vaisala rfl100 manual

And while standard Bluetooth wont have many GxP applications beyond networking your personal devices, BLE might just find some inroads into GxP, in specific roles that match the capabilities of the technology. We started in weather measurement when founder Professor Vilho Vaisala invented the operating principles of radiosonde technology for high altitude weather measurement. In 2018, LSNE decided to standardize several facilities environmental monitoring with the Vaisala viewLinc continuous monitoring system. We have lots of features, and each one has been carefully named and given recognizable icons so that its function and use can be easily remembered. Can we use the GMP231 with Indigo for this? Vaisala also keeps multiple GxP and Regulatory Experts on staff dedicated to supporting our GxP customers in maintaining the required validation documents for their viewLinc installation. Tel: 083 635 3436 The cabinets small footprint and the fact that its pre-configured make it very convenient. As an example, an RFL100 data can store 30 days worth of 1-minute samples, while a DL2000 data logger can hold 1.7 years of data at a 15-minute sample rate. And they can still provide reports in any time zone required without conversions, even for seasonal time changes due to Daylight Saving Time. Gabrault was able to further streamline the documents for simplicity. For most applications, they use VaiNet wireless data loggers the RFL100. Is there any particular way the server must be installed? When not supporting validations, our GxP Experts are busy ensuring that Vaisala maintains their position as a thought leader in monitoring compliance with regular webinars and seminars for our customers. <> Vaisala is a global leader in weather, environmental, and industrial measurements. First, viewLinc serves as a database to securely store data collected from an array of sensors. The alarm reports are especially helpful. It depends on the customer, his personal background, and problems they may have had with prior systems. In selected areas, Vaisala provides mapping as a paid service. In addition the mapping data may be used to decide where to place monitoring sensors for the viewLinc system. endstream /CS1 242 0 R >> Notifications of alarm situations can occur by email, SMS, or audible alarm on the viewLinc client window. For any application, there are multiple choices of Data Logger and connection types. Thats not surprising because it, Commissioning, Qualification & Validation: Fundamental for pharmaceutical products & life-saving therapies, Data integrity keeps life-saving research and information safe, Envirotainer controls container conditions with Vaisala temperature probes, Mean Kinetic Temperature in GxP Environments, Vaisalas viewLinc Monitoring System Used in Clinical Research at CTC North, Germany. Close to the cabinet end user can install a ViewLinc display to see all channel in one time ; Alternative is to connect PDT101 to DL4000 loggers via analog wiring without cabinet ; no display in that case for each measurement location., GMP Manufacturers (Pharmaceuticals and medical devices). With those measurements in viewLinc, we ensure compliance with local requirements for environmental protection.. Its not hard to learn. One sample / channel / minute (nonchangeable). x[m6_-! The following measurements are available with proprietary Vaisala devices: If Vaisala does not provide the needed sensor, or if the customer prefers to use a legacy sensor, the data may be easily brought into viewLinc if the sensor has an analog electrical output (4-20 mA, 15V, or 1-10V) using a DL-4000 Universal Input Logger. If tampering is detected in the database files the system will shut down and prevent all access, until the database is restored to an earlier valid version. Temperature Mapping is a validation activity used to verify that a room or chamber can maintain the required environmental conditions, and is usually done before a monitoring system is deployed. Glenwood, Durban, Kwazulu-Natal, Cape Town Branch It is intended for new sales managers and distributors. If a user forgets, we have provided several layers of assistance on board in the software. In addition, viewLinc may be configured to provide alarms at remote alarm towers. For more information, refer to the viewLinc User Manual Section 2.7 Validate Your System [see Additional viewLinc Resources at end of this document], Ethernet Cable via Digi MultiPort Adaptor, VaiNet Long Range RF Protocol (over 100M range indoors), Vaisala Intrinsically Safe Sensors (Explosion Proof). Since then, we have invested heavily in improving the viewLinc offering, and in developing new products for the CMS line. /BleedBox [ 0 0 595.27563 841.88977 ] Vaisala can also support customers that want to send instruments out for service by offering our Depot Calibration Services. The