Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:49
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 49
Character Range: 42285–43546

49  Storage and transportation

     Human amnion
 (1) Immediately following collection and prior to processing, a human amnion must be:
 (a) stored at less than 10°C in a suitable storage medium, or as otherwise validated by the manufacturer to prevent microbial proliferation and to ensure the quality and safety of the human amnion; and
 (b) transported in a manner that ensures the relevant storage conditions specified in paragraph (a) are maintained during transportation.

     Human amnion products
 (2) Human amnion products must be stored as follows:
 (a) if the products are cryopreserved—at less than minus 80°C for not more than 2 years after collection of the human amnion; or
 (b) if the products are dehydrated or freeze-dried—at room temperature for not more than 5 years after collection of the human amnion; or
 (c) in accordance with conditions that are validated on the basis of validated data or documented evidence from relevant scientific literature, including justified time and temperature specifications, to ensure the quality, safety and efficacy of the products.
 (3) Human amnion products must be transported in a manner that ensures the relevant storage conditions specified in subsection (2) are maintained during transportation.