BNP SOP

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BNP-诊断仪使用操作流程使用

高级数据分析
与正常值对比与解读
正常值参考
获取并参考正常值范围，以便对患者的数据进行解读。
比对分析
将患者数据与正常值进行比对，找出差异及趋势。
临床意义
结合临床经验对数据进行分析，解读结果的临床意义。
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仪器维护与保养
日常保养与维护
每日清洁
每天使用柔软的湿布擦拭仪器表面，保持仪器清洁。
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根据操作手册的要求，准备样本并将其放入诊断仪的指定位置。
患者信息录入与样本准备
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在操作界面上选择“患者信息录入”选项，输入患者的基本信息，如姓名、年龄、性别等。
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根据需要，为患者拍摄清晰的照片或视频，以便后续观察和分析。
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进行测量并记录结果
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在操作界面上选择“测量”选项，启动测量过程。
诊断仪将自动进行测量，并记录测量的结果。
将测量结果记录在病例报告中，以便后续分析和参考。
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数据分析与解读
原始数据
获取并整理患者的原始数据，包括血液样本、心电图等。
基础数据分析
数据清洗
去除异常值、填补缺失值，确保数据准确性。
整理归纳
将原始数据整理归纳为可分析的数据格式。
统计分析
模型构建
诊断报告
每周校准
每周进行一次仪器校准，确保仪器准确性。
每月检测
每月进行一次仪器检测，检查仪器性能是否正常。
维护记录
记录仪器的维护和检测情况，方便日后查阅。
定期校准与检测
故障排查与维修
联系售后
无法自行解决时，应联系售后服务部门寻求帮助。
维修记录
记录故障情况和维修过程，方便日后查阅。

BNP临床检测的意义(最新整理)

BNP（B型尿钠肽）1、简介BNP是是由心肌细胞合成的具有生物学活性的天然激素，主要在心室表达，同时也存在于脑组织中。

当左心室功能不全时，由于心肌扩张而快速合成释放入血，有助于调节心脏功能。

2、作用BNP作为心衰定量标志物，不仅反映左室收缩功能障碍，也反映左室舒张功能障碍、瓣膜功能障碍和右室功能障碍情况。

在急性呼吸困难患者中有30-40%存在急诊医生难以确诊而影响预后，以BNP 100pg/ml作为临界值的阴性预测值达到90%，可以减少74%的临床不确定性；而BNP 超过400pg/ml提示患者存在心力衰竭的可能性达95%。

而BNP 在100-400pg/ml时可能由肺部疾病、右心衰、肺栓塞等情况引起。

呼吸困难患者急诊就诊时的BNP水平以及治疗后的变化也可以反映其出院时风险。

①BNP是HF的定量标志物；②BNP对于诊断HF是高度准确的；③BNP可以帮助给急诊科病人进行危险分层以便判断是该入院还是出院。

④BNP测试有助于改善病人管理，减少总治疗费用；⑤BNP测试节省6个月内费用；⑥BNP是HF最强大的预测物；⑦BNP水平有助于评估出院的安全性；⑧BNP指导的治疗能提高慢性HF疗效；⑨BNP水平，以及症状和体重增加，是确定临床失代偿的最好方法；⑩BNP是急性冠脉综合征病人死亡的最强大的预测物。

3、参考范围 BNP参考范围为0-100ng/ml；TAT时间为30分钟4、临床应用①急诊科在急诊科，就诊的病人往往带着诊断结果。

由于急诊病人表现出来的严重症状，使得医生必须立即判断最可能的病因，因此对于急诊科，在使用药物治疗之前需要一种非常准确的关键的诊断手段。

然而不乐观的是，以前使用的快速诊断工具缺乏高的灵敏度和特异性，这就给急性发作的病人带来巨大的危险，使得病人的治疗延迟或者造成错误的诊治，并有可能使死亡风险大大的增加。

在急诊科中开展B型钠尿肽评估，是提高初始诊断准确性的一个非常有价值的手段，这就为尽可能早的获得良好的诊断效果提供了极大的可能性。

人B型脑钠肽(BNP)酶联免疫分析试剂盒使用说明书

人B型脑钠肽(BNP)酶联免疫分析试剂盒使用说明书本试剂盒仅供研究使用。

检测范围： 96T2μg/L -80μg/L使用目的：本试剂盒用于测定人血清、血浆及相关液体样本中B型脑钠肽(BNP)含量。

实验原理本试剂盒应用双抗体夹心法测定标本中人B型脑钠肽(BNP)水平。

用纯化的人B型脑钠肽(BNP)抗体包被微孔板，制成固相抗体，往包被单抗的微孔中依次加入B型脑钠肽(BNP)，再与HRP标记的B型脑钠肽(BNP)抗体结合，形成抗体-抗原-酶标抗体复合物，经过彻底洗涤后加底物TMB显色。

TMB在HRP酶的催化下转化成蓝色，并在酸的作用下转化成最终的黄色。

颜色的深浅和样品中的B型脑钠肽(BNP)呈正相关。

用酶标仪在450nm波长下测定吸光度(OD值)，通过标准曲线计算样品中人B型脑钠肽(BNP)浓度。

试剂盒组成标本要求1．标本采集后尽早进行提取，提取按相关文献进行，提取后应尽快进行实验。

若不能马上进行试验，可将标本放于-20℃保存，但应避免反复冻融2．不能检测含NaN3的样品，因NaN3抑制辣根过氧化物酶的(HRP)活性。

操作步骤1.标准品的稀释：本试剂盒提供原倍标准品一支，用户可按照下列图表在小试管中进行稀释。

2.加样：分别设空白孔(空白对照孔不加样品及酶标试剂，其余各步操作相同)、标准孔、待测样品孔。

在酶标包被板上标准品准确加样50μl，待测样品孔中先加样品稀释液40μl，然后再加待测样品10μl(样品最终稀释度为5倍)。

加样将样品加于酶标板孔底部，尽量不触及孔壁，轻轻晃动混匀。

3.温育：用封板膜封板后置37℃温育30分钟。

4.配液：将30倍浓缩洗涤液用蒸馏水30倍稀释后备用5.洗涤：小心揭掉封板膜，弃去液体，甩干，每孔加满洗涤液，静置30秒后弃去，如此重复5次，拍干。

6.加酶：每孔加入酶标试剂50μl，空白孔除外。

7.温育：操作同3。

8.洗涤：操作同5。

9.显色：每孔先加入显色剂A50μl，再加入显色剂B50μl，轻轻震荡混匀，37℃避光显色15分钟.10.终止：每孔加终止液50μl，终止反应(此时蓝色立转黄色)。

N-端脑钠肽测定SOP_PBNP临床意义_检验科生化项目SOP

3试剂和设备
N-端脑钠肽测定
文件编号：
版本号：
页码：第页共页
3.1试剂
采用西门子医学诊断产品（上海）有限公司提供的试剂盒。
3.1.1试剂组成
试剂船1~2孔为FADP 0.056 mg/mL，D-脯氨酸68.8mg/mL，片剂；3~4孔为Apo-D-氨基酸氧化酶0.23 mg/mL，辣根过氧化物酶0.19 mg/mL，DCHBS 3.9 mg/mL，4-AAP 0.94mg/mL，片剂；6孔为抗体-CrO2 1.3mg/mL，片剂；7孔为缓冲液，稳定剂，液体；8孔为抗体-碱性磷酸酶，缓冲液，稳定剂，液体。
10参考文献
[1]西门子医学诊断产品（上海）有限公司N-端脑钠肽（PBNP）测定试剂说明书。
编写：审核：批准：
8生物参考区间
＜75岁的患者：125pg/mL
≥75岁的患者：450pg/mL
9临床意义
NT-proBNP可以用于疾病的诊断和预测。血浆中NT-proBNP的浓度指示着左心室功能障碍患者的
N-端脑钠肽测定
文件编号：
版本号：
页码：第页共页
预后情况。它还可以用于确定症状为心源性或者非心源性。对于怀疑患有充血性心力衰竭(CHF)的患者，NT-proBNP的测定可以作为诊断和评估严重程度的辅助方法，还可以指示急性冠状动脉症状和心力衰竭患者的风险等级。NT-proBNP是急性冠状动脉症状患者一年死亡率的最强独立预测值。NT-proBNP水平在不稳定心绞痛和随后的心肌梗死的患者中有所升高。虽然对这些疾病没有诊断意义，一系列研究显示NT-proBNP检测可以为不稳定心绞痛和心肌梗死患者的短期与长期的风险等级提供预测信息。
2标本采集与处理
2.1采血方法
空腹肝素锂、肝素钠与乙二胺四乙酸抗凝静脉血2~3ml。

