1 空间环境卫生控制规程：                                                                                       1.1 职责:                                                                                              1.1.1现场质检员负责车间空气净化系统的开关;                                                           1.1.2车间卫生员负责空间消毒;                                                                          1.2.3现场生产主管负责监督车间空间卫生的实施工作;                                                                            1.2 实施:                                                                                            1.2.1 每天生产前1-2小时，现场质检员应负责开启车间空气净化系统，确认净化设备正常工作，确认车间空气压力≥8pa;并作好相关记录;                                                                                   1.2.2生产结束后,质检员应负责关闭空气净化系统;并做好相关记录;                                          1.2.3 每天生产前半小时,车间卫生员应用95%的食用酒精对净化车间及相关缓冲间进行消毒;                                                                            1.2.4 在每天就餐时间结束后,卫生员应用95%的食用酒精对人员出入口及缓冲间进行消毒;                                                                               1.2.5 卫生员在消毒过程中,应注意避免将酒精直接喷向产品上;                                               1.2.6 所有出入净化车间的人员进出车间必须随手关门,以保证现场空间的洁净度和安全气压;                                                                           2 车间地面卫生控制规程:                                                                                          2.1 职责:                                                                                              2.2.1卫生员负责班前、班后及生产过程中车间地面的清洁卫生工作;                                        2.1.2现场生产主管和质检员负责监督和指导卫生员的工作;                                                     2.2 实施:                                                                        2.2.1每天生产前卫生员应用吸水拖把和清洁的自来对水车间地面进行清洁;                                                     2.2.2生产过程中,卫生员应随时清除地面的废弃物和污物,并用吸水拖把和清洁自来水清洁地面;                                                                                 2.2.3每天生产结束后,卫生员应将灭菌片配制成300ppm的消毒液,将洗净凉干的普通拖把用消毒液浸泡20min后,对净化车间及其缓冲间的地面进行消毒处理;如地面污染较严重,中途应更换消毒液;                                                 2.2.4地面消毒20分钟后,卫生员应用吸水拖把和清洁的自来对地面进行二次清洁;                                                        2.2.5所有出入净化车间的人员和物品必须按照规定的通道进出,防止对现场的污染;                                                         3 人员卫生控制规程                                                                                              3.1职责:                                                                                              3.1.1所有出入净化车间的人员应严格执行卫生标准操作规程;                                              3.1.2卫生员负责净化车间人员消毒药品的准备;                                                                   3.1.3质检员负责检查和指导车间人员卫生实施工作;                                                         3.1.4现场生产主管全面监督人员卫生控制工作;                                                            3.2实施:                                                                                               3.2.1每天生产前，卫生员应将净化车间内及缓冲间的酒精消毒器中注满75%食用酒精；                                                                                    3.2.2每天生产前,卫生员应更换净化车间消毒地垫,并用灭菌片配制成300ppm的消毒液,注入消毒地垫盘中,消毒液用量以能淹没地垫为准;                                                                         3.2.3 每天员工首次进入车间及员工就餐后进入车间高峰期间,质检员应在净化车间人流通道口对员工的个人卫生及规范着装进行检查,并用粘发器除去连体服表面的毛发及其它杂质,卫生合格的人员才能进入车间;                                                             3.2.4所有出入净化车间的人员应严格按照卫生标准操作规程的要求更衣并洗手消毒后，经人流通道进入缓冲间二次消毒,再经风淋室进入净化车间；                                                                        3.2.5生产过程中,质检员和现场生产主管应随时观察员工的个人卫生及卫生规范操作,发现不合格情况应立即指出并要求员工进行改正;                                                                                          4 设备/工器具卫生控制规程:                                                                                        4.1职责                                                                                               4.1.1操作工负责本岗位设备及工器具的卫生;                                                              4.1.2班组长和机台长负责其责任范围内的设备及工器具的卫生检查;                                           4.1.3现场生产主管和质检员负责整个净化车间内的设备及工器具的卫生监督和指导;                                                                                4.2实施                                                                                                  4.2.1每天生产前,操作工应将本岗位的设备及工器具表面用75%的食用酒精消毒,并用消毒毛巾擦拭;                                                               4.2.2生产过程中如因故停产15分钟以上或连续生产2小时,操作工应将本岗位的设备及工器具表面用75%的食用酒精消毒,并用消毒毛巾擦拭;                                                                                4.2.3生产过程中,如设备及工器具表面被污染物污染,或接触了被污染的物品,应用75%的食用酒精消毒,并用消毒毛巾擦拭;                                                                                               4.2.4生产结束后,操作工应清理本岗位工作产生的废弃物,并清洁设备及工器具表面;必要进,应按照设备清洁消毒规程要求对设备进行全面的清洁消毒工作。 

4.2.5生产结束后, 班组长及机台长应安排专人对本岗位所用毛巾用餐具洗洁精清洗,再用250-300ppm 的消毒液浸泡20分钟后,用清洁自来水清洗,晾干备用。                                                                           5 净化车间洁净度验证规程:                                                                                  5.1职责:                                                                                              5.1.1由质检课化验室每周对净化车间洁净度进行一次微生物采样验证;                                              5.1.2现场生产主管负责对不合格情况进行整改;                                                             5.2实施：                                                                                             5.2.1质检课每周应对净化车间的空间,设备/工器具表面,操作工的手,连体工作服,内包装材料进行微生物采样,检验车间的洁净度,作好记录,并将检验结果报告相关部门和人员;                                                                             5.2.2化验室应将不合格检测结果的检验留存,经相关人员确认后方可消毁;                                      5.2.3质检课应协助生产车间分析不合格原因,并提出整改意见和建议;                                         5.2.4现场生产主管负责对相关人员进行培训和教育,并负责纠正预防措施的实施;                              5.2.4车间质检员应跟踪不合格整改的全过程,并记录;

相关要求：

工具设备/器具：酒精喷壶、吸水拖把、普通拖把、消毒毛巾、粘发器；

清洁剂/消毒药品：餐具洗洁精、95%食用酒清、75%食用酒精、灭菌片；

安全预防措施：连体工作服、工作鞋、一次性口罩、一次性手套；

人员配备：车间卫生员、车间质检员；

相关文件：《卫生标准操作规程》、《SSOP验证规程》

相关记录：《消毒液测试记录》、《工器具、设备消毒记录表》、《验证记录表》、     《纠偏记录表》；下载本文