Process Control, Automation, and PAT

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.

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.

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.

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.

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.

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.

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

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.

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

The role of micro-biological testing in real-time release is too important to ignore.

In recent years, AI has become important in a number of fields in helping to make better use of information, increasing efficiency and enhancing productivity.

EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

Quality by design and PAT approaches are increasingly being used for the biotech manufacturing of medicines. Complex manufacturing processes can not only be controlled using PAT principles, but optimized with respect to both product quality and economic value. This column describes how the fermentation process is often the first to benefit from this type of implementation.

This article examines what other industries have done to address the challenges associated with successfully implementing the principles and concepts of process analytical technology, particularly the specific elements of measurement, analysis, and control. The author explores how other industries' approaches can be applied directly to pharmaceutical manufacturing.

Modeling conducted in the process development and early commercialization stages can increase process efficiency and lead to process-control improvement. A virtual plant environment, running on a PC, can incorporate the same industrial control systems and configuration expertise used in manufacturing and helps many parts of process analytical technology. It also can make possible the enlightened use of technologies such as model predictive control, first-principal models, neural networks, and multivariate statistical process control.

Thermal effusivity and power consumption may help predict granulation end point in high-shear granulators. In this study, power consumption was monitored and compared with percent relative standard deviation (RSD) on thermal effusivity measured at-line. Lactose monohydrate, microcrystalline cellulose, and magnesium oxide were granulated, and the effect of load size on granule growth in a fixed-volume granulator was evaluated using three load levels. Load size, liquid addition rate, and impeller speed were measured, and the correlation among RSD on effusivity, power consumption, mean granule specific surface area, and granule compressibility index were determined.

Contract manufactures are faced with multiple challenges when determining whether to implement process analytical technology into their clients' or their own infrastructure.

The process analytical technology (PAT) initiative has been percolating at the US Food and Drug Administration for a long time, explained FDA's John E. Simmons at the AAPS Annual Meeting and Exposition on Wednesday. "If you think of PAT as an isolated set of applications, I think you are missing the point," Simmons said. "The FDA would like PAT to become commonplace?not to be an initiative, but common practice."

"The better we understand the relationship between process parameters and product attributes, the better control we'll have over product quality," said Beth Fowler, PhD, during Tuesday?s session on process monitoring at the AAPS Annual Meeting.

To implement process analytical technology systems into the current information technology landscape, manufacturers will need to adopt continuously available systems and infrastructures.

The authors propose a strategy for classifying and validating inprocess testing methods.

The C-SOC team must develop a network of committed industrial partners who will participate in the direction, execution, and evaluation of research and educational activities.

ISA-88 Automation Standard Gains IEC PAS Status

Emerging high-tech solutions prepare to cater to industrial automation with promises of increased efficiencies, faster communications, and custom applications.

The author describes the efforts of the standards committees to establish guidelines for PAT implementation and the impact of the guidelines on the industry.

From data acquisition to enterprise resource planning, software systems operating at all levels of pharmaceutical manufacturing prepare for the seemingly inevitable implementation of process anlytical technology.

The author brings attention to the connectivity problems among various data-gathering systems and discusses the drivers and benefits of change, including PAT.

This article outlines the key concepts that define process analytical technology and emphasizes the relevant theory and applications of chemometrics.

A limited number of container sizes, dispensing lanes, computerized tracking, and polyethylene mailing bags are just a few of the new elements of packaging launched at one company's automated pharmacy facility.