消防水系统维保操作规程-诺华制药

Replaces No: N/AReason for Change:New SOP1 Regulatory Basis and Reference DocumentsNovartis GuidelineCorporate HSE Guideline 2 (NEM) HSEBNP SOPs SOPSOP-000119 Fire Prevention PlanOthers< The Law of People’s Republic of China on Fire Protection>< The Code of People’s Republic of China Code of design for sprinkler systems>GB 50084-2001< The Code of People’s Republic of China Code of Construction and Acception for sprinkler systems>GB50261-962 PurposeThis SOP describes prevention maintenance procedure of fire fighting facilities (water system) in Changping Plant, and the relative staff’s responsibilities was described .SOP()ScopeThis SOP covers :the fire fighting pump station located in boiler houseunderground fire fighting pipingfire hydrant indoor and outdoorfire-extinguisher indoor and outdoor4 sprinkler systems in new warehouse B15, old warehouse B13, canteen, officebuilding.SOP4B15B13Procedures4.1The preventive maintenance procedures of fire fighting water pumpstationDailyCheck two switches of the main fire fighting pump and jockey pump on“AUTO” position. Reference Figure 1.“AUTO”1Figure 11Check the jockey pump running in good order, To listen the motor, there is nostrange noise, the motor and pump casing is not very hot by touching them.Check all valves in right status open or close. Especially the Valves VH07should be opened to ensure the main fire fighting pump (P02) and auxiliary firefighting pump (P01) is full. Re: Figure 2 and table 1./VH07P02P0121Figure 22Table 1 Valves Status1Equipment Name P&ID StatusOutlet valve VH05OpenOutlet valve VH06OpenDrain tap VH01ClosedDrain tap VH02ClosedEmpty valve VH03ClosedEmpty valve VH04ClosedWater feed valve VH07OpenCheck all pressure gauges reading in the correct scope.P=6.0~7.0bar.Re:Figure 3.6~73Figure 33Check main pump and assistant pump is full. Open the valves VH01 andVH02 and close them until steady water flow out. Reference: Figure 2.VH01VH022Check the water level of the Fire Fighting Tank. It must be more than 85%.Reference: Figure 4.85%4Figure 44Make sure power is here.All above actions are carried out by boiler operator in evening shift per day.MonthlyAct all valves, partly open and close them, then put them in right position. Re:Figure 2 and table 1.//21Act all pressure gauges, close related valves, screw the vent pin, check thehand should move to ‘’Zero’’ position, if it’s ok, put all related valves in rightposition(open).Act main pump and assistant pump, rotate the shafts ten circles by screwingthe shaft connection using hands. Re: Figure 5.105Figure 55Manually running the two fire-fighting pump for a very short time.Check pump oil level.Re:Figure6:6Figure 66AnnuallyTest the pressure switch, stop the jockey pump, let the pressure reduce, main pump should automatically start and stop.(this will be performed together with4.3)Re: Figure 7./4.37Figure 7 7Maintenance bottom valve if necessary. Re: Figure 8.8Figure 8 8Replace pump oil. Add oil to valves, screw and bolt.7.8Pump internal maintenance if necessary.maintenance motor if necessary.Check electrical elements, blow the electrical elements using compressed air.4.2 The preventive maintenance procedures of outdoor underground and indoorFire-Fighting Water PipingMonthlyCheck all valves in right position. Re: Figure 9 and Table 2.92Figure 99Table 2 Valves Status2P&ID Location StatusVH01 Outdoor, east to boiler house. Open ()VH02 Outdoor, east to boiler house. Open ()VH03In underground piping tunnel.Open ()VH04North to new office building.Open ()VH05West to new office building.Open ()VH06North to new warehouse.Open ()VH07North to new office building.Open ()Check leak.Check fire-fighting pump connector.AnnuallyAct all valves, partly close and open. Several times for difficult parts. Re:Figure 99Check the non-return valves.Check and clean the well.Add oil to valves, screw and bolt.4.3MonthlyCheck the quantity of nozzle and fire hose.Check leak.Check the cabinet damage or not.Check all valves in right position./AnnuallyAct the fire hydrant, connect the fire hose, spray water(this will be performedtogether with 4.1).4.1Act all valves, partly close and open, Several times for difficult partsPaint them if necessary.Add oil to screw and bolt.Clean the cabinet.4.4 Automatically sprinkler systemMonthlyCheck all valve of wet alarm valve sets in right position. Re: Figure 10/10Figure 10 automatically sprinkler system in old warehouse (For example)10Figure 1111Check the pressure of wet alarm valve sets in the correct scope. Re: figure 1111Check leak anywhere by walk-down the piping.OpenClose Close CloseCheck all sprinklers.AnnuallyAct the Separately open the end water test sets-01,02, the water-driving alarmbell should ring. the fire information should be translated to Fire Fightingcontroller. Re: figure 12010212Figure 12 end water test sets in new warehouse12Alarm system test, firstly open the test valve-02, the alarm bell should ring;secondly open test valve-01, the alarm bell should ring, the fire informationshould be translated to Fire Fighting controller.valve-2valve-1Figure 13 automatically sprinkler system in new administration (For example)13Act all valve, partly close and open them, several times for difficult partsRe:Figure13./13Check leak anywhere for wet alarm valve setspaint them if necessary.Add oil to screw and bolt.Watch all sprinklers.Clean the pipe filter if necessary.4.5 Portable Fire-extinguisherMonthlyCheck the quantity, type, pressure of the portable fire-extinguisher.AnnuallySend the portable fire-extinguishers to government authority for checking.All above action should be record in FRM-000337 in time. And the utility engineer should review the logbook on time.FRM-000337Responsibilities5.1Prepare, update and publish this SOPs.Ensure that the fire fighting facilities are in operational condition withappropriate preventive maintenance. And all preventive maintenance activitiesare properly documented.Train the utility team to be able to start fire fighting maintenance procedures .SOP5.2 HSE officer HSELiaise with the local fire brigade and the area authorities to ensure that ourefforts fully comply with all laws and regulations.At random to test the performance of the SOP.SOPAdditional InstructionsN/ASOP: Standard Operation ProcedureHSE: Health Safety EnvironmentAnnexes/Related FormsFRM-000337: Fire Fighting Facilities (water system) Preventive Maintenance Logbook ()。

