Templates for Cyropreservation Bag Validiation


As you may be aware, there is a critical issue facing Cellular Therapy Laboratories todayThe major manufacturer and supplier of cryopreservation bags, in the world, will no longer produce these bags as of May 2010. Almost every laboratory that cryopreserves a product will need to evaluate one or more bag types and validate the bag for use. This is a huge project for the CT community, especially the smaller labs with fewer resources.

The ISCT Laboratory Practices Committee has taken leadership role on this initiative and has created two template Validation SOPs for the CT community. Please see the two resources below.

Cryo Bag Validation Template 1

Cryo Bag Validation Template 2

Cryo Bag Validation Template 3

If anyone would like to submit additional procedures or validations to be posted on the ISCT website please submit to Deborah Lamontagne dlamonta@bidmc.harvard.edu or Geraldine Bollard at G.bollard@alfred.org.au.
All items submitted will be deidentified prior to posting.