环境参数分布试验确认 维萨拉提供全面的参数分布试验确认解决方案,帮助您遵守 GDP (良好分销规范)法规,例如欧盟 GDP (2013/C 343/01) 和美国药典 36 版第 <1079> 以及即将出台的第 <1083 章>. 环境参数分布试验确认(在存储人用和研究药品的区域必须完成)由药品生产商、储存设施、批发分销商和 GxP 供应链中的其他利益相关者进行。查看维萨拉 IQOQ 协议样本 (PDF)。 观看系统概述视频 请参阅设备选择指南 查看库里的GxP监管条文 维萨拉环境分布试验确认包括: 分布试验套件:维萨拉数据记录仪,用于采集测量数据的 vLog 软件,以及根据联邦法规第 21 章第 11 款和附录 11 验证软件的 vLog IQ/OQ 协议。 世界级 参数分布试验服务 用于描述冷藏库、冷冻库、冷冻间、仓库、储藏区、配送中心、恒温箱或稳定室的温度和相对湿度动态。(服务范围包括欧洲、日本和中国) 可选的 自定义校准 以行业最佳准确性为目标 参数分布试验确认要求更加严格,提高了法规期望 过去几年中,良好分销规范(GDP)增加了监管重点。在很大程度上,是由加拿大卫生部门 (GUI-0069, 2011) 发起的,该机构是第一个提到温度分布试验的监管机构。全球监管机构很快就重申了这一方向,其中包括: 印度 CDSCO(中央药品标准控制组织) 中国国家药监局(中国食品与药品管理局) 欧洲 EMA(欧洲药品管理局) 这些组织先后发布了新的或更新的指导原则和文件。美国随后更新了美国药典第< 1079 >章“药品良好分销规范”。此后不久,出现了几个提供具体说明的指南。例如,国际制药工程学会的冷链管理出版物就分布试验确认传感器的放置提出了建议。美国注射剂协会的技术报告 58 讨论了如何进行与 GDP 相关的风险评估。药品检验合作计划发布了自己的 GDP 指南,紧扣欧盟的 GDP 法规。这是向全球标准化迈出的重要一步,因为 PIC/S 目前拥有 40 多个参与国。 温控供应链的行业变革迫切需要指导 同时,分销活动也在不断发展,分销链日益国际化。然而,这导致温度偏差风险增加。若得以良好执行,环境分布试验确认就是评估和消除偏差风险的理想方法。但是,良好执行分布试验确认都包括什么呢? 首先,在任何规定的药品进入冷藏区、仓库和温度控制室之前,应该始终进行分布研究。分布试验要在有代表性的条件下进行。在实践中,这意味着在冬季和夏季进行季节性分布研究。另外,分布试验要包括空载条件和装载条件。对一个区域或室进行分布试验确认后,就要根据温度波动最大的位置布置监测传感器,这些位置通常称为热点和冷点。 验证原则带来客观的确认结果 环境分布试验确认的最终目标可以总结如下: 证明温度(和湿度(需要时))的一致性。 识别不合适的存储区域。 确定有代表性的监测点 记住,参数分布研究确认不限于固定地点。对于配送链中的温度控制车辆,根据上述基本原则进行原始温度分布试验确认:装载和空载状态下具有代表性的条件下,根据研究结果,将区域排除在存储位置之外或对其进行连续监测。 有关维萨拉环境参数分布试验确认解决方案的更多信息,请参阅我们的手册,或联系您当地的服务中心。 资源 欧盟良好分销规范 GDP (2013/C 343/01) 2013 年 11 月 5 日关于人用药品良好分销规范的指导原则 美国药典 36 版 – 第 <1179> 章药品良好存储和分销规范 美国药典 36 版 – 第 <1083> 章良好分销规范(将在未来发布) 联邦法规第 21 章第 11 款电子记录/电子签名 联邦法规第 21 章第 11 款电子记录/电子签名 GUI- 0069 药品贮运中的温度控制指南,2011 年。 CDSCO 生物制品良好分销规范指导原则,2012 年。 中国国家食品药品监督管理局药品经营质量管理规范(GSP),卫生部令第 90 号,2013 年。 ISPE 良好实践指南:冷链管理,2011 年。 PDA: 技术报告 58 - 温度受控销售风险管理,2012 年。 PIC/S 良好药品分销规范指南,2014 年。 进一步阅读 法国标准 AFNOR NFx15-140 澳大利亚标准 AS2853-1986 德国标准 DIN 12880。 存储区域温度分布试验,世卫组织技术报告系列,2011 年第 961 号,附录 9 的技术补充:时间和温度敏感型药品存储和运输指南,2014 年 1 月。 温度控制存储区域的确认,世界卫生组织技术报告系列,2011 年第 961 号,附录 9 的技术补充:时间和温度敏感型药品存储和运输指南,2014 年 1 月。 相关产品 DL1000-1400 温度记录仪 用于受控环境温度监测与温湿度参数分布研究 维萨拉 DL1000-1400 是一款高准确度温度数据记录仪。DL1000-1400 温度记录仪可提供稳定、可靠的测量,非常适用于受调节环境下的超低温冷冻库、冰箱和冷藏室。DL1000-1400 系列的测量范围覆盖 -90°C 至 +70°C,准确度稳定在 ±0.10°C,可处理多达四个输入... Read more VaiNet 无线接入点 AP10 针对无线监测 VaiNet 无线连接点 AP10 是一款无线网路硬件设备,针对维萨拉的专有无线技术: VaiNet 。AP10 最多可将 32 个 VaiNet 无线数据记录器(例如, RFL100 )连接到维萨拉的监测系统软件: viewLinc 企业服务器。 Read more VaiNet 无线数据记录器 RFL100 针对无线温度与湿度监测 RFL 系列数据记录器采用维萨拉的专有 VaiNet 无线技术 来监测环境,从仓库到生产区域再到洁净室和实验室。VaiNet 无线技术基于 LoRa™ 调制技术,以提供超强的无线信号,这种信号在长距离范围内以及复杂、闭塞的条件中依旧非常可靠。该无线技术使每个 RFL 数据记录器可以将信号传输 100... Read more Wi-Fi 数据记录仪 HMT140 用于监控温度、相对湿度、电流、电压与门开关传感器 维萨拉 HMT140 无线数据记录仪为洁净室、仓库、冷冻机、实验室、血库和其它生命科学应用的湿度、温度和模拟信号的监测而设计。这种电池供电的设备简化了安装,无需电源或网络电缆。 Read more 以太网记录器接口连接的 vNet 电源 用于将 DL 系列数据记录仪连接至网络 以太网记录器接口连接的 vNet 电源是网络连接的托架,它将 DL 系列数据记录仪连接至以太网这一过程十分简便、可靠且经济高效。 Read more 温湿度数据记录仪 DL2000 用于监测温度、湿度,具有可选择的模拟输入 维萨拉 DL2000 数据记录仪使用高度校准的温湿度传感器来提供准确稳定的测量,并且提供针对其他参数和门触点的可选模拟输入通道。除了超高的准确度之外,DL2000 数据记录仪还记录和存储测量点的数据,以确保在断电或断网时不会丢失数据。DL 系列记录仪连接到 维萨拉的 viewLinc 软件... Read more 验证参数分布研究套件 对于 GxP 环境下温度和湿度的确认 一个可靠的、易于使用的系统用来代替基于热电偶测量的设备,和一些庞大的数据采集系统,以及不太坚固的数据记录仪。适用于稳定性试验箱、冰箱、冰柜、保温箱、仓库以及周围环境等其他要求较高的研究。包含 vLog VL 软件,VLOG 的 IQOQ,以及维萨拉数据记录仪的绘制配套元件包括: 温度:-90 °C... Read more vLog VL 软件 为验证/参数分布研究 GxP 环境 该 vLog 系统是用于了解您的环境和遵守规范的最准确、最有效的解决方案。易于设置和自行安装的数据记录仪,您可以在几分钟内绘制一个房间。 vLOG 有多个文件的安全功能以帮助监管合规,包括: 每个报告都能被识别数据的安全状态 每次数据下载、上传生成一个唯一的校验值,这是日志文件 ID 号。 文件... Read more viewLinc 应用程序编程接口 将 viewLinc 与现有系统集成 维萨拉 viewLinc 监测系统 测量工业和监控 GxP 应用中的各种环境参数。与楼宇自动化系统并行运行的连续监测系统要求更简单的验证,并提供故障安全报警、符合 GxP 法规和标准的报告以及安全数据完整性。 但是,在某些情况下,来自专用监测系统(如 viewLinc... Read more 采用 VaiNet 技术的无线监测系统 长距离无线通信 Read more TMP115 宽量程温度探头 适用于要求严苛的温控环境 TMP115 温度探头采用铂电阻 RTD 温度传感器,具有卓越的测量稳定性,适用于控温箱体:低温应用、恒温箱、液氮罐、血液/组织库和高低温试验箱。 