Pharma 4.0 Archives - Medical Design Sourcing

No room for error: How a holistic quality management strategy can help pharma firms adhere to strict quality standards

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Ever heard the phrase “one bad apple spoils the barrel”? The proverb rings especially true in pharmaceutical manufacturing, where even trace amounts of contaminants can have grave consequences for patient safety. “In the case of pharma, the stakes are so high that even the tiniest contaminants can endanger patients and result in wasted therapeutics, amounting to millions of dollars,” says Dan UpDyke, life sciences strategic marketing manager at Rockwell Automation.

In the following interview, UpDyke explains how a holistic quality management strategy in pharma can help manufacturers adhere to the industry’s strict regulatory standards. Such an approach can help pharma companies avoid problems related to sub-standard ingredients, possible contamination, or a temperature excursion during delivery, all of which can jeopardize the integrity of the entire product.

In the following interview, UpD…

A brief guide to Pharma 4.0 adoption

View of a production line at the Reig Jofre company’s headquarters. Image courtesy of Wikimedia Commons.

Pharma 4.0 projects may have gotten off to a slow start, but they have ramped up recently.

And many of such projects to date have been in the Big Pharma space, according to the CRB’s 2021 Life Sciences Horizons report. “It makes sense because a lot of these digital technologies have a big dollar sign with them and Big Pharma tends to have the funds for that,” said Yvonne Duckworth, senior automation engineer at CRB.

As adoption matures, more startups will likely embrace Pharma 4.0 technologies, Duckworth said. Even cash-strapped startups building new facilities could lay the groundwork for smart factory upgrades in the future. “It’s about being forward-thinking in designing new facilities,” Duckworth said.

[Related: Pharma 4.0: Industry 4.0 Applied t…

Pharma and biotech companies set their sites on sustainability

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Sustainability continues to be a hot topic, and the pharmaceutical industry faces pressure to reduce its carbon footprint. As a result, a growing number of pharma companies are stepping up sustainability efforts.

In a growing number of locations, pharma companies are seeing drivers in the regulatory environment to force them to prioritize sustainability. “We’re seeing [pressure] from both regulatory authorities having jurisdiction at the federal, state and local level of different jurisdictions,” said Jeff Wegner, a mechanical engineer at CRB.

A growing number of jurisdictions on the East Coast and West Coast are restricting or banning the use of, for instance, natural gas.

While such restrictions are not yet pervasive, the trend is building, said Wegner, who was among the authors of the Horizons: Life Sciences Report.

Another dimensi…

Pharma’s been slow to adopt Industry 4.0 — but that could change

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The pharma industry has been relatively slow to embrace concepts such as Industry 4.0, but COVID-19 is serving as a catalyst for sweeping changes within the industry.

The philosophy has roots in a German framework that prioritizes digitization to drive manufacturing efficiency, promising that cyber-physical systems will usher in the next industrial revolution. The Industry 4.0 framework spans connectivity, analytics and AI and integrated automation technologies.

But the deployment of Industry 4.0–inspired technologies has been uneven in the pharma industry. “The industry is pretty cautious,” said John Younes, COO of Litmus Automation, the developer of an industrial edge computing platform.

Get the full story from our sister site, Pharmaceutical Processing World.