Pharmaceutical Manufacturing Preview

October 2014 Issue Preview

Ad Closing: September 19, 2014 | Material Closing: September 26, 2014

Cover Story
Clash of the Packaging Titans: Plastic and Glass Wrestle for Dominance
When it comes to the primary packaging of liquid pharmaceuticals, glass has dominated for millennia, literally. However, glass has a real competitor from a more recent innovation dating back to the 1930s; plastic, aseptic, Blow-Fill-Seal (BFS) packaging. According to recent industry research, of all pharmaceutical packaging product groups, parenteral containers will post the fastest gains as advancements in biologics lead to new injectable therapies adapted to prefillable syringes, unit dose vials and other forms. Plastic is gaining ground but there remain very compelling reasons to deliver pharmaceuticals packaged in glass. Editor Steven Kuehn talks to category leaders, industry experts and others in both camps to find out which applications suite each material best.

Best Practices
Preparing for Pharma's Challenging Opportunities
According to Dr. Johannes Rauschnabel, of Bosch Packaging Technology understands that new legislation, expiring patents and increasing healthcare costs call for decisive changes in the global pharmaceutical industry's direction. The coming years will see markets across the globe implement new best practices and manufacturing concepts: What they all have in common is the need for safe, high-quality and consistent operations and Rauschnabel wants readers to know there's never been a better time to institute safe, high-quality and consistent operations to sustain competitive agility and business success.

Management's Role in Sustaining Continued Process Verification
Noted consultant Ronald D. Snee, says companies getting 483 warning letters are now getting criticized for their continued process verification (CPV) approach. Theses observations often include inadequate sampling plans, wrong statistical methods and notes that company employees do not understand the statistical methods being used. Only a single quality engineer knows how the tools are being used. He says the results are predictable: the company scurries about figuring out how to respond including the adoption of better procedures and more clearly explaining the methods being used. So what is the problem here? Who is at fault? The quality engineer? His supervisor? The plant manager? Snee explains how this situation can be remedied.

Proactive Quality & Compliance
Surrogate Testing Helps Predict Performance of Contained Dust Collection Systems
The proper selection and operation of contained dust collection equipment is critical to pharmaceutical plants for a host of reasons, says Camfil's David Steil. From environmental requirements and employee health and safety to production cleanliness and efficiency. Historically, no performance data has existed on contained dust collection systems until they were already installed. Surrogate testing offers a way to provide meaningful performance information prior to installation, to help pharmaceutical manufacturers determine if the equipment will meet required specifications and standards for a specific project.

Supply Chain Excellence
Advantages of Paper or Film Banding in Pharmaceutical Packaging
Banding with paper and film is becoming a preferred packaging option for the pharmaceutical industry to bundle and unitize their products while seeking to improve productivity and reduce costs. Pacific Packaging Products Magdi Bichay outlines the options, features and innovation made possible via this approach to packaging.

Plant Tour
Catalent's Blow-Fill-Seal Jewel
Catalent's Blow-Fill-Seal processing facility in Woodstock, Illinois has for years been busy pioneering BFS filling operations for some of Pharma's most elite companies. The company's legacy of introducing BFS to Pharma allows it to innovate in creative ways for its clients and that's a good thing. Pharmaceutical Manufacturing walks you through Catalent's extremely well organized operations for a closer look at operational excellence in action.

Solutions Focus
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