Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:16:p1
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 16 (pt 1/2)
Character Range: 20140–23134

16  Storage and transportation

     HCT materials
 (1) Immediately following collection and prior to processing, HCT materials must be:
 (a) stored as follows:
 (i) at less than 10°C for not longer than 72 hours; or
 (ii) as otherwise validated by the manufacturer to prevent microbial proliferation and to ensure the quality, safety and efficacy of the biological manufactured using the HCT materials; and
 (b) transported in a manner that ensures the relevant storage conditions specified in paragraph (a) are maintained during transportation.
 (2) Subsection (1) does not apply in relation to:
 (a) human cardiovascular tissue products to which Part 4 applies; and
 (b) human skin products to which Part 6 applies; and
 (c) human amnion products to which Part 7 applies.
Note 1: Part 4 provides storage and transportation requirements in relation to cardiovascular tissue used in the manufacture of cardiovascular tissue products that are subjected to only minimal manipulation and are manufactured for allogeneic use only. However, subsection (1) applies in relation to all other human cardiovascular tissue products.
Note 2: Part 6 provides storage and transportation requirements in relation to human skin used in the manufacture of human skin products that are subjected to only minimal manipulation. However, subsection (1) applies in relation to all other human skin products.
Note 3: Part 7 provides storage and transportation requirements in relation to human amnion used in the manufacture of human amnion products that are subjected to only minimal manipulation. However, subsection (1) applies in relation to all other human amnion products.
 (3) HCT materials that are collected and transported for use in the manufacture of a biological must be packaged using aseptic technique and with at least one moisture impermeable barrier.

     Biologicals
 (4) Biologicals must be stored and transported under conditions that are validated, including justified time and temperature specifications, to ensure the quality and safety of the biologicals.
 (5) Subsection (4) does not apply in relation to:
 (a) human musculoskeletal tissue products to which Part 3 applies; and
 (b) human cardiovascular tissue products to which Part 4 applies; and
 (c) human ocular tissue products to which Part 5 applies; and
 (d) human skin products to which Part 6 applies; and
 (e) human amnion products to which Part 7 applies.
Note 1: Part 3 provides storage and transportation requirements in relation to human musculoskeletal tissue products that are subjected to only minimal manipulation. However, subsection (4) applies in relation to all other human musculoskeletal tissue products.
Note 2: Part 4 provides storage and transportation requirements in relation to human cardiovascular tissue products that are subjected to only minimal manipulation and are manufactured for allogeneic use only. However, subsection (4) applies in relation to all other human cardiovascular tissue products.
Note