Articles

Implementing Disposable Cleanroom Apparel into the Manufacturing Process

In the case of disposable cleanroom apparel the benefits can include an easier gowning process, elimination of variability in filtration performance that can result from reusing apparel, less waste and improved levels of contamination control.
Post Date: 05/02/2012
Author: Damon Larkin, Category Manager at Kimberly-Clark Professional

Striving for a Better Prefilled Syringe

West and Vetter look to meet the needs of parenteral manufacturers demanding new, safer syringe options.
Post Date: 03/28/2012
Author: Paul Thomas, Senior Editor

Split Decisions: Tablet Scoring Under More Scrutiny

FDA provides more direction as questions arise about dosage consistency.
Post Date: 01/11/2012
Author: Paul Thomas, Senior Editor

NIPTE, IPEC Work to Standardize Excipient Properties Database

Excipients, many of them naturally derived, are a source of variability in drug manufacturing, as differences in processing and other factors can lead to significant differences in the properties and performance of materials of the same grade, not only between different vendors but from the same vendor.
Post Date: 04/14/2011
Author: Agnes Shanley, Editor in Chief

Optimizing Coating Parameters to Improve Tablet Performance by Means of Terahertz Pulsed Imaging (TPI)

Through TPI, coating thickness that can be correlated to both the mean dissolution time and the onset of dissolution. TeraView’s Alessia Portieri, PhD, details how.
Post Date: 03/02/2011
Author: Alessia Portieri, PhD

Taking the Plunge to Harmonize Pharmaceutical Regulations

Within the past five years, more of world's regulatory agencies and pharmacopeias have gotten on the same wavelength.
Post Date: 03/04/2010
Author: Agnes Shanley, Editor in Chief

Getting More Scientific About Tableting

Last month brought news of resources and newer techniques being brought to bear on tableting.
Post Date: 02/23/2010
Author:

A Business Case for Isolation Technology

Every sterile facility is unique, but a recent Jacobs study suggests that advanced isolation technology pays dividends in the long run.
Post Date: 01/11/2010
Author:

Putting Particulates on the Map

Contamination mapping isn’t exactly cartography, but it can be an effective troubleshooting tool.
Post Date: 01/06/2010
Author: Paul Thomas, Senior Editor

Pharma Facilities: Can One Patent Agility?

A facility design under development for a decade is now gaining appreciation.
Post Date: 12/07/2009
Author: Agnes Shanley, Editor in Chief

Flexible Pharma: Puzzling Out the Plant of the Future

The need to improve agility and reduce financial risk is driving new approaches to plant design and operation, and the use of new technologies. Industry experts look at the future pharmaceutical plant from all angles.
Post Date: 11/30/2009
Author: Agnes Shanley, Editor in Chief, with Paul Thomas, Senior Editor

Get a Grip: Controlling Solid Product Properties

Spectroscopic and other analytical techniques can enhance control of blending, granulation, drying and coating.
Post Date: 08/12/2009
Author: P. Patel, R. Kamani, B. G. Prajapati, S. Atara, A. M. Suthar

Aseptic Blow-Fill-Seal Technology vs. Traditional Aseptic Processing

Acknowledged by the FDA as an advanced aseptic process for the packaging of sterile pharmaceutical liquids, blow-fill-seal technology is gaining increasing acceptance by providing a high assurance of product sterility, eliminating the need for human intervention, improving flexibility in container design and ...
Post Date: 06/25/2009
Author: Chuck Reed, B.Sc/MS Director, Sales & Marketing, Weiler Engineering, Inc.

Value-Adding Valves

From plant to process, having the right valve in place, and healthy, can save time, energy, money and, yes, headaches.
Post Date: 06/05/2009
Author: Paul Thomas, Senior Editor

Low-Risk Lyophilization

Developing a successful lyophilization program requires equal parts design, technology, and expertise.
Post Date: 03/16/2009
Author: Brian Bucur, Associate Director, Lyophilization & Sterilization and Timothy ...

Air-Coupled Acoustics: Sound PAT for Tablet Characterization

A non-destructive, online technique aims to meet the increasing demands of tablet quality.
Post Date: 03/12/2009
Author: Ilgaz Akseli and Cetin Cetinkaya, Clarkson University

Interphex Stands Test of Time (and Economy)

Despite a tough economy, few question the value of attending Interphex, and this year’s show promises to be as good as ever.
Post Date: 02/05/2009
Author: Paul Thomas, Senior Editor

The Sleuthing Behind Heparin

Finding the contamination source was no small feat.
Post Date: 09/10/2008
Author: Emil Ciurczak, Contributing Editor

Weak Links

A recent survey suggests that manufacturers don’t have as much control over supply chain security as they think they do.
Post Date: 09/03/2008
Author: Carla Reed, Marsh Inc.

Vaccine Manufacturing Déjà vu: A 483 Review

Noncompliance appears to focus on the same issues: inadequate SOPs, root cause analysis and CAPA
Post Date: 06/24/2008
Author: Agnes Shanley, Editor-in-Chief