2021年氟苯尼考粉工艺验证报告10%
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NY5140—2021无公害食品巴氏杀菌乳1 范畴本标准规定了巴氏杀菌乳的产品的分类、技术要求、试验方法、检验规则和标签、包装、运输、贮存要求。
本标准适用于以生鲜牛(羊)乳为原料,经巴氏杀菌制成的液体产品。
2 规范性引用文件下列文件中的条款通过本标准的引用而成为本标准的条款。
凡是注明日期的引用文件,其后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓舞依照本标准达成协议的各方研究是否可使用这些文件的最新版本。
凡是不注明日期的引用文件,其最新版本适用于本标准。
GB 191 包装储运图示标志GB 2760 食品添加剂使用卫生标准GB 4789.2 食品卫生微生物学检验菌落总数测定GB 4789.3 食品卫生微物物学检验大肠菌群测定GB 4789.4 食品卫生微物物学检验沙门氏菌检验GB 4789.5 食品卫生微物物学检验志贺氏菌检验GB 4789.10 食品卫生微物物学检验金黄色葡萄球菌检验GB 4789.11 食品卫生微物物学检验溶血性链球菌检验GB 4789.18 食品卫生微物物学检验乳与乳制品检验GB/T 5009.11 食品中总砷的测定方法GB/T 5009.12 食品中铅的测定方法GB/T 5009.17 食品中总汞的测定方法GB/T 5009.19 食品中六六六、滴滴涕残留量的测定方法GB/T 5009.24 食品中黄曲霉毒素M1和B1的测定方法GB/T 5409 牛乳的检验方法GB/T 5413.1 婴幼儿配方食品和乳粉蛋白质的测定GB/T 5413.30 乳与乳粉杂质度的测定GB/T 5413.32 乳粉硝酸盐、亚硝酸盐的测定GB 7718 食品标签通用标准GB 14880 食品营养强化剂使用卫生标准GB/T 14962 食品中铬的测定方法GB/T 17331 食品中有机磷的氨基甲酸酯类农药多种残留的测定JJF 1070 定量包装商品净含量计量检验规则NY 5045 无公害食品生鲜牛乳3 产品分类3.1 无公害全脂巴氏杀菌乳以生鲜牛(羊)乳为原料,经巴氏杀菌制成的液体产品。
四川省成都七中2021-2021高二生物上学期10月阶段性考试试题考试时间:80分钟满分:90分一、选择题(共35题,1-30每题1分,31-35每题2分,共40分)1.下列有关现代生物进化理论的叙述,错误的是()A.种群是生物繁殖和生物进化的基本单位B.捕食者和被捕食者种群会相互选择,共同进化C.突变和基因重组,自然选择及隔离是物种形成的一般过程D.生物进化的实质是对环境的适应性不断增强的过程2.近日,科学家在墨西哥湾的深海中发现了一种新的鮫鏮鱼,雌鱼头顶自带“钓鱼竿”——若干个肉状突起,可发出光源,吸引猎物。
雄鱼则吸附在雌鱼体表提供繁殖所需的精子,同时通过雌鱼血液获取营养物质。
下列叙述正确的是()A.头顶发光“钓鱼竿”的形成是海底黑暗环境长期诱导的结果B.雌雄鱼的生活繁殖方式是它们长期共同进化中相互适应形成的C.鮟鱇鱼种群在深海环境条件稳定时,基因频率也可能会改变D.鮟鏮鱼形成的过程仅靠基因突变和基因重组提供进化的原材料3.如图表示生物多样性的形成过程,下列说法不正确的是()A.生物多样性主要包括基因多样性、物种多样性和生态系统多样性B.突变和基因重组产生进化的原材料,决定生物进化方向C.图中P表示自然选择;R表示生殖隔离D.两个能相互交配产生后代的生物不一定属于同一物种4.水稻是人类赖以生存最重要的粮食作物之一。
我们的祖先通过长期不断的实践,把野生稻驯化成栽培稻。
野生稻谷粒细小、芒长、脱壳困难而栽培稻谷粒变大、芒变短甚至无芒、不易脱壳。
下列分析正确的是()A.野生稻有关谷粒芒刺的基因构成该种群的基因库B.水稻芒的长短变化是适应自然环境的变异造成的C.野生稻驯化成栽培稻,种群基因频率发生改变D.人工选择加速了水稻种群生殖隔离的出现5.现代生物进化理论以自然选择学说为核心,下列有关叙述不合理的是()A.人与黑猩猩DNA序列一致性比猕猴高,说明人与黑猩猩的亲缘关系较近B.通过化石了解已灭绝生物的形态结构特点是研究生物进化最直接的证据C.种群间互有迁入和迁出,会引起种群间遗传差异的减少D.达尔文自然选择学说认为种群是生物进化的基本单位6.在一个种群中随机抽出100个个体,经调查发现,其中基因型为AA、Aa、aa的个体分别有18、78和4个,则该种群中A、a基因的基因频率分别是()A.36%、64% B.92%、8%C.45%、56% D.57%、43%7.绿头鸭和琵嘴鸭、绿翅鸭、斑嘴鸭都是野生鸭类,它们常常在同一栖息地生活。
国内主要塔吊(塔式起重机)参数目录一、中联塔吊 (1)TCR6055(动臂式) (1)TC7030B (2)TC7035 (4)TC7052 (6)TCT7527(平头) (7)TC8039 (8)二、四川机械厂 (10)C7022 (10)C7050B (11)M630 (13)M900D (14)M1500(A) (15)D650(动臂式) (17)三、永茂厂 (18)ST60/14 (18)ST60/15 (20)ST70/27 (22)ST70/30 (24)STT553 (25)STT293 (27)四、沈阳厂 (29)K30/21 (29)K30/30 (31)K40/21 (33)K50/50 (34)M125/75 (36)五、江麓厂 (38)QTD480(江麓动臂式) (38)一、中联塔吊TCR6055(动臂式)塔身截面:2.5×2.5米现没有行走底架塔身节主要构件重:基础节:5.95米整体标准节:5.37米最大自由高度基础受力(吨):工作状态非工作状态自重F2 320t 285tF3 215t 195t 145t起重性能:幅度18 20 25 28 30 35 38 40 45 48 50 55 58 6016t-32.8m 单绳16.00 16.00 16.00 16.00 16.00 14.66 12.94 11.93 9.74 8.68 8.05 6.65 5.92 5.5016t-31.9m 双绳16.00 16.00 16.00 16.00 16.00 13.91 12.22 11.24 9.14 8.07 7.48 6.11 5.44 5.12幅度18 20 25 28 30 35 38 40 45 48 50 5516t-34.3m 单绳16.00 16.00 16.00 16.00 16.00 15.00 13.30 12.31 10.18 9.11 8.51 7.2024t-24.2m 双绳24.00 24.00 23.02 19.82 17.95 14.30 12.66 11.95 9.60 8.58 7.97 6.83幅度18 20 25 28 30 35 38 40 45 48 5016t-33.5m 单绳16.00 16.00 16.00 16.00 16.00 15.52 13.76 12.76 10.67 9.599.0032t-19.6m 双绳32.00 31.45 23.75 20.53 18.66 15.01 13.27 12.28 10.23 9.188.62幅度18 20 25 28 30 35 38 40 4516t-34m 单绳16.00 16.00 16.00 16.00 16.00 15.97 14.30 13.27 11.2032t-19.6m 双绳32.00 31.93 24.35 21.00 19.23 15.56 13.85 12.84 10.83幅度18 20 25 28 30 35 38 4016t-35m 单绳16.00 16.00 16.00 16.00 16.00 15.90 14.39 13.4032t-19.9m 双绳32.00 31.83 23.86 20.75 18.97 15.43 13.99 13.04幅度18 20 25 28 30 3516t-34.3m 单绳16.00 16.00 16.00 16.00 16.00 16.0032t-20m 双绳32.00 32.00 24.93 21.68 19.93 16.40幅度18 20 25 28 3016t-30m 单绳16.00 16.00 16.00 16.00 16.0032t-20m 双绳32.00 32.00 24.81 21.64 20.00自由高度:最大自由高度60米塔吊机构参数:主卷扬机构:起升速度(米/分):(单)0~35米/分(16t); 0~70米/分(8t); 0~80米/分(2.5t)(双)0~17.5米/分(32t); 0~35米/分(16t); 0~44米/分(5t)主卷扬电机功率: 110kw卷筒最大容绳量: 480m变幅机构:变幅速度(米/分): 3.5(15°~87°)变幅电机功率: 75kw回转机构:回转速度(r/min): 0~0.7回转电机功率: 5.5×3kw行走机构:行走速度(米/分):0~25行走电机功率: 5.5×6kw顶升机构:顶升速度(米/分):0.32顶升电机功率: 11kw塔吊电网参数:电源:380V/50Hz 电容量:234.5KW440V/50HzTC7030B塔身截面:2.2×2.2米塔身节主要构件:标准节:3.75米行走底架固定底架:6.5×6.5米最大自由高度基础受力(吨):工作状态非工作状态自重F2 156t 210tF3 98t 154t 88t起重性能:幅度22 25 28 30 35 40 45 48 50 55 58 60 65 68 70吊重6t~40.9m 单绳66666 6 5.33 4.92 4.67 4.14 3.86 3.70 3.32 3.12 3.00 12t~22.3m 双绳12 10.53 9.21 8.49 7.05 5.99 5.16 4.75 4.50 3.97 3.69 3.53 3.15 2.95 2.83 幅度22 25 28 30 35 40 45 48 50 55 58 60 65吊重6t~42.5m 单绳666666 5.59 5.16 4.91 4.35 4.07 3.89 3.50 12t~23.2m 双绳12 11.01 9.64 8.89 7.39 6.28 5.42 4.99 4.74 4.18 3.90 3.72 3.33 幅度22 25 28 30 35 40 45 48 50 55 58 60吊6t~43.4m 单绳666666 5.74 5.30 5.04 4.47 4.18 4.00重12t~23.7m 双绳12 11.28 9.88 9.11 7.58 6.45 5.57 5.13 4.87 4.30 4.01 3.83 幅度22 25 28 30 35 40 45 48 50 55吊重6t~44.4m 单绳666666 5.90 5.45 5.18 4.60 12t~24.2m 双绳12 11.56 10.14 9.35 7.79 6.62 5.73 5.28 5.01 4.43 幅度22 25 28 30 35 40 45 48 50吊重6t~45.2m 单绳6666666 5.57 5.30 12t~24.6m 双绳12 11.81 10.35 9.55 