探头的工作温度范围为 -196°C 到 +90°C。 TMP115 探头可与 VaiNet RFL100 无线温度数据记录器兼容,并配有 0.5 米或... Read more 维萨拉数据记录仪的电缆 维萨拉电缆用于将维萨拉数据记录仪连接至标准 USB 端口和标准 RS-232 系列端口。 Read more 相关案例 博客 | May 13, 2019 Using Mapping Study Data to Select Monitoring Sensor Placement To be honest, I don’t recommend using the mapping data to select the location of your monitoring sensors . The entire idea is counter-intuitive.... 了解更多 博客 | Apr 16, 2019 Answers from our Latest Mapping Webinar In this blog, we answer questions we received during our recent webinar “Mapping Made Easy.” If you have not seen it already, watch it now.... 了解更多 博客 | Mar 9, 2019 Ready or Not, Bluetooth is coming… I’ve always loved Bluetooth for personal use. That’s not surprising because it was first designed as a tool for a PAN (Personal Area Network).... 了解更多 博客 | Jan 24, 2019 ERES Reminiscing: Thoughts on 21 CFR Part 11 Past, Present & Future I’d never heard of an Electronic Signature until 21 CFR Part 11 was first published in 1997. This iconic regulation had the uninspiring title... 了解更多 博客 | Dec 6, 2018 Temperature Mapping Worst-Case Scenarios in Refrigerators We recently received a question from a pharmaceutical customer on re-qualifying a refrigerator that had been repaired. This customer was... 了解更多 博客 | Nov 20, 2018 7 Data Integrity Hacks for GxP Compliance Last week we had a webinar on data integrity giving our Senior Regulatory Expert Paul Daniel the opportunity to answer questions on data... 了解更多 博客 | Apr 12, 2018 Q&A New VaiNet (LoRa-based) Wireless Data Loggers We had over 480 registrants for our webinar "VaiNet - a Wireless Technology that Rises Above the Crowd" Thank you to everyone who joined in, and... 了解更多 博客 | Mar 12, 2018 With Wireless Monitoring on the Rise, What Changes in Ensuring Compliance with 21 CFR Part 11? As wirelessly networked monitoring devices become more popular, many of our GxP-regulated customers ask about 21 CFR Part 11 and how it impacts... 了解更多 博客 | Feb 20, 2018 Data Base Transfers & Validation for Part 11 & Annex 11 Compliance We recently received these questions: “Are data base transfers part of software validation? If yes, how can we validate the transfer?” The... 了解更多 博客 | Feb 2, 2018 Thermal Damping of Temperature Probes: Monitoring yes, Mapping no (maybe) We receive a lot of questions on the use of thermal damping devices for temperature sensors. Mostly it depends on your application, but for... 了解更多 博客 | Jan 19, 2018 Can you Validate a Refrigerator Truck like a Walk-in? Four Key Differences in These Storage Areas In this week's blog we answer a question about validating cold-storage for pharmaceutical and biotechnology ... are there differences? Hello... 了解更多 博客 | Jan 1, 2018 Our Most-Read Life Science Blogs in 2017 Happy New Year! Once again we bring you a list of our most popular blogs from the last year. In case you missed them, and according to our Web... 了解更多 博客 | Dec 14, 2017 Why Not Use Mean Kinetic Temperature in Cold Applications? Here’s why… Back for more on Mean Kinetic Temperature with a customer question: Hi Paul, I have reviewed Vaisala’s application note on mean kinetic... 了解更多 博客 | Nov 28, 2017 Trusting Fans for Temperature Uniformity Vs. Loading Styles & Mapping Studies We received this question from a customer performing mapping studies in fridges and cold rooms: Dear Paul, In mapping a cold chamber or room,... 了解更多 博客 | Nov 2, 2017 Learn Three Keys to Data Integrity in this new Infographic 了解更多 博客 | Oct 20, 2017 What's your open door (mapping study) policy? In this week's blog, answer a question about open door mapping studies and offer some considerations that may close the issue (and the door). Hi... 