change is Coming - Are You Ready?
In this webinar, a key part of the discussion centered on the experimental aspect of examining for elemental impurities - in particular extraction solvent selection. Historically, extraction solvents have included purified water, pH adjusted water, water/solvent mixtures, dilute acids, salt solutions, solutions with surfactants or chelating agents, and specifically-tailored solvent systems. These may not be ideal when the goal is to establish a baseline profile of extractable elements. In selecting the right solvent system, consideration must be given to the following points, to match with analytical capabilities, and ensure suitability of resultant data:
Material characterization is essential to selecting the right containment/delivery system for a drug product. West’s Analytical Laboratory has a staff of scientists who can design and execute studies in this area, and state-of-the-art facilities to support those studies. For more information, contact a Technical Customer Service (TCS) representative or account manager.
<strong>My greatest achievement is founding West without Borders*</strong><br />I’ve worked at West for 21 years! One of my friends approached me and said he would love it if I joined West. He kept telling me what a great company West was and eventually I agreed. I loved the job in the sales department because I got to work with a lot of bold personalities. I’m very outgoing and talkative and so are account managers.
For the healthcare industry, the last decade has brought profound changes that continue to shape how drugs are discovered, developed and commercialized. At West, we pride ourselves on helping customers manage change by continuously delivering innovative products and services. Our company keeps close tabs on industry trends to anticipate unmet need in the market and, when appropriate, to disrupt existing value networks.
West presented a webinar: Navigating Particle Challenges in Sterile Drugs from Component to Patient by Fran DeGrazio, Vice-President, Scientific Affairs & Technical Services, and John Rech, Technology Manager – Particles, Analytical Lab Services, LLC. <br />
To meet the ever-increasing demand of growing domestic pharmaceutical markets, the AccelTRA<sup>®</sup> Components Program has expanded to include an RTS/RTU product line with Ready-to-Sterilize (RTS) and Ready-to-Use (RTU) gamma sterilized stoppers developed to provide an innovative customer service package to help customers get their products to market quickly.
There is increasing demand for advanced manufacturing technologies for fill-finish operations of parenteral drug products. To meet manufacturing requirements for multiple container and component types, flexible fill-finish equipment is at the forefront of most pharmaceutical, biotech, and CDMOs’ fill-finish strategy. Flexible fill-finish technology is suitable for variable batch sizes allowing for scaling from clinical to commercial in multiple drug delivery presentations. With the ability to launch in vial configurations, prefilled syringes, or other combination products including devices, flexible fillers are beneficial to drug developers who are looking for lifecycle management of their drug products.
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