viewLinc software was designed to be easy to learn. Does it take up 2 channels?. Alarms and Notifications: Some customers are concerned about receiving timely alarms and notifications from the viewLinc system. We have a calibration team as part of our engineering group, so we calibrate our sensors in-house, says Gabrault. Do we require a server for each site? The viewLinc system gave us a single, centralized solution.. The design of viewLinc as a simple configurable system makes it easy to validate. It will not stop the alarm until its been responded to.. Vaisala data loggers are superior instruments for mapping spaces from -80C to 50C, especially larger wide open spaces such as warehouses where many sensor are needed and wires cannot be tolerated. There is a single license fee based on the number of sensors, not the number of users, so license cost is always managed at a level that matches the level of deployment. Data is protected within the system with multiple points of redundancy (data logger, server, database backup so that no single point of failure can cause data loss. Ive worked with other systems where the devices are excessively large. Data retention > 20 years backup without power. Our analysis showed that while this was a popular mode of notification in the past, it has fallen in popularity and is little requested by the next generation workforce. Instead, lyophilization uses freezing conditions under vacuum. &cxTHM2orW6/nM\@tA2[*N8* 29k _n2$]E|b QSY8)`@\`i We can support customers that want to calibrate instruments themselves, by providing the necessary software utility programs and reference instruments. With the PCI acquisition, the combined companies now offer global end-to-end integrated CDMO services for clients, including development and manufacturing, clinical trial services, and commercial packaging. It was important to us to have as much environmental data as possible in one system, says Gabrault. With accredited temperature and humidity calibration services and quality customer support, the data loggers offer a completely integrated solution for all your continuous monitoring and reporting or validation/ mapping applications. Reliability and Resilience: This value usually comes from a customer who has had previous problems with a system that didnt work well, or had a bad audit experience due to missing data. Because sometime you need indigo flexiblity for a CMS case.. I took the data in the IQ and OQ from Vaisala and customized it for our needs. Who is Vaisala, and what is the Vaisala presence in the CMS Market? Data Protection and Security: Some customers are primarily concerned with protecting the data collected by viewLinc. In the pharmaceutical industry, regulations require close monitoring of the manufacturing and logistics of drugs to guarantee their quality, safety and efficacy. Any reports for Cold Room 101 will detail which data came from which device. I like that I can see whats happening in our facility out in Wisconsin from my location in New Hampshire. In terms of alarming, viewLinc is relentless. You can sell Vaisala as a business partner. These users may inadvertently change settings or parameters and impact other sites. /Rotate 0>> endobj Or you can install the server in the corporate IT Server Room and then any site on the LAN can use viewLinc as an Enterprise Server. Data in viewLinc is stored in a secure encrypted database and cannot be changed by any user. An IQOQ performed by Vaisala Field Services can be completed in under a week, compared to the months it would take to validate a BMS from integrators like Siemens or Rockwell Automation. Can customers use virtual servers? Daniel Gabrault has been a plant engineer with LSNE for over three years. When it is time to calibrate Logger S/N 1234, we can simply put another data logger (Logger S/N 5678) of the same model in CR-101 and change the linkage, so that Virtual Location Cold Room 101 is now collecting data from Logger S/N 5678. Tel: 073 492 1390 The RFL100 is a wireless logger with enough range (over 100m) to map a huge warehouse and provide live data feeds, reducing the time required to map, or to fix mistakes. It can be installed in the IT Server Room as a physical server and be used by the entire site. In the last 15 years of these ongoing efforts, mean kinetic temperature (MKT) has been identified as one, We need uninterrupted and reliable monitoring, because in a single refrigerator we can lose material worth more than 10,000 euros. viewLinc can run as virtual server in your own private cloud. Calibration Capabilities: Some customers are concerned about the requirements for calibration of the sensors used by the system. Long-term cost of ownership: Some customers are concerned with the long-term cost of ownership. Yes, it can be tricky at times for example, every time you enter your password