了解更多 博客 | Sep 29, 2017 When the mapping study says move the probe, do you need other criteria to relocate? In this week's blog, Senior Regulatory Expert Paul Daniel offers some practical advice on moving probes in validation/mapping. Plus, you are... 了解更多 博客 | Jun 29, 2017 5 Ways to Treat a Misbehaving Refrigerator Go high-end, Tune it up, Block it off, Worst-Case Scenario, Change the Set-point In this week's blog, Paul offers some advice on problem spots... 了解更多 成功案例 McKesson Specialty Health achieves over 100 audits without a single observation Bullet-proof environmental monitoring technology that answers auditors’ questions. McKesson Corporation, currently ranked 5th on the FORTUNE 500... 了解更多 成功案例 Vaisala Honorary In-kind Donator for New Children’s Hospital Vaisala will be contributing humidity, temperature, and carbon dioxide measurement instruments to the new children’s hospital to be constructed... 了解更多 博客 | May 2, 2017 Regulatory Round up - Plus new Q&A from our latest webinar on VaiNet Technology This week we offer several items for your blog-reading pleasure: A link to our recent VaiNet Wireless monitoring webinar, recording, and slides... 了解更多 博客 | Apr 10, 2017 Part 11 for Process Equipment, Audit Trail Reviewing, Requirements for Bulk Chemicals, And Cal Certs Without Pass/Fail This week we have five move post-webinar questions from the Data Integrity webinar. The questions are: Do we need to comply with Part 11 for a... 了解更多 博客 | Mar 28, 2017 Q&A from our Data Integrity Webinar (Plus - another Webinar!) This week we are sharing some of the post-webinar questions sent to us after our Data Integrity webinar. If you missed it, watch the recorded... 了解更多 博客 | Feb 25, 2017 Common questions on MKT answered: Trending, Interpreting Reports, & Default Activation Energy In this week's blog, Paul Daniel answers a few questions that we often receive on using mean kinetic temperature. Dear Paul, I have a couple... 了解更多 博客 | Feb 15, 2017 Three Questions you need to Answer for Monitoring Controlled-Temperature Chambers In PharmTech's recent publication Vol 9, Issue 12 Manufacturing Sector Editor Jennifer Markarian interviewed Vaisala Regulatory Expert Paul... 了解更多 博客 | Jan 21, 2017 Get this NEW Interactive eBook: Measurement Solutions for Life Science Industries We just published a new eBook that contains links to articles, videos, webinars and case studies on tools and systems for keeping life science... 了解更多 博客 | Dec 17, 2016 Can you use Mean Kinetic Temperature to Account for Spikes in Accelerated Aging Chambers? In this week's blog, Paul Daniel has a little back and forth on a question he received from a webinar attendee on using mean kinetic temperature... 了解更多 博客 | Dec 6, 2016 Sensor Breakdown for Chambers Vs Room Monitoring: What Sensors are best for Your Application? Many chamber applications are cold temperature applications and usually temperature is the only parameter monitored. Cold air cannot hold much... 了解更多 博客 | Oct 22, 2016 Loaded Room Studies for Performance Qualification: Can We Just Say No? Hello, I recently watched your webinar "Modern Rules for an Old Practice: Sensor Placement for GxP Temperature Mapping" and found the... 了解更多 博客 | Jul 1, 2016 Using MKT to Justify Normal Temperature Excursions during Qualification: Should you? (Short answer: No. Long answer and some options: Read on!) Hi Paul, In regards to the recent MKT webinar, I have a question. Have you ever used... 了解更多 有关 GxP 标准和法规的文章 访问我们的文章、白皮书、应用说明和电子书库...
