ISO22716 微生物知识及人、设备、原料、环境控制
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1、1ISO22716:2007化妆品良好操作规范Cosmetics-Good Manufacturing Practices (GMP)-Guidelines On Good Manufacturing Practices人、设备、原物料和操作的卫生人、设备、原物料和操作的卫生2v肉眼看不到的世界的知识肉眼看不到的世界的知识v微型有机体和他们生存环境的知识微型有机体和他们生存环境的知识v卫生对产品所产生影响的知识卫生对产品所产生影响的知识v鉴别污染源鉴别污染源v了解如何保护产品及在车间需要遵循的卫生规定了解如何保护产品及在车间需要遵循的卫生规定v工厂环境卫生工厂环境卫生v人员管理人员管理v人员操
2、作卫生人员操作卫生v原物料防护原物料防护v设备的清洁和消毒设备的清洁和消毒 培训项培训项3Visible to human eye肉眼可见的肉眼可见的Invisible to human eye肉眼不肉眼不可见的可见的SIZE OF MICRO ORGANISMS4Molds霉Bacteria细菌Yeasts酵母5Escherichia coliBACILLI杆菌杆菌Staphylococcus epidermidisSHELLS球状菌球状菌Some common bacteria一些常见细菌.6YEAST酵母酵母MOLDS霉菌霉菌Some common fungi一些常见的霉菌 7WHERE
3、 CAN WE FIND MICROORGANISMS In industry we can find them在工业中在工业中我们可以找到它们我们可以找到它们RAW MATERIALS原材料原材料Water, liquid materials, labels, packaging, 水，液体材料，标签，包材，IN THE ENVIRONMENT环境中环境中air, floor, walls, ceiling, insects, rodents 空气，地板，墙壁，天花板，昆虫，腐蚀性的东西MACHINES AND OTHER EQUIPMENT机器和其它设备机器和其它设备machines, p
4、roduction line, small equipment 机器，产线，小设备STAFF员工员工hands, hair, clothes, shoes 手，头发，衣服，鞋子.8FAVORABLE CONDITIONS FOR MICROORGANISMS DEVELOPMENT微生物生长的有利环境微生物生长的有利环境Nutrients营养营养 Carbohydrates, proteins, lipids 水、碳水化合物，蛋白质，油脂（脂肪，乳酪）Water environment (Ex, humidity)含水环境（如，湿度）含水环境（如，湿度）Temperature温度温度: 154
5、5CFreezing (-18C) does not stop bacteria but stop the development.低度 (-18C）不会停止微生物但会终止它的生长Sterilization (120C) destroy bacteria杀菌(120C) 消灭细菌Presence or absence of oxygen含氧或者不含氧含氧或者不含氧Optimal pH最佳最佳PH值值9HOW DO THEY REPRODUCE? Microorganism reproduction微生物的繁殖微生物的繁殖124820 mn20 mn20 mn10To sum up汇总汇总Aft
6、er之后 there are有2h 643h10 1 0004h45 20 0005h57 220 0007h10 1 600 0008h36 60 000 0009h15 180 000 00010h40 4 000 000 00011UNDESIRABLE MICROBES不受欢迎的微生物不受欢迎的微生物ASPECT:外貌外貌presence of sediments, changes opacity, gas bubbles, loss of homogeneity .有深沉,变为不透明,气泡,同质损失SMELL:气味气味microbiological substances, ferme
7、nted products微生物物质,发酵产品 COLOR:颜色颜色pigment production originated by microorganisms or modification of color due to changes on pH由微生物引起的产品变色或者因PH值变化而导致颜色变化TEXTURE:性质性质changes on viscosity, changes of mechanical properties粘度变化,物理变化DEGRADATION OF ACTIVE INGREDIENTS IN THE PRODUCT产品里的活性成分减少产品里的活性成分减少12IN
8、CIDENCE OF PATHOLOGIC CONTAMINATING FLORA病菌污染病菌污染的范围的范围 Infection risk传染病风险传染病风险: some microorganisms are capable of provoking abscesses and eye infections (conjunctivitis, cornea ulcers.)有些微生物可以导致砂眼和眼疾(结膜炎,角膜溃疡) Toxic and allergic risk中毒和过敏的风险中毒和过敏的风险: it is related to the release or production of
9、microbiological substances with toxic or irritating effects. They can also cause allergic reactions (Eyes are particularly sensible)是关于有毒释放或者有有毒微生物物质的产品或者刺激的影响。它们也可能引起过敏反应（眼睛特别敏感）HARMFUL MICROORGANISMS有害的微生物有害的微生物13PRODUCT产品产品ENVIRONMENT环境环境HUMAN 人类人类ADD CONSERVANT增加管理TEMPERATURE (hot -cold)温度(热-冷)B
10、ODY HYGIENE人体卫生FILLING (sealed primary packaging, use lid )灌装(最初包装的密封，用盖子)MACHINES AND MATERIAL CLEANING AND DISINFECTION WORKSHOP MAINTENANCE机器和原料清洁和消毒,车间维护HANDS CLEANING AND DISINFECTION手的清洁和消毒PRODUCT FORMULA(pH, ingredients, less water)产品配方(PH值,成分,少量水)AIR: NO AIR FLOWWELL CLOSED CONTAINERS (BOTH