7.96 6.77 5.86 5.40 5.13 幅度22 25 28 30 35 40 45吊重6t~45m 单绳666666612t~25.1m 双绳12 12 10.58 9.76 8.14 6.93 6.00起重臂重量及吊点位置:自由高度:最大自由高度54米塔吊机构参数:主卷扬机构:起升速度(米/分):(2) 0~50米/分(6t); 0~100米/分(3t)(4) 0~25米/分(12t);0~50米/分(6t)主卷扬电机功率: 60kw卷筒最大容绳量: 400m变幅机构:变幅速度(米/分): 0~75变幅电机功率:5.5kw回转机构:回转速度(r/min): 0~0.6回转电机功率: 2×7.5 kw行走机构:行走速度(米/分):0~25行走电机功率:4×5.5 kw;顶升机构:顶升速度(米/分):0.45顶升电机功率: 7.5kw塔吊电网参数:电源:380V/50HZ 电容量:102.5KWTC7035塔身截面:2.2×2.2米塔身节主要构件:标准节:3.75米;行走底架固定底架:6.5×6.5米最大自由高度基础受力(吨)工作状态非工作状态自重F2 170t 220tF3 110t 170t 90t起重性能:幅度22 25 30 35 38 40 45 50 55 58 60 65 68吊重5.33t~49.7m双绳5.33 5.33 5.33 5.33 5.33 5.33 5.33 5.30 4.72 4.43 4.25 3.84 3.63 10.66t~27m四绳10.66 10.66 9.45 7.91 7.19 6.77 5.88 5.18 4.60 4.30 4.12 3.72 3.51 16t~18.5m六绳13.07 11.26 9.07 7.53 6.81 6.38 5.50 4.79 4.22 3.92 3.74 3.34 3.13 幅度22 25 30 35 38 40 45 50 55 58 60 65吊重5.33t~53.4m双绳5.33 5.33 5.33 5.33 5.33 5.33 5.33 5.33 5.14 4.48 4.63 4.20 10.66t~29m四绳10.66 10.66 10.24 8.58 7.80 7.35 6.40 5.64 5.02 4.70 4.51 4.08 16t~19.8m六绳14.15 12.21 9.86 8.20 7.42 6.97 6.02 5.26 4.64 4.32 4.13 3.70 幅度22 25 30 35 38 40 45 50 55 58 60吊重5.33t~55m双绳5.33 5.33 5.33 5.33 5.33 5.33 5.33 5.33 5.33 5.00 4.80 10.66t~29.8m四绳10.6610.6610.58 8.87 8.07 7.60 6.62 5.84 5.21 4.88 4.68 16t~20.3m六绳14.63 11.62 11.20 8.49 7.69 7.22 6.24 5.46 4.83 4.50 4.30 幅度22 25 30 35 38 40 45 50 55吊重5.33t~55m双绳5.33 5.33 5.33 5.33 5.33 5.33 5.33 5.33 5.33 10.66t~30.6m四绳10.6610.6610.669.55 8.70 8.20 7.15 6.32 5.6516t~20.9m 六绳15.75 13.61 11.02 9.20 8.35 7.85 6.80 5.97 5.29幅度22 25 30 35 38 40 45 50吊重5.33t~50m双绳5.33 5.33 5.33 5.33 5.33 5.33 5.33 5.33 10.66t~31.4m四绳10.6610.6610.669.76 8.89 8.38 7.31 6.47 16t~21.4m六绳16.00 13.90 11.27 9.41 8.54 8.03 6.96 6.11 幅度22 25 30 35 38 40 45吊重5.33t~45m双绳5.33 5.33 5.33 5.33 5.33 5.33 5.33 10.66t~32.3m四绳10.6610.6610.6610.85 9.64 9.09 7.95 16t~22m六绳16.00 15.06 12.23 10.23 9.29 8.74 7.59自由高度:最大自由高度54米塔吊机构参数:主卷扬机构:起升速度(米/分):(2) 0~50米/分(5.33t); 0~100米/分(2.67t)(4) 0~25米/分(10.66t);0~50米/分(5.33t)(6) 0~16.6米/分(16t); 0~33.3米/分(8t)主卷扬电机功率: 60kw卷筒最大容绳量: 400m变幅机构:变幅速度(米/分): 0~100变幅电机功率:11kw回转机构:回转速度(r/min): 0~0.6回转电机功率: 2×7.5 kw行走机构:行走速度(米/分):0~25行走电机功率:4×5.5 kw;顶升机构:顶升速度(米/分):0.45顶升电机功率: 7.5kw塔吊电网参数:电源:380V/50HZ 电容量:108KWTC7052塔身截面: 2.5m×2.5m塔身节主要构件:标准节:5.95米;最大自由高度基础受力(吨)工作状态非工作状态自重F2 230t 255tF3 135t 175t 135t塔吊起重性能表幅度18 20 25 30 35 40 45 50 55 60 65 7吊重12.5t~33.8m双绳12.512.512.512.512.02 10.30 8.97 7.90 7.04 6.32 5.72 5 25t~17.6m 四绳24.32 21.48 16.46 13.17 10.85 9.12 7.79 6.73 5.87 5.15 4.54 418 20 25 30 35 40 45 50 55 60吊重12.5t~34.6m双绳12.512.512.512.512.33 10.57 9.20 8.12 7.23 6.50 25t~17.9m 四绳24.93 22.03 16.89 13.53 11.16 9.39 8.03 6.94 6.06 5.33 幅度18 20 25 30 35 40 45 50吊重12.5t~34.9m双绳12.512.512.512.512.45 10.67 9.29 8.20 25t~18.1m 四绳25 22.24 17.06 13.67 11.27 9.50 8.12 7.03幅度18 20 25 30 35 40吊重12.5t~35.2m双绳12.512.512.512.512.510.80 25t~18.3m 四绳25 22.51 17.27 13.84 11.42 9.63自由高度:最大自由高度73米塔吊机构参数:主卷扬机构:起升速度(米/分):(2) 27米/分(12.5t); 53米/分(6.25t);80米/分(1t);(4) 13.5米/分(25t); 27米/分(12.5t);40米/分(2t);主卷扬电机功率: 63kw卷筒最大容绳量: 560m变幅机构:变幅速度(米/分): 0~100变幅电机功率:11kw回转机构:回转速度(r/min): 0~0.72回转电机功率: 3×5.5 kw行走机构:行走速度(米/分):0~25行走电机功率:4×5.5 kw;顶升机构:顶升速度(米/分):0.46顶升电机功率: 11kw塔吊电网参数:电源:380V/50HZ 电容量:112.5KWTCT7527(平头)塔身截面: 2.2×2.2米塔身节主要构件:标准节:3.75米;行走底架固定底架:6.5×6.5米最大自由高度基础受力(吨)工作状态非工作状态自重F2 223t 230tF3 165t 175t 97t起重性能:幅度20 25 30 35 40 45 50 55 60 65 70 7吊重10t~26.8m 双绳10.0010.008.757.29 6.20 5.36 4.70 4.15 3.70 3.31 2.98 2 20t~13.9m 四绳13.01 9.87 7.81 6.35 5.27 4.43 3.76 3.21 2.76 2.37 2.05 1幅度20 25 30 35 40 45 50 55 60 65 70吊重10t~28.1m 双绳10.0010.009.267.73 6.59 5.70 5.00 4.42 3.95 3.54 3.20 20t~14.6m 四绳13.79 10.49 8.33 6.79 5.65 4.76 4.06 3.48 3.01 2.61 2.26 幅度20 25 30 35 40 45 50 55 60 65吊重10t~29m 双绳10.0010.009.608.02 6.84 5.93 5.20 4.61 4.12 3.70 20t~15.1m 四绳14.31 10.90 8.67 7.08 5.90 4.99 4.26 3.67 3.18 2.76 幅度20 25 30 35 40 45 50 55 60吊重10t~29.4m 双绳10.0010.009.788.17 6.97 6.04 5.30 4.70 4.20 20t~15.3m 四绳14.57 11.11 8.84 7.23 6.03 5.10 4.36 3.76 3.26 幅度20 25 30 35 40 45 50 55吊重10t~29.9m 双绳10.0010.009.968.23 7.10 6.16 5.41 4.80 20t~15.5m 四绳14.85 11.33 9.06 7.38 6.16 5.22 4.47 3.86 幅度20 25 30 35 40 45 50吊重10t~30.3m 双绳10.0010.0010.008.45 7.22 6.26 5.50 20t~15.7m 四绳15.07 11.51 10.00 7.51 6.28 5.32 4.56 幅度20 25 30 35 40 45吊重10t~33.2m 双绳10.0010.0010.009.40 8.05 7.0020t~17.2m 四绳16.77 12.86 10.29 8.37 7.11 6.06 幅度20 25 30 35 40吊重10t~33.7m 双绳10.0010.0010.009.58 8.20 20t~17.5m 四绳17.08 13.10 10.49 9.06 7.26自由高度:最大自由高度61 米塔吊机构参数:主卷扬机构:起升速度(米/分):(2) 40米/分(10t); 80米/分(5t);100米/分(3t);(4) 20米/分(20t);40米/分(10t);50米/分(6t);主卷扬电机功率: 75kw卷筒最大容绳量: 620m变幅机构:变幅速度(米/分): 0~100变幅电机功率: 11kw回转机构:回转速度(r/min): 0~0.6回转电机功率: 7.5×3 kw行走机构:行走速度(米/分):0~25行走电机功率: 5.5×4 kw;顶升机构:顶升速度(米/分):0.46顶升电机功率: 7.5kw塔吊电网参数:电源:-380V/50HZ 电容量:130.5KWTC8039塔身截面: 2.5×2.5米塔身节主要构件:标准节:5.95米;行走底架固定底架:8×8米最大自由高度基础受力(吨)工作状态非工作状态自重F2 