维萨拉提供全面的参数分布试验确认解决方案,帮助您遵守 GDP (良好分销规范)法规,例如欧盟 GDP (2013/C 343/01) 和美国药典 36 版第 <1079> 以及即将出台的第 <1083 章>. 环境参数分布试验确认(在存储人用和研究药品的区域必须完成)由药品生产商、储存设施、批发分销商和 GxP 供应链中的其他利益相关者进行。查看维萨拉 IQOQ 协议样本 (PDF)。 观看系统概述视频 请参阅设备选择指南 查看库里的GxP监管条文 维萨拉环境分布试验确认包括: 分布试验套件:维萨拉数据记录仪,用于采集测量数据的 vLog 软件,以及根据联邦法规第 21 章第 11 款和附录 11 验证软件的 vLog IQ/OQ 协议。 世界级 参数分布试验服务 用于描述冷藏库、冷冻库、冷冻间、仓库、储藏区、配送中心、恒温箱或稳定室的温度和相对湿度动态。(服务范围包括欧洲、日本和中国) 可选的 自定义校准 以行业最佳准确性为目标 参数分布试验确认要求更加严格,提高了法规期望 过去几年中,良好分销规范(GDP)增加了监管重点。在很大程度上,是由加拿大卫生部门 (GUI-0069, 2011) 发起的,该机构是第一个提到温度分布试验的监管机构。全球监管机构很快就重申了这一方向,其中包括: 印度 CDSCO(中央药品标准控制组织) 中国国家药监局(中国食品与药品管理局) 欧洲 EMA(欧洲药品管理局) 这些组织先后发布了新的或更新的指导原则和文件。美国随后更新了美国药典第< 1079 >章“药品良好分销规范”。此后不久,出现了几个提供具体说明的指南。例如,国际制药工程学会的冷链管理出版物就分布试验确认传感器的放置提出了建议。美国注射剂协会的技术报告 58 讨论了如何进行与 GDP 相关的风险评估。药品检验合作计划发布了自己的 GDP 指南,紧扣欧盟的 GDP 法规。这是向全球标准化迈出的重要一步,因为 PIC/S 目前拥有 40 多个参与国。 温控供应链的行业变革迫切需要指导 同时,分销活动也在不断发展,分销链日益国际化。然而,这导致温度偏差风险增加。若得以良好执行,环境分布试验确认就是评估和消除偏差风险的理想方法。但是,良好执行分布试验确认都包括什么呢? 首先,在任何规定的药品进入冷藏区、仓库和温度控制室之前,应该始终进行分布研究。分布试验要在有代表性的条件下进行。在实践中,这意味着在冬季和夏季进行季节性分布研究。另外,分布试验要包括空载条件和装载条件。对一个区域或室进行分布试验确认后,就要根据温度波动最大的位置布置监测传感器,这些位置通常称为热点和冷点。 验证原则带来客观的确认结果 环境分布试验确认的最终目标可以总结如下: 证明温度(和湿度(需要时))的一致性。 识别不合适的存储区域。 确定有代表性的监测点 记住,参数分布研究确认不限于固定地点。对于配送链中的温度控制车辆,根据上述基本原则进行原始温度分布试验确认:装载和空载状态下具有代表性的条件下,根据研究结果,将区域排除在存储位置之外或对其进行连续监测。 有关维萨拉环境参数分布试验确认解决方案的更多信息,请参阅我们的手册,或联系您当地的服务中心。 资源 欧盟良好分销规范 GDP (2013/C 343/01) 2013 年 11 月 5 日关于人用药品良好分销规范的指导原则 美国药典 36 版 – 第 <1179> 章药品良好存储和分销规范 美国药典 36 版 – 第 <1083> 章良好分销规范(将在未来发布) 联邦法规第 21 章第 11 款电子记录/电子签名 联邦法规第 21 章第 11 款电子记录/电子签名 GUI- 0069 药品贮运中的温度控制指南,2011 年。 CDSCO 生物制品良好分销规范指导原则,2012 年。 中国国家食品药品监督管理局药品经营质量管理规范(GSP),卫生部令第 90 号,2013 年。 ISPE 良好实践指南:冷链管理,2011 年。 PDA: 技术报告 58 - 温度受控销售风险管理,2012 年。 PIC/S 良好药品分销规范指南,2014 年。 进一步阅读 法国标准 AFNOR NFx15-140 澳大利亚标准 AS2853-1986 德国标准 DIN 12880。 存储区域温度分布试验,世卫组织技术报告系列,2011 年第 961 号,附录 9 的技术补充:时间和温度敏感型药品存储和运输指南,2014 年 1 月。 温度控制存储区域的确认,世界卫生组织技术报告系列,2011 年第 961 号,附录 9 的技术补充:时间和温度敏感型药品存储和运输指南,2014 年 1 月。
相关产品 DL1000-1400 温度记录仪 用于受控环境温度监测与温湿度参数分布研究 维萨拉 DL1000-1400 是一款高准确度温度数据记录仪。DL1000-1400 温度记录仪可提供稳定、可靠的测量,非常适用于受调节环境下的超低温冷冻库、冰箱和冷藏室。DL1000-1400 系列的测量范围覆盖 -90°C 至 +70°C,准确度稳定在 ±0.10°C,可处理多达四个输入... Read more VaiNet 无线接入点 AP10 针对无线监测 VaiNet 无线连接点 AP10 是一款无线网路硬件设备,针对维萨拉的专有无线技术: VaiNet 。AP10 最多可将 32 个 VaiNet 无线数据记录器(例如, RFL100 )连接到维萨拉的监测系统软件: viewLinc 企业服务器。 Read more VaiNet 无线数据记录器 RFL100 针对无线温度与湿度监测 RFL 系列数据记录器采用维萨拉的专有 VaiNet 无线技术 来监测环境,从仓库到生产区域再到洁净室和实验室。VaiNet 无线技术基于 LoRa™ 调制技术,以提供超强的无线信号,这种信号在长距离范围内以及复杂、闭塞的条件中依旧非常可靠。该无线技术使每个 RFL 数据记录器可以将信号传输 100... Read more Wi-Fi 数据记录仪 HMT140 用于监控温度、相对湿度、电流、电压与门开关传感器 维萨拉 HMT140 无线数据记录仪为洁净室、仓库、冷冻机、实验室、血库和其它生命科学应用的湿度、温度和模拟信号的监测而设计。这种电池供电的设备简化了安装,无需电源或网络电缆。 Read more 以太网记录器接口连接的 vNet 电源 用于将 DL 系列数据记录仪连接至网络 以太网记录器接口连接的 vNet 电源是网络连接的托架,它将 DL 系列数据记录仪连接至以太网这一过程十分简便、可靠且经济高效。 Read more 温湿度数据记录仪 DL2000 用于监测温度、湿度,具有可选择的模拟输入 维萨拉 DL2000 数据记录仪使用高度校准的温湿度传感器来提供准确稳定的测量,并且提供针对其他参数和门触点的可选模拟输入通道。除了超高的准确度之外,DL2000 数据记录仪还记录和存储测量点的数据,以确保在断电或断网时不会丢失数据。DL 系列记录仪连接到 维萨拉的 viewLinc 软件... Read more 验证参数分布研究套件 对于 GxP 环境下温度和湿度的确认 一个可靠的、易于使用的系统用来代替基于热电偶测量的设备,和一些庞大的数据采集系统,以及不太坚固的数据记录仪。适用于稳定性试验箱、冰箱、冰柜、保温箱、仓库以及周围环境等其他要求较高的研究。包含 vLog VL 软件,VLOG 的 IQOQ,以及维萨拉数据记录仪的绘制配套元件包括: 温度:-90 °C... Read more vLog VL 软件 为验证/参数分布研究 GxP 环境 该 vLog 系统是用于了解您的环境和遵守规范的最准确、最有效的解决方案。易于设置和自行安装的数据记录仪,您可以在几分钟内绘制一个房间。 vLOG 有多个文件的安全功能以帮助监管合规,包括: 每个报告都能被识别数据的安全状态 每次数据下载、上传生成一个唯一的校验值,这是日志文件 ID 号。 文件... Read more viewLinc 应用程序编程接口 将 viewLinc 与现有系统集成 维萨拉 viewLinc 监测系统 测量工业和监控 GxP 应用中的各种环境参数。与楼宇自动化系统并行运行的连续监测系统要求更简单的验证,并提供故障安全报警、符合 GxP 法规和标准的报告以及安全数据完整性。 但是,在某些情况下,来自专用监测系统(如 viewLinc... Read more 采用 VaiNet 技术的无线监测系统 长距离无线通信 Read more TMP115 宽量程温度探头 适用于要求严苛的温控环境 TMP115 温度探头采用铂电阻 RTD 温度传感器,具有卓越的测量稳定性,适用于控温箱体:低温应用、恒温箱、液氮罐、血液/组织库和高低温试验箱。 探头的工作温度范围为 -196°C 到 +90°C。 TMP115 探头可与 VaiNet RFL100 无线温度数据记录器兼容,并配有 0.5 米或... Read more 维萨拉数据记录仪的电缆 维萨拉电缆用于将维萨拉数据记录仪连接至标准 USB 端口和标准 RS-232 系列端口。 Read more
