Manufacturing

Christian Dunne is Aseptic global product manager at ChargePoint.

Articles

Choosing the right contamination control platform requires considerable research into what a product needs for an effective process design.

Aseptic Transfer Technology: Weighing Up the Advantages of Varying Approaches for Sterile Drug Manufacturing

Simon Cote is a principal engineer, Technical Customer Services, West Pharmaceutical Services, Inc.

Ready-to-use components eliminate the need for component preparation by the drug product manufacturer, enabling them to streamline their processes and focus on their core competencies, such as drug product development and manufacturing.

Ready-to-Use Parenteral Packaging Components Address Evolving Aseptic Fill/Finish Requirements

Ed Trappler is president and founder of Lyophilization Technology, Inc. a contract research and technical services firm dedicated to freeze drying. He has over 40 years of experience in lyophilization that ranges from product development to equipment application engineering. He received his Bachelor of Science degree in chemistry at The College of New Jersey. His experience in the pharmaceutical industry includes product development, toxicology supply preparation, clinical manufacturing and parenteral production.

Amy M. Bosch is Scientist I at Lyophilization Technology, Inc. (LTI). As a Scientist I and Project Director, she is involved in managing client projects including product and process development, clinical and toxicological material preparation, technical support, and troubleshooting. Amy holds a B.S. degree from Millersville University in Biology. 

Understanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials--and the respective limitations--aids in selecting the most appropriate method for testing.

Residual Moisture Testing Methods for Lyophilized Drug Products

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

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.

Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?

Lies That Environmental Monitoring Systems Tell

Telstar has a dedicated process analytical technology (PAT) corner at its booth to display new developments for pharmaceutical freeze drying systems and aseptic manufacturing processes. 

Telstar Presents PAT Tools for Freeze Drying and Aseptic Manufacturing at Achema 2018

The technology, known as Verifi, is available with the ChargePoint’s range of valves that ensure safe and contamination-free handling of API and other formulation ingredients.

ChargePoint Technology Launches Smart Monitoring Technology at Achema 2018

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.

Freeze-Drying Process Optimization

Hallie Forcinio is BioPharm International's packaging editor, editorhal@sbcglobal.net

Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.

Improving Visual Inspection

Manuel M. Garza is a principal consultant with PAREXEL Consulting, a subsidiary of PAREXEL International, manuel.garza@parexel.com.

Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.

How to Plan Smoke Studies

Understanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials-and the respective limitations-aids in selecting the most appropriate method for testing. 

Aseptic/Sterile Processing