Manufacturing

Andrew G. Edwards is a senior consultant at EduQuest.

Articles

FDA is modernizing and streamlining current good manufacturing practices. The author examines FDA's evolving approach to quality systems and how a manufacturer can implement a quality system framework.

Quality Systems for Drugs and Biologics

To date, calorimetry has not been given a fair trial in the PAT arena. Recent advances in reactor technology and design will ensure that real-time calorimetry is the present and future of PAT.

Calorimetry — the fully scalable PAT tool

Recent regulatory initiatives have emphasized the need to improve pharmaceutical manufacturing. PAT marked the beginning of a number of regulatory efforts to encourage innovation and a transition towards science-based manufacturing. This article reviews the progress of the regulatory initiatives and describes two significant research initiatives to develop a future pharmaceutical manufacturing environment based on scientific understanding of pharmaceutical materials and processes.

Research initiatives to support science-based pharmaceutical manufacturing

In biomanufacturing, multiple sensors provide a wealth of data that could be used to enhance process understanding and assist in performance improvement. This article looks at how to move from a data-rich environment to one where the data are translated to useful information that leads to knowledge and, ultimately, process improvements.

From data to knowledge: the challenge in bioprocess development

A new Raman spectroscopic method to detect magnesium stearate in powder blends and tablets is described. High-volume pharmaceutical manufacturing requires the use of lubricants to facilitate tablet ejection from compressing machines. However, lubricants may also bring a number of undesired problems that have been widely documented in pharmaceutical scientific literature. New analytical methods are needed to understand lubrication and provide process knowledge in support of FDA's process analytical technology initiative. The detection of magnesium stearate in lactose, mannitol, corn starch and other commercially important excipients is reported. The Raman spectroscopic method has a detection limit of about 0.1% (w/w) based on the 2848 cm-1 band that corresponds to the symmetric stretch of the methylene group in magnesium stearate.

A Raman spectroscopic method to monitor magnesium stearate in blends and tablets

Christie Deitz is a senior principal engineer in the Emerson Life Sciences Industry Center.

Bob Lenich is Director Syncade product platform at Emerson Process Management.

Automation took hold gradually in the life-science industry. Its adoption brought the industry innovations and improved efficiency. Recent years witnessed the emergence of batch-automation systems and the development of standards for automation. The authors discuss the major changes automation brought to the industry and examine the rapid pace of technological development.

A Look at 30 Years of Change in Pharmaceutical Automation

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Interphex2007, New York, NY (Apr. 25)-One of the challenges facing pharmaceutical manufacturers is how to implement process analytical technology (PAT) into their commercial manufacturing processes. Michael Abad, engineering section manager, Abbott Laboratories shared insight from a project within Abbott in his presentation "Engineering for PAT" at Interphex today.

Abbott Forwards Project Using Process Analytical Technology

Implementing process analytical technology principles can be a challenging task. This article presents a straightforward approach.

The Five Steps to Starting PAT

Several problematic issues are associated with the development and installation of automated drug manufacturing and testing processes. The author addresses how vendors can overcome these factors to deliver robust automation across multiple sites.

Commercial Product Supply of Robotic Automation to the Pharmaceutical Industry

Innovations in process analysis and control offer significant opportunities for improving pharmaceutical manufacturing operations

Process and Automation