10Stability data

10 Stability data

(1) Subject to subsections (2) and (3): (a) the physical and chemical stability; and (b) the microbial efficacy; of a disinfectant must be established in accordance with the requirements in: (c) Division 1 of Part 2 of the Instructions; and (d) section 1 of Division 2 of Part 2 of the Instructions; using the final formulation of the disinfectant when stored in its proposed container and packaging material for supply. (2) Laboratory batches of a disinfectant may be used for the purposes of subsection (1), provided that those batches properly reflect the scaled-up production process for the manufacture of the disinfectant for supply. (3) If batches of a disinfectant have been stored in a container that is not the container that is intended for supply, that container may be used for the purposes of subsection (1), if: (a) the container is composed of the same material as the proposed container for supply; and (b) either: (i) the ratio of surface area to volume of the container is the same as that of the proposed container for supply; or (ii) the ratio of surface area to volume of the container is different to that of the proposed container for supply, but this difference is justified. (4) The physical and chemical stability of a production batch of a disinfectant must also be established in accordance with the requirements in Division 1 of Part 2 of the Instructions, including in relation to any changes made to the manufacturing process for the disinfectant, or the quality of a raw material used in its manufacture, after the establishment of the disinfectant’s stability in accordance with subsections (1) to (3).