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From August 5-6, 12 employees from West’s Grand Rapids facility participated in a 200 mile, overnight relay race. The Fred 200 Mile Relay spans the Fred Meijer White Pine Trail through Comstock Park and Cadillac, MI. This was the third year that our Grand Rapids, Michigan facility coordinated a team for the Relay.
The Fred 200 Mile Relay includes 36 “spurs” or legs, ranging from 2 to 9.5 miles per leg. The West team included runners, van drivers, bike support and a catering service.
Over the past three years, the team has raised over $18,000 for the Company’s employee-led fundraising campaign—West without Borders. This year the team’s fundraising efforts benefited the Children’s Healing Center in Grand Rapids, MI. The Children’s Healing Center is the first of its kind in the nation, and provides a safe, fun and healing environment, where kids living with weak immune systems and their families can connect with each other.
Congratulations team!
West’s Andy Polywacz, VP Quality & Regulatory Affairs, and Jennifer Riter, Sr. Director, Global Analytical Services, will present at the 2015 Interphex conference on April 21-22, 2015. The conference will be held at the Javits Center, New York City, NY.
Many complex biologic drug products, such as gene and cell therapies, require storage at low temperatures (from -60oC to -180oC). This presents a challenge for containment systems when maintaining container closure integrity (CCI) – especially for glass-rubber vial systems.
<p style="margin: 0in 0in 10pt;"><span>In <a href="/blog/2017/may/part-1-packaging-supplier-reg-sup-for-med-products">Part 1</a> of this series, we discussed the primary questions to consider when evaluating potential regulatory support from a packaging component supplier. Beginning with this post, we’ll start to look into each of these questions in more detail.</span></p>
Container systems must protect parenteral drug products through the entire shelf life. To accomplish this, container components (vial, elastomer stopper, and metal seal) must fit together well, and maintain an impervious seal. In a sealed system, elastomers are under compression, and it is well known that under compression they undergo relaxation. This raises the question whether such relaxation will affect the seal performance over time, and thus container closure integrity (CCI).
<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>
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