PJSC "TERA" has been engaged in the development, production, and installation of wired and wireless automated humidity and temperature monitoring systems for the pharmaceutical and food industries since 2009. All installed monitoring systems have successfully passed validation procedures at PJSC "TERA" customers in accordance with the requirements of GMP, GDP, GCP, GPP, FDA 21 CFR (Part11), GAMP, and HACCP.
COMPONENTS OF THE WIRELESS SYSTEM
The wireless monitoring system based on GSM and Wi-Fi loggers consists of the following components:
Wireless GSM and Wi-Fi humidity and temperature loggers use a built-in GSM or Wi-Fi modem to transmit data to a cloud server. The device operates on the principle of waking up, measuring, transmitting, and going back to sleep. In the absence of a connection to the operator’s tower or Wi-Fi router, the logger stores the collected humidity and temperature data in its internal non-volatile flash memory.
The logger features a high-contrast OLED display that shows humidity and temperature readings for all measurement channels. Additionally, the display shows signal strength, battery charge, and serial number. The logger comes with a rubber boot for protection against impacts and falls and has a built-in magnetic mount. The logger is equipped with two IP67 M8 connectors, to which one or two external Pt1000 thermocouples or air humidity and temperature sensors (SHT) can be connected. The device also has a USB-C port for connecting the battery charger. The logger's replaceable lithium battery, type 18650, can be quickly replaced by the user if needed.
ColdChainCloud software, hosted in the cloud, provides a user-friendly WEB HMI interface built on web technologies. The application is designed to perform all necessary monitoring system functions in real time, including data collection, processing, display, and archiving from sensors, alarm signaling, database management, logging user actions and events, administering access, roles, and user rights, data export, report and graph creation, and more. Users need an internet connection and the Google Chrome browser to access the ColdChainCloud application.
STRUCTURAL DIAGRAM OF THE WIRELESS SYSTEM
FEATURES OF THE WIRELESS SYSTEM
Advantages of the wireless monitoring system:
The most budget-friendly option for pharmacies, vaccination points, medicine storage rooms in hospitals or clinics, and food storage rooms in restaurants and cafes—places where it's necessary to monitor one or more points within a single room
Loggers are easily installed and removed thanks to magnetic mounting, and the system can be easily relocated to another site if needed.
Simple installation that can be performed by the user.
The wireless system can be used for equipment and room mapping (finding critical points).
Disadvantages of the wireless monitoring system:
The radio signal from the logger can be blocked by external obstacles (pallets with goods, walls, etc.) or radio interference.
Battery life depends on the polling frequency of the logger (the more frequent, the quicker the battery drains).
The practical polling frequency of loggers is no more than once per minute, with a recommended interval of once every 5 or 10 minutes.
A monthly subscription fee is required for access to the ColdChainCloud cloud software and for mobile internet.
PLACEMENT FEATURES OF LOGGERS IN REFRIGERATORS
For air temperature monitoring in refrigerators (freezers, cold storage boxes, climatic chambers), single- and dual-channel GSM and Wi-Fi temperature loggers are used. The logger itself is mounted on the refrigerator body using a magnetic mount. One or two wired external thermocouples are routed inside the refrigerator chamber. The cable is either passed through a technical hole in the refrigerator (if available) or through the door (a special thermocouple with a flat cable adapter is supplied to avoid a gap at the cable entry point when the door is closed). If the refrigerator has two chambers with different temperatures, two external thermocouples are used, connected to the logger via two M5 connectors (DLT-20-2Pt model). For cold rooms, a hole is made in the sandwich panel, flanges with gland seals are installed on both sides, through which the wired external thermocouple is routed inside the room.
PresentationThis conformity certificate confirms the conformity of the product with essential safety requirements of the following EC/EU New Approach Directives as amended.
2014/30EU EMC Directive
Harmonized standards used for the conformity assessment:
EN 61326-1:2013
EN 55011:2016/A1:2017/A11:2020
The certificate has been issued on the basis of the tests of the product type sample. The results are recorded in the Conformity assessment report No. 220500341 dated 15.11.2022.
CertificateSince 2009 year PJSC TERA designs, manufactures and installs wired / wireless automatic temperature and humidity monitoring systems (ATHMS) for the companies being into pharmacological and food industries. Every complete monitoring system successfully passed required validated procedures by TERA’s customers corresponding to requirements GMP, GDP, GCP, GPP, FDA 21 CFR (Part11), GAMP and HACCP.
