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
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.
The process of crimping an aluminum seal onto a pre-stoppered vial should not be overlooked or underemphasized. Within the pharmaceutical industry, there is a need for an elegant and effective seal not only from the cosmetic perspective, but also more importantly, because of the correlation between seal quality and container closure integrity. Even in laboratory settings and during early-stage evaluations of a drug product and containment system, reliable, robust and consistent crimped seals are necessary.
Even though glass syringes are predominantly used for primary containment of parenterals, the (bio)pharmaceutical industry continues to cope with certain limitations associated with glass containment systems. This is especially true when the drug is administered via prefilled drug-delivery systems such as auto-injectors or pens where glass cracks and breakage can be a serious risk for patients.
There are many benefits associated with the use of combination products (e.g., SmartDose® and SelfDose® Drug Delivery Platforms). Since combination products are often patient centered, they are designed to be convenient, assist in maintaining a drug therapy from home, and help to enable better compliance. To ensure these benefits, developers must formulate and execute a proper design verification study to minimize impacts by unknown risks. <br />
At West, we pride ourselves for our passion for our customers. We work hard to be by the side of their journey to ultimately create a healthier world. Our customers, both big and small, work every day to help patients with various diseases, syndromes, and conditions live a better life. We consider the success of our customers to be our success as well.
For injectable drug product package systems, seals are considered to be secondary package components. Though not in direct contact with drug products, they perform critical functions such as: Maintain an integral sterile seal by holding the stopper firmly in place, protect the injection site on the stopper and provide evidence of tampering (dependent on seal design).
English
Chinese
