Document ID: chunk:federal_register_of_legislation:F2021C01065:clause:1_17
Version: federal_register_of_legislation:F2021C01065
Segment Type: clause
Provision Reference: sch 1 cl 17
Character Range: 26430–28845

17  Microbial control procedures

General requirements
 (1) Microbial control procedures that are validated must be implemented in the manufacture of FMT products and must:
 (a) include a strategy to minimise the proliferation of intrinsic microbial contamination and to prevent extrinsic microbial contamination of stool during the manufacture of FMT products; and
 (b) specify storage, handling and transportation requirements (including in relation to temperature and duration) for stool used in the manufacture of FMT products.

Immediate processing of stool following collection
 (2) Stool used in the manufacture of FMT products, other than fresh FMT products, must:
 (a) be processed as soon as possible, and not later than 6 hours after defaecation; and
 (b) during any interval to the processing mentioned in paragraph (a) including transportation of the stool—be cooled to 4C or kept as otherwise validated by the manufacturer; and
 (c) following the processing mentioned in paragraph (a)—be stored in accordance with subsection (5).

Processing and storage of stool used in the manufacture of fresh FMT products
 (3) Stool collected from an accepted donor for use in the manufacture of fresh FMT products must be processed not later than 6 hours after defaecation:
 (a) at ambient temperature (maximum 37°C); or
 (b) under specifications set and validated by the manufacturer.
 (4) Fresh FMT products must be administered to, or applied in the treatment of, a person:
 (a) on the same day the stool is collected; or
 (b) not later than 5 days after the stool is collected where the fresh FMT products are stored under conditions that will not impact the quality, safety or efficacy of those products.

Storage and transportation of stool and FMT products
 (5) FMT products, other than fresh FMT products, and stool to be used in the manufacture of FMT products must be stored:
 (a) at or below minus 70°C in a suitable cryopreservation agent for not longer than 12 months; or
 (b) in accordance with justified time and temperature specifications.
 (6) FMT products must be appropriately sealed within a sterile container that:
 (a) prevents leakage of the FMT products from the container; and
 (b) ensures that any breach of integrity of the container is evident.
 (7) FMT products, other than fresh FMT products, must be transported in accordance with justified time and temperature specifications.