Manufacturing

Articles

Even when all is well at the facility, one must expect the worst while braving the elements.

Frozen Assets

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Experts share insights into analytical tools and techniques.

Analytical Tools for a Quality-by-Design Approach to Lyophilization

Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.

Lyophilization: How to Meet Scale-Up Challenges Using QbD

Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers.

Using Closed-Vial Technology in Aseptic Filling

Experts discuss the best practices for developing a QbD-based lyophilization process.

Freeze-Drying: Is Technology Advancing Fast Enough?

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

There are no two completely identical freeze dryer units in operation anywhere.

The Freeze Drying Challenge

Lyophilisation is often necessary for pharmaceutical products to improve stability or shelf-life. However, the process can present difficulties, particularly when scaling up from the laboratory to commercial production. We bring experts together to discuss best practices for developing a lyophilisation process, including quality by design (QbD) and design space.

Freeze Drying: The Experts' View

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

Comparing Lyophilization in Vials and Dual-Chamber Systems

We have changed the brand of our stoppers for a product that we freeze-dry in vials. Since the change, we have observed a significant increase in rejects for collapsed cakes. Why are the cakes collapsing? What can we do to prevent this problem?

Collapsed Cakes

In our manufacturing process, we are running into issues with our vial stoppers clumping in the feeder bowl. How can we ensure that the stoppers go through smoothly without clumping up?

Manufacturing, Lyophilization