Cover: Pharmaceuticals are not only regulated by traditional pharmaceutical legislation but are also increasingly influenced by related environmental and stewardship laws. Extended producer responsibility is reshaping the pharmaceutical industry with regulatory burdens, challenges, and strategic opportunities.
Featured: Sustainability principles can be e ectively integrated into commissioning and quali cation (C&Q) projects to support environmental goals without compromising compliance, quality, or patient safety. By positioning C&Q as both a veri cation tool and an enabler of sustainable intent, this article outlines a practical path for the pharmaceutical sector to enhance operational e ciency, reduce environmental impact, and support eco-conscious future.
Featured: The pharmaceutical industry’s embrace of digital technologies and sustainability is no longer a competitive advantage, but an operational necessity. As Pharma 4.0™ matures, its integration will be vital for achieving net-zero objectives and achieving pharmaceutical excellence.
Technical: Containment systems are essential in pharmaceutical manufacturing, ensuring product quality and protecting worker safety. They prevent cross-contamination, reduce occupational exposure to potent compounds, and support compliance with global Good Manufacturing Practice standards. As manufacturing evolves, robust and adaptable containment strategies are increasingly vital for maintaining safety, e ciency, and regulatory alignment. This article presents a case study demonstrating the design and verifi cation of containment systems in a large-scale facility, highlighting best practices and industry relevance.
Technical: Oligonucleotide therapies hold great promise for treating a wide range of diseases, including the undruggable, but their journey from lab to patient hinges on fundamental manufacturing challenges that the industry is racing to solve
This article defines what constitutes a holistic control strategy in pharmaceutical development and manufacturing. It highlights the limitations of traditional, siloed approaches and demonstrates the added value of integrating these approaches across multiple dimensions. By identifying key gaps and proposing technological enablers, the article outlines a path toward a more comprehensive,...
Water and steam are essential in the pharmaceutical industry. Both are used for multiple purposes, including cleaning and sterilizing equipment, laboratory activities, and as an ingredient.
Oligonucleotide therapies hold great promise for treating a wide range of diseases, including the undruggable, but their journey from lab to patient hinges on fundamental manufacturing challenges that the industry is racing to solve.
Michelle Vuolo is currently Head of Quality at Tulip Interfaces, Inc., a platform developer that enables manufacturers of many industries to build digital content to manage their operations. Before joining Tulip, Michelle spent more than 24 years in the biopharmaceutical and medical devices industries in quality control (QC) laboratories, engineering technical support, quality assurance...
Stephanie Stärkle is a project engineer at VTU Engineering in Switzerland, where she leads engineering projects from concept to execution in GMP-regulated environments including cost estimation, equipment design and specification, deadline management, and coordination with cross-functional stakeholders such as vendors, quality assurance, operations, and qualification. She holds a bachelor’s...
The development of platform drug delivery devices for combination products offers a transformative approach to drug delivery by enabling the reuse of device data across multiple drug and device combinations.
Crafting a sustainable packaging strategy for the pharmaceutical industry is complex and requires balancing environmental responsibility with regulatory compliance and operational costs. In this article, we explore the key drivers, challenges, and best practices for developing such a strategy.
The pharmaceutical industry’s embrace of digital technologies and sustainability is no longer a competitive advantage, but an operational necessity. As Pharma 4.0™ matures, its integration will be vital for achieving net-zero objectives and achieving pharmaceutical excellence.
Sustainability principles can be effectively integrated into commissioning and qualification (C&Q) projects to support environmental goals without compromising compliance, quality, or patient safety. By positioning C&Q as both a verification tool and an enabler of sustainable intent, this article outlines a practical path for the pharmaceutical sector to enhance operational efficiency,...
The rapid pace of digital innovation, offers plenty of unprecedented opportunities as well as a few unforeseen challenges. The ISPE Pharma 4.0™ Conference has been helping life science industry professionals embrace opportunities and overcome challenges since 2017. This year’s conference is no exception. We’ll examine EU GMP Chapter 4 Annex 11 and Annex 22’s new focus on emerging technologies...
With nearly 2,000 drugs currently in shortage across the UK—a staggering increase from 1,608 just one year prior—the pharmaceutical industry faces an unprecedented crisis that demands immediate attention.
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Eric Brown, Digital Developer in the Professional Development Department.
ISPE reached new heights in its 45th year with the launch of the ISPE Academy, a new podcast, and the 20th anniversary of the Facility of the Year Awards (FOYA). As 2025 comes to a close, Pharmaceutical Engineering®...
In the heart of traditional Chinese kitchens lies a profound respect for resources: nothing is wasted, and simple ingredients and different flavors are combined to achieve a well-balanced meal through a defined process with suitable tools. What does ancient cuisine and modern pharmaceutical production have in common? And what could we learn in terms of sustainability?
As I conclude my tenure as Chair of the Women in Pharma® International Steering Committee, I reflect on a journey that has been professionally enriching and personally transformative.
When I began my career as an engineer in a major pharmaceutical company, I worked in an engineering department filled with highly experienced senior engineers. I admired their depth of knowledge and the way they had accumulated a wealth of practical information over decades. Their grasp of systems, processes, and equipment was impressive and humbling. I found myself anxious to build that same...
