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Published on 9 June 2010

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Detection of silicone oil leakage in freeze dryers

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On 4th May GEA Pharma Systems hosted the practical part of an interest group meeting on behalf of the Parenteral Drug Association (PDA) to explore problems associated with the occurrence of silicone oil leakage in freeze dryers.

The meeting was attended by 27 senior freeze drying experts from leading European pharmaceutical companies.

Leaked oil can cause contamination of the product if not detected early and controlled adequately. Silicone oil leaks in freeze dryers can be caused by the demanding conditions that occur within the equipment. These include pressures between 2 bar and 0.1 mbar and temperatures as low as -90°C. These pressures, in combination with the mechanical movement of the shelves, cause considerable stress within the machinery that can, after years of operation, cause small leaks in the silicone oil circulation system.

The meeting was chaired by Dr Harald Stahl, Senior Pharmaceutical Technologist for GEA Pharma Systems. Harald also joined with his GEA colleague Daniel Steinkellner to discuss an in-line system to detect traces of silicone oil in a freeze dryer. The two other speakers during the morning were Iftekar Ahmed from Maya Heat Transfer Tech who presented simulation results showing the distribution of silicone oil within freeze dryers; and Claudia Dietrich from Schott Forma Vitrum who compared the benefits of different types of containers for freeze drying.

In the afternoon a successful demonstration of the in-line detection of a defined small quantity of silicone oil (less than 10 ppm) in a production scale freeze dryer (>20 m² shelve area) was conducted at the premises of GEA Lyophil GmbH. This method based on mass spectroscopy allows the early detection of leaks.

To find out more, please click on the link below:

GEA Pharma Systems



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