Heat-sealing label in cryopreservation bag pouch meets definition of “Affix”
Written by Sarah Litel-Smith, BSMT (ASCP), Accreditation Services Supervisor
The Accreditation Committees recently affirmed that inserting a label into a cryopreservation bag pouch and heat sealing the pouch would categorize the contents (label) as affixed. When the definitions of “affix” and “attached” were written, the goal was to distinguish labels connected to the bag with a physical intermediary device (e.g., plastic, string, or metal linkage) from a label that was integral to the bag (e.g., direct bag to label contact). While glue is the most common method, we interpret that a sealed portion of the bag containing the label is equivalent to secure direct contact between bag and label.
Affix: To adhere in physical contact with the cellular therapy product container.
Attach: To fasten securely to the cellular therapy product container by means of a tie tag or comparable alternative. Any information required to be attached to a cellular therapy product container may alternatively be affixed.