Lyo Controlled Ice Nucleation

Assessing Process Performance of Controlled Ice Nucleation


Analyzing the controlled ice nucleation process with a focus on the process performance and product attributes

What is controlled ice nucleation?

Lyophilization, or freeze-drying, has been around for centuries, dating back as far as the 13th century. However, in the past few decades there has been little change to process design, monitoring, and quality control assessment. Controlled ice nucleation (CIN) technology is a new method to improve efficiency in time and cost for lyophilization in addition to increasing batch homogeneity and product quality.

controlled ice nucleation CIN freeze drying lyophilization microporosity
Quantitative data gathered from XRM images using artificial intelligence to calculate the microporosity size of two samples processed at different temperatures.

The technique involves cooling the batch to a specific temperature in order to reduce the randomness that ice generation can bring to a lyophilized sample such as ice crystal size and distribution. DigiM’s non-invasive X-ray imaging has been used to improve the understanding of the relationships between CIN process parameters and performance with product quality attributes. With AI technology, microstructure quality attributes including microporosity and cake wall thickness can be directly quantified.

Our Expertise

In Numbers


Programs Supported


Formulations Digitized


Pharmaceutical Partners

stats background

Transform Your Program with Microstructure Science

Get started with a drug product digital twin.