230t 225tF3 135t 175t 135t起重性能:幅度20 25 30 35 40 45 50 55 60 65 70 75 80 吊12.5t双12.5012.5012.50 10.85 8.77 8.7.12 6.33 5.68 5.13 4.66 4.25 3.90重~31.5m绳0825t~16.3m 四绳19.62 15.06 12.08 9.78 7.697.006.04 5.25 4.60 4.05 3.58 3.18 2.82幅度20 25 30 35 40 45 50 55 60 65 70 75吊重12.5t~32.7m双绳12.5012.5012.5011.39 9.758.497.49 6.67 5.99 5.41 4.92 4.5025t~16.9m四绳20.57 15.82 12.70 10.31 8.687.416.41 5.59 4.91 4.34 3.85 3.42 幅度20 25 30 35 40 45 50 55 60 65 70吊重12.5t~33.7m双绳12.5012.5012.5011.95 10.248.927.78 7.02 6.31 5.71 5.2025t~17.5m四绳21.38 16.89 13.17 10.87 9.167.856.80 5.94 5.23 4.63 4.12 幅度20 25 30 36 40 45 50 55 60吊重12.5t~34.5m双绳12.5012.5012.5011.89 10.539.188.10 7.23 6.5025t~17.9m四绳21.97 16.88 13.55 10.81 9.458.107.03 6.15 5.42幅度20 25 30 36 40 45 50吊重12.5t~34.8m双绳12.5012.5012.5012.02 10.659.298.2025t~18.1m四绳22.22 17.08 13.72 10.95 9.578.217.12幅度20 25 30 36 40吊重12.5t~35.2m双绳12.5012.5012.5012.19 10.08 25t~18.3m四绳22.53 17.33 13.92 11.11 9.72自由高度:最大自由高度67米塔吊机构参数:主卷扬机构:起升速度(米/分):(2) 27米/分(12.5t); 53米/分(6.25t);80米/分(1t);(4) 13.5米/分(25t); 27米/分(12.5t);40米/分(2t);主卷扬电机功率: 63kw卷筒最大容绳量: 561m变幅机构:变幅速度(米/分): 0~100变幅电机功率: 11kw回转机构:回转速度(r/min): 0~0.7回转电机功率: 5.5×3 kw行走机构:行走速度(米/分):0~25行走电机功率: 5.5×6 kw;顶升机构:顶升速度(米/分):0.46 顶升电机功率: 11kw塔吊电网参数: 电源:380V/50HZ 电容量:123.5KW二、四川机械厂C7022塔身截面: 2×2米 底架: 6×6米 塔身节主要构件重量:基础节 3.5米(3.78吨) 标准节 3米(1.95吨)套架总成:(9.06吨) 过渡节 7.5米(4.22吨) 回转 (6.6吨) 平衡臂 20.27米(12.395吨)塔头 (2.57吨)最大自由高度基础受力(吨):P= , M= , H= 起重性能(最大起重量16吨):吊点位置:自由高度:固定式:满顶13节标准节,钩高48.7米。
塔吊覆盖范围内建筑物防护方案2024年10月目录一、工程概况 (1)二、编制依据 (1)三、现场现状分析 (2)四、方案确定与实施 (2)五、防护棚搭设技术要求 (4)六、塔吊操作要求 (6)七、作业风险风险管控 ............................................. 错误!未定义书签。
八、应急措施 (7)九、防护棚(扣件式)计算书 ......................................... 错误!未定义书签。
一、工程概况本工程位于山东省。
为确保施工任务的圆满完成,在基础及主体结构施工阶段,我们决定采用一台型号为QTZ63、臂长44米的塔吊作为现场垂直运输机械。
鉴于施工现场东侧紧邻多栋民房,为避免高空作业中可能发生的物体坠落及物体打击等安全隐患,保障工程施工的平稳推进,特此制定并实施塔吊邻近建筑物的专项防护方案。
图1:现场平面示意图二、编制依据中华人民共和国建筑法主席令第29号建设工程质量管理条例国务院令第279号(2019修订)建设工程安全生产管理条例国务院令第393号危险性较大的分部分项工程安全管理规定建设部第37号令建筑地基基础设计规范GB50007-2011建筑结构荷载规范GB50009-2012塔式起重机安全规程GB5144—2006建筑施工脚手架安全技术统一标准GB51210-2016钢结构设计标准GB50017-2017木结构设计标准GB50005-2017施工脚手架通用规范GB55023-2022混凝土结构通用规范GB55008-2021钢结构通用规范GB55006-2021工程结构通用规范GB55001-2021建筑与市政施工现场安全卫生与职业健康通用规范GB55034-2022建筑与市政工程施工质量控制通用规范GB55032-2022消防设施通用规范GB55036-2022建筑防火通用规范GB55037-2022建筑施工扣件式钢管脚手架安全技术规范JGJ130-2011建筑施工临时支撑结构技术规范JGJ300-2013建筑施工安全检查标准JGJ59-2011建筑施工高处作业安全技术规范JGJ80-2016建筑施工塔式起重机安装使用拆卸安全技术规程JGJ196-2010住房城乡建设部办公厅关于实施《危险性较大的分部分项工程安全管理规定》有关问题的通知建办质(2018) 31号住房和城乡建设部办公厅关于印发《危险性较大的分部分项工程专项施工方案编制指南》的通知建办质〔2021〕48号房屋市政工程生产安全重大事故隐患判定标准(2022版)建质规〔2022〕2号建筑施工手册第五版建筑施工脚手架实用手册三、现场现状分析根据当前施工现场的具体需求和工程建筑物的实际情况,塔吊被精心布置于13号楼的南侧区域。
六艺十式第一式训练目标配图第二式俯卧撑墙壁俯卧撑初级目标:1组,10次中极目标:2组,各25次升级目标:3组,各50次上斜俯卧撑深蹲肩倒立深蹲初级目标:1组,10次中极目标:2组,各25次升级目标:3组,各50次折刀深蹲引体向上垂直引体初级目标:1组,10次中极目标:2组,各20次升级目标:3组,各40次水平引体向上举腿坐姿屈膝初级目标:1组,10次中极目标:2组,各25次升级目标:3组,各40次平卧抬膝桥短桥初级目标:1组,10次中极目标:2组,各25次升级目标:3组,各50次直桥初级标准:30秒中极标准:1分钟升级标准:2分钟乌鸦式倒立撑顶墙倒立训练目标配图第三式训练目标初级目标:1组,10次中极目标:2组,各20次升级目标:3组,各40次膝盖俯卧撑初级目标:1组,10次中极目标:2组,各15次升级目标:3组,各30次初级目标:1组,10次中极目标:2组,各20次升级目标:3组,各40次支撑深蹲初级目标:1组,10次中极目标:2组,各15次升级目标:3组,各30次初级目标:1组,10次中极目标:2组,各20次升级目标:3组,各30次折刀引体向上初级目标:1组,10次中极目标:2组,各15次升级目标:3组,各20次初级目标:1组,10次中极目标:2组,各20次升级目标:3组,各35次平卧屈举腿初级目标:1组,10次中极目标:2组,各15次升级目标:3组,各30次初级目标:1组,10次中极目标:2组,各20次升级目标:3组,各40次高低桥初级目标:1组,8次中极目标:2组,各15次升级目标:3组,各30次初级标准:10秒中极标准:30秒升级标准:1分钟靠墙倒立初级标准:30秒中极标准:1分钟升级标准:2分钟配图第四式训练目标配图第五式半俯卧撑初级目标:1组,8次中极目标:2组,各12次升级目标:2组,各25次标准俯卧撑半深蹲初级目标:1组,8次中极目标:2组,各35次升级目标:3组,各50次标准深蹲半引体向上初级目标:1组,8次中极目标:2组,各11次升级目标:3组,各15次标准引体向上平卧蛙举腿初级目标:1组,8次中极目标:2组,各15次升级目标:3组,各25次平卧直举腿顶桥初级目标:1组,8次中极目标:2组,各15次升级目标:3组,各25次半桥初级目标:1组,5次中极目标:2组,各10次升级目标:3组,各20次标准倒立撑半倒立撑训练目标配图第六式训练目标初级目标:1组,5次中极目标:2组,各10次升级目标:2组,各20次窄距俯卧撑初级目标:1组,5次中极目标:2组,各10次升级目标:2组,各20次初级目标:1组,5次中极目标:2组,各10次升级目标:3组,各30次窄距深蹲初级目标:1组,5次中极目标:2组,各10次升级目标:3组,各20次初级目标:1组,5次中极目标:2组,各8次升级目标:3组,各10次窄距引体向上初级目标:1组,5次中极目标:2组,各8次升级目标:3组,各10次初级目标:1组,5次中极目标:2组,各10次升级目标:3组,各20次悬垂屈膝初级目标:1组,5次中极目标:2组,各10次升级目标:2组,各15次初级目标:1组,8次中极目标:2组,各15次升级目标:3组,各20次标准桥初级目标:1组,6次中极目标:2组,各10次升级目标:2组,各15次初级目标:1组,5次中极目标:2组,各10次升级目标:3组,各15次窄距倒立撑初级目标:1组,5次中极目标:2组,各9次升级目标:2组,各12次配图第七式训练目标配图第八式偏重俯卧撑初级目标:1组,5次中极目标:2组,各10次升级目标:2组,各20次(全部为每侧)单肩半俯卧撑偏重深蹲初级目标:1组,5次中极目标:2组,各10次升级目标:3组,各20次(全部为每侧)单腿半深蹲偏重引体向上初级目标:1组,5次中极目标:2组,各7次升级目标:3组,各8次(全部为每侧)单臂半引体向上悬垂屈举腿初级目标:1组,5次中极目标:2组,各10次升级目标:2组,各15次悬垂蛙举腿下行桥初级目标:1组,3次中极目标:2组,各6次升级目标:2组,各10次上行桥偏重倒立撑初级目标:1组,5次中极目标:2组,各8次升级目标:2组,各10次(全部为每侧)单臂半倒立撑训练目标配图第九式训练目标初级目标:1组,5次中极目标:2组,各10次升级目标:2组,各20次(全部为每侧)杠杆俯卧撑初级目标:1组,5次中极目标:2组,各10次升级目标:2组,各20次(全部为每侧)初级目标:1组,5次中极目标:2组,各10次升级目标:3组,各20次(全部为每侧)单腿辅助深蹲初级目标:1组,5次中极目标:2组,各10次升级目标:3组,各20次(全部为每侧)初级目标:1组,4次中极目标:2组,各11次升级目标:2组,各8次(全部为每侧)单臂辅助引体向上初级目标:1组,3次中极目标:2组,各5次升级目标:2组,各7次(全部为每侧)初级目标:1组,5次中极目标:2组,各10次升级目标:2组,各15次悬垂半举腿初级目标:1组,5次中极目标:2组,各10次升级目标:2组,各15次初级目标:1组,2次中极目标:2组,各4次升级目标:2组,各8次合桥初级目标:1组,1次中极目标:2组,各3次升级目标:2组,各6次初级目标:1组,4次中极目标:2组,各6次升级目标:2组,各8次(全部为每侧)杠杆倒立撑初级目标:1组,3次中极目标:2组,各4次升级目标:2组,各6次(全部为每侧)配图第十式训练目标配图单臂俯卧撑初级目标:1组,5次中极目标:6组,各10次升级目标:1组,各100次(全部为每侧)单腿深蹲初级目标:1组,5次中极目标:2组,各10次升级目标:2组,各50次(全部为每侧)单臂引体向上初级目标:1组,1次中极目标:2组,各3次升级目标:2组,各6次(全部为每侧)悬垂直举腿初级目标:1组,5次中极目标:2组,各10次升级目标:2组,各30次铁板桥初级目标:1组,1次中极目标:2组,各3次升级目标:2组,各30次单臂倒立撑初级目标:1组,1次中极目标:2组,各2次升级目标:1组,各5次(全部为每侧)。
