What a CE-marked laboratory instrument should arrive with: the declaration of conformity, technical file evidence, test reports, labelling and EU representative details - and the six gaps that stop a shipment at customs or an audit.
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Low viability after thawing usually has one of ten causes. A troubleshooting table ordered from most to least likely, with the check that confirms each one and the fix that actually changes the result.
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Vials and bags are not interchangeable at the thaw step. How volume, thermal contact, records and downstream handling differ, and which container forces which instrument choice.
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DMSO protects cells at -80 °C and harms them at 37 °C. Why the minutes after thaw matter more than the freezing step, how to dilute without osmotic shock, and the four mistakes behind most losses.
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GAMP 5 is a risk-based framework, not a regulation. What it actually asks of a bench-scale instrument, which software category a thawing device falls into, and the four documents that are enough.
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Why the -1 °C/min rate an isopropanol box delivers drifts with alcohol concentration, and what changes when the container reaches the same rate with no liquid medium at all.
Read article →Send the cell line, container format (1.5/2 ml tube, 5 ml tube, 50 ml bag) and throughput. You get a written recommendation, spec sheets and dealer terms.