Moisture Headspace Analysis For Efficient Scaleup Of Freeze Drying Capacity And Validation
Source: Lighthouse Instruments
![Vial analysis Vial analysis](https://vertassets.blob.core.windows.net/image/a3267543/a3267543-b0f3-4cc8-b37e-9139ab06216d/375_250-vial_analysis.jpg)
Background:
- A vaccine production facility needed to replace an old freeze dryer in an existing facility during running operations.
- Activity involved a scale up of freeze-drying capacity from 14 m2 to 28 m2.
- Additional objectives included improvements such as point-of-fill filtration and optimization of the existing lyophilization cycle.
- It was decided to robustly determine intra- and inter-batch variability and use a systematic QbD approach to comply with recent FDA guidelines.
access the Case Study!
Log In
Get unlimited access to:
Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue.
X
Enter your credentials below to log in. Not yet a member of Pharmaceutical Online? Subscribe today.
Subscribe to Pharmaceutical Online
X
Subscribe to Pharmaceutical Online
Lighthouse Instruments
This website uses cookies to ensure you get the best experience on our website. Learn more