B310 LTE CPE Quick Start31507294_011Getting to know your B310Power indicator ●On: the B310 is powered on.●Off: the B310 is powered off.Network mode indicator ●Steady cyan: connected to an LTE network.●Steady green: connected to an Ethernet network.●Steady red:–The SIM card is not recognized, the PIN has not been entered, or the PIN verification failed.–Failed to connect to a mobile network or anEthernet network.Wi-Fi/WPS indicator ●Steady on: Wi-Fi turned on.●Blinking: a WPS connection is being set up.●Off: Wi-Fi turned off.LAN/WAN indicator● Steady on: LAN/WAN port is connected to a LANdevice or an Ethernet port.● Blinking: data is being transmitted through the LAN/WAN port.● Off: LAN/WAN port is not connected to a LAN device or an Ethernet port.Signal strength indicator ● On: signal reception available (more bars meanbetter reception).● Off: no reception.SIM card slot Install a standard SIM card to access the Internet via an LTE data connection.External antenna port Connect to external antenna after remove the cover.WPS buttonPress and hold for 2 or more seconds until is blinking to active WPS connection when Wi-Fi is turned on.Power buttonPress and hold for about 3 seconds to power the B310 on or off.Reset buttonRestoring the default settings of the B310 will eraseall previous settings.When the B310 is powered on, use a sharplypointed object to press and hold for about 3 seconds until indicator is blinking to restore the B310 to its factory settings. After the factory defaults are restored, the B310 will restart automatically.Power port Connect to compatible power adapter.LAN/WAN port● Working as a LAN port when connected to acomputer, switch, or other LAN device.● Working as a WAN port when connected to an Ethernet port on the wall. Telephone portConnect to a telephone.2InstallationScenario 1: Accessing the Internet using an LTE networkStep 1: Installing the SIM card1.Slide off the card slot cover.2.Insert the SIM card into the card slot. Ensure that the beveled edge of the SIM cardaligns with that of the card slot.3.Close the card slot cover.Do not remove the SIM card when it is in use. Doing so will affect the performance of your B310 and data stored on the SIM card may be lost.Step 2: Connecting cablesOnce connected to a power outlet, the B310 automatically powers on.Power adapterComputerTelephoneLaptop, tablet, or smart phone● To prevent interference caused by radio signals, place the B310 at least 1 meter (3.28 feet) away from telephone and other electrical devices. ● The B310's power adapter model is HW-120100XYW. X and Y represent letters or numbers that vary by region. For details about the specific adapter model, contact an authorized dealer.Do not connect the B310 to the telephone wall outlet (or any Public SwitchedTelephone Network), because doing so could damage the B310 due to excessive heat.Optional: Installing the external antennaIn areas with poor reception, connect external antenna to the B310's external antenna port to improve signal reception.1. Power off the B310 and disconnect it from the power outlet.2. Remove the cover from the antenna port. (Keep it in a safe place.)3. Install one or two external antennas as you need. Make sure the external antennas are securely connected to the antenna ports.If you are using only one external antenna, connect it to port 1.The external antenna is an optional accessory, and may not included in the packagingbox. If required, please contact your local dealer to purchase it.● Before installing the external antenna, ensure that the B310 is powered off and disconnected from the power outlet. ● Only use the external antenna indoors, and do not use it during thunderstorm. ● Do not change another unexpected antenna unless manufacturer provide.Scenario 2: Accessing the Internet using EthernetConnect the B310 to a wall-mounted Ethernet port or an ADSL modem for Internetaccess.Once connected to a power outlet, the B310 automatically powers on.Power adapterEthernet port on the wall TelephoneLaptop, tablet, or smart phone● To prevent interference caused by radio signals, place the B310 at least 1 meter (3.28 feet) away from telephone and other electrical devices. ● The B310's power adapter model is HW-120100XYW. X and Y represent letters or numbers that vary by region. For details about the specific adapter model, contact an authorized dealer.Do not connect the B310 to the telephone wall