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Watch how easy it is to change out the wetted parts on the new 45cm diameter column.
Astrea Bioseparations Webinar#6 - The Role of Process Development in Chromatography
Astrea Bioseparations announces acquisition of Essential Life Solutions
Astrea Bioseparations fitting guide for Evolve columns accessory support bracket
Section 1 contains Astrea Bioseparations Ltd Quality Policy & Accreditation
Section 8 contains a technical user guide and packaging information.
The regulatory support file for EvolveD columns contains all relevant support information to use the columns for GMP production purposes.
Section 9 contains version control and document approval.
Section 7 contains information related to stability and shelf life of the packed columns. This includes an efficiency study, mechanical stability study (of the empty column) and a sanitisation study.
Section 4 contains analytical information and methods used.
Section 6 contains safety information including shipping studies to demonstrate the column packing robustness.
Section 5 contains details of extractable and leachables, including supporting documentation on materials of construction, a risk assessment and a column schematic.
Section 3 contains details of the product specifications, including an example of certificate of analysis and labelling.
Section 2 provides a brief overview of the EvolveD column.
Learn about our approach to implementing a GMP compliant Quality Management System, the issues that arose and how we dealt with them.
A review of pre-packed EvolveD™ column technologies from Astrea Bioseparations, providing ready to use GMP columns. An open platform suitable for any Bioprocess chromatography media.