摘要
为确保干法混合的合理性和稳定性,本研究通过混合均匀性、营养成分符合性及工艺稳定性对干法混合工序进行验证。同一配方3批次重复性生产,不同位置的营养成分变异系数在5%以内,说明物料可充分混合均匀;产品营养成分的检测值与设计值偏差均在±10%以内(除硒外),其中一批次硒的偏差为13.05%(检测方法的精密度为±20%),说明产品可满足设计要求;批次间的相对标准偏差均在5%以内,说明工艺可行且稳定。得出结论,现有干法混合工序可满足特殊医学用途全营养配方食品的连续生产,同时产品质量可控,可保证在临床使用中的有效性及安全性。本文通过对特殊医学用途全营养配方食品干法混合工序进行工艺验证,旨在为使用干法混合工艺生产特殊医学用途配方食品的企业提供混合工序工艺验证的方案。
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.
作者
刘宝华
徐庆利
巴宁宁
杜玲玲
LIU Baohua;XU Qingli;BA Ningning;DU Lingling(Qingdao Shengtong Nutritional Food Co.LTD.,Beijing 101100)
出处
《中国乳业》
2022年第6期75-80,86,共7页
China Dairy
关键词
特殊医学用途全营养配方食品
干法混合工序
工艺验证
whole nutrition formula food for special medical purpose
dry mixing process
process validation
作者简介
刘宝华(1990-),女,黑龙江牡丹江人,本科,工程师,研究方向为特殊人群营养研究及特膳食品研发;徐庆利(1975-),男,山东青岛人,本科,助理工程师,研究方向为特殊人群营养研究及特膳食品研发;巴宁宁(1990-),女,湖北武汉人,硕士,研究方向为特殊人群营养研究及特膳食品研发;杜玲玲(1990-),女,黑龙江齐齐哈尔人,硕士,研究方向为特殊人群营养研究及特膳食品研发。