outlet (or any Public SwitchedTelephone Network), because doing so could damage the B310 due to excessive heat.3 Setting up a Wi-Fi connectionStep 1: Enabling Wi-Fi on the B310When theindicator is steady on, the Wi-Fi function of the B310 is turned on.Step 2: Recording the SSID and Wi-Fi keyThe default SSID and Wi-Fi key are printed on the B310's bottom label.Step 3: Setting up a Wi-Fi connection on your clientMethod 1: Setting up a Wi-Fi connection manually1. From your Wi-Fi enabled client, scan for wireless networks in your area.2. Connect to the network name that matches the SSID found on the device label.3. When prompted for password, enter the Wi-Fi Key found on the device label. (TheWi-Fi key is case sensitive.) Your client will notify you when it is connected.Make sure your client (computer, tablet, or smart phone) also supports Wi-Fi.For details about how to manually enable or disable the Wi-Fi function, refer to theWLAN settings section of the help information on the web management page.To prevent unauthorized parties from accessing your Wi-Fi network, it isrecommended that you change the SSID and Wi-Fi key from time to time. For details, see the help information on the web management page.Method 2: Setting up a Wi-Fi connection through WPSIf the client supports WPS, you can set up a WPS connection as follows:1.Ensure that Wi-Fi is enabled on the client.2.Press and hold the WPS button for 2 or more seconds. The indicator thenstarts blinking.3.Activate the WPS connection on the client in 2 minutes.user guide.4 Configuring your B3101. After a client is connected to the B310 through Wi-Fi or LAN port, launch a browser on the client and visit http://192.168.8.1.2. Enter the user name and password to log in to the web management page. Thedefault user name and password are printed on the B310's bottom label.3. Follow the quick setup wizard to check or set network connection parameters step by step. For details, see the help information on the web management page.Once you are done, try opening a web page on the client to verify whether you haveInternet access.● To protect your account, change the password after your first login. For details, see the help information on the web management page.● If you modify the SSID and Wi-Fi key, you must set up the Wi-Fi connection on the client again.5For more helpIf you are experiencing any issues with the B310:●Restart the B310.●See the help information on the web management page.●Restore the B310 to its factory settings.●Contact your service provider.Please visit /en/support/hotline for recently updated hotline and email address in your country or region.Figures in this guide are for your reference only. Specific models may vary slightly, contact your service provider for more detailed information.6Safety informationThis section contains important information about the operation of your device. It also contains information about how to use the device safely. Read this information carefully before using your device.Electronic deviceDo not use your device if using the device is prohibited. Do not use the device if doing so causes danger or interference with other electronic devices.Interference with medical equipment●Follow rules and regulations set forth by hospitals and health care facilities. Do notuse your device where prohibited.●Some wireless devices may affect the performance of hearing aids or pacemakers.Consult your service provider for more information.●Pacemaker manufacturers recommend that a minimum distance of 15 cm bemaintained between a device and a pacemaker to prevent potential interference with the pacemaker. If using a pacemaker, hold the device on the side opposite the pacemaker and do not carry the device in your front pocket.Areas with flammables and explosives●Do not use the device where flammables or explosives are stored (in a gas station,oil depot, or chemical plant, for example). Using your device in these environments increases the risk of explosion or fire. In addition, follow the instructions indicated in text or symbols.●Do not store or transport the device in containers with flammable liquids, gases, orexplosives.Operating environment●Avoid dusty, damp, or dirty environments. Avoid magnetic fields. Using the devicein these environments may result in circuit malfunctions.●Before connecting and disconnecting cables, stop using the device and disconnectit from the power supply. Ensure that your hands are dry during operation.●Place the device on a stable surface.●Keep the device away from electronic appliances that generate strong magnetic orelectric fields, such as a microwave oven or refrigerator.●During thunderstorms, power off your device and remove all cables connected to itto protect against lightning strikes.