Pharmaceutical Manufacturing Preview

July 2014 Issue Preview

Ad Closing: June 13, 2014 | Material Closing: June 20, 2014

Cover Story
All-Star Innovators 2014
Necessity is the mother of invention, or should we say "innovation?" Since last August, vendors, suppliers and PhM contributors have nominated recently introduced products and technologies for their intrinsic innovation and submitted them for consideration by our editorial panel. The top picks become our All-Star Innovators for 2014. The feature covers technologies serving the manufacturing and operational excellence of drug processors across the production continuum from development to packaging.

Best Practices
Designing Weighing Processes with Quality in Mind
Tobias Wölfing is segment marketing specialist for industrial weighing solutions for Mettler-Toledo notes that in pharmaceutical manufacturing, inaccurately measured ingredients can lead to bad batches and waste. If not caught in the manufacturing process, defective products could end up in the hands of consumers, potentially causing physical harm. He contends in this article that when designed well, weighing processes can help ensure consistent final product quality.

Quality and Compliance in Solid Dose Processing
Speaking at PhRMA's annual conference in Washington, DC, FDA Commissioner Margaret Hamburg highlighted recent reasons for concern that quality standards are not being adhered to… as well as the agency's renewed focus on enforcing those standards. "We are … trying to really reshape some of how we address the quality issue, to try to incentivize better practice and more accountability around quality," she said." Contributing editor Emil W. Ciurczak thinks this is the time when we need to be recommitting to it. With the benefit of more than four decades in the industry Ciurczak offers a few observations and recommendations to increase and enforce both compliance and quality in solid dose pharmaceutical processing.

Proactive Quality & Compliance
Integrating Safety Testing Into The Scale-Up Of Pharmaceutical Processes
Authors Swati Umbrajkar, Ph.D., Andrew J. Starkie, Ph.D., and Stephen M. Rowe, Ph.D. of Chilworth Global find that due to the novel nature of the materials being developed by pharmaceutical and fine chemical companies, all the information required for safe scale-up, storage etc, is not readily available. The process lifecycle for a drug and fine chemical manufacture involves multiple stages. Once the chemical route and optimum process conditions have been defined, the scale-up process begins. When scaling-up a chemical process from the laboratory to the pilot plant, and then from pilot plant to plant/production scale, there is an appreciable increase in the risk posed by the process and the authors offer some good advice on how to manage such risk effectively.

Supply Chain Excellence
Eight Opportunities for QbD
Heath Rushing, Principal, Adsurgo explains that mitigating risk within the product lifecycle begins with an open mind As first presented in Guidance for Industry – Q8 Pharmaceutical Development, pharmaceutical development studies should include a systematic understanding of the process to establish a control plan. According to Rushing, although QbD was originally presented in the context of pharmaceutical development, in order to achieve the objectives of a more complete model for pharmaceutical quality system, the QbD mindset should be built into the entire product lifecycle.

Automation & Control
Curb Control Valve Cavitation
Steven Hocurscak and Kyle Rayhill of Neles & Mapag explain note cavitation is a damaging phenomenon that occurs within and downstream of control valves. The damage done by cavitation can impair control valve performance which may require reducing the process throughput (and profits) to compensate. However, there are mitigation strategies and authors guide readers as to which may best, given particular conditions.

Solutions Focus
Piping and Tubing
Product round-up from prominent equipment suppliers.

Advertising & Editorial Information

For advertising information contact your district manager or Tonia Becker, Publisher, at 630/467-1300 ext. 455, Send insertion orders to Rita Fitzgerald, Production Manager, at Pharmaceutical Manufacturing, 1501 E. Woodfield Rd., Suite 400N, Schaumburg, IL 60173; fax 630/467-1120.

For editorial information, contact Steve Kuehn, Editor-in-Chief, at 630/467-1301, Ext. 410,

Pharmaceutical Manufacturing