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Good container closure integrity (CCI) is an essential feature in preserving the sterility of a drug package over its shelf life. How sterility has been demonstrated, however, has changed substantially over the past 30 years.
Prior to the mid-90s, sterility testing itself was the "go-to" approach. That changed in 1994, when US FDA published Guidance for Industry for Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products, which promoted the importance of verification of microbial barrier properties of a parenteral product package (i.e., CCI). Sterility testing alone was determined to be insufficient.
In 2008, US FDA published: Guidance for Industry on Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products. This further guidance reiterated the importance of CCI tests, vis-a-vis sterility tests, and enumerated the limitations of sterility tests, e.g., possibility of false positive readings due to interference from adventitious microbial contamination introduced at the time of testing, destructive nature – not allowing opportunity to reexamine samples in the event of either positive or negative findings.
Recently published guidance USP <1207> Package Integrity Evaluation – Sterile Products discusses CCI methods in detail, in particular promoting the use of deterministic methods, and emphasizing the importance of pharmaceutical companies understanding the maximum allowable leak limits (MALL) of their drug products. At West, CCI is thrust area for Analytical Lab Services – having the staff, expertise, and facility to design and execute those methods specified in <1207>. Please feel free to contact your West Account Manager and Technical Account Specialist (TCS) for more.
West is now celebrating the one-year anniversary of its Integrated Solutions initiative, known as Simplify the Journey™. Throughout 2019, we socialized the program through marketing materials and face-to-face conversations with customers. Now it’s time to reflect on the lessons we’ve learned — and to look forward to the opportunities on the horizon.
Since its inception in 2011, the <a href="http://www.dasd.org/STEM"><span style="text-decoration: underline;">Downingtown Science, Technology, Engineering and Mathematics (STEM) Academy</span></a> has quickly earned the ranking as the number one high school in the state of Pennsylvania. With the STEM Academy located in the same district as West’s corporate headquarters, and a strong corporate culture of giving back to the community, a partnership between the two organizations was a natural fit.
<p>Color has a surprising number of uses in injectables packaging.</p><p>European guidance states that “similarity in packaging which contributes to medication error can be reduced by the judicious use of color on the pack” ¹. Draft guidance issued by the U.S Food and Drug Administration (FDA)² similarly recommends that “sponsors use color prudently to bring attention to the product name, strength, and important warning(s).” Color – when applied thoughtfully and with full awareness of the context in which the drug will be used – can be an important way for manufacturers to help practitioners and patients differentiate products and support their correct use.</p>
<em>West is pleased to welcome guest blogger Katrina Firlik, MD, Chief Medical Officer and Co-Founder of </em><a href="https://healthprize.com/"><span style="text-decoration: underline;"><em>HealthPrize Technologies</em></span></a><em>. This is the second installment in a series on the West/HealthPrize collaboration.</em>
Gene therapies are stored and shipped at ultra-low temperature (approximately -80<sup>o</sup>C, either in a refrigerator or on dry ice). This provides a challenge to the primary package systems in maintaining container closure integrity (CCI), especially systems comprising glass vials and elastomer stoppers. These materials have different coefficients of thermal expansion. Upon cooling from room temperature to ultra-low temperature, they contract at different rates; this may lead to gaps and CCI loss.
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