DL1000-1400 温度记录仪 用于受控环境温度监测与温湿度参数分布研究 维萨拉 DL1000-1400 是一款高准确度温度数据记录仪。DL1000-1400 温度记录仪可提供稳定、可靠的测量,非常适用于受调节环境下的超低温冷冻库、冰箱和冷藏室。DL1000-1400 系列的测量范围覆盖 -90°C 至 +70°C,准确度稳定在 ±0.10°C,可处理多达四个输入... Read more
VaiNet 无线接入点 AP10 针对无线监测 VaiNet 无线连接点 AP10 是一款无线网路硬件设备,针对维萨拉的专有无线技术: VaiNet 。AP10 最多可将 32 个 VaiNet 无线数据记录器(例如, RFL100 )连接到维萨拉的监测系统软件: viewLinc 企业服务器。 Read more
VaiNet 无线数据记录器 RFL100 针对无线温度与湿度监测 RFL 系列数据记录器采用维萨拉的专有 VaiNet 无线技术 来监测环境,从仓库到生产区域再到洁净室和实验室。VaiNet 无线技术基于 LoRa™ 调制技术,以提供超强的无线信号,这种信号在长距离范围内以及复杂、闭塞的条件中依旧非常可靠。该无线技术使每个 RFL 数据记录器可以将信号传输 100... Read more
Wi-Fi 数据记录仪 HMT140 用于监控温度、相对湿度、电流、电压与门开关传感器 维萨拉 HMT140 无线数据记录仪为洁净室、仓库、冷冻机、实验室、血库和其它生命科学应用的湿度、温度和模拟信号的监测而设计。这种电池供电的设备简化了安装,无需电源或网络电缆。 Read more
以太网记录器接口连接的 vNet 电源 用于将 DL 系列数据记录仪连接至网络 以太网记录器接口连接的 vNet 电源是网络连接的托架,它将 DL 系列数据记录仪连接至以太网这一过程十分简便、可靠且经济高效。 Read more
温湿度数据记录仪 DL2000 用于监测温度、湿度,具有可选择的模拟输入 维萨拉 DL2000 数据记录仪使用高度校准的温湿度传感器来提供准确稳定的测量,并且提供针对其他参数和门触点的可选模拟输入通道。除了超高的准确度之外,DL2000 数据记录仪还记录和存储测量点的数据,以确保在断电或断网时不会丢失数据。DL 系列记录仪连接到 维萨拉的 viewLinc 软件... Read more
验证参数分布研究套件 对于 GxP 环境下温度和湿度的确认 一个可靠的、易于使用的系统用来代替基于热电偶测量的设备,和一些庞大的数据采集系统,以及不太坚固的数据记录仪。适用于稳定性试验箱、冰箱、冰柜、保温箱、仓库以及周围环境等其他要求较高的研究。包含 vLog VL 软件,VLOG 的 IQOQ,以及维萨拉数据记录仪的绘制配套元件包括: 温度:-90 °C... Read more
vLog VL 软件 为验证/参数分布研究 GxP 环境 该 vLog 系统是用于了解您的环境和遵守规范的最准确、最有效的解决方案。易于设置和自行安装的数据记录仪,您可以在几分钟内绘制一个房间。 vLOG 有多个文件的安全功能以帮助监管合规,包括: 每个报告都能被识别数据的安全状态 每次数据下载、上传生成一个唯一的校验值,这是日志文件 ID 号。 文件... Read more
viewLinc 应用程序编程接口 将 viewLinc 与现有系统集成 维萨拉 viewLinc 监测系统 测量工业和监控 GxP 应用中的各种环境参数。与楼宇自动化系统并行运行的连续监测系统要求更简单的验证,并提供故障安全报警、符合 GxP 法规和标准的报告以及安全数据完整性。 但是,在某些情况下,来自专用监测系统(如 viewLinc... Read more
TMP115 宽量程温度探头 适用于要求严苛的温控环境 TMP115 温度探头采用铂电阻 RTD 温度传感器,具有卓越的测量稳定性,适用于控温箱体:低温应用、恒温箱、液氮罐、血液/组织库和高低温试验箱。 探头的工作温度范围为 -196°C 到 +90°C。 TMP115 探头可与 VaiNet RFL100 无线温度数据记录器兼容,并配有 0.5 米或... Read more
相关案例 博客 | May 13, 2019 Using Mapping Study Data to Select Monitoring Sensor Placement To be honest, I don’t recommend using the mapping data to select the location of your monitoring sensors . The entire idea is counter-intuitive.... 了解更多 博客 | Apr 16, 2019 Answers from our Latest Mapping Webinar In this blog, we answer questions we received during our recent webinar “Mapping Made Easy.” If you have not seen it already, watch it now.... 了解更多 博客 | Mar 9, 2019 Ready or Not, Bluetooth is coming… I’ve always loved Bluetooth for personal use. That’s not surprising because it was first designed as a tool for a PAN (Personal Area Network).... 了解更多 博客 | Jan 24, 2019 ERES Reminiscing: Thoughts on 21 CFR Part 11 Past, Present & Future I’d never heard of an Electronic Signature until 21 CFR Part 11 was first published in 1997. This iconic regulation had the uninspiring title... 了解更多 博客 | Dec 6, 2018 Temperature Mapping Worst-Case Scenarios in Refrigerators We recently received a question from a pharmaceutical customer on re-qualifying a refrigerator that had been repaired. This customer was... 了解更多 博客 | Nov 20, 2018 7 Data Integrity Hacks for GxP Compliance Last week we had a webinar on data integrity giving our Senior Regulatory Expert Paul Daniel the opportunity to answer questions on data... 了解更多 博客 | Apr 12, 2018 Q&A New VaiNet (LoRa-based) Wireless Data Loggers We had over 480 registrants for our webinar "VaiNet - a Wireless Technology that Rises Above the Crowd" Thank you to everyone who joined in, and... 了解更多 博客 | Mar 12, 2018 With Wireless Monitoring on the Rise, What Changes in Ensuring Compliance with 21 CFR Part 11? As wirelessly networked monitoring devices become more popular, many of our GxP-regulated customers ask about 21 CFR Part 11 and how it impacts... 了解更多 博客 | Feb 20, 2018 Data Base Transfers & Validation for Part 11 & Annex 11 Compliance We recently received these questions: “Are data base transfers part of software validation? If yes, how can we validate the transfer?” The... 了解更多 博客 | Feb 2, 2018 Thermal Damping of Temperature Probes: Monitoring yes, Mapping no (maybe) We receive a lot of questions on the use of thermal damping devices for temperature sensors. Mostly it depends on your application, but for... 