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 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.