Volume 27, Number 1

Table of Contents

Articles

NIR spectrometry for the characterization of fuel components in a novel tamper-resistant pill bottle

Choosing Technologies for Aseptic Filling: “Back to the Future

by James Agalloco, James Akers, Russell Madsen
This article reviews the considerations involved in the selection of appropriate technologies for aseptic processing. It compares and contrasts conventional cleanroom operations, Restricted Access Barrier Systems (RABS), and isolation technology with respect to the advantages/disadvantages of each for use in aseptic filling. It evaluates all aspects of the selection process, beginning with project time lines, facility concerns, operation, and compliance.

Advanced Aseptic Processing: RABS and Isolator Operations

by Eric A. Isberg
This article compares the use of Restricted Access Barrier Systems (RABS) and Isolator Systems for product final fill operations.

The Physical Chemistry of Decontamination with Gaseous Hydrogen Peroxide

by Carl Hultman, Aaron Hill, Gerald McDonnell
This article reviews the physical chemistry of the safe production of hydrogen peroxide vapor and how to maintain a constant concentration of the vapor in a chamber. This article also reviews the calculations and procedures used to obtain the maximum concentration of vapor without allowing condensation of liquid to occur.

Automated Loading and Unloading Systems for Lyophilizers

by Peter Heyman
This article discusses the basics of Automated Loading and Unloading Systems (ALUS), including the differences between fixed and flexible systems, as well as covers the evolution of the technology, challenges associated with the use of such systems, industry growth, and recent technology trends.

Biofilms – Survival and Growth of Bacteria in Compendial High Purity Water Systems

by Frank Riedewald, Aidan W. Sexton
This article presents an overview of how bacteria can grow and multiply in compendial water systems.

The Use of Virtual Infrastructures in Pharmaceutical Manufacturing

by Adrian Wildangier, Jon Jensen
This article presents the ability to consolidate various regulated and non-regulated applications onto the same physical server hardware, and discusses how system virtualization works, benefits and limitations, and how to qualify such an infrastructure.

Industry Interview Series:

Dr. Gold talks about the challenges of a small company bringing a drug to clinical trials and incorporating advanced manufacturing methods that involve cooperation between manufacturer and equipment vendors.

Thin-Cake Filtration Technologies for Removing Activated Carbon, Catalysts, and other Trace Solids from Active Pharmaceutical Ingredient (API) Slurries 

by Barry A. Perlmutter
This article discusses how the use of thin-cake vertical candle filters and horizontal pressure plate filters can efficiently remove activated carbon, metal catalysts, and trace insolubles from Active Pharmaceutical Ingredient (API) slurries.

Departments

Global Regulatory News

New Products and Literature

Industry and People

ISPE Update

Classified Advertising

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