bnp操作规程

bnp操作规程操作规程是为了规范和统一操作流程、方法和操作要求而制定的文件。

对于BNP（B-type natriuretic peptide）的操作规程，主要包括样本采集、试剂准备、仪器操作、结果分析和质控等方面内容。

以下是一份大致的BNP操作规程，共约1200字。

一、样本采集1. 采集样本应遵循无菌技术操作，确保样本的准确性和可靠性。

2. 选择适宜的采样管或容器，采集静脉血3-5ml（或指纹血距主静脉采样点20-30cm的位置）。

3. 尽量避免造成样本污染，仔细清洁采样点，使用无菌针头或无菌激光穿刺器具。

4. 采集的血样应立即送至实验室，避免样本长时间暴露于室温下。

二、试剂准备1. 检查试剂的名称、批号和有效期，确保试剂的质量和可靠性。

2. 根据试剂说明书中的指导，准确配制试剂的浓度和体积。

三、仪器操作1. 确保仪器的正常工作状态，按照操作手册中的指导开机。

2. 根据操作手册或使用说明书中的指导，正确调整仪器的参数和设置。

3. 将样本放入仪器的样本槽中，根据仪器界面的提示，设置样本编号和其他必要信息。

4. 启动仪器运行程序，等待仪器自动完成样本的检测和分析。

5. 检查检测结果是否出现异常，如出现异常，及时排查并解决问题。

四、结果分析1. 检查仪器上显示的结果，确保结果准确和可靠。

2. 对于不同浓度的样本，根据标准曲线或浓度范围判断样本结果的阈值。

3. 分析结果时，应结合临床病史、其他辅助检查结果和临床表现，综合判断结果的意义。

五、质控1. 根据质控文件，进行质控品的配制和准备。

2. 每天使用前，进行质控品的检测，比对实验室的质控结果和标准范围，确保仪器性能和结果的准确性。

3. 记录质控结果，并及时处理异常结果，及时修正仪器或操作中的问题。

六、数据处理和报告1. 将仪器上的结果记录到实验室的数据库或记录表中，确保数据的完整性和可追溯性。

2. 根据不同样本和检测项目的要求，处理结果的单位换算和参考范围的判断。

BNP-诊断仪使用操作流程使用

BNP-诊断仪使用操作流程相关知识一、分级标准二、临床意义诊断和评估充血性心力衰竭三、判读方法急性心力衰竭诊断界值（根据2011年NT-proBNP中国专家共识）四、清洁维护1.请在仪表变脏时使用普通的无尘棉签或无尘棉织物随时进行清洁。

2.在清洁前请关闭仪表，并拔下电源设备。

首先用水或肥皂水除。

3.血液或其它污物，然后对仪表进行消毒。

4.垂直滴加标本可减少样本加样区的受污染程度。

BNP-诊断仪使用评分标准模拟病例一①基本信息：患者张发坤，男性，67岁，退休工人，ID: 10120611②主诉；因“反复胸闷、气促10余年，加重4天”入院③一般体格检查；体温36.5℃，脉搏104次/分，呼吸20次/分，血压179/102mmhg，精神一般，食欲欠佳，睡眠正常，大小便正常。

④专科体检：神清，双肺呼吸音粗，可闻及少量湿性啰音，心率104次/分，心律齐，未闻及病理性杂音。

腹部查体无特殊，双下肢轻度凹陷性水肿。

⑤既往史：有高血压病病史20余年，最高血压180/100mmHg，规律服药治疗，具体不详，自诉血压控制可。

有糖尿病史20年，目前使用胰岛素控制血糖，具体不详。

2009年5月在梅州市人民医院行支架置入术，具体不详。

⑥主要辅助检查及实验室检查；中山市博爱医院13/2胸片示：双肺浸润性阴影，较前吸收。

心电图示：完全性右束支传导阻滞，下壁导联可见病理性Q波。

⑦诊断：1.慢性心功能不全急性加重心功能III~IV级2.冠心病支架置入术后 3.高血压病3级（很高危组） 4.2型糖尿病 5.双肺社区获得性肺炎⑧医嘱：BNP检查。

bnp的分类

BNP的分类
BNP（脑钠肽）主要有三个成员：心房钠尿肽（atrial natriuretic peptide，ANP）、脑型钠尿肽（brain natriuretic peptide，BNP）和C型钠尿肽（C-type natriuretic peptide，CNP）。

BNP是1988年由日本人Matruo等人从猪脑中分离纯化出来，又称脑钠素、脑钠尿肽、脑钠肽，BNP不仅存在于脑内，也存在于心脏、肺脏等组织器官当中。

在神经系统中，BNP主要是以小分子形式存在。

在中枢神经系统内，延髓内BNP含量最高，其次是尾状核、豆状核、海马和垂体，在下丘脑外侧区、视上核、室旁核和三叉神经节也含有丰富的BNP。

在外周神经系统中，皮质、脊髓内、脊神经节和三叉神经节也含有BNP。

在脑内，BNP的受体主要存在于穹隆下器、视前区、视上核、视旁核、蛛网膜等处。

以上内容仅供参考，建议查阅医学书籍或咨询专业医生获取更准确的信息。

1。

尿毒症心力衰竭-2020血液透析SOP

急性左心力衰竭的治疗流程
急性左心力衰竭的治疗
1.减少静脉回流：端坐位 2.吸氧、必要时予机械通气 3. 超滤脱水：0.5-1L/30min 4.镇静：吗啡3-5mg iv,高龄、COPD者慎用 5.血管扩张药：
血管扩张药的应用
血管扩张药
硝酸甘油
硝普钠硝酸酯类
5～
10μg/min 静脉滴注
0.6ml/h （10μg/m
透析患者心力衰竭的预防
• 定期评估透析充分性，患者单次透析 spKt/V≥1.2 且 URR≥65%；保障透析时间，丧失残肾功能的患者，每周血液透析时间≥12h；残肾功能＞2ml/min 的患者，每周血液透析时间≥10h。
• 使用超纯透析液，改善微炎症状态。 • 加强透析治疗过程中的管理，避免透析液反超的发生。 • 透析结束回血流速应缓慢，防止患者血容量快速上升。 • 心血管状态不稳定的患者，建议采用血液滤过或血液透析滤过
透析患者心力衰竭的预防
• 加强患者容量管理
建议患者低盐饮食，每日钠盐摄入量＜5g，并以 3g 以下为宜。 • 控制透析间期体重增长率＜5%干体重。 • 对于容量负荷显著增加的患者应适当增加透析时间，或采用缓慢透析或夜间透析的方式，避免患者容量负荷快速波动，理想超滤率＜10～13ml/（kg•h）。 • 定期评估调整干体重，实现干体重达标。对于干体重超标：胸部 X 线显示肺淤血征象；心胸比值男性＞50%、女性＞53%以及透析前水肿的患者，应积极超滤治疗。建议应用生物电阻抗、超声测量下腔静脉等方法，客观评估患者的体液状态，早期发现容量负荷增加。
尿毒症患者心力衰竭的诊治
2020版血液透析SOP
定义
• 心力衰竭（heart failure，HF）是指由于任何心脏结构或功能异常导致心室充盈和/或射血功能受损，心排量不能满足机体代谢需要，以肺循环和/或体循环淤血，器官和组织血液灌注不足为临床表现的一组综合征，主要临床表现为呼吸困难和乏力，以及液体潴留。心力衰竭是多种心血管疾病的严重终末阶段，是急性及慢性肾衰竭患者的主要死亡原因之一。

