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In the third and final installment of the West On The Road visit with our Clearwater, Florida facility, we dive a little bit deeper into the day-to-day processes and outside-the-box thinking that allows us to deliver packaging components and drug delivery systems of the highest quality.
As Andy Phillips, Director of Operations in Clearwater, says, “We specifically look for engineers who have a strong desire to come in and do things differently—look at the process, determine where the waste is, find the problems in the process and eliminate them.”
This approach, also known as Lean manufacturing, is a cornerstone in our ability to continually evolve with the healthcare environment and address the current and future needs of our customers. It’s this dedication to continuous improvement that allows us to support our pharmaceutical partners in providing safe, effective drug products to even the youngest of patients.
“We had a customer come in and tell us that over the past 20 years, we’ve helped save a million babies’ lives…our seal goes on a product that is used when newborn babies can’t breathe,” shares Andy. “That kind of information really makes you want to come here and do the best things that you can.”
“We affect peoples’ lives every day,” adds Glenn York, Engineering Manager. “That drug would not be getting to the patient unless we were there to package it—it’s important.”
<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>
Regulatory and market expectations constantly increase. Novel drug products such as cell and gene therapies have a very high value and therefore each dose is precious. With that, drug product manufacturers face increased pressure to minimize rejects of finished drug products. One aspect of this is controlling particulate matter. Particulate matter in finished drug products can come from a number of sources, including the ingredients in the drug product, manufacturing equipment and environment, or the components of the container closure system. This blog describes approaches to control and measure particulate matter.
In China, the industrial and regulatory landscape has been evolving rapidly – and in particular as it relates to generic drug products. In 2015, the China State Council announced Opinions on Reforming the Review and Approval System for Drugs and Medical Devices (No. 44). At this same time, a series of reforms were announced by the National Drug Administration of China (formerly the China Food and Drug Administration, CFDA) to upgrade the pharmaceutical industry by raising marketed products to international standards in terms of quality, safety and efficacy.
In a previous <a href="/blog/2012/may/lifecycle-planning"><span style="text-decoration: underline;">post</span></a>, my colleague Fran DeGrazio discussed lifecycle planning and the use of a single material for packaging components from development through commercialization. There has been a great deal of innovation around drug container materials. Although glass has been the traditional material of choice for drug containment, it has significant limitations including breakage, glass particulate, visual quality and functional performance.
The Drug, Chemical & Associated Technologies Association (DCAT) Week took place in New York City the week of March 16, and again proved that this gathering is a terrific networking event for the pharmaceutical industry and its partners. Celebrating its 125<sup>th</sup> Anniversary, the association demonstrated its continued relevance and leadership in our business sector. DCAT Week always provides a unique opportunity for companies like West to engage in high-level, strategic meetings with our key customers and other business partners.
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