As heat treatment for high acid products is not sufficient for killing all kinds of microorganisms including heat resistant spores, the temperature/time regime affects the final results of the validation. It is recommended to apply the highest temperature and longest holding time which the process unit allows for in order to minimize this influence. For explanation of heat treatment see appendix 3.
It is recommended to detect thermophilic spore formers in the raw product just before the heat treatment as well as in the aseptic storage tank and in the filled bottles.
