12. Requirements in relation to microbial control
(1) A strategy for the minimisation of intrinsic and extrinsic microbial contamination in a product must be established based on a risk assessment considering the nature and therapeutic use of the product.
(2) Human cells and tissues from a deceased donor that are proposed to be used in a recipient must be collected:
(a) as soon as possible after asystole and be completed within 24 hours of asystole provided the body has been refrigerated at less than 10°C within 12 hours of asystole; or
(b) if the body has not been refrigerated, within 15 hours of asystole death; or
(c) as set in another, current Therapeutic Goods Order made under section 10 of the Act that applies to the relevant product.
(3) The transport and storage conditions of the blood, blood components, cells or tissues after collection but prior to processing (other than plasma for fractionation) must be no more than 72 hours in duration, and temperature must be maintained at less than 10°C, unless otherwise validated by the sponsor manufacturer, or otherwise specified in another, current Therapeutic Goods Order made under section 10 of the Act that applies to the relevant product.
(4) The transport and storage conditions of the human blood and blood components, human tissues and human cellular therapy products after processing must be determined and validated by the sponsor or manufacturer of the product including, at minimum, the temperature and duration of storage and transport, unless otherwise specified in another, current Therapeutic Goods Order made under section 10 of the Act which applies to the relevant product.
(5) Human blood, blood components, human tissues or human cellular therapy products must meet the following bioburden specifications:
(a) the absence of microorganisms; or
(b) the absence of specified microorganisms; or
(c) the surveillance and control measures for minimisation of microbial contamination of the product during collection and manufacture; or
(d) requirements specified in another, current Therapeutic Goods Order made under section 10 of the Act which applies to the relevant product; or
(e) qualification of the sterilisation process to ensure that a sterility assurance level of 10-6 is achieved for the specific blood, blood component, tissue or cellular therapy product, where the product has been subjected to a terminal sterilisation process.