wrong, its recorded; nothing can ever be erased. We are a truly global institution that believes in the value of accurate measurement in solving the important problems of our day. Vaisala also provides calibration options to ensure sensors maintain their accuracy, including: Vaisala service center calibration, probe replacement service, or software and equipment for in-house calibration. Alarms ensure that products are safeguarded 24/7. As a monitoring system grows larger, typically the administration needs will grow at the same pace. Can the GMP251 be used during high heat sterilization? The viewLinc system is also easy to standardize across applications. no, reason why its a removable probe to be removed during sterilization process. Vaisala understands this need and supports it in several ways. Available now with RFL100 for incubator application.see 6. Tel: 031 201 2705 The purpose of this document is to provide an introductory level of awareness and education to the. In all cases, these notifications are configurable for recipients and delays, as well as method of notification. This can be overridden if desired. These proprietary sensors speak the same language, and communicate without any need for custom programming. Does theGMP231 only work with Indigo? They cannot see the data or devices from the other sites. We also supply the validation protocols needed throughout the typical system life cycle, such as the addition of new sensors, occasional service updates, and version upgrades. The Vaisala Industrial Cabinet CAB100 integrates multiple sensors into a simple, pre-configured instrument panel. Not to mention the delay in development when it comes to blood samples from clinical trials. Ralf Freese, Medical Director, Director Business & Corporate Development, CTC North Developing medicines, Bluetooth is likely here to stay. Vaisala The data collected for Virtual Location Cold Room 101 is continuous and has no gaps when the devices are swapped. For deepereducation or advanced questions refer to your designated Vaisala path of contact. What is qualification and validation? Second, viewLinc monitors the incoming data and the sensor array, generating alarms and notifications as needed to ensure the incoming data remains within specifications. With a VaiNet device, virtually no infrastructure is needed, drastically reducing the cost and time to deploy. Currently he provides overall support for facilities, systems, utilities, and equipment. Currently most alarms are sent by email, but weve also set up important alarms to go directly to phone, says Gabrault. How does viewLinc deal with sites in different Time Zones? viewLinc may be implemented as a stand-alone physical machine on a private network or an enterprise-level server supporting multiple sites either as a physical box or as a virtual machine. Is the Differential Pressure Transmitter PDT101 used with the CAB100 or can we use it independently with for example RFL100 loggers?, CAB100 is the professionnal and elegant solution for dP measurement form us. viewLinc is designed to be reliable and resilient. If your customer has a demanding application, they may value an accurate and stable instrument. For more information, refer to the viewLinc User Manual Section 10.7 Swap Devices [see Additional viewLinc Resources at end of this document]. We believe in the value selling method in which you determine what is important to your customer (what your customer values) and then show how the viewLinc products satisfies the concerns of the customer. This process is called a swap. Do we have to use viewlinc software for this or is there an alternative? Please go overviewLinc Application Programming Interface, 16. 5. 3. A complete solution, our mapping tools eliminate costly downtime from pre- and post-calibration and deliver accurate, validatable results. We have continued our spirit of innovation in the CMS market as well, developing our own RF communication network called VaiNet to allow unprecedented ranges (over 100m) in wireless communication over a private sensor network. What kind of validation support is provided for GxP Customers? This means less time and cost to install. K8 ~(m W20A@c`d`jb>U@ @ u-8:bE " Some users set their preferences to send to both email and text message. Kirstenhof, Cape Town, Gauteng Branch If they absolutely need phone capability, there are multiple solutions such as an aftermarket software, a centralized security call service, or a 3rd party web service. Our DL 2000 logger has long been a workhorse four our mapping customers, due to its high accuracy, extremely long battery life (10 years), configurable sample rate, and huge memory. Read more about Vaisalas viewLinc system here! Or, you can sell the customer by identifying the things that the customer values. To demonstrate this, you must determine what it is that your customer values! RS-232 serial, USB, Ethernet, WiFi network interface available. Can a customer import data from an older version of viewLinc? You can sell the system features. I k':*"% A Monitoring System, in this context, collects temperature, humidity, and other environmental data for a manufacturing facility (or laboratory, pharmacy, museum, etc.). Your email address will not be published. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); Vaisala data loggers are a versatile and reliable replacement for chart recorders and bulky data acquisition systems, ideal for mapping/validation, the data loggers provide high accuracy humidity and/or temperature measurement and recording. To ensure that the Vainet loggers will communicate with the access point (through walls etc), best option is to use a demo system at customer site with one AP10 + loggers, 8. Connectivity options provide an easy, scalable network capability using Ethernet and/or WiFi for remote and centralised monitoring, real-time data display, data redundancy and email alarms. We have hundreds of devices over seven facilities, soon to be eight. This means numerous measurements, Regulatory bodies and stakeholder organizations in drug and device manufacturing and distribution have long been working toward creating standards for temperature monitoring that ensure the shelf life, quality and safety of products. What does that mean? This value is important because it ensures a perspective beyond price, or the immediate cost of acquisition. How does viewLinc prevent configuration changes at one site from affecting other sites? viewLinc can be used in 8 different languages. What is the Vaisala viewLinc Monitoring System?viewLinc is a best-in-class enterprise-level monitoring system. cas)f?Nxq$". !Q In addition, these products are regulated by organizations like the FDA (Food and Drug Administration) and the manufacturer must prove that the products have been stored correctly. Everyone seems to like using viewLinc. It can be implemented on a local PC to monitor only local sensors in a one-room lab. /PageLayout/SinglePage endobj If you attempt to sell viewLinc based on price alone, you will likely have little success viewLinc is rarely the cheapest option. Douglasdale, Sandton, Please fill in this form and we will get back to you soon, Region * /OpenAction 200 0 R /Names 192 0 R >> endobj This data is used to prove that a space is suitable for controlled storage. An Enterprise-Level System is a system that is installed t one site, but can be used at multiple sites. The system sends alerts on thresholds and communication failures immediately, without loss of data., Gabrault also appreciates viewLincs reporting capabilities. Vaisala loggers also excel at mapping tightly controlled environments, such as stability chambers, where a highly accurate sensor is required for both temperature and humidity. In addition, these customers have a responsibility to provide proof of successful maintenance of conditions to a third party, such as a regulatory agency, customer, or a business partner. Vaisala instruments, especially for humidity, are known for high accuracy and high stability. << Vaisala's humidity and temperature validation solution is the easiest, most cost-effective method for mapping equipment, areas, and systems in FDA regulated and GxP environments. While LSNE provides multiple services, such as formulation processes for emulsions, suspensions, liposomes, and polymer or lipid nanoparticles (LNPs), the company is an industry leader in lyophilization (freeze drying), which stabilizes biologic substances through freezing and the sublimination of frozen water under high vacuum. Can we combine product families on one viewLinc platform? Validation is a specialized activity requiring usually high paid personnel and a lot of time to develop documents. /ProcSet[/PDF/Text/ImageC] Can you do a quote example forRFL, DL and WIFI range systems? Vaisala provides a care agreement which ensures timely upgrades as the system is improved, and ensures access to validation documents and support. Initially, we had Vaisala do the installation and validation for system deployment, recalls Gabrault. Typically, a dense array of sensors is placed in a space to be mapped, and data is collected at 5 to 15 minute intervals for 2 days to 1 week. no ; but you are authorized to sell it with a CMS case. &\f lfKFP> The Event Log will capture the Swap in the Audit Trail. /XObject<< So, we use other devices in viewLinc to monitor parameters the RFL100 loggers dont currently include. Withnell Sensors specialises in the temperature and humidity validation sector offering product solutions and service predominantly to the Pharmaceutical and Biotech industries. endobj endstream viewLinc has been specifically designed to be easy to use without being too simple to be useful. Third, viewLinc serves as the configuration utility to maintain the database, alarms, and the sensor array. In addition, in select areas, we also can provide personnel to execute the validation protocols as a paid service. 