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
Integrity of a drug product container/delivery system is essential to guarantee safety and efficacy. USP has recently issued Chapter <1207> “Package Integrity Evaluation – Sterile Products”—a guidance for the pharmaceutical industry in measuring container closure integrity (CCI). In line with this guidance, West has just expanded its capability in measuring CCI by adding high-voltage leak detection (HVLD) –a method endorsed in Chapter <1207>.
HVLD operates by applying a high electrical potential to electrically conductive products inside package materials that are non- or semi-conductive, and sensing current flow resultant from a defect. The method has several advantages:
West scientists have validated HVLD in syringes with various solutions – protein (albumin - 100mg/mL), saline, Tween® 20, buffer, and sterile water for injection – with defects as small as 2 microns.
With the addition of HVLD, West has at its disposal several methods to measure CCI (along with helium leak, headspace analysis, vacuum decay, dye ingress). These methods not only support internal development, but reflect strong partnerships with customers to address their specific needs.
To learn more please visit:
Knowledge Center - Container Closure Integrity
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
TWEEN is a registered trademark of Croda International PLC
The pharmaceutical industry is shifting toward pre-filled syringes (PFS) as the optimal delivery system for many drug products. The utility of a syringe system is dependent upon its ability to maintain good container closure integrity (CCI) through drug product shelf life.<br />
Exposure to light is a concern with numerous medications due to the potential for photodegradation or other chemical reactions during manufacturing, storage, and administration<sup>(1)</sup>. This may result in potency loss, altered efficacy and adverse biological effects. The sensitivity of a drug to a distinct spectral region of light may vary with its chemical structure, photoreactivity, and nature of the dosage form. The photochemical behavior of a drug provides guidance for handling, packaging, and labeling of drug products. The use of the appropriate containers and packaging material can protect the products from the deleterious effects of light.
Polymeric container systems are not new to the pharmaceutical industry, and their benefits in terms of break resistance, cosmetic quality and dimensional precision have been recognized by many companies around the world who have chosen to use a polymer vial or syringe.
As global healthcare systems become more heavily reliant on radiopharmaceuticals for diagnostics and treatment, ensuring that the radioactive drug is safely contained for the duration of its shelf life has never been more vital.<br />
<p>Tibor Hlobik, Director, Prefillable Solutions and Technologies<br />Mike Gills, Customer Technical Support Process Engineer</p><p>Growth in biopharmaceutical therapeutics is leading innovation with prefillable syringe systems. These complex sensitive drug products require highly inert primary packaging materials for improved stability and delivery in perfect quality for reduced safety risk. This <span style="text-decoration: underline; color: #0000ff;"><a href="https://www.westpharma.com/west-login">poster</a></span> will provide a quality comparison of primary prefillable syringe options including glass, coatings/laminates and cyclic olefin polymers, and highlight the findings of a case study comparing 1mL long syringe attributes.</p>
English
Chinese
