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
Container closure integrity (CCI) is a critical factor every drug manufacturer and compounder is required to achieve. To achieve CCI, one must consider factors such as vial material, blowback, and stopper design. One vital factor – too often an afterthought – is the aluminum seal.
Example of a good crimp and seal
Although considered a secondary component (since it does not contact drug product), the importance of a proper seal and crimp cannot be overstated. Three aspects of achieving a proper crimp are: skirt length, compression force, and cosmetics.
Skirt Length: This is the length of the aluminum part of a seal. Ideal skirt length is determined based on the stopper flange height, the vial crown height, and the percent compression used. If a skirt is too short, CCI may be risked. If the skirt is too long, the appearance of the system may cause the perception of lack of CCI.
Compression Force: This is the force used during the crimping process to push seals down onto the stopper/vial system. If systems are not sufficiently compressed during fill/finish, CCI may not be achieved. Excessive compression can cause the stopper to push through the hole in the top of the seal.
Seal Cosmetics: This relates to the appearance of the aluminum skirt of the seal post-crimping, particularly around the bottom of the crown of the vial. This appearance ought to be smooth, with no visible “wrinkles.” Wrinkles may pose a CCI risk and may result in rejected product.
West is able to offer both preliminary and detailed recommendations to help companies select seals. West’s Integrated Solutions lab team can help prepare a closure container system to meet FDA guidelines. Contact us today for more information.
<p><em>Lloyd Waxman, Harold Murray and Vinod Vilivalam</em></p><div id="g_93cd4f5a_be87_417c_be5f_5391eae75b241"><div><div><em></em> </div><div><strong>ABSTRACT</strong></div><div><strong> </strong></div><div><strong>Purpose: </strong>The shipment and storage of biopharmaceuticals in prefilled syringes (PFS) places new demands on PFS performance. Studies compared package integrity of glass and plastic PFS: piston movement was evaluated under reduced pressures to simulate transport by air in non-pressurized holds, and container closure integrity was tested on PFS that had been frozen or frozen and thawed, since some biopharmaceuticals are stored and transported in the frozen state. Piston release and travel forces were also measured in plastic PFS since in order to be competitive with siliconized glass PFS, the functional characteristics of plastic PFS must meet or exceed the criteria established for glass PFS.</div></div></div>
<strong>Diane Paskiet</strong>, Director, Scientific Affairs, recently published, “The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP),” in the<em>PDA Journal</em>. PQRI is a non-profit consortium involving industry organizations, academia and regulatory agencies that together provide recommendations in support of regulatory guidance to advance drug product quality.
Primary packaging components come in intimate contact with drug products – they can affect both drug product and patient safety. Many elastomer components are offered with a FluroTec<sup>®</sup> film that serves as a chemical barrier to minimize the migration of compounds from the elastomer into the drug product. FluroTec film comprises an ethylene-tetrafluoroethylene co-polymer (ETFE) – selected based upon flexibility, ability to be laminated to an elastomer, and of course, permeability resistance.
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.
<em>With employees’ students across the U.S. receiving $5,000 each year over four years, the Foundation fosters a culture of support for education and family at West.</em>
English
Chinese
