Manufacturing

Articles

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2010 edition from EMD Millipore and Sartorius.

October 2010 Editor's Picks: Products from EMD Millipore and Sartorius

Salavadi S. Easwaran is Technology Manager-PMT, at Merck Millipore, India.

The willingness of the industry to use single-use bioreactors is currently influenced by the criticality of the step, the value of the product and the time for product development and production.

The Pros And Cons Of Single-Use Systems

Jerold Martin was the senior vice president of global scientific affairs at Pall Life Sciences and the chairman of the Board and Technology Committee at Bio-Process Systems Alliance.

The development of quality agreements has long been recognised as a critical activity to ensure a product's quality meets regulatory requirements.

Developing A Quality Agreement Template For Single-Use Systems

The authors describe the operational requirements and design of a process-ready PAT-based IBD system.

Process Analytical Technology-Based In-Line Buffer Dilution In Downstream Bioprocessing

US Pharmacopeia apparatuses for testing the dissolution of transdermal drugs produce good, reproducible results. Yet some scientists believe that further modifications could improve the instruments? suitability for this application.

How Can We Improve Dissolution Testing for Transdermals?

Life-sciences companies spend proportionally more resources on information technology and get less in return on their investment than companies in other industries. The poor return on investment partly results from regulatory costs that are unique to the pharmaceutical industry, but also stems from a failure to manage data strategically.

Using Strategic Data Management to Boost Efficiency

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2010 edition from ATMI and SciLog.

May 2010 Editor's Picks: Products from ATMI and SciLog

The author proposes techniques, based on Six Sigma methods, for monitoring such processes to discover their airflow patterns and reduce opportunities for spillage.This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

Spillage Prevention and Airflow-Pattern Monitoring for High-Shear Process Operations

Thomas Paust is global director of marketing at Sartorius Stedim Biotech GmbH in Goettingen, Germany.

The authors describe the origins of single-use components and explain their application to aseptic processes. They also show how disposable devices have changed over time and offer a glimpse of the future.

The Evolution of Single-Use Technologies in Aseptic Processing

Drugmakers have many incentives to avoid overfilling their containers, including the scarcity, and correspondingly high cost, of certain cells and ingredients. These concerns highlight the need for techniques that can fill small volumes of product with great accuracy. Many strategies are available to the industry, but which one works best?