May 19 2010
rap.ID Particle Systems GmbH provides instrumentation, applications, and laboratory contract testing support to most of the world's top industrial companies and academic institutions for fundamental research, product development, quality assurance and control, production, and process control applications.
Silicone Oil Layer Control:
The Layer Explorer (UT) is integrated with precision technology for advanced silicone oil layer detection down to 15 nm in prefillable syringes. The LE(UT) quickly determines the thickness and chemical distribution of the silicone oil layer in syringes and other pharmaceutical glass or plastic containers. All data such as position, layer thickness, audit trail information, and raw data are stored in a 21 CFR Part 11 compliant format.
Layer Explorer BI : Controls Baked In (Emulsion)Silicone Oil Layers from 50 nm and larger.
Layer Explorer + Single Particle Explorer = Monoclonal Antibody Development
Combined analyses offer quick formulation optimisation in primary packaging with regard to the formation of agglomerates. The combined analysis methods provide comprehensive product information that facilitate modern Quality by Design (QbD) in parenteral product development and control.
2010 has been a year of new product developments and improvements.