Pharmaceutical Manufacturing Preview

September 2015 Issue Preview

Ad Closing: August 14, 2015 | Material Closing: August 21, 2015

Special Report
Pharmaceutical Packaging Trends 2015
Most everything the consuming public consumes is delivered in some form of packaging, and that is especially true for pharmaceuticals. Packaging in Pharma takes on many important roles and it is integral to pharmaceutical manufacturing's core values of delivering safe and effective medications to their users. Certainly a broad category, Pharmaceutical Manufacturing's editor-in-chief Steven Kuehn will look across the landscape and the horizon to bring a balanced view of this dynamic-technology driven sector and where the industry is innovating to fulfill packaging's increasingly vital mission.

Operational Excellence
Designing and Implementing a Compliance Process with Global Governance
Technical or asset change refers to the modification of any defined automated or manual technical system or its documentation. Because the modification may impact production processes or product characteristics, Asset Change Control (ACC) is a key regulatory requirement (see ICH Q7A, ISO or FDA Pharmaceutical cGMP Regulations). Arne Buthmann, author and Pharma Practice Area leader at Valeocon Management Consulting, outlines the path a prominent, leading Branded Pharma player took to align this aspect of compliance across its facilities worldwide.

Technology at Work
Advanced Filter Technology Optimizes High Viscosity Blow-Fill-Seal Filling
Dedicated to sterile monodose parenteral products, Unolab Manufacturing S.L., a Spanish CMO, offers its customers access to advanced BFS technology to fill customer's products into their final dosage forms. Specializing in liquid ophthalmics, Unolab processes a variety of formulations including highly viscous, high-density, large molecule formulations with viscosities as high as 80 centipoise. Difficult to filter efficiently, this solution from Pall helps Unolab speed its sterile BFS process and get these compounds to market that much faster.

Best Practices
Biopharmaceutical Manufacturing's Top 15 Trends for 2015
The quest for efficiency continues in Biopharma as demand fuels capacity growth and process throughput. Eric S. Langer and Jean-Claude Lupis, of BioPlan Associates Inc., offer their answer to the question: "What's driving Biopharma manufacturing production in 2015?" To get to that answer and rank the industry's Top 15 trends for 2015, Langer and Lupis drew insight from their "12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production" as well as input from BioPlan's Biotechnology Industry Council, a panel of more than 500 biopharma industry subject matter experts.

Proactive Quality & Control
Photonics for Improved Pharma Process
In the multidisciplinary pharmaceutical industry, photonics plays an increasingly crucial role in the manufacturing process. According to author David Benderly, CEO, PhotoScribe Technologies, from quality assurance to marking, the scope of photonics is wide-reaching. Specifically, the use of lasers and machine vision in oral solid dose (OSD) manufacturing is revolutionizing functionality, security and speed while reducing costs and boosting efficiency.

Automation & Control
Environmental Monitoring FAQs
Data loggers can measure nearly any physical or electrical value, so they're used in many laboratory applications, whether to record data from experiments or to handle measurement of the required temp and humidity for equipment such as refrigerators and freezers, incubators, climate chambers, autoclaves, etc. CAS Dataloggers' Stewart Thompson offers a quick guide to better application of these devices.

Product Round-Up
Packaging Systems and Technology
Product round-up from prominent packaging system and related equipment suppliers.

Advertising & Editorial Information

For advertising information contact your district manager or Mark Wiebusch, Publisher, at 630/467-1300 ext. 393, 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