Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:21
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 21
Character Range: 26074–27587

21  Bioburden testing

     Tissue not subjected to processing
 (1) Human musculoskeletal tissue that is not subjected to processing prior to packaging must be sampled at the time of collection for bioburden testing.
 (2) Human musculoskeletal tissue sampled in accordance with subsection (1) must be tested for bioburden and:
 (a) demonstrate no microbial contamination; or
 (b) be rejected for therapeutic use if microbial contamination is demonstrated; or
 (c) be subjected to further processing in accordance with subsection (3) if microbial contamination is demonstrated with microorganisms other than specified microorganisms.

     Tissue subjected to processing
 (3) Human musculoskeletal tissue that is subjected to processing prior to packaging (including, for example, a bioburden reduction process) must be:
 (a) sampled for bioburden testing at the time of collection or prior to the processing to exclude tissue contaminated with specified microorganisms; and
 (b) either:
 (i) sampled for bioburden testing after the processing and must demonstrate no microbial contamination; or
 (ii) subjected to a bioburden reduction process that has been validated to render the tissue free from any microbial contamination.
 (4) Human musculoskeletal tissue that demonstrates:
 (a) contamination with specified microorganisms when tested in accordance with paragraph 21(3)(a); or
 (b) any microbial contamination when tested in accordance with subparagraph 21(3)(b)(i);
must be rejected for therapeutic use.