WHAT'S INCLUDED
ATHMS includes the following parts:
CS10600 Data Logger is using for data collecting of wired transducers. This device acts several functions: aggregates and saves information receiving from transducers, provides with data access via Internet using the web interface of the pre-installed software inside, notifies alarms, functions as database server. Data Logger has RS485 port for TSP RST & DVT RST wired transducers connection. Регистратор-вебсервер использует порт RS485 для подключения проводных преобразователей TSP RST и DVT RST. Internet access implements via Ethernet or built-in 4G/LTE modem. Data Logger is fixing inside of a plastic box along with N1-UPS Uninterruptible Power Supply. Data Logger is able to aggregate and save data of up to 30 wired transducers. Non-volatile memory is able to store information of the period by over than 10 years.
Y-Case Wired Temperature Transducers TSP RST and Y-Case Wireless Humidity & Temperature Transducers DVT RST designed for placing it in warehouses, on shelvings, shelves, in freezers and refrigerators. Transducers has dual-channel temperature and humidity sensor. It may have one or two more channels for temperature probe connection. An external temperature probe measures temperature of goods inside of a package or inside of a freezer. Transducers use RS485 interface for data transfer. It has magnetic holder for comfortable placing.
The shield with the uninterruptible power supply supplies with power CS10600 data logger. It transduces mains power 230 VDC to 24 VDC. The shield contains two replaceable AGM storage batteries (gel-based lead-acid) with capacity 9 Ah for each one to power the data logger and a net of coordinators uninterruptibly during 20 hours in a case when there is no mains power (depends on a number of transducers on RS485 line).
LOCAL WEB is pre-installed application in Data Logger, which uses WEB HMI interface, developed with web technologies. This application developed to fulfill all necessary functions of the monitoring system in real-time, namely transducer’s data collecting, processing, displaying and archiving, notifying alarms, database storing, user’s action and event logging, access, roles and rights administration, data export, reports and graphs generating, etc. The application requires Internet or Ethernat access and Google Chrome browser to get access for users.
ATHMS DIAGRAM
PLACING IN THE WAREHOUSE
FEATURES
Advantages
The most budget option for warehouses with big number of rooms, low ceilings and number of storeys
Transducers can be easily mounted and dismounted by M12 connector, that eases to serve it by staff and to fulfill periodical verification
Transducers are consistently connected on a single RS485 line
Much stable system due to data transfer by a cable between a transducer and Data Logger
Wired transducers are cheaper a little comparing to wireless ones
The distance of data transfer between a transducer and Data Logger can reach 1000 meters
Real response time of a transducer starts from 1 second
Disadvantages
Montage is expensive a little, than the wireless system due to cabling
It needs more time to montage
Montage is fulfill by persons with engineering qualification
In case of moving the system to the new spot, it requires new cabling
Long cabling lines with transducers require installation an extra power supply at the end of line
PLACING ON SHELVING WITH PALLETS
Triple-channel transducer is using for air temperature and humidity monitoring by shelf storage. A transducer itself with built-in sensor is placing on bottom of a shelving by magnetic holder (a green mark on an image). An external probe is placing on top of a shelving (a red mark on an image), that’s connected to a transducer by M8 connector. A transducer with an external probe hides inside of rack to avoid physical damage while loading goods.
Such approach solves several issues. Firstly, easy management of whole temperature gradient between of top and bottom of the shelving. That eases for a customer to search critical points on the shelving and to move transducers in the winter-summer mode. Secondly, it cheapens whole system by using triple-channel transducers with an external probe. The external probe costs three times less than a regular transducer.
PLACING IN REFRIGERATOR
Single-channel and dual-channel temperature transducers are using to check air temperature inside of refrigerators (freezers, refrigerator chests, climate cameras). A transducer itself is placing on the refrigerator case by a magnetic holder. One or two external temperature probes are placing inside of a refrigerator. A cable passes either through a technological hole in a refrigerator (if exists), or through refrigerator’s door corner. If a refrigerator has two cameras with temperature difference, then it’s using two external temperature probes, that’re connected to a transducer by M5 connector (2-15 Model). Installation for a refrigeration room require to make a hole in sandwich-structured composite by two sides, to mount a flange with a cable gland, and to lay an external temperature probe through it. Such approach has significant advantage. A transducer with indication placed outside, and it allows to view temperature value without open the door.
Brochure
See also: Wireless Temperature and Humidity Monitoring SystemSince 2009 year PJSC TERA designs, manufactures and installs wired / wireless automatic temperature and humidity monitoring systems (ATHMS) for the companies being into pharmacological and food industries. Every complete monitoring system successfully passed required validated procedures by TERA’s customers