Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:17
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 17
Character Range: 24211–24920

17  Containers of biologicals
 (1) A biological must be sealed within a sterile container and must be at least double packaged so as to:
 (a) prevent ingress or egress of all materials; and
 (b) ensure that any breach of integrity of the container and packaging is evident.
 (2) This section does not apply in relation to human ocular tissue products to which Part 5 applies.
Note: Part 5 provides requirements in relation to containers of human ocular tissue products that are subjected to only minimal manipulation and are manufactured for allogeneic use only. However, this section applies in relation to all other human ocular tissue products.

Part 3—Standard for human musculoskeletal tissue products