洁净室监视操作规程-诺华制药

Replaces No.: SOP-000192 version 04Reason for Change:1. Integration of all HVAC Units of EPCP in operation.2. The RMS is in operation.3. FRM-000221 / FRM-000346 were updated accordingly to cover the existing plantand the area of EPCP.1 Regulatory Basis and Reference DocumentsNovartis Quality Manual:N6.2.2: Cleanness ZoningBNP SOPs:SOP-000328: General Operating Procedure in case of HVAC Shut DownSOP-000475: Room Condition Monitoring in case of RMS none availabilitySOP-000477 Monitoring of the clean rooms conditions (pressure, temperature, relative humidity) using the Room Monitoring System (RMS)SOP-000478 Operating procedures of the Room Monitoring System (RMS)SOP-000479 System Management of the Room Monitoring System (RMS)NB. Upon approval of the RMS SOP these SOPs will be referenced to this SOP.2 PurposeThis SOP describes:The demonstration of the correct air flow direction by the cascading of various standard air pressure differences between the rooms and different working areas.The pressure difference between the whole production area and the outside ambient pressure is defined in this SOP and recorded on the relative forms.The manual monitoring and recording of room P Pa, T, RH % for the existingplant and the EPCP areas wherever conventional instruments are installed and are included in the FRMs (FRM-000221,FRM-000222 ,FRM-000346 and FRM-000407)The automatically monitoring and recording of rooms P Pa, T, RH % by RMS forthe EPCP areas is dealt by a separate SOP. (Reference SOP-000477 and theSOP-000475 )3 ScopeThis SOP applies to all Zones 2, 3 and 4 areas on the BNP Site.It applies to the 8 HVAC systems on the existing BNP Site which serve the Zone 2 areas.It also applies to the integrated EPCP HVAC systems, PCU1, PCU2, AHU11, AHU12, AHU14, AHU15, AHU16, AHU17, AHU18, AHU19, AHU20, AHU21, AHU22, AHU24, AHU25.The set criteria and action as described in chapter 4 apply throughout the plant (existing and EPCP HVACs)The Sampling Cabin HVAC system is excluded from this SOP. Its operation is described by SOP-000213.Note: This SOP will be under observation by engineering, production and QA and will be revised as required to reflect the real situation of the plant.3.1 Existing HVAC systems3.1.1 System 1.1Covers Solid Dosage Form Production Area and includes rooms 301, 303, 310, 308, 313, 504, 506, 508.1, 508.2, 510, 512, 514, 516, corridor 300 and corridor 500.3.1.2 System 2.1Covers the Encapsulating and Tablet Printing Area and includes rooms 509, 511, 507.3.1.3 System 2.2Covers Semi-Solid Dosage Form, Tube Filling Area and includes rooms 505, 505.1, 505.2, 505.3 and 501.1.3.1.4 System 2.3Covers Semi-Solid Dosage Form Processing Area and includes Rooms 501, 503 and 503.1 ,Ex-proof area.3.1.5 System 3.0Covers Packaging Area, rooms 110, 106, 305, 307, 309, 405, 405.1, 405.2 and corridor 150.3.1.6 System 8.0Covers Alu/Alu Blister packing Room 304 and Tablet compressing room 306.3.1.7 System 10.0Covers Air Lock, room No. 306 and Material Transfer Air Lock, room No. 918.3.1.8 System 13.0Covers the Equipment washing/storage Area, Rooms 314, 314.1 and the Purified Water generation room 316.3.2 Extension project HVAC systems3.2.1 PCU-1Preconditioning system 1 Air Handling System (PCU1) is supplying with preconditioned air in the extension AHU12, AHU16, AHU17, AHU18, AHU19, AHU23 and AHU24.3.2.2 PCU-2Preconditioning system 2 Air Handling System (PCU2) is supplying with preconditioned air in the extension AHU11, AHU14, AHU15, AHU21, AHU22 and in the old building AHU1.1, AHU3.0, AHU5.0, AHU6.1, AHU6.2, AHU8.0, AHU2.1, AHU2.2, AHU2.3, AHU13.0.3.2.3 AHU11Dispensary Area, Covers A-320 Airlock, A-322 Clean store, ,A-324 Dirty Equipment,A-326 Washing,A-328 Drying,A-330 Breached material store, A-332 Emergency Shower,A-334 Change room, A-918 Dispensed batch store, A-921 Dispensing room 1, A-922 Dispensing room 2,A-924 Dispensary material store,A-928 Pallet transfer.3.2.4 AHU12Main corridor. Covers A-600,A-700,A-603 Production waste airlock,A-605 Production outer airlock.3.2.5 AHU14Granulation Suite, Covers A-602 Blending room,A-604Storage,3.2.6 AHU15Compression suite,CoversA-612 Compression corridor,A-608 Compression room 1,A-610 Compression room 2.3.2.7 AHU16Coating, Covers A-628 Coating,A-628.1 PersonalAirlock,A-630 Control room,A-632 Printing, A-634 Bulk storage.3.2.8 AHU17Covers the Clean Change A-232, Uniform Store A-230, Dirty Change A-226, Shoe Change A-222, Clean Stair1 A-238, Clean Stair 2 A-240, and Factory Shoe Change A-236.Covers the Clean Change A-132, Uniform Store A-130, Dirty Change A-126, Shoe Change A-122, Reserve A-138, Clean Staircase 2 A-140 and Factory Shoe Change A-136.3.2.9 AHU18Covers the Buster Pack A-710, New Pack A-720, UPS Pack A-730 and Blister Pack A-740.3.2.10 AHU19Covers the Packaging Area A-407, Packaging Waste Air Lock and A-409.3.2.11 AHU20Covers the Warehouse Receiving Area, A-804 and the High Rack Storage Area,A-806.3.2.12 AHU21Covers the Conditioned Storage, A-932.3.2.13 AHU22New wash bay, Covers A-624 Equipment drying room, A-620 Dirty equipment room.3.2.14 AHU24Granulation, Covers A-638 Material Airlock,A-640 Personal Airlock,A-636 Granulation room,A-642 Emergency Shower.3.2.15 AHU25The Sampling Cabin HVAC system is excluded from this SOP. Its operation is described by SOP-000213.This SOP applies to all BNP personnel including temporary or SLA contractor’s employees dealing with the HVAC of BNP.4 Proceduresplant.The pressure difference (P Pa) between the rooms, the various areas and theCorridor compared to the outside ambient pressure, as well as, the temperature, and Relative Humidity (T, RH % ) at critical areas are monitored and recordedmanually.The pressure difference (P Pa) of filters installed in AHUs monitored andrecorded manually.The monitoring and recording activities are performed twice a day, morning and evening. See Record Forms (FRM-000222, and for the T, RH % FRM-000407).The acceptance criteria are shown on the “Record Form”. The records are required to be confirmed and signed by Head of Utility , Head of Engineering and QA Compliance., RH % of the extensionplant.The pressure difference (P Pa) of filters installed in AHUs monitored andrecorded manually.( FRM-000346)The pressure (P Pa) of the rooms, the various areas and the Corridor compared to the outside ambient pressure, as well as, the temperature, and Relative Humidity (T, RH %) at critical areas are monitored and recorded automatically by RMS.Whenever an out of range indication of room parameter (P/P Pa, T , RH %) is observed, or an alarm was raised from RMS, a call must be made immediately to Head of Utility/Utility persons and the process area supervisor.When an alarm was raised from RMS, P between the alarm room with surrounding area should be quickly calculated. The flow direction air should be judged correct or wrong. Action follow the list sheet.The Supervisor of the process area will inform the head of production to take the decision for immediate production protection activities based on an evaluation of the process stage (if product is open etc.) and with the criteria stipulated on the table below:P Pa(within zone 2 and acrossP Pa(within zone 2 and acrossP finishing batch production might be continued in agreement with QAP Pa(within zone 2 and acrossP cascadeRH %:The criteria for the T , RH % are based on the BNP risk assessment“Compliance-RA2008060310” and the URS, EPCP_01_00_HLD_URS_2.0 T =18~26 and RH % = ambient RH %<65%Parameter Value ActionT (within zone 2,3)26 to 28Continue production process to finish batch, call utility engineer, and processarea supervisor and production head. Follow production head instructions initiatea deviation. After finishing batch production might be continued in agreement with QA for 24 hrs. Follow SOP-000328.T(within zone 2,3)> 28 Continue process to finish batch. Call area supervisor and initiate a deviation. After finishing batch stop production. Call utility engineer. Follow SOP-000328. RH %(within zone 2,3)< 65% Continue production, no actionsRH %(within zone 2,3)65% to 70%Call utility engineer, process area supervisor and production head. Follow their instructions to continue production to finish batch. Initiate a deviation. Do not start an other batch until conditions are in compliance according to Chinese GMP.RH %(within zone 2,3)>70%Call utility engineer, process area supervisor and production head. Follow their instructions to stop production and initiate a deviation.If the case requires, a risk analysis has to be formulated and must beapproved by Head of Production and QA-Compliance.The Head of Utility should investigate the facility problem and get it solved.5 Responsibilities5.1 GeneralIt is the responsibility of the Head QA, Production manager, Site Engineering and their personnel to carry out the related operations of this SOP to ensure familiarity with this SOP and execution accordingly.Each BNP employee including temporary and/or SLA contractor’s employees involved in activities related to the monitoring of HVAC systems is responsible for reading and understanding the content of this SOP.5.2 EngineeringResponsible for the professional and timely execution of the above gauge readings, recording and adjustment work by trained experienced and knowledgeable staff and for documenting details in the >Filter and Room Pressure Difference Record”<. Return the rooms and systems to the production in a fully working condition after any engineering work.The Head of Utility must review the daily record and sign the record on the same day. The week end record can be reviewed and signed off retrospectively the following Monday morning.The Head of Engineering must review and sign the daily record weekly, every Monday.5.3 ProductionThe production area supervisor in all critical areas monitors from time to timeThe room controlled parameters.If an abnormal function is observed reports the head of utilities and the head of production and follows the instruction of the relative SOPs, (SOP-000192 and SOP-000475).5.4 ComplianceThe daily record must be reviewed and signed by the Compliance weekly ,on Mondays. If Monday is an off-day, the review may be postponed to the next working day.5.5 Document AuthorFor new documents or those being revised, requesting and using the assigned document numbers, and ensuring that they are unique and correct and in accordance with the SVMP of BNP.6 Additional InstructionsN/A7 Definitions & AbbreviationsEPCP: Extension Project ChangPing PlantQA: Quality AssuranceSLA: Service Level Agreement (between Novartis and relative supplier rendering the service).8 Annexes/Related FormsFRM-000221: Pressure Layout of Production AreaFRM-000222: Filter and Room Pressure Difference RecordFRM-000346: Filter and Room Pressure Difference Record for Extension HVAC SystemFRM-000407: Records for BNP Rooms T and RH %。