了解更多 博客 | Jan 19, 2018 Can you Validate a Refrigerator Truck like a Walk-in? Four Key Differences in These Storage Areas In this week's blog we answer a question about validating cold-storage for pharmaceutical and biotechnology ... are there differences? Hello... 了解更多 博客 | Jan 1, 2018 Our Most-Read Life Science Blogs in 2017 Happy New Year! Once again we bring you a list of our most popular blogs from the last year. In case you missed them, and according to our Web... 了解更多 博客 | Dec 14, 2017 Why Not Use Mean Kinetic Temperature in Cold Applications? Here’s why… Back for more on Mean Kinetic Temperature with a customer question: Hi Paul, I have reviewed Vaisala’s application note on mean kinetic... 了解更多 博客 | Nov 28, 2017 Trusting Fans for Temperature Uniformity Vs. Loading Styles & Mapping Studies We received this question from a customer performing mapping studies in fridges and cold rooms: Dear Paul, In mapping a cold chamber or room,... 了解更多 博客 | Nov 2, 2017 Learn Three Keys to Data Integrity in this new Infographic 了解更多 博客 | Oct 20, 2017 What's your open door (mapping study) policy? In this week's blog, answer a question about open door mapping studies and offer some considerations that may close the issue (and the door). Hi... 了解更多 博客 | Sep 29, 2017 When the mapping study says move the probe, do you need other criteria to relocate? In this week's blog, Senior Regulatory Expert Paul Daniel offers some practical advice on moving probes in validation/mapping. Plus, you are... 了解更多 博客 | Jun 29, 2017 5 Ways to Treat a Misbehaving Refrigerator Go high-end, Tune it up, Block it off, Worst-Case Scenario, Change the Set-point In this week's blog, Paul offers some advice on problem spots... 了解更多 成功案例 McKesson Specialty Health achieves over 100 audits without a single observation Bullet-proof environmental monitoring technology that answers auditors’ questions. McKesson Corporation, currently ranked 5th on the FORTUNE 500... 了解更多 成功案例 Vaisala Honorary In-kind Donator for New Children’s Hospital Vaisala will be contributing humidity, temperature, and carbon dioxide measurement instruments to the new children’s hospital to be constructed... 了解更多 博客 | May 2, 2017 Regulatory Round up - Plus new Q&A from our latest webinar on VaiNet Technology This week we offer several items for your blog-reading pleasure: A link to our recent VaiNet Wireless monitoring webinar, recording, and slides... 了解更多 博客 | Apr 10, 2017 Part 11 for Process Equipment, Audit Trail Reviewing, Requirements for Bulk Chemicals, And Cal Certs Without Pass/Fail This week we have five move post-webinar questions from the Data Integrity webinar. The questions are: Do we need to comply with Part 11 for a... 了解更多 博客 | Mar 28, 2017 Q&A from our Data Integrity Webinar (Plus - another Webinar!) This week we are sharing some of the post-webinar questions sent to us after our Data Integrity webinar. If you missed it, watch the recorded... 了解更多 博客 | Feb 25, 2017 Common questions on MKT answered: Trending, Interpreting Reports, & Default Activation Energy In this week's blog, Paul Daniel answers a few questions that we often receive on using mean kinetic temperature. Dear Paul, I have a couple... 了解更多 博客 | Feb 15, 2017 Three Questions you need to Answer for Monitoring Controlled-Temperature Chambers In PharmTech's recent publication Vol 9, Issue 12 Manufacturing Sector Editor Jennifer Markarian interviewed Vaisala Regulatory Expert Paul... 了解更多 博客 | Jan 21, 2017 Get this NEW Interactive eBook: Measurement Solutions for Life Science Industries We just published a new eBook that contains links to articles, videos, webinars and case studies on tools and systems for keeping life science... 