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Validation of Cryopreservation Bags - CBMTG

Validation of Cryopreservation Bags - CBMTG

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<strong>CBMTG</strong> Laboratory Committee-Laboratory GuidanceSummary <strong>of</strong> <strong>Validation</strong> <strong>of</strong> <strong>Cryopreservation</strong> <strong>Bags</strong>Miltenyi Biotech CryoMACS Freezing Bag 250 (mfg # 200-074-406)# <strong>of</strong>bagstestedCRYO SOLUTION FREEZING STORAGE TRANSPORT THAW10%DMSOother uncontrolled controlledliquidphaseLN2vapourphaseLN2dry shipper14 0 0 14 0 14 14 0 14 0# <strong>of</strong>failures0 0 0 0 0 0 0 0 0 0otherwaterbathotherOrigen Biomedical Cryostore EVA 500ml (mfg # CS500n)CRYO SOLUTION FREEZING STORAGE TRANSPORT THAW10%DMSO5%DMSOuncontrolledcontrolledliquidphaseLN2vapourphaseLN2dry shipperotherwaterbathother# <strong>of</strong>bagstested 24 2 2 24 8 18 26 0 26 0# <strong>of</strong>failures 0 0 0 0 0 0 0 0 0 0Maco Biotech Freezing-EVA <strong>Bags</strong> 60 - 100ml (mfg # GSR5001AU)CRYO SOLUTION FREEZING STORAGE TRANSPORT THAW# <strong>of</strong>bagstested10%DMSOother uncontrolled controlledliquidphaseLN2vapourphaseLN2dry shipper24 2 2 24 8 18 26 0 26 0otherwaterbathother# <strong>of</strong>failures0 0 0 0 *3 0 0 0 0 0*leaking from end <strong>of</strong> segment after cycle 3 (seal broke after cycle 2 but didn’tleak)May 2010 Page 4 <strong>of</strong> 5

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