洁净空调启停操作规程-诺华制药

SOP-000309 Version : 04Effective from : 24.10.2008HVAC System Operation Procedure空调系统操作程序Approvals 批准: Name 姓名:Date 日期:Signature签名:Approvers 批准人:Final Approver 最终批准人:Applicability: document applies for Beijing Novartis Pharma Ltd. 适用于：文件适用于北京诺华制药有限公司All Plant QC QA HR/Admin. Production Processing Packaging Semi SolidEngineering SCMBPAother :空调系统操作程序Replaces No.: SOP-000309 version 02Reason for Change:1. Integration of all HVAC Units of EPCP in operation.1 Regulatory Basis and Reference DocumentsNovartis Quality Manual:Module N6.2: Cleanliness ZoningIGs N6.2.2: Cleanliness Zoning Policy for The Manufacture of Non-Sterile Drug Products and the Respective Drug SubstanceBNP SOPs:SOP-000066: Filter Replacement for HVAC InstallationSOP-000192: Room Monitoring Cleanliness Zoning parameters P Pa, T℃, RH % SOP-000213: Operation and Cleaning for Sampling Cabin (R907) in WarehouseSOP-000217: Preventive Maintenance for HVAC UnitsSOP-000328: General Operating Procedures in case of HVAC Shut DownSOP-000390: Cleanliness ZoningSOP-000475 Room Condition Monitoring in case of RMS fails (none availability)NB. Upon approval of the RMS SOP these SOPs will be referenced to this SOP.2 PurposeTo specify the general sequence of HVAC system start up and shut down.To specify the general instructions on how to operate the HVAC systems.3 ScopeThis SOP is valid for all the following production related HVAC systems in Beijing Novartis Pharma. Ltd, ChangPing.No. Function Servicing areas Cleaning Zone1.1 Production area Dispensing A-308, Day storage Room A-310, Blending Room A-313, Intermediate Storage A-504, Granulation Room A-506, CompressingRooms A-508.1, Compressing ante-room A-510, Capsule filling room A-508.2, Coating Room A-514, Coating drying room A-516, Corridors 300and 500 etc.Zone 22.1 Capsule filling Encapsulating A-511, Printing A-509 and locker 507 Zone 22.2 Emugel filling Cream/Ointments Filling A-505 and Personnel Lockers 505.1, 505.2,505.3, 501.1Zone 22.3EmugelprocessingCream/Ointments Processing A-503 and locker 501, Storage room 503.1 Zone 23.0 Packaging Secondary packaging A-405,Air locker 405.1 etc. Zone 24.0 N/A N/A Zone 35.0 Lockers Offices and Production Lockers Zone 26.0 QC QC Laboratories Zone 4 8.0 Alu-Alu Alu-Alu Blister Packing A-302, Compressing Room A-304 Zone 2空调系统操作程序No. Function Servicing areas Cleaning Zone packaging9.0 Sampling Sampling Cabin A-907 with Personnel Lockers 905, 906 Zone 210.0 Material lock Material Entry A-910Material Air-Lock A-306Zone 4Zone 313.0 Washing Washing Area A-314.1, Equipment storage room A-314, PW Plant RoomA-316Zone 220NewWarehouseReceiving/Dispatch Area A-804, High Rack Storage Area A-806 Zone 421NewConditionedStorage AreaNew Conditioned Storage Area 932 Zone 4PCU1 Inlet to AHU Central fresh-air pre-conditioning unit N/A AIC 1 Air Inlet Fresh-air Inlet Chamber 1 N/A PCU2 Inlet to AHU Central fresh-air pre-conditioning unit N/A AIC 2 Air Inlet Fresh-air Inlet Chamber 2 N/A ------ Canteen Canteen N/AAHU11 Dispensary A-320 Airlock, A-322 Clean store, ,A-324 Dirty Equipment,A-326 Washing,A-328 Drying,A-330 Breached material store, A-332 EmergencyShower,A-334 Change room, A-918 Dispensed batch store, A-921 Dispensing room 1, A-922 Dispensing room 2,A-924 Dispensary materialstore,A-928 Pallet transfer.Zone 2AHU12 Clean corridor New HVAC system is used for production area step by step Zone 2AHU14 GranulationSuiteA-602 Blending room,A-604Storage,Zone 2AHU15 CompressionsuiteCovers Corridor A-612 Compression corridor,A-608 Compression room1,A-610 Compression room A-616 , Compression room A-618Zone 2AHU16 Coating, Covers A-628 Coating, A-628.1 PersonalAirlock, A-630 Control room, A-632 Printing, A-634 Bulk storage.Zone 2AHU17 Clean Change Clean Stair1 A-238, Clean Stair 2 A-240 : operated zone 2Zone 2 Shoe Change A-238 : operated zone 2Clean Change A-232 : operated zone 4*Rooms A-230, A-234 : operated zone 4*Rooms A-222, A-226 : operated none zone**Rooms A-224, A-228, A-228.1 : operated none zoneNote:*: AHU17 is designed for Zone 2(A-232, A-234, A-230), the operation mode of the rooms are defined as listed above.**: AHU17 is designed for Zone 3(A-222, A-226), the operation mode of the rooms are defined as listed above.Clean Stair1 A-140 : operated zone 2Shoe Change A-136 : operated zone 2Clean Change A-132 : operated zone 4*Rooms A-130, A-134 : operated zone 4*Rooms A-122, A-126 : operated none zone**Rooms A-124, A-128, A-128.1 : operated none zoneNote:*: AHU17 is designed for Zone 2(A-132, A-134, A-130), the operation mode of the rooms are defined as listed above.**: AHU17 is designed for Zone 3(A-122, A-126), the operation mode of the rooms are defined as listed above.AHU18Primarypackaging areaPrimary packaging room A-710, A-720, A-730, A-740. Zone 2AHU19Secondarypackaging areaPackaging Area, A-407, Packaging Waste Air Lock, A-409. Zone 3AHU20 WarehouseWarehouse Receiving Area, A-804 and the High Rack Storage Area, A-806.Zone 4AHU21Warehouse Conditioned Storage, A-932. Zone 4AHU22Process area New wash bay, Rooms A-624 Equipment drying room, A-620 Dirty equipment room. Zone 2空调系统操作程序No. Function Servicing areas Cleaning ZoneAHU24Process area Granulation, Covers A-638 Material Airlock, A-640 Personal Airlock, A-636 Granulation room, A-642 Emergency Shower. Zone 2AHU 25 Sampling Rooms A 820, A 821, A 822, A823, A 8244 Procedures4.1 Sequence of Existing Systems Start-upAll the HVAC systems are continuously running, 24hours/day, except the AHU 9.0 system for the Sampling Room (see SOP-000213 Operation and Cleaning for Sampling Cabin (R907) in Warehouse ) and future Sampling Cabin served by AHU 25. In case of maintenance activities requirements or system failure, the system can be shut down in accordance with the SOP-000328.The room Pressure status Representation (Image 1) shows the pressure cascade of the production area. In principle, The HVAC systems should be started-up from the higher pressure area to the lower pressure area to ensure the correct air flow direction, which defines the HVAC and the related production area start-up sequence.The PCU1 and PCU2 units are always in operation, because they supply with pre-conditioned air to the Air Handling Units in all buildings (e.g. existing and New Extension Production Building 12A, 13, etc.). The adjustments for the various air volume amounts is controlled automatically by the DDC system. No further activities are necessary.Start up sequence:Step 1: 40Pa’s areas, including∙AHU 2.3 (Emugel Processing Area)∙AHU 2.2 (Emugel Filling Area)Step 2: 39Pa’s areas including∙AHU12 (Clean Room Corridors A 600 & A 700)∙AHU 11 (serving rooms on 39 Pa level: materials airlock A 320,dispensed batch store A 918, dispensary store A 924 plus roomson lower pressure level)30Pa’s areas, including∙HVAC system 1.1 (Clean Room corridors A 300 & A 500 plusProduction Rooms on lower pressure level)空调系统操作程序Step 3: Low pressure production areas (26Pa), including∙AHU 14 (serving Blending & Storage)∙AHU 15 (serving Clean corridor A 612 and compression rooms onlower pressure level)∙AHU 16 (serving Coating)∙AHU 17 (serving Zone 2 change lockers)∙AHU 18 (serving Primary packaging)∙AHU 22 (serving new wash bay area)∙.AHU 24 (serving granulation air locks A 638 & A 640 andgranulation room on lower pressure level)Low pressure production areas (25Pa)∙AHU 2.1 (serving locker A 507 and capsule filling room at lowerpressure level)Low pressure production areas (20Pa)∙AHU 8.0 (serving Room A 302 and A 304)∙AHU 10.0 (serving Material Air lock A 910 & A 306)∙AHU 13.0 (serving room A316 and washing area at lowerpressure level)Low pressure production areas (13Pa)∙AHU19 (Secondary packaging area)Low pressure production areas (10Pa)∙AHU 10.0 (material lock)∙AHU 3.0 (secondary packaging area)Notes:∙In case of HVAC systems start-up, all the room related Spot Suction systems(e.g. dispensing room, granulation room, compressing rooms, primarypackaging rooms, etc.) must be in operation at the same time.∙After any HVAC is stopped the time interval from re-starting the HVAC system supplying room air into GMP Zones 2 for production re-start should be at least30 minutes to ensure clean rooms recovery conditions.