Manufacturing

Articles

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

Process Analytical Technology: Real-Time Reliability

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

Analytical Methods Validation In-Process Control Methods for the Manufacture of Active Pharmaceutical Ingredients

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.

PAT and Process Understanding: A Call to Arms

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.

Automation in a Digital, Webbed, and Wireless Age

Nancy Mathis, PhD, is employed by Blend-Tech, 14 Easton Ave., #360, New Brunswick, NJ 08901-1918, tel. 866.425.3637, fax 866.881.8080.

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

Process Analytical Technology: A First-Birthday Standardization Update

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.

Validation and Compliance: Software Systems Prepare Manufacturers for Com(PAT)ibility

Justin Neway, PhD, is executive vice-president and chief science officer at Aegis Analytical Corporation.

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

Filling the Void: PAT in a Connected Manufacturing Environment

Mark L. Balboni is a senior compliance consultant at KMI, a division of PAREXEL International, LLC.

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

Process and Automation