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Publications

Date Title Abstract / Details Download options

January 2010

Atmospheric Spray Freeze Drying: A New Approach

The ASFD process has been developed as a new method for manufacturing powder. The goal was to reduce drying time and operate atmospheric conditions with reasonable collection efficiency.

PDF, 289KB Download.

November 2009

White Paper: Using Laser-Based Headspace Moisture Analysis for Rapid Nondestructive Moisture Determination of Sterile Freeze-Dried Product

Residual product moisture content is a critical parameter when considering stability and shelf life of lyophilized product. Traditional moisture analysis includes Karl Fischer or TGA methods. Replacing these methods with a rapid non-destructive method would streamline moisture analysus and improve the quality of the finished product.

PDF, 2.2MB Download.

November 2009

A study of vial headspace moisture in an entire freeze dried batch and the factors affecting moisture content variability.

The moisture content within a freeze dried material has a direct effect on long term stability and storage temperature. Estabilshing moisture content uniformity is an important quality control tool.

Presentation in PDF format, 422KB Download.

April 2009

Why, What, How - Understanding the Freeze Drying Process

An overview of the freeze-drying process, designed for those with little or not experience of the process. This article also looks at the importance of critical temperatures in formulation and cycle design.

PDF, 208KB Download.

August 2008

Freeze-Dried Cakes - Where is the Water?

Frequency Modulation Spectroscopy is a relatively new technique that measures the moisture and pressure in the vial headspace. The aim of the study is to understand the relationship between the moisture analysed by Karl Fischer and Frequency Modulation Spectroscopy and further our understanding of product-water interactions within a freeze dried cake.
This study was carried out in collaboration with Lighthouse Instruments - visit their website here.

PDF, 2.5MB Download.

August 2008

The Use of Impedance Analysis for the Study of Critical Events in the Frozen State, for Formulation and Lyo-Cycle Development

Lyotherm2 was employed to analyse a wide range of simple solutions and more complex formulations prior to freeze-drying in order to establish whether the measurement of Zsinφ can provide meaningful information that other techniques may be unable to detect. Carried out in collaboration with NIBSC - visit their site here

PDF 1.2MB. Download.

January 2008

The Importance of Critical Temperatures in the Freeze Drying of Pharmaceutical Products

Every formulation will have a critical temperature, below which it should be cooled in order to minimise processing defects. Therefore in order to design freeze drying cycles on a rational, product-specific basis, such information should be identified. Abstract

PPT 1.8MB. Download.

PDF 1.0MB. Download.

October 2007

Advanced Uses of Freeze-Drying Microscopy for Product Formulation and Lyo-Cycle Development

Presentation.

PPT 12.6MB. Download.

PDF 3.0MB. Download.

June 2007

Electrical Impedance Analysis of Nutraceutical Formulation Stability in the Frozen State

Presentation. Downloads from www.HealthLinks-Events.co.uk.

PDF, 363KB. Download

December 2003

Development of a freeze-drying protocol for model protein Lactate Dehydrogenase

Objectives: To use a range of thermal and analytical techniques to evaluate the applicability of a range of excipient formulations containing lactate dehydrogenase; To determine whether any correlation exists between the key parameters determined by these methods with respect to freeze-drying behaviour and final product qualities.

PPT 2.8MB. Download.

PDF 194KB. Download.

September 2003

An investigation using thermal and microscopic analysis to determine an optimal freeze-drying protocol for lyophilized proteins

The aim of this study was to evaluate the pre- and post- lyophilisation properties of a large series of protein-excipient combinations using different analysis methods. The success of these mixtures were evaluated on the basis of retained protein activity and other qualitative and quantitative analyses.

PPT 2.8MB. Download.

PDF 166KB. Download.

August 2003

Rationalising the freeze-drying of protein formulations: Comparison of a series of pre- and post- lyophilisation properties

The aim of the study was to evaluate the pre- and post- lyophilisation properties of a large series of protein-excipient combinations and to evaulate them on the basis of retained protein activity and other qualitative and quantitative analyses.

PPT 3.1MB. Download.

PDF 257KB. Download.

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