Dosage Forms

Articles

The author discusses the relative advantages and disadvantages of lyophilization in vials and dual-chamber systems.

Comparing Lyophilization in Vials and Dual-Chamber Systems

Contamination is almost always related to human error and there is a clear drive to reduce human implications in aseptic operations. This can be achieved in multiple ways.

Avoiding Contamination Risks in Aseptic Processes

The future, and increasingly the present, for aseptic operations is isolated robotics. Companies that wish to gain competitive advantages in their operations are stepping up and taking notice.

Isolated Robotics: The Future of Aseptic Operations

The International Society for Pharmaceutical Engineering will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide and contain practical information about technological advances in sterile manufacturing.

ISPE to Publish Updated Sterile-Product Manufacturing Guide

Podcasts

Meeting Co-Chair Susan Schniepp provides insight into this year's regulatory conference.

PDA-FDA 2011 to Focus on Compliance

Henrik Schwartzbach is a Senior Process Technologist at GEA Niro.

Henrik Schwartzbach, senior process technologist at GEA Niro, explins why spray drying is seeing increased uptake in the pharma industry.

Achieving Aseptic Drying With Spray Drying Technologies

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

The authors question certain aspects of the industry's current regulatory-compliance strategy and suggest that aseptic-process control and evaluation should be revised.

Regulation of Aseptic Processing in the 21st Century

A technical forum moderated by Patricia Van Arnum

Strategies in Parenteral Drug Manufacturing

We want to fill one of our oxygen-sensitive products inside an isolator system. Can we run an isolator with pure nitrogen and defined humidity?

A Nitrogen-Filled Isolator?

Regulators question whether particles that they can't see hurt patients.

Parenterals and Injectables