N.J. Admin. Code § 8:8-13.16

Current through Register Vol. 56, No. 11, June 3, 2024

Section 8:8-13.16 - Storage

(a) The storage of HPC shall be in accordance with 8:8-11.3.

(b) HPC stored in a liquid state shall be maintained at a temperature and for a period of time specified in a written procedure approved by the laboratory director. Appropriate documentation shall be available to support these specifications.

(c) HPC stored in a frozen state shall be within a temperature range as determined to be appropriate for the cryoprotectant used.

(d) For HPC components immersed in liquid nitrogen, written procedure to minimize the risk of microbial cross contamination of components shall be defined in the SOP and followed.

(e) The storage device shall be located in a secure area with available locking capability for use.

(f) Liquid nitrogen freezers shall have a mechanism to ensure that levels of nitrogen are maintained.

(g) An inventory control system shall be operational to locate any HPC component or quality control vial from that component, if available.

N.J. Admin. Code § 8:8-13.16