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Understanding siliconization by measuring silicone oil layer distributions
20 January 2009
Understanding siliconization by measuring silicone oil layer distributions
About the Workshop
Rapid
Prefilled syringes are of growing importance in the pharmaceutical manufacturing. Silicone oils are usually applied to the containers to form lubricating films on the inner surface of prefilled syringes or to gain hydrophobic container walls.
However, there are several issues related to the interaction of silicone oil and particular protein based formulations like agglomeration (of the active) and absorption of the API in the silicon layer
In order to control the siliconization process methods like weighing of silicone oil or the determination of silicone oil by extraction and measuring the content with AAS (atomic absorption spectroscopy) are currently used. But these technologies are very time consuming and not able to give an information about the silicone oil distribution within the barrel of the syringe.
Recently white light interference was developed as a technology which is able to measure reliably the silicone layer thickness in a syringe in a few seconds. The accuracy can be verified with known standards. Data will be shown for the  correlation of this technology with  data as force displacement measurement and extraction results.  Furthermore the influence of different kinds siliconization of the silicone layer will be presented. The application of the technique in the analysis of failures and process variations will be shown.
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About the workshop Leader
Dr. Markus Lankers is one of the co-founders of rap-ID Particle Systems GmbH a company that develops manufactures and sales rapid particle identification and siliconization measurement systems. Within rap.ID Dr. Lankers is responsible for research and development of specific solution of particulate analysis. Prior to this position he worked as scientist in different development departments with Schering AG, Berlin, Germany. He has published and presented work in the field of analytical methods for particle analysis and spectroscopic analysis.
He helped to establish the Visual Inspection of Parenterals Interest Group in Europe and to setup the first company independent vis. Inspection trainings course. He served as program cochair for Scientific Conference on Visual Inspection of Partenterals 2001-2007  in Europe and USA.

Workshop agenda

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13:00

Registration

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13:30

Reasons, types and methods of siliconization

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14:10

Test Methods

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14:50

Afternoon Tea

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15:20

Influence of process parameters on silicone layer

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16:00

Characteristics of silicone oil layers in dependence of siliconization process

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16:40

Summary and Close of Workshop

VENUE

Crowne Plaza Hotel - St James

Buckingham Gate 45/51, London, United Kingdom

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Crowne Plaza Hotel - St James

Buckingham Gate 45/51
London SW1E 6AF
United Kingdom

Crowne Plaza Hotel - St James

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