2. As the viewLinc administrator, I segregate all the data, so staff only sees the applications they care about.. LSNE comprises five FDA-inspected facilities in the U.S. and Europe, with a sixth facility opening in 2022. @ qv6.A#qfx(t7 zqm5Bl4~IiU4uNFnmj_jn2y]i2y43D]bjeq/jG_(qL*uvxTiM Ziy BM$`+hY>[&o&E];bas]E]yukjhU'TU%Pe^i{ ~sP.-YZV:ok_!!iYx\Ccq~!mkD However, the Vaisala viewLinc system is often the lowest cost system in the long-term. %PDF-1.7 % Even if you were to delete the unit or the device, the data stays forever, which is ideal for GMP. +46 40 298 991 << /Length 5172/Filter /FlateDecode >> viewLinc provides an array of potential alarms to ensure that users are notified of system problems, including system errors, configuration issues, calibration expiration, and data that is out of specification. In the case of the CAB100, based on my past experience of cleanroom monitoring systems, I estimate most systems would take up about four times the space as the Vaisala CAB100. Building on over 85 years of experience, Vaisala provides observations for a better world, with space-proof technology even exploring Mars and beyond. When he started with the company, there were multiple different monitoring systems distributed across facilities. When an alarm condition is identified by viewLinc, the most critical step in fixing the problem is notifying the correct employees. We have over 40 years combined experience in our field and continue to be sought out as experts in the services that we offer. Kwa-Zulu NatalGautengWestern CapeEastern CapeLimpopoNorthern CapeNorth WestFree StateMpumalangaOutside South Africa, I have read and accept the Privacy Policy, Please fill in this form to download our brochure, Autoclaves, Ultralow Freezers, Laboratory Refrigerators, Balances, Baths and Circulators, Centrifuges, Colony Counter, Concentrators, Consumables, Data Loggers, Density Meters, Dry Baths, Elisa Plate Readers and Washers, Environmental Chambers, Filtration Systems, Freeze Dryers, Temperature Controllers, Homogenizers, Laminar Flow Hoods, Co2 Incubators, Incubators, Laboratory Chairs, Micropipettes, Microscopes, Laboratory Ovens, Overhead Stirrers, Rotary Evaporators, Temerature Test Chambers, UV Spectrophotometers, Vacuum Pumps, Desiccators, https://www.vaisala.com/sites/default/files/documents/viewLinc-Connectivity-Guide-B211150EN.pdf, https://www.vaisala.com/en/file/138901/download?token=UUz1oLH8, https://www.vaisala.com/en/products/instruments-sensors-and-other-measurement-devices/rflco2, https://www.vaisala.com/sites/default/files/documents/Wireless-CO2-Incubator-Monitoring-viewLinc-B212303EN.pdf, https://www.vaisala.com/sites/default/files/documents/Multi-Site-Monitoring-Application-Note.pdf, 1. Accuracy/Stability: Some customers are concerned about accuracy of measurement. How is mapping related to the viewLinc system? How does viewLinc keep administration from getting too difficult? By nature, this customer is risk-averse. The viewLinc server uses only stable and supported Microsoft Operating Systems no unique or outdated operating systems are required. Using heat to remove moisture would degrade many products. The typical viewLinc customer stores, manufactures, or distributes expensive assets that are sensitive to environmental conditions, such as temperature, humidity, and pressure. If your customer requires voice notification, challenge them to see if they truly need the feature or have just requested it for historical reasons. Such products typically have storage specifications that require storage at a narrow range of temperature and humidity. But we need that kind of data integrity and access control for GMP.. viewLinc has 3 main functions. For more information, refer to the viewLinc User Manual Section 1.3.2 Watch a Tour [see Additional viewLinc Resources at end of this document], Kwa-Zulu Natal (Head Office) Vaisala calibrations always include both calibration and adjustment, if necessary. This means that when you upgrade to a new version of viewLinc, you can bring your legacy data into the new system, and continue to use your existing sensors. For legitimate changes to configuration data, all changes are tracked and recorded in a 21 CFR Part 11 compliant audit trail. The RFL100s also have a digital display, so we can quickly check conditions and see whether the device is working properly.. Its helpful to think of the system in five parts: Sensors, Data Loggers, Ethernet Adaptors, Device Host Servers, and the viewLinc Server. In 1973, we moved into industrial measurements when we invented the modern way of measuring humidity with a capacitive hygrometer. How does viewLinc deal with sites that use different languages? If that isnt enough, the user can immediately access the Help menu, or directly email Technical Support from a link within the Help. viewLinc is designed to integrate smoothly with existing IT implementations. What is a typical setup for this.. For example we have some customers that only want to monitor their CO2 incubators. 