March / April 2021

Online Exclusives

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.

Online Exclusives

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

  • 1Zawadzki, P., and K. Żywicki. “Smart Product Design and Production Control for Effective Mass Customization in the Industry 4.0 Concept.” Management and...
Technical

Pharmaceutical manufacturers rely heavily on powder processes, the majority of which are designed and operated on the basis of empirical correlations between material properties and performance. The development of material properties databases for pharmaceutical excipients and active pharmaceutical ingredients (APIs) has the potential to enhance such correlations and, more generally, to...

Technical

For a multiproduct facility where equipment is shared, there is always a risk from cross-contamination. The correct calculation of the cleaning validation limits from maximum allowable carryover (MACO) of a marker compound to the next product is vital for the integrity and success of the cleaning validation program. However, the process yielding those limits often involves cumbersome,...

InTouch

Equipment reliability helps reduce and manage the risk of failures in equipment, providing focus on availability, fitness for purpose, and cost. Reliable equipment improves the likelihood of achieving reliable manufacturing operations, which improves the supply of critical therapies to patients worldwide.

Features

Across every industry today, digitalization is driving the use and value of data to disrupt traditional business models and ways of working. In pharmaceuticals, the promises of Industry 4.0 are expected, and needed, to finally modernize the legacy approaches that have evolved since the 1970s. Validation is an obvious target for digital disruption because of the inefficient, document-heavy...

Features

Digital transformation and digitalization are on the agenda for all organizations in the biopharmaceutical industry. But what are the main enablers of intelligent manufacturing? We hypothesize that data science–derived manufacturing process and product understanding is the main driver of digitalization in the bioprocessing industry for biologics manufacturing. In this article, the first of a...

Features

The fourth Industrial Revolution (also known as Industry 4.0) is the era of smart machines, storage systems, and production plants that can autonomously exchange information, trigger actions, and control operations free of any human intervention. To ensure future success in the delivery of therapeutic medicines to patients, it is imperative that the pharmaceutical industry move deeper into the...