N.J. Admin. Code § 8:8-13.12

Current through Register Vol. 56, No. 11, June 3, 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