Abstract: In order to ensure the rationality and stability of dry mixing,this study verified the dry mixing process through mixing uniformity,nutrient compliance and process stability. The same formula was produced repeatedly in 3 batches,and the variation coefficient of nutrient components at different positions is within 5%,indicating that the materials can be fully mixed.The deviation between the tested value and the design value of the nutritional components of the product was within ±10% （except for selenium）,and the deviation of a batch of selenium was 13.05% （the precision of the detection method was ±20%）,indicating that the product could meet the design requirements.The relative standard deviation between batches was within 5%,indicating that the process was feasible and stable. It is concluded that the existing dry mixing process can meet the continuous production of full nutrition formula food for special medical purposes,and the product quality is controllable,which can ensure the effectiveness and safety in clinical use. In this paper,the process verification of dry process mixing process of whole nutrition formula food for special medical purposes was carried out,aiming to provide a scheme of process verification of mixed process for enterprises producing formula food for special medical use using dry process mixing process.

Key words: whole nutrition formula food for special medical purpose, dry mixing process, process validation