●Do not use your device during thunderstorms to protect your device against anydanger caused by lightning.●Ideal operating temperatures are 0°C to +40°C. Ideal storage temperatures are-20°C to +70°C. Extreme heat or cold may damage your device or accessories.●Keep the device and accessories in a well-ventilated and cool area away fromdirect sunlight. Do not enclose or cover your device with towels or other objects.Do not place the device in a container with poor heat dissipation, such as a box or bag.●To protect your device or accessories from fire or electrical shock hazards, avoidrain and moisture.●Keep the device away from sources of heat and fire, such as a heater, microwaveoven, stove, water heater, radiator, or candle.●Do not place any object, such as a candle or a water container, on the device. Ifany foreign object or liquid enters the device, immediately stop using it, power it off, and remove all cables connected to it. Then, contact an authorized service center.●Do not block device openings. Reserve a minimum of 10 cm around the device todissipate heat.●Stop using your device or applications for a while if the device is overheated. If skinis exposed to an overheated device for an extended period, low temperature burn symptoms, such as red spots and darker pigmentation, may occur.●Do not touch the device's antenna. Otherwise, communication quality may bereduced.●Do not allow children or pets to bite or suck the device or accessories. Doing somay result in damage or explosion.●Observe local laws and regulations, and respect the privacy and legal rights ofothers.●The device should be installed and operated with a minimum distance of 20 cmbetween the radiator and your body.●Keep the device in a place with good reception. The distance between the deviceand other metal materials (such as metal brackets or metal doors and windows) should be greater than 25 cm and the distance between the device should be greater than 30 cm.Child's safety●Comply with all precautions with regard to child's safety. Letting children play withthe device or its accessories may be dangerous. The device includes detachable parts that may present a choking hazard. Keep away from children.●The device and its accessories are not intended for use by children. Children shouldonly use the device with adult supervision.Accessories●Using an unapproved or incompatible power adapter, charger or battery may causefire, explosion or other hazards.●Choose only accessories approved for use with this model by the devicemanufacturer. The use of any other types of accessories may void the warranty, may violate local regulations and laws, and may be dangerous. Please contact your retailer for information about the availability of approved accessories in your area. Power adapter safety●The power plug is intended to serve as a disconnect device.●For pluggable devices, the socket-outlet shall be installed near the devices and shallbe easily accessible.●Unplug the power adapter from electrical outlets and the device when not in use.●Do not drop or cause an impact to the power adapter. If it is damaged, take it toan authorized service center for inspection.●If the power cable is damaged (for example, the cord is exposed or broken), or theplug loosens, stop using it at once. Continued use may lead to electric shocks, short circuits, or fire.●Do not touch the power cord with wet hands or pull the power cord to disconnectthe power adapter.●Do not touch the device or the power adapter with wet hands. Doing so may leadto short circuits, malfunctions, or electric shocks.●If your power adapter has been exposed to water, other liquids, or excessivemoisture, take it to an authorized service center for inspection.●Ensure that the power adapter meets the requirements of Clause 2.5 in IEC60950-1/EN60950-1/UL60950-1 and has been tested and approved according to national or local standards.Cleaning and maintenance●During storage, transportation, and operation of the device, keep it dry andprotect it from collision.●Keep the device and accessories dry. Do not attempt to dry it with an external heatsource, such as a microwave oven or hair dryer.●Do not expose your device or accessories to extreme heat or cold. Theseenvironments may interfere with proper function and may lead to fire or explosion.●Avoid collision, which may lead to device malfunctions, overheating, fire, orexplosion.●If the device is not going to be used for an extended period of time, power it off,and remove all cables connected to it.●If anything unusual occurs (for example, if the device emits smoke or any unusualsound or smell), immediately stop using it, power it off, remove all cablesconnected to it, and contact an authorized service center.