Sartorius Stedim Biotech GmbH is a global partner of the biopharmaceutical industry and helps to develop production processes and manufacture biotech medications and vaccines more efficiently. Technologies cover, inter alia, cell line technologies, cell culture media, bioreactors, and a wide range of products for separation, purification, and concentration of biological intermediates and finished products, as well as solutions for their storage and transportation.
A new centrifuge system for the purification of biotechnology products for industrial downstream processes was to be developed, tested and made market-ready at the Göttingen site.
gempex supports Sartorius Stedim Biotech GmbH.
For the development verification and qualification of the new centrifuge system, an external test manager was to act as an interface between product development, quality management and project management, providing coordination support and ensuring GMP compliance.
As part of the team, the role of test manager was implemented at the customer as a coordinating interface between project management, quality experts and development engineers as well as laboratory specialists. In close coordination, the necessary hardware and software tests were derived in the respective product development phase and optimized planning was carried out, taking into account resource availability and given milestones.
Qualification plans were drawn up to demonstrate compliance with the respective requirements. The aim was to ensure compliant and traceable test documentation that could be used by practitioners in the laboratory. Specifically developed templates were used to generate test reports and verification documents that fit neatly into the customer's quality management system.
With regard to GMP, competent consultancy and support was provided in the creation of test specifications, derivation of acceptance criteria and measurement uncertainty analyses. Risk analyses were used in the evaluation of deviations.
The new Ksep® 50 Centrifuge System was, comprehensively tested and qualified, successfully launched on the market.
Key Performances of gempex were:
- Test management
- Project management for product testing
- Verification and qualification
- Test planning and support test specification
- Measurement uncertainty evaluations
- GMP and quality management consultancy
- Qualification documentation
- Strengthening resources and external expertise
For any questions on the topic Quality-Management for GMP-Compliance, Ralf Gengenbach, Managing Director of gempex GmbH, will be happy to be contacted via contact@gempex.com.