了解更多 博客 | Dec 17, 2016 Can you use Mean Kinetic Temperature to Account for Spikes in Accelerated Aging Chambers? In this week's blog, Paul Daniel has a little back and forth on a question he received from a webinar attendee on using mean kinetic temperature... 了解更多 博客 | Dec 6, 2016 Sensor Breakdown for Chambers Vs Room Monitoring: What Sensors are best for Your Application? Many chamber applications are cold temperature applications and usually temperature is the only parameter monitored. Cold air cannot hold much... 了解更多 博客 | Oct 22, 2016 Loaded Room Studies for Performance Qualification: Can We Just Say No? Hello, I recently watched your webinar "Modern Rules for an Old Practice: Sensor Placement for GxP Temperature Mapping" and found the... 了解更多 博客 | Jul 1, 2016 Using MKT to Justify Normal Temperature Excursions during Qualification: Should you? (Short answer: No. Long answer and some options: Read on!) Hi Paul, In regards to the recent MKT webinar, I have a question. Have you ever used... 了解更多
博客 | May 13, 2019 Using Mapping Study Data to Select Monitoring Sensor Placement To be honest, I don’t recommend using the mapping data to select the location of your monitoring sensors . The entire idea is counter-intuitive.... 了解更多
博客 | Apr 16, 2019 Answers from our Latest Mapping Webinar In this blog, we answer questions we received during our recent webinar “Mapping Made Easy.” If you have not seen it already, watch it now.... 了解更多
博客 | Mar 9, 2019 Ready or Not, Bluetooth is coming… I’ve always loved Bluetooth for personal use. That’s not surprising because it was first designed as a tool for a PAN (Personal Area Network).... 了解更多
博客 | Jan 24, 2019 ERES Reminiscing: Thoughts on 21 CFR Part 11 Past, Present & Future I’d never heard of an Electronic Signature until 21 CFR Part 11 was first published in 1997. This iconic regulation had the uninspiring title... 了解更多
博客 | Dec 6, 2018 Temperature Mapping Worst-Case Scenarios in Refrigerators We recently received a question from a pharmaceutical customer on re-qualifying a refrigerator that had been repaired. This customer was... 了解更多
博客 | Nov 20, 2018 7 Data Integrity Hacks for GxP Compliance Last week we had a webinar on data integrity giving our Senior Regulatory Expert Paul Daniel the opportunity to answer questions on data... 了解更多
博客 | Apr 12, 2018 Q&A New VaiNet (LoRa-based) Wireless Data Loggers We had over 480 registrants for our webinar "VaiNet - a Wireless Technology that Rises Above the Crowd" Thank you to everyone who joined in, and... 了解更多
博客 | Mar 12, 2018 With Wireless Monitoring on the Rise, What Changes in Ensuring Compliance with 21 CFR Part 11? As wirelessly networked monitoring devices become more popular, many of our GxP-regulated customers ask about 21 CFR Part 11 and how it impacts... 了解更多
博客 | Feb 20, 2018 Data Base Transfers & Validation for Part 11 & Annex 11 Compliance We recently received these questions: “Are data base transfers part of software validation? If yes, how can we validate the transfer?” The... 了解更多
博客 | Feb 2, 2018 Thermal Damping of Temperature Probes: Monitoring yes, Mapping no (maybe) We receive a lot of questions on the use of thermal damping devices for temperature sensors. Mostly it depends on your application, but for... 了解更多
博客 | Jan 19, 2018 Can you Validate a Refrigerator Truck like a Walk-in? Four Key Differences in These Storage Areas In this week's blog we answer a question about validating cold-storage for pharmaceutical and biotechnology ... are there differences? Hello... 了解更多
博客 | Jan 1, 2018 Our Most-Read Life Science Blogs in 2017 Happy New Year! Once again we bring you a list of our most popular blogs from the last year. In case you missed them, and according to our Web... 了解更多
博客 | Dec 14, 2017 Why Not Use Mean Kinetic Temperature in Cold Applications? Here’s why… Back for more on Mean Kinetic Temperature with a customer question: Hi Paul, I have reviewed Vaisala’s application note on mean kinetic... 了解更多