●Do not trample, pull, or excessively bend any cable. Doing so may damage thecable, causing the device to malfunction.●Before you clean or maintain the device, stop using it, stop all applications, anddisconnect all cables connected to it.●Do not use any chemical detergent, powder, or other chemical agents (such asalcohol and benzene) to clean the device or accessories. These substances may cause damage to parts or present a fire hazard. Use a clean, soft, and dry cloth to clean the device and accessories.●Do not place magnetic stripe cards, such as credit cards and phone cards, near thedevice for extended periods of time. Otherwise the magnetic stripe cards may be damaged.●Do not dismantle or remanufacture the device and its accessories. This voids thewarranty and releases the manufacturer from liability for damage. In case ofdamage, contact an authorized service center for assistance or repair. Environmental protection●The device and its accessories (if included), such as the power adapter, headset,and battery should not be disposed of with household garbage.●Disposal of the device and its accessories is subject to local regulations. Supportproper collection and recycling.Disposal and recycling informationThis symbol (with or without a solid bar) on the device, batteries (if included), and/or the packaging, indicates that the device and its electrical accessories (for example, a headset, adapter, or cable) and batteries should not be disposed of as household garbage. These items should not be disposed of as unsorted municipal waste and should be taken to a certified collection point for recycling or proper disposal.For more detailed information about device or battery recycling, contact your local city office, household waste disposal service, or retail store.Disposal of the device and batteries (if included) is subject to WEEE Directive Recast (Directive 2012/19/EU) and Battery Directive (Directive 2006/66/EC). The purpose of separating WEEE and batteries from other waste is to minimize the potential environmental impacts and human health risk of any hazardous substances that may be present.Reduction of hazardous substancesThis device is compliant with the REACH Regulation [Regulation (EC) No 1907/2006] and RoHS Directive Recast (Directive 2011/65/EU). Batteries (if included) are compliant with the Battery Directive (Directive 2006/66/EC). For up-to-date information aboutREACH and RoHS compliance, please visit the web site/certification.EU regulatory conformanceStatementHereby, Huawei Technologies Co., Ltd. declares that this device is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.For the declaration of conformity, visit the web site/certification.The following marking is included in the product:This device may be operated in all member states of the EU.Observe national and local regulations where the device is used.This device may be restricted for use, depending on the local network. Restrictions in the 2.4 GHz band:Norway: This subsection does not apply for the geographical area within a radius of 20 km from the centre of Ny-Ålesund.7Legal NoticeCopyright © Huawei Technologies Co., Ltd. 2015. All rights reserved. No part of this manual may be reproduced or transmitted in any form or by any means without prior written consent of Huawei Technologies Co., Ltd. and its affiliates ("Huawei").The product described in this manual may include copyrighted software of Huawei and possible licensors. Customers shall not in any manner reproduce, distribute, modify, decompile, disassemble, decrypt, extract, reverse engineer, lease, assign, or sublicense the said software, unless such restrictions are prohibited by applicable laws or such actions are approved by respective copyright holders.Trademarks and Permissions, , and are trademarks or registered trademarks of HuaweiTechnologies Co., Ltd.LTE is a trade mark of ETSI.Other trademarks, product, service and company names mentioned may be the property of their respective owners.NoticeSome features of the product and its accessories described herein rely on the software installed, capacities and settings of local network, and therefore may not be activated or may be limited by local network operators or network service providers.Thus, the descriptions herein may not exactly match the product or its accessories which you purchase.Huawei reserves the right to change or modify any information or specifications contained in this manual without prior notice and without any liability. 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印刷日期使用說明書編號改版內容2008年5月1055NT0初版印刷序言感謝購買MONITOUCH V系列的畫面編輯用軟體 "V-SFT-5"。
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手冊的種類和用途本書是MONITOUCH V8系列相關的手冊中,對V8系列的功能進行詳細說明的手冊。
在和MONITOUCH V8系列相關的手冊中,還有其他如下的手冊。
