Manufacturing

Articles

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?

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 revisit their previous effort to refine the terms that describe interventions and to dispel confusion that arose after the original article was published.

Revisiting Interventions in Aseptic Processing

Richard Bhella is Global Product Manager, Single-Use Storage and Delivery Technologies at ATMI Lifesciences.

The growing uptake of single-use sterile packaging in pharmaceutical production processes mirrors the broader trend towards single-use across every sector of the pharmaceutical industry.

Developing Sterile Packaging For Aseptic Environments

Maik Guttzeit is Head of Quality Assurance at GEA Pharma Systems, Germany.Tel: +49 2233 6999 401 

This article examines the difficulties in designing lyophilisation processes that can be faithfully scaled up to production volumes and suggests the most effective ways in which this can be achieved.

Designing An Effective PAT-Driven Scale-Up Of Lyophilization Processes

Duke University researchers have found a possible alternative to lyophilization.

A Glass Act

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

There are a variety of vaccine types, each varying in safety and efficacy, and each possessing its own formulation challenges. To overcome potential instabilities when developing vaccines, one formulation strategy is to produce a dried product.

Developing a safe lyophilised adjuvant vaccine

The most important consideration when choosing a freeze dryer is to ensure the system is fit for both today's applications and future needs.

Selecting a freeze dryer

Pharmaceutical Technology Europe discusses some of the latest challenges and innovations in pharmaceutical lyophilization.

Challenges and trends in lyophilization

Last year, a member of the PTE editorial team attended the 2nd Annual Lyophilisation Conference in London (UK).

Manufacturing, Parenterals and Injectables