空调系统操作程序 ∙ Before production related activities are being restarted, the room pressureshould be checked to be compliant with the pressure difference requirements.∙ All activities implemented must be recorded in both room log-book and AHU logbook. It is the responsibility of the HVAC engineer to bein contact with the production supervisor so that all records are consistent. Legend:空调系统操作程序Image 1: Production Area Pressure Cascade4.2 Individual System Start-upThe Individual system start-up must be performed by trained and qualified personnel.Automatic start-upFor starting-up of an individual HVAC system with automatic start-up program, e.g. HVAC system 1.1, 8.0, 9.0, 10.0, 13.0, AHU-11,12,14,15,16, 17, 18, 19, 20, 21, 22,24,25 the steps are:∙Check the pre-conditioned units PCU1/PCU2 are in operation mode and run normally (only for the AHUs connecting with PCU1/ PCU2 i.e. AHU 9,10 notconnected)∙Check the system status for starting-up, e.g. positioning of the switches on the control panel and the auxiliary equipment, utilities supply, etc.∙Switch on the “Release Control” on the control panel∙Reset the system by pushing the “Reset” button on the control panel∙The system automatic starts, if the system fails to start-up, contact with the responsible utility engineer.∙Check the system status after the start-up, e.g. running of fans, motors, control valves, dampers, auxiliary equipment utilities, sensors, alarms, etc. to ensurethe system is running in a correct mode.∙Check the room-s temperature, humidity and pressure ensuring that they are in compliance with cleanliness zone requirements.∙Ensure room cleanliness status according to SOP-000328.空调系统操作程序The pre-programmed automatic start-up sequence for the HVAC system is:∙Dampers∙Supply air fan∙Return/exhaust air fan∙Instruments (control valves, pumps of coils, etc.)Note:The system start-up may take some time (about 5 minutes) because the dampers need a certain time to reach the starting positions.For start-up of an individual HVAC system without automatic start-up program, e.g. HVAC system 2.1, 2.2, 2.3, 3.0, 4.0:∙Check the position of the dampers, coil valves for system start-up∙Switch on the supply air fan switch from the control panel∙Switch on the return air fan switch from the control panel∙Switch on the coils circulation pumps, regulate the manual valves, to achieve the required temperature, humidity and pressure∙Perform room cleanliness monitoring according to SOP-000328.4.3 System OperationThe system operation should be performed by trained and qualified personnelProduction activities can only be performed under the fulfillment of the Cleanliness Zone conditions required.All the HVAC systems should be routinely monitored according to Monitoring Procedures SOP-000192.All the HVAC systems should be routinely maintained, e.g. filter replacement, mechanical element checking, etc, e.g. SOP-000217. All the maintenance activities should be recorded in the HVAC system Logbook.4.4 Sequence of System Shutting-downTo ensure the correct air flow direction in case of shut-down, sequence should follow as:Step 1: Low pressure production areas (10Pa)∙AHU 10.0 (material lock)∙AHU 3.0 (secondary packaging area)Low pressure production areas (13Pa)∙AHU19 (Secondary packaging area)Low pressure production areas (20Pa)∙AHU 8.0 (serving Room A 302 and A 304)∙AHU 10 (serving Material Air lock A 910 & A 306)∙AHU 13 (serving room A316 and washing area at lower pressure空调系统操作程序level)Low pressure production areas (25Pa)∙AHU 2.1 (serving locker A 507 and capsule filling room at lowerpressure level)Low pressure production areas (26Pa), including∙AHU 14 (serving Blending & Storage)∙AHU 15 (serving Clean corridor A 612 and compression rooms onlower pressure level)∙AHU 16 (serving Coating)∙AHU 17 (serving Zone 2 change lockers)∙AHU 18 (serving Primary packaging)∙AHU 22 (serving new wash bay area)∙AHU24 (serving granulation air locks A 638 & A 640 andgranulation room on lower pressure level)Step 2: 30Pa’s areas, including∙HVAC system 1.1 (Clean Room corridors A 300 & A 500 plusProduction Rooms on lower pressure level)39Pa’s areas including∙AHU12 (Clean Room Corridors A 600 & A 700)∙AHU 11 (serving rooms on 39 Pa level: materials airlock A 320,dispensed batch store A 918, dispensary store A 924 plus roomson lower pressure level)Step 3: 40Pa’s areas, including∙AHU 2.3 (Emugel Processing Area)∙AHU 2.2 (Emugel Filling Area)Step 4: Ensure the PCU2 unit remains in operation, because of it supplies as well the AUH in the new building with pre-conditioning air. Theadjustment on the changed air volume amount is automaticallycontrolled. (DDC system). No further activities necessary.Note:空调系统操作程序In case of HVAC systems shutting down, all the room related Spot Suction systems (e.g. dispensing room, granulation room, compressing rooms, primary packaging rooms, etc.) must be shut down at the same time.In case of PCU-2 shutting down, immediately open the door of the air chamber to guarantee the pressure of the production area is positive.For HVAC systems which are not involved in the pressure cascade (e.g. AHU9.0, AHU20, AHU21, AHU 25, etc.), no shutting-down sequence required.4.5 System Emergency Shutting-downIn case of the lower pressure areas HVAC System (25Pa, 20Pa, 10Pa, 5Pa) emergency shutting-down, while the high pressure area HVAC Systems are still in operation providing clean air to the shutting-down area [e.g. HVAC System 8.0 shutting-down with the HVAC system 1.1 in operation], only the non-ventilated area due to the HVAC shutting-down should follow the SOP-000328, other production areas will not be impacted.In case of the HVAC system 1.1 emergency shutting down, which provides the 30Pa’s cleaning production corridor as a cleanliness protection environment, all the production activities in the lower pressure areas (e.g. Alu-Alu Blistering, Fette Compressing, etc.) should be stopped, SOP-000328 should be followed.In case of HVAC system 2.2 and system 2.3 emergency shutting-down, only the non-ventilated area due to the HVAC shutting-down should follow the SOP-000328, other production areas will not be impacted.In case of the lower pressure areas HVAC System (26Pa, 13Pa, 5Pa, 0Pa) emergency shutting-down, while the high pressure area HVAC Systems are still in operation providing clean air to the shutting-down area [e.g. AHU19 shutting-down with the AHU18 in operation], only the non-ventilated area due to the HVAC shutting-down should follow the SOP-000328, other production areas will not be impacted.In case of the AHU12 or AHU17 emergency shutting down, which provides the 39Pa’s cleaning production corridor as a cleanliness protection environment, all the production activities in the lower pressure areas (e.g. Primary packaging room A-710, A-720, A-730, A-740 etc.) should be stopped, SOP-000328 should be followed.4.6 Individual system shut-downThe system shut-down must be performed by trained and qualified personnel.For shut-down of an individual HVAC system with automatic shutting-down program, e.g. HVAC system 1.1, 8.0, 8.5, 9.0, 10.0, 13.0, AHU-11,12,14,15,16, 17,18,19,20,21,24,25:∙Switch off the “Release Control” on the control panel∙The system automatic shut-down, if the system failure in shut-down, contact with the engineers.The pre-programmed automatic shut-down sequence for the HVAC system is:SOP-000309Version : 04Effective from : 24.10.2008HVAC System Operation Procedure空调系统操作程序∙Return/exhaust air fan∙Supply air fan∙Instruments (control valves, pumps of coils, etc.)∙DampersFor shut-down of an individual HVAC system without automatic start-up program, e.g. HVAC system 2.1, 2.2, 2.3, 3.0, 4.0:∙Switch off the return air fan switch from the control panel∙Switch off the supply air fan switch from the control panel5 ResponsibilitiesEngineering must follow the operation/instructions given in this SOP.Engineering must coordinate with Production and QA in case of system shut-down and start-up.Production must follow the operation/instructions defined in the production SOP in case of system shut-down and start-up.6 Additional InstructionsN/A7 Definitions & AbbreviationsPCU pre conditioning unitHVAC Heating Ventilation Air Conditioning8 Annexes/Related FormsFRM-000289: HVAC System LogbookPage: 11/11。

