Sustainability by Design for Pharmaceutical Products
Cover: As the pharmaceutical industry faces ever-changing global challenges and market forces, it must review and revise product design to ensure that quality products remain available in the marketplace while moving toward zero pollution for air, water, and soil. This article provides an introduction on how quality products can integrate sustainability by design.
Challenges for Net Zero Carbon Pharmaceutical Manufacturing
Feature: Many organizations in the pharmaceutical industry have set net zero carbon goals and targets; they participate in the science-based targets initiative or sustainable markets initiative and disclose carbon emissions in databases like the Carbon Disclosure Project. The vast majority of those in the pharmaceutical industry have shared partial decarbonization plans, but do not yet have concrete plans to achieve these decarbonization goals in the next 10–15 years, often citing a highly regulated environment as a hurdle. Growing public awareness and pressure, as well as technological advances coupled with CO2 prices, are slowly changing the focus, putting the needs of our planet on the agenda.
Sustainability: Corporate Ambition, Governance, & Accelerated Delivery
Feature: The imperative for global action to tackle climate change is clear and the pharmaceutical industry has a key role to play. Governments have entered into international commitments to reduce climate impact (carbon emissions) and protect nature (water, land, air, and biodiversity) with policy frameworks established to facilitate and drive progress against agreed targets. The effect to the pharmaceutical industry spans its end-to-end activities, including the residual impact of used and unused medicines on the environment. Research and development, manufacturing, commercial (sales and marketing) activities, and their extended supply chains including logistics are all within this scope.
Case Study: Meeting Manufacturing Needs with a Net Zero Energy Facility
Case Study: The expected FDA approval for a Treprostinil dry powder inhaler revealed a need for the manufacturer to expand its warehousing and logistics capabilities to support its growing operations. The company’s senior leadership wanted to ensure this expansion came with as minimal an impact on the environment as possible, so a key priority was to provide a net zero energy facility. With a vision for what the project could be, the team named the upcoming endeavor Project Lightyear. To infinity and beyond, indeed.
Cleanroom Recovery Study: Using Computational Fluid Dynamics Methodology
Technical: Computational fluid dynamics (CFD) can reduce or eliminate the uncertainty associated with a cleanroom facility as the planned design can be simulated to predict performance to a high degree of accuracy. This article discusses the use of CFD for the purpose of predicting and optimizing the performance of a cleanroom facility in terms of steady-state airborne particulate levels and for estimating the recovery time to a particulate challenge per ISO 14644-3.