博客 | Nov 28, 2017 Trusting Fans for Temperature Uniformity Vs. Loading Styles & Mapping Studies We received this question from a customer performing mapping studies in fridges and cold rooms: Dear Paul, In mapping a cold chamber or room,... 了解更多
博客 | Oct 20, 2017 What's your open door (mapping study) policy? In this week's blog, answer a question about open door mapping studies and offer some considerations that may close the issue (and the door). Hi... 了解更多
博客 | Sep 29, 2017 When the mapping study says move the probe, do you need other criteria to relocate? In this week's blog, Senior Regulatory Expert Paul Daniel offers some practical advice on moving probes in validation/mapping. Plus, you are... 了解更多
博客 | Jun 29, 2017 5 Ways to Treat a Misbehaving Refrigerator Go high-end, Tune it up, Block it off, Worst-Case Scenario, Change the Set-point In this week's blog, Paul offers some advice on problem spots... 了解更多
成功案例 McKesson Specialty Health achieves over 100 audits without a single observation Bullet-proof environmental monitoring technology that answers auditors’ questions. McKesson Corporation, currently ranked 5th on the FORTUNE 500... 了解更多
成功案例 Vaisala Honorary In-kind Donator for New Children’s Hospital Vaisala will be contributing humidity, temperature, and carbon dioxide measurement instruments to the new children’s hospital to be constructed... 了解更多
博客 | May 2, 2017 Regulatory Round up - Plus new Q&A from our latest webinar on VaiNet Technology This week we offer several items for your blog-reading pleasure: A link to our recent VaiNet Wireless monitoring webinar, recording, and slides... 了解更多
博客 | Apr 10, 2017 Part 11 for Process Equipment, Audit Trail Reviewing, Requirements for Bulk Chemicals, And Cal Certs Without Pass/Fail This week we have five move post-webinar questions from the Data Integrity webinar. The questions are: Do we need to comply with Part 11 for a... 了解更多
博客 | Mar 28, 2017 Q&A from our Data Integrity Webinar (Plus - another Webinar!) This week we are sharing some of the post-webinar questions sent to us after our Data Integrity webinar. If you missed it, watch the recorded... 了解更多
博客 | Feb 25, 2017 Common questions on MKT answered: Trending, Interpreting Reports, & Default Activation Energy In this week's blog, Paul Daniel answers a few questions that we often receive on using mean kinetic temperature. Dear Paul, I have a couple... 了解更多
博客 | Feb 15, 2017 Three Questions you need to Answer for Monitoring Controlled-Temperature Chambers In PharmTech's recent publication Vol 9, Issue 12 Manufacturing Sector Editor Jennifer Markarian interviewed Vaisala Regulatory Expert Paul... 了解更多
博客 | Jan 21, 2017 Get this NEW Interactive eBook: Measurement Solutions for Life Science Industries We just published a new eBook that contains links to articles, videos, webinars and case studies on tools and systems for keeping life science... 了解更多
博客 | Dec 17, 2016 Can you use Mean Kinetic Temperature to Account for Spikes in Accelerated Aging Chambers? In this week's blog, Paul Daniel has a little back and forth on a question he received from a webinar attendee on using mean kinetic temperature... 了解更多
博客 | Dec 6, 2016 Sensor Breakdown for Chambers Vs Room Monitoring: What Sensors are best for Your Application? Many chamber applications are cold temperature applications and usually temperature is the only parameter monitored. Cold air cannot hold much... 了解更多
博客 | Oct 22, 2016 Loaded Room Studies for Performance Qualification: Can We Just Say No? Hello, I recently watched your webinar "Modern Rules for an Old Practice: Sensor Placement for GxP Temperature Mapping" and found the... 了解更多
博客 | Jul 1, 2016 Using MKT to Justify Normal Temperature Excursions during Qualification: Should you? (Short answer: No. Long answer and some options: Read on!) Hi Paul, In regards to the recent MKT webinar, I have a question. Have you ever used... 了解更多