BNP标准操作程序

Triage®BNP快速检测试验标准操作规程试验名称：Triage®BNP快速检测试验本规程每年复审一次。

审核日期：2011年1月3日1.检测原理Triage®BNP试验利用单次使用的免疫荧光检测板对EDTA抗凝的全血或血浆标本中BNP 浓度进行测定。

当标本加入后，将检测板插入Triage仪器。

当标本到达检测板试剂位时，仪器中的固有程序会自动进行BNP测试。

检测时间约为15分钟。

仪器根据在检测板测量区检测到的荧光数量对BNP进行测量，仪器检测到的荧光数量越多表明标本中BNP的浓度越高。

2.试剂品牌和包装规格采用英维利斯医疗器械（北京）有限公司提供Biosite公司生产的Triage®BNP检测板。

2.1试剂成分：标记有荧光颜料的鼠BNP单克隆抗体和多克隆抗体。

该类抗体固定在固相稳定器上。

2.2．试剂规格：检测板25T移液管25T试剂密码芯片1个打印纸1卷3.产品检测参数Triage® BNP检测范围：5-5,000pg/mL4.样本采集及处理要求符合该产品测试要求的标本为EDTA抗凝全血或血浆。

注意事项：●待测血液或血浆标本可立即进行测试，也可于采集后24小时内测试。

血液和血浆标本可于室温或冷藏状态储存24小时。

●如果在24小时内不能测试，应将血浆分离，储存于零下20℃，直至测试为止。

●标本可在室温或用冰袋运输，但要避免出现温度极端。

●如果标本出现严重溶血，重采1份标本进行测试。

5.检测试剂要求5.1未开封的检测板放2－8℃冰箱保存时可稳定至失效期。

5.2检测板在室温可稳定14天，但不要超过外包装上的失效期。

在外包装上写上从冰箱取出的日期，把厂商打印的失效期钩掉，仔细记录产品在室温存放的时间。

5.3在使用冷藏(2－8℃)的检测板前,要使之达到室温，单包装检测板最少需要15分钟，如果从冰箱取出的是含多个检测板的试剂盒，最少需要1小时才能达室温。

5.4用前将检测板从包装中取出，用后要丢掉。

7心力衰竭(SOP)

心力衰竭药物临床试验方案设计（SOP）编号：SOP－SJ－00007·02 页数：4制定部门心血管内科2010年7月6日起草人(签名)：2010年7月6日审核人(签名)：2010年7月8日批准人(签名)：2010年7月16日执行部门：心血管内科2010年7月16日医院药物临床试验管理机构盖章生效日期：2010 年7 月16 日颁发日期：2010年7 月16 日修订登记：I．目的：建立心力衰竭药物临床试验方案设计SOP,确保心力衰竭药物临床试验的规范和质量。

II．范围：适用于心力衰竭的药物临床试验。

Ⅲ．规程：为搞好中药新药治疗心力衰竭的临床试验工作，按照上级有关规定和医院及我科的实际情况，特制定以下具体操作规程，请各位医师遵照执行。

一、认真学习临床试验方案临床试验开始前，首先要认真学习临床试验方案，特别要重点掌握以下几点：1．药物的适应证。

2．受试者的入选标准。

特别注意方案要求的病因诊断要正确。

3．受试者的排除标准。

4．受试者需要检查的项目，一定按要求查全，不能遗漏。

5．嘱受试者严格按观察时点复诊。

6．疗程。

二、药品的管理与发放1．试验药物由科主任统一管理和发放，或由科主任指定专人负责。

任何人不得乱拿乱动试验药物。

2．试验药物的发放按日期和药物的随机号（顺序号）从小到大发放，不得打乱顺序号发放。

3．受试者全部检查单据到齐后，确定入选，受试者签署知情同意书后方可发药。

4．当天发放当天拿药，不得提前或拖后拿药。

5．剩余药品或出现不良反应而中止试验的药品按规定收回。

三、关于合并用药1．不得应用方案禁止的治疗心力衰竭的药物。

2．因患其他疾病需要合并应用的药物，请按要求在合并用药记录表上填写清楚。

四、观测项目与指标1．一般记录项目：医院中心编码、试验药物编码、受试者姓名拼音缩写、受试者联系电话、单位或住址、研究开始时间、病程等。

2．一般指标：性别、年龄、身高、体重、体温、脉搏、呼吸、血压、心律、心率、心音。

bnp标准值

bnp标准值
需要注意的是，BNP的标准值是基于一般健康人群的参考范围，对于特定的个体或特定的病情，可能存在个体差异或变化。因此，在解读BNP的检测结果时，应结合临床病史、症状和其他相关检查结果进行综合分析和判断，以确定是否存在心脏疾病或评估心脏功能的情况。
bnp标准值
BNP（脑钠肽）是一种心脏标志物，用于评估心脏功能和心脏疾病的诊断和监测。BNP的标准值是指在正常健康人群中的参考范围。
一般来说，BNP的正常参考范围是：
- BNP：0-100 pg/mL 值可以根据实验室的标准和测试方法略有不同，因此在具体的医学检查中，应以实验室提供的参考范围为准。

bnp注意事项

bnp注意事项
哎呀呀，说起bnp 注意事项，这可太重要啦！
嘿，朋友们！bnp 这东西，咱可得认真对待呀！首先呢，检测bnp 的时候，一定要选择正规靠谱的医疗机构，就像选一个可靠的伙伴一样。

