N.J. Admin. Code § 8:8-13.12

Current through Register Vol. 56, No. 24, December 18, 2024
Section 8:8-13.12 - Cryopreservation
(a) Cryopreservation methods known to preserve HPC viability, recovery, and potency shall be used.
(b) The following records shall be maintained for each cryopreserved unit:
1. Starting product and volume;
2. Relevant cell count;
3. Cell viability;
4. Name, volume and concentration of cryoprotectant, anticoagulants and/or additives;
5. Cooling record from controlled-rate freezing, if applicable;
6. Endpoint temperature of cooling; and
7. Location of HPC and stored test aliquots.

N.J. Admin. Code § 8:8-13.12