Many emerging tools and technologies support the environmental sustainability of the pharmaceutical industry. In facility design, solutions are derived through science-based analyses of environmental impacts from the materials, processes, services, and architecture. From greener energy sources to a reduction in the type and amount of emissions, we are seeing improvement in this sector’s...
This article shows how non-supervised artificial intelligence (AI) methods can strongly support common processes in the pharmaceutical industry such as wet granulation drying. The techniques used demonstrate how continuous process optimization can be enabled and the process control strategy is permanently updated while keeping product quality under strong assurance and also increasing energy...
An interview with Shin Kawamata of Japan’s Foundation for Biomedical Research and Innovation (FBRI) highlights exciting work to move cell therapy toward reliable and scalable commercialization.
The 2022 ISPE Aseptic Conference Regulatory Panel session on 15 March was as always one of the highlights of the conference, and this year’s discussion with regulators followed in that tradition.
The 30th ISPE Aseptic Conference culminated in the interactive regulatory panel, which offered attendees the unique opportunity to ask questions directly to the regulators.
Robotic process automation (RPA) software automatically handles manual, repetitive, time-consuming, and highly structured tasks such as data entry and back-office functions. Certain processes specific to the pharmaceutical industry represent strong candidates for RPA implementation, with significant potential savings and the possibility of ensuring compliance.
Industry 4.0 is the recent movement toward intelligent automation technology. In this new era, the integration of modern manufacturing skills and novel information technologies plays an important role on economic competitiveness.1
As noted in the ISPE Drug Shortages Prevention Plan,1 business continuity planning is a powerful, methodology, essential...
As noted in the ISPE Drug Shortages Prevention Plan,1
Knowledge management (KM) has been a recognized discipline for over 20 years in other industries, although within the biopharmaceutical industry, its discussion and formal implementation have been slow to gain momentum. The topic gained regulatory significance in 2008 when the ICH guidance document Pharmaceutical Quality System: Q10 included knowledge management as a key enabler of a...
In 2000, the U.S. Green Building Council (USGBC) introduced Leadership in Energy and Environmental Design (LEED) to create a methodology to promote sustainability-focused practices in the building industry. This article reviews the earliest protype that we know of for a LEED manufacturing facility, presents a real-world case study of a pharmaceutical manufacturing facility achieving LEED Gold,...
We have some clarity over the desired end point of zero carbon within the next 30 years (or sooner for some pharma companies), but our industry is uncertain how we will achieve this objective. As pharma engineers, we will all play a role in delivering this end point through the continuous improvement of existing facilities and by designing, equipping, and building new facilities that will be...