要是随便找个地方，那结果能准吗？肯定不行呀！
还有哦，日常生活中，如果发现bnp 数值不太对劲，千万不能掉以轻心！这可不像偶尔忘带钥匙那么简单。

要赶紧去咨询专业的医生，听听他们的意见，可别自己瞎琢磨，延误了病情。

哇塞，在治疗过程中，遵循医嘱那是必须的！医生让怎么用药就怎么用，让怎么调整生活方式就怎么调整，别觉得自己聪明能自作主张。

这就好比开车得按照交通规则，乱来是要出大问题的！
而且呀，心态也很重要！别一看到bnp 有问题就吓得不行，整天忧心忡忡的。

要保持乐观积极的心态，相信现代医学的力量，相信自己能战胜困难。

这就像在黑暗中点亮一盏明灯，给自己照亮前行的路。

哎呀，家人和朋友的支持也不能少！他们就像温暖的阳光，能给我们力量和勇气。

多和他们交流，分享自己的感受，一起面对bnp 带来的挑战。

总之啊，对待bnp 一定要谨慎小心，把注意事项牢记在心。

只有这样，我们才能更好地应对，保持健康，过上幸福美好的生活呀！。

BNP——一个化验指标与房颤的故事

BNP——一个化验指标与房颤的故事BNP●房颤什么是BNP？这三个字母究竟代表什么？有心的朋友可能会记得，在化验单里面见过它。

BNP就是脑钠肽（Brain Natriuretic Peptide，BNP），又称B型利钠肽（B-type Natriuretic Peptide），首先由日本学者于1988年从猪脑分离出来，因而得名。

但它可跟“猪脑子”没啥关系，实际上它主要来源于心脏，特别是心室。

它是一种心脏神经激素，在心脏容量和压力超负荷引起心肌牵张时释放。

换言之，就是心脏特别累的时候就会加量分泌。

当心功能不全时，由于心脏容量负荷或压力负荷增加，心肌受到牵张或室壁压力增大，BNP分泌增多，就会使血中BNP的浓度增高，故BNP是诊断心功能衰竭较为敏感的指标。

房颤时BNP升高的可能机制近几年国外研究发现在心房颤动（房颤）患者中血浆BNP水平明显升高。

不仅慢性房颤患者的血浆BNP水平升高，而且在急性房颤患者中也有血浆BNP水平的升高。

房颤患者血浆BNP水平升高的机制尚不十分清楚。

目前的研究认为，慢性房颤患者心房组织的严重肥厚、纤维化和炎症反应等病理变化可以导致心室肌产生的BNP增加，这可以解释慢性房颤患者BNP水平的升高。

在急性房颤时，不规则的心室节律引起心功能的减弱，可能是导致BNP水平的升高的原因。

BNP检查在房颤中的意义1、在成功电复律后下降。

持续性房颤的患者血中BNP水平升高，特别是在合并有器质性心脏疾病的患者，反映了心脏容量和压力的超负荷状态。

房颤患者直流电复律（电复律）转为窦性心律后BNP水平迅速降低。

2、BNP能用于预测房颤患者电复律后的复发及窦性心律的维持。

如果电复律后BNP水平降低较快且维持在较低的水平，维持窦性心律的可能较大。

特别是在伴有轻度心衰的老年患者中，预测价值更大。

3、血浆BNP水平预测心脏外科患者术后房颤发生的可能性。

术后房颤的发生达到心脏外科术后患者的60%，导致住院时间的延长和治疗费用的增加。

BNP特种蛋白分析仪SOP简明操作步骤（new）

注意不要用工具通进样针内部！如清洗后仍有问题请与工程师联系。 3.2 进样针表面和wet section的清洁 3.2.1 进入System菜单，点击Clean probe键。 3.2.2 点击Park probe for cleaning。 3.2.3 打开右侧盖子，用70%酒精棉球或棉签擦拭进样针表面和菱形区及其两侧的圆孔表面。如菱形区有结晶，移去稀释杯并盖好比色仓盖，用湿布擦去结晶后再消毒。 3.2.4 关闭盖子，点击Close并OK退出该保养程序。 3.3 检查注射器是否有渗漏。 3.4 用70%酒精对水桶进行消毒。
发放号：12
标题： BNP特种蛋白分析仪简明操作步骤文件编号： PLA301- LJ K- ZY- YQ -05-CZ-01 生效日期： 2005年 02月 01日编制人：杨丽、白洁批准人 (签章 )：丛玉隆
版本号：A 修订号：0 发布日期： 2005年 01月 30日发布部门：技术管理小组审核人：白洁页码：第 1页，共 2页
BNP特种蛋白分析仪简明操作步骤
1 每日开关机程序
1.1 起始准备 1.1.1 准备好试剂检查稀释液、缓冲液及所有试剂是否在使用的效期内和试剂量。 1.1.2 清洁仪器表面 1.1.3 检查并确认洗液桶中是否有足够的蒸馏水 1.1.4 检查废液桶的状况
1.2 开机程序 1.2.1 在开机之前，先检查各种试剂量及废液桶。 1.2.2 依次打开分析仪主机、电脑主机、显示器、打印机电源开关。 1.2.3 电脑屏幕提示输入用户名及密码，双击 BN PROSPEC Viewer 快捷键，程序装载完毕后，仪器开始启动，完成初始化，出现主菜单。 1.2.4 进入 System 菜单，点击 System liquid and waste 进试剂更换界面，在waste 栏打勾，点击 Save 后按[OK]。 1.2.5 进入Start菜单，在Program中的BN Spec中双击BN ProSpe Host，将弹出的对话框最小化。 BN PROSPEC SYSTEM分析系统仪器设备的测定样本项目必须在仪器校准通过的情况下，且每天测试前先进行质控物测试，质控合格后才能进行样品测定。

8BNP特种蛋白SOP

8BNP特种蛋白SOP8 DADE BEHRING BN II 全自动血浆蛋白分析系统SOP适用DADE BEHRING BN II 全自动血浆蛋白分析系统的操作[目的]描述BNII血浆蛋白分析系统的使用和维护。

[范围]适用DADEBEHRINGBNII全自动血浆蛋白分析系统的操作。

[标本要求]1.种类血清、血浆、脑脊液和尿液。

2.收集与准备用于检测的血清和肝素、EDTA抗凝的血浆样本，不能含有任何颗粒和纤维蛋白。

血脂很高的样本或融化后混浊的冷冻样本在检测前必须离心（15000xg，10分钟）使变澄清。

尿液标本及含有颗粒或细胞的脑脊液样本检测前必须先离心后使用（大约15,000xg,10分钟）。

确保在仪器上使用的样品量足够，对原始管，其上清（血清/血浆）必须比沉淀细胞或分离胶至少高10mm，如果使用75x12mm试管，大约需要450～500μl血清/血浆。

3.保存3.1.血清或血浆新鲜样本采集后，在18～25℃的室温环境中，必须在8小时内进行检测。

样本在2～8℃保存，最多可以保存8天，在低温（-25℃及以下）最多可以保存3个月，条件是在样本采集后24小时内冷冻且应避免反复冻融。

冷冻样品应解冻或缓慢升温至室温。

此外，检测前冷冻样本必须很好地加以混合并离心。

3.2.尿液和脑脊液应尽量使用新鲜的尿液和脑脊液标本,在18–25℃的室温环境中，必须在8小时内进行检测，在2~8℃的环境下最多可以保存8天。

尿液标本不应被深低温冰冻。

在将尿液和CSF样品上放到分析仪上之前应该进行离心，以去除可能存在的细胞。

[试剂]1.DadeBehringBN试剂，2-8℃冷藏保存。

有效期，参见未打开的试剂盒。

2.本试剂含有叠氮钠，务必小心使用，切勿食入或接触皮肤及粘膜！叠氮钠遇铜、锂之类的金属物质会形成易爆的叠氮化物。

3.用于标准品质控品生产的每一份血液样品都经过了FDA认证的乙肝表面抗原、抗-HCV、抗-HIV1和抗-HIV2检测方法的测定。