10: What are important things to look for during a site survey?. Why does it matter to our customers? The software recognizes the language settings used in the client PC, and presents the viewLinc interface in the local language by default. Every version of viewLinc is always backwards compatible for data and devices. While typical parameters include differential pressure, ambient temperature, and relative humidity, the CAB100 can also take a variety of analog inputs, which can also be made intrinsically safe. 9. The first layer of assistance is the Tours which guides the user through basic viewLinc tasks so that the user can learn by doing. This can be over-ridden if desired, and reports may be generated in any time zone. A typical viewLinc installation would be monitoring of temperature and humidity in facility manufacturing or storing pharmaceutical products or medical devices. Before we installed viewLinc, we had several different monitoring methods, recalls Gabrault. For the first four parts, the pieces all work a little differently depending on which type of Logger you are using, as the Sensors and/or Ethernet Adaptors may be integrated into the Logger, and the logger may not utilize a Device Host: How many ways can the system communicate? Our clients also audit our Quality Systems, says Gabrault. ?JK@m4@k;tx-to` Yes. With over 30 lyophilizers across the world, LSNE is currently one of the largest service providers in the industry. We also use Vaisalas CAB100 in our clean suites to monitor ambient temperature, relative humidity, and differential pressure., VaiNet Wireless Temperature & Humidity Data Logger RFL100 for wireless monitoring of controlled areas. /Contents[ 202 0 R] The Vaisala Team analyzed viewLinc to create as many opportunities as possible to utilize templates to simplify management. For instance, a given Cold Room (CR-101) is equipped with a Vaisala Data Logger (S/N 1234). Can you briefly describe all the components in the RFL, DL and WIFI range? /Group<> RS-232 serial, USB, Ethernet, PoE, WiFi network interface available. What is the difference between Lora and2.4 GHz RF frequency.. Why is this superior? Lyophilization Services of New England, Inc. (LSNE, now part of PCI Pharma Services) is a contract development and manufacturing organization (CDMO) that serves global pharmaceutical, biotechnology, and medical device companies. No charts, wires, connections or power cords are required. We are proud to work with many of the market leading, international pharmaceutical manufacturers. Ive always loved Bluetooth for personal use. Validatable datalogger software version offers complete datalogger communication, graphing and reporting functions. To ensure the highest level of quality to client companies and patients, LSNE must undergo regulatory inspections from multiple agencies and host numerous client and Qualified Person audits. We offer support for our customers Mon - Fri 9:00am - 5:30pm (GMT), Withnell Sensors The Old Silk Mill Withnell, Chorley Lancashire PR6 8RX United Kingdom. You may notice that viewLinc does not include notification by voice call over telephone. However, the central focus for which viewLinc is designed, is to monitor environmental conditions for the manufacture and storage of high-value sensitive products, especially in situations when it is necessary to prove to another entity, such as a regulatory agency, that conditions were maintained correctly. This may also be done with a utility software named vLog. In support of commercially approved medical devices and drug products to over 30 countries across North America, South America, Europe, Africa, Middle East, and Asia, LSNEs services fall into three categories: development, manufacturing, and analytical. How do we support qualification and validation? Vaisala is an established long-standing European company providing pioneering and innovative measurement solutions for over 80-years. 12. Browser based ViewLinc software delivers real time continuous viewing, monitoring and alarm alerts to cell phones, local or networked PC's providing immediate notification of out of compliance conditions in critical applications. Internal lithium battery with life of 10 years at 1 minute sampling rate. The Vaisala viewLinc system is designed with the idea that it can virtually deploy itself. Because our clients are seeking FDA approval, the FDA needs to survey everything involved with the product that has been submitted for approval.

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