08 June 2010
PDA Interest Group Meeting - Hosted by GEA Pharma Systems
Detection of Silicone Oil Leakage in Freeze Dryers
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, held at the Marienburger Bonotel Hotel in Cologne, 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 m˛ shelve area) was conducted at the premises of GEA Lyophil GmbH. This method based on mass spectroscopy allows the early detection of leaks.
Latest results from the ongoing project will be demonstrated during the PDA annual Freeze Drying Conference in November 2010 in Vienna.
For further editorial information contact:
Steve Jordan - The Words Workshop Ltd.
26 Swanwick Lane, Milton Keynes, MK10 9LD
Tel: (44) (0) 1908 695500 Fax: (44) (0) 1908 690099
E-mail: steve@thewordsworkshop.co.uk
Web: www.thewordsworkshop.co.uk
For further business information contact:
Dr. Harald Stahl – GEA Pharma Systems
Senior Pharmaceutical Technologist
harald-stahl@geagroup.com
www.geapharmasystems.com
Editor’s note:
GEA Pharma Systems is dedicated to innovation and thereby providing durable quality through its well-established brands: Aeromatic-Fielder™ and Collette™ - batch and continuous granulation, drying, pelletizing and coating; Buck® - contained materials handling; Courtoy™ - tablet compression; and Lyophil™ - pharmaceutical freeze drying.
2010 Pharmaceutical Freeze Drying Technology: Modern Trends in Production
November 23-24, 2010 | Vienna, Austria |
Overview
Freeze Drying is one of the most popular routes for stability enhancement of temperature sensitive products. Even though it has been used in pharmaceutical production for many decades the process is still not completely understood. This conference will provide a forum to present and discuss new developments in freeze drying process understanding. As a result of ICH Q9, risk based approaches will receive a greater focus. The minimization of risk will be a key topic which will be examined from an investment point of view as well as from a quality assurance perspective. As during the Interest group meeting in April, the detection of traces of silicone oil had a huge amount of interest. As a result an update on strategies to minimize the risk connected to the products will be presented on this conference.
This conference is an excellent opportunity to learn more about the latest developments in freeze drying and to discuss these with the experts. We have provided time in the program for networking with the speakers and for discussion of your specific challenges. As in past years, the meeting will feature an exhibition where attendees can learn about the latest in freeze drying hardware and in process control systems. |
Contacts
For additional conference information, please contact:
PDA Europe gGmbH
Adalbertstrasse 9
16548 Glienicke/Berlin, Germany
Tel:+49 (0) 33056-237710
Fax:+49 (0) 33056-237777
info-europe@pda.org |
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