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1、Review Date: 复审日期:Effective Date:生效日期:Approvals 批准:Author(s)作者：Signature 签名：Date日期：Approver(s)批准人：Final Approver最终批准人：New新文件& Change更改_J No Change无变更Applicability: document applies for Beijing Novartis Pharma Ltd.适用性：文件适用于北京诺华制药有限公司-1 All Plant 全厂1 Compliance 质保-1 QC质量控制-1 HR/Admin.人事1 Production 生产
2、1 Processing 制成1 Packaging 包装-1 Semi Solid 半固体-1 IPC在线控制审 Engineering 工程-1 SCM供应链1 Warehouse 库房-1 BPA商业计划控制1 Purchasing 采购IT信息技术DL&PD注册协调与包装1 Other 其它：开发Replaces No:SOP-000266 Version 01替代：SOP-000266 Version 01Reason for Change 变更原因: Regularly revised per three years. In section 4.5 , 4.6, 4.7, Boil
3、er water and feed water quality control procedure is described newly. 三年的常规修订。 在章节4.5,4.6, 4.7中，增加锅炉炉水和锅炉给水水质控制的内容。1 Regulatory Basis and Reference Documents 依据及参考文献 Novartis Quality Manual 诺华质量手册：N 6.8: Water and Clean Steam for Pharmaceutical Manufacturing Processed 制药用水和洁净蒸汽 Others 其它：The Code of
4、 Peoples Republic of China Boiler water treatment superviseguideline Quality standard of water used in low pressure boilerAnalysis of water used in boiler andcooling system determination of alkalinityAnalysis of water used in boiler andcooling system determination of hardnessOperating Instructions f
5、or HOVAL-Steam Boiler Plant Operating Instructions for Fulton- Steam Boiler Plant Beakerv 200 ml or 250ml capacity Burette and Burette standv 50 ml capacity 1%Phenolphthaleinv Standard 0.1 N H2SO4 solutionv 0. 1 %Methylicv Ammonium buffer solutionv 0. 5%Eriochrome black Tv EDTAv 锥形瓶（200 ml 或 250ml）滴
6、定管和支架（50ml） 1 %酚酞指示剂 0.1N的硫酸标准溶液 0. 1%甲基橙指示剂氨一氯化铵缓冲溶液 0. 5%铬黑T指示剂 EDTA4.3 Sampling locations 取样Water Sample Taking Prepare a clean plastic bottle of 250 ml capacity. Firstly open the cooling water supply valve aside the sampling cooler, when the cooling water flow out of the sampling cooler, then op
7、en the water sample tap and let the water flow for one minute. Fill up the bottle and empty it three times. Take water sample about 200 ml.水样取样时准备 1 个 250ml 容量的，干净的塑料瓶。首先打开取样冷却器冷却水供水阀 门，当冷却水从取样冷却器流出时，打开取样阀门，让水流 1分钟。冲洗塑料瓶 3次。取大 约 200ml 的水样。4.4 Water testing procedures 水化验程序4.4.1 Boiler water total al
8、kalinity test 锅炉炉水全碱度化验Take 100 ml transparent water sample. Pour the water sample into a 250 ml conical flask. Trip two drops of phenolphthalein indicator, the solution present dark pink color. Titration with standard 0.1 N H2SO4 solution till the dark pink color just fade away. record the consumpt
9、ion of the acid as V1, then trip two drops of methyl orange indicator and the solution present orange color. Titrate continuously with standard 0.1 N H2SO4 solution till the orange color change to orange-red color. Record the consumption of the acid as V2.取 100mL 透明水样注于 250ml 的锥形瓶中。加入 2，3 滴 1%酚酞指示剂，
10、此时溶液显红 色，则用0.1N硫酸标准溶液滴定至恰无色，记录耗酸体积VI。然后再加入2滴甲基橙指示 剂，溶液显示橙色，继续用上述硫酸滴定至溶液橙红色为止，记录第二次耗酸体积 V2。calculation: JD = N ( V1 + V2 ) x 103 / 100 = 0.1 x ( V1 + V2 ) x 103 / 100 = V1 + V2 unit: V1: mlV2: mlJD: mmol / l计算公式: JD = N ( V1 + V2 ) x 103 / 100 = 0.1 x ( V1 + V2 ) x 103 / 100 = V1 + V2式中: JD: 全碱度，单位：毫
11、摩尔/升V1:第一终点所消耗硫酸标准溶液的体积，单位：毫升V2:第二终点所消耗硫酸标准溶液的体积，单位：毫升4.4.2 Feed water total hardness test 给水全硬度化验Take 100 ml transparent water sample. Pour the water sample into a 250 ml conical flask. Add 3 ml of ammonium buffer solution, drip 2 drops of eriochrome black T indicator, then titrate with standard 0.
12、001 M EDTA solution till the solution become blue-violet. Record the consumption of EDTA solution as V1. calculation: YD = 2MV1 x 103 / 100 = 2 x 0.001 x V1 x 103 / 100 = 0.02V1 unit: V1: mlYD: mmol / l取100mL透明水样注于250mL锥形瓶中，加入3mL氨一氯化铵缓冲溶液和2滴0. 5%铬 黑 T 指示剂，不断摇动，用 0.001 M EDTA 标准溶液滴定至溶液变为蓝色即为终点，记录 EDTA标准溶液所消耗的体积VI。计算公式：YD = 2MV1 x 103 / 100 = 2 x 0.001 x V1 x 103 / 100 = 0.02V1
