4Definitions

4 Definitions

Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:

advertise;

(b) batch;
(c) British Pharmacopoeia;
(d) default standard;
(e) European Pharmacopoeia;
(f) label;
(g) supply; and
(h) United States Pharmacopoeia-National Formulary.

In this instrument:

acceptable microbiological quality, in relation to water, means a microbial count that is less than 100 colony forming units per mL.

Act means the Therapeutic Goods Act 1989.

food standard grade means compliance with an applicable standard in the Food Chemicals Codex, as in force or existing at the commencement of this instrument.

Note: The Food Chemicals Codex is available online at: www.foodchemicalscodex.org.

other purification process, in relation to water, means a process, such as reverse osmosis, that meets the following requirements:

(a) the process is validated to produce and distribute water that is of acceptable chemical quality and acceptable microbiological quality; and
(b) regular microbiological testing of the water is undertaken, including sampling at the point of use, using one of the following methods:
(i) filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating on a single plate at 30-35°C for not less than 5 days; or
(ii) filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating on separate plates at 35-37°C and 20-22°C for not less than 5 days.

pharmacopoeial grade means compliance with an applicable default standard.

Note: The default standards are the British Pharmacopoeia, European Pharmacopoeia and the United States Pharmacopoeia-National Formulary.