手冊名使用說明書編號用途V8 系列參考手冊(本書)1055NTx對MONITOUCH V8系列的功能、進行詳細說明V 系列巨集參考1056NTx對V-SFT Ver. 5的巨集的概要、巨集編輯器的操作方法,巨集指令的內容等進行詳細說明V8系列引進手冊1057NTx對MONITOUCH V8系列的概要、製作編輯畫面時的基本操作方法、進行詳細說明V8 Series Operation Manual1058NEx對V-SFT Ver. 5 的結構、各個專案的編輯方法,限制事項等操作的相關內容進行詳細說明的手冊V8 Series Hardware Specifications2016NEx對MONITOUCH V8系列的硬體規格、使用方法等進行說明V8 Series Connection Manual2201NEx對MONITOUCH V8系列和其他公司的設備進行連接的方法,佈線圖等進行說明V Series DLL Function Specifications1059NEx對EthernetDLL (HKEtn20.dll)、CF卡DLL(VCFAcs.dll) 的概要、內容進行詳細說明關於V8系列的種類和記述形式MONITOUCH V8系列有以下種類。
YZ/CP/30-01欧阳光明(2021.03.07)武汉诺见生物技术有限公司验证文件氟苯尼考粉工艺验证报告验证文件类别:验证报告编号:YZ/CP/30-01部门:共页氟苯尼考粉工艺验证报告版次:□新订□修订验证形式:前验证()同步验证()回顾性验证()再验证()起草:年月日审阅会签:(验证领导小组)批准:年月日实施日期:年月日复印数:复印人:批准人:分发单位:目录一、概述二、验证目的五、验证范围四、验证时间五、验证职责六、判定标准七、验证结果判定方法八、生产工艺流程及说明九、氟苯尼考粉生产工艺验证中所用的公用系统及设备的验证文件十、生产要素的评价十一、质量系统要求的评价十二、生产工艺变量的评价十三、验证过程十四、结果评价与结论十五、确定再验证周期一、概述:我们对粉/散/预混剂车间的厂房等进行了验证。
对主要生产设备热风循环干燥烘箱、V-300混合机、全自动粉剂分装机进行了验证,详见清单。
制定了粉剂/预混剂各产品生产工艺规程。
制定了粉剂/预混剂各岗位标准操作规程。
合理的生产工艺是指导生产者进行规范化操作,生产出合格产品的根本保证。
其规范性和可操作性将直接影响兽药的质量,因此必须对兽药产品的生产工艺进行验证。
本厂氟苯尼考粉的生产是在一般生产区,该工艺根据兽药GMP有关预混剂生产工艺规定设计,符合预混剂生产要求。
二、验证目的本工艺验证是在厂房、生产用设备验证的基础上进行的。
在于评价生产系统要素和生产过程中等能影响产品质量的各种生产工艺变化因素提供系统的验证计划。
对准备投入商业化生产的氟苯尼考粉,用现行工艺生产三个批量(为上市批量)的产品,每批2000袋,从而检验氟苯尼考粉工艺规程、岗位操作规程及有关监控文件的可行性和重现性,使产品确定达到规定的质量标准。
三、验证的范围: 氟苯尼考粉产品质量控制方法、氟苯尼考粉产品生产工艺过程以及各工序的物料平衡等;重点评价在此生产工艺条件下生产出的中间产品、成品能否达到相应标准,各工序的物料平衡是否控制在所制定范围。
四、验证时间:2006年06月09日至2006年06月11日六、判定标准1 产品质量标准及工艺规程2 GMP有关要求七、验证结果判定方法1按照《氟苯尼考粉生产工艺规程》、生产批量及岗位操作规程的要求,生产三批,对生产过程各岗位的重点工艺条件和参数进行监控、测定、分析、确认,保证工艺过程的可行性及重现性。
2 验证结果判定方法:三批经检验全部合格,宣布本次验证成功。
如果一批未达到本验证标准,应增加两个批次验证,如果该两批有一批未达到本验证标准,判定本次验证失败。
3 根据验证过程及三批产品的验证结果,确认和调整工艺条件及参数。
4修改完善《氟苯尼考粉工艺规程》和《岗位操作规程》。
5颁发工艺验证证书八、生产工艺流程及说明 2工艺过程及说明2.1 工艺过程(按氟苯尼考粉工艺规程中详写的有关工艺参数和设备标准操作规程操作)。
(水分检查)细度检查(复核)(含量均匀度等检查)原辅料 粉碎、过80筛原、辅料脱外包装混 合称量、配料(外观)图例2.2 说明氟苯尼考粉工艺规程中详写的有关工艺参数,主要以小试、中试和回顾性数据确定的,质量控制参数以企业内控为标准;有关工艺中关键设备如:热风循环干燥烘箱、V-300混合机、全自动粉剂分装机都已验证。
九、氟苯尼考粉生产工艺验证过程中所用的厂房与公用系统及设备的验证文件、操作文件: 1 厂房与公用系统验证:1.1 检查厂房验证方案是否能达到验证的目的。
1.2 检查厂房验证记录及结果是否符合要求。
评价标准:验证记录结果显示该厂房与公用系统符合氟苯尼考粉生产的要求。
1.4 单项验证结论: 检查人:审核人:检查日期:审核日期: 2设备确认:2.1检查各生产设备的验证方案是否符合实际,并达到对设备进行验证的目的。
2.2检查各设备验证结果及验证记录。
评价标准:各设备验证记一般生产区外 包录结果显示各设备均符合生产的要求。
2.4 单项验证结论:检查人:审核人:检查日期:审核日期:3生产文件确认3.1确认所需生产文件已经齐全3.3单项验证结论:检查人:审核人:检查日期:审核日期:4结论:_________________________检查人:审核人:检查日期:审核日期:十、生产要素的评价1 操作间、设备1.1 操作间清洁在每批生产前,遵照一般生产区卫生清洁程序对操作间进行实地检查,操作间内应无任何物料和文件。
结果见附表1。
1.2 设备清洁在生产前按照热风循环干燥烘箱、V-300混合机、全自动粉剂分装机等设备清洁程序清洁整个生产线设备,应没有上批生产遗留下的污染物。
1.3 生产文件完备氟苯尼考粉工艺规程完备,岗位标准操作规程、设备操作规程、设备清洁规程、设备维护保养规程、洁净区清洁规程均完备,现场使用的批记录完备。
1.4状态标志根据生产过程中状态标志使用程序检查,确认现场使用状态标记符合生产管理要求。
2 生产环境2.1 温度、相对湿度检查在生产前记录一次各重要工序的温度、相对湿度。
见附表2。
十一、质量系统要素的评价提供文字依据证明质量要求符合氟苯尼考粉质量检验、质量保十二、验证过程1 验证方法1.1 按照氟苯尼考粉生产工艺规程,主配方,批记录及岗位操作规程的要求,选择投料量分别为100kg,各连续生产三批,对生产过程各岗位的重点工艺条件和参数进行监控,测定、分析、确认、保证工艺过程的可行性及重现性。
1.2 工艺流程:见“粉剂/预混剂生产工艺规程通则”项下粉剂/预混剂生产工艺流程图及区域划分示意图。
1.3 验证结果判定:1.3.1 经检验三批全部合格,宣布本次验证成功。
1.3.2 如一批不合格,应增加两个批次验证,如该两批有一批不合格,则宣布本次验证失败。
3 生产操作:3.1 原辅料:所有原辅料取样,每种物料分别取样,取得的样品分别测定。
项目:粒度,方法:用40目筛检测100g,筛上物用天平称量。
应能全部通过。
单项验证结论:检查人:审核人:检查日期:审核日期:3.2配料、混合3.2.1 操作依据:氟苯尼考粉生产工艺规程,称量岗位标准操作规程、V-300混合机操作规程,V-300混合机验证报告,粉散剂混合岗位操作规程、一般生产区卫生清洁规程。
3.2.2 操作记录:称量岗位记录,混合岗位记录,称量、混合岗位清场记录。
3.2.3 取样:混合结束后以取样钎分别从两个进料口进入V型混合机装料筒中,于不同深度在混合物料的5个点依次取样:1 左上层,2 右上层,3左中层,4 右中层,5 底部,各取20克左右,按照氟苯尼考粉半成品检验操作规程分别检验。
总取样量100g。
3.2.4 氟苯尼考粉总混料检测项目标准:3.2.4.1项目1:性状,白色或米黄色粉末,方法:目测。
项目2:含量测定:91.0%-109.0%。
项目3:干燥失重,取本品5g用水分快速测定仪测定,应≤9.0%。
各取样点的检测项均符合半成品质量标准,则可证明混合的均一性。
3.2.4.2.混合物料平衡应≥99%3.2.5 记录检查人:__________ 复核人:日期:___________3.2.5.2.混合工序物料平衡:检查人:__________ 复核人:日期:___________3.2.5.3 单项验证结论:检查人:审核人:检查日期:审核日期:3.3 分装:3.3.1 操作依据:氟苯尼考粉生产工艺规程,全自动粉剂分装机操作规程,粉散剂分装岗位操作规程、一般生产区卫生清洁规程。
3.3.2检查方法:在分装后不同时间段取第一袋及最后一袋,中间均匀取8袋,按装量检查法操作规程操作进行装量差异检查,并计算出偏差范围。
3.3.3。
验证标准:装量:应符合最低装量检查标准规定,每袋装量不得少于标示装量的97%,平均装量不得小于标示装量。
物料平衡:≥98%3.3.4 验证结果:3.3.4.1.装量差异检验记录:检查人:__________ 复核人:日期:___________3.3.4.2.分装工序物料平衡:检查人:__________ 复核人:日期:___________3.3.5 单项验证结论:检查人:审核人:检查日期:审核日期:3.4 氟苯尼考粉工艺验证成品质量检验3.4.1 验证标准:氟苯尼考粉成品质量标准3.4.2检验:按氟苯尼考粉成品内控质量标准检验验证产品的外观均匀度、装量、干燥失重等。
3.4.2 成品检验结果:检验员:__________ 复核人:日期:___________3.4.3 单项验证结论:检查人:审核人:检查日期:审核日期:十四、工艺验证结果分析与评价:评定人: 日期: 年月日验证小组成员组长:组员:批准人:年月日十五、再验证周期:1 工艺、质量控制方法、主要原辅料改变时需要进行工艺再验证;2 生产批量数量级改变时需要进行工艺再验证;3 更换关键设备时需做该设备适用性再验证;检验记录单编号:JL/ZL/30-01 共页第页结果为。
取样点2 (右上层):干燥失重:取本品5g用水分快速测定仪测定,结果为。
取样点3(左中层):干燥失重:取本品5g用水分快速测定仪测定,结果为。
取样点4(右中层):干燥失重:取本品5g用水分快速测定仪测定,结果为。
取样点5(底部):干燥失重:取本品5g用水分快速测定仪测定,结果为。
规定:≤9.0%结论:检验员复核人检验记录单编号:JL/ZL/30-01 共页第页取样点2 (右上层):性状:。
取样点3(左中层):性状:。
取样点4(右中层):性状:。
取样点5(底部):性状:。
规定:本品为白色或类白色粉末。
结论:检验员复核人检验记录单编号:JL/ZL/30-01 共页第页步骤:取本品约250mg,精密称定,置50ml量瓶中,加流动相适量使溶解并稀释至刻度,摇匀;精密量取5ml,置50ml量瓶中,用流动相稀释至刻度,摇匀,精密量取10µl,注入液相色谱仪,记录色谱图。
另取氟苯尼考对照品适量,同法测定。
按外标法以峰面积计算,即得。
含氟苯尼考(C12H14ClFNO4S)应为标示量的91.0%-109.0%。
名称称量峰面积计算平均对照品mg //取样点1( 左上层)(1)mg (2)mg取样点2 (右上层)(1)mg(2)mg取样点3(左中层)(1)mg(2)mg取样点4(右中层)(1)mg(2)mg取样点5(底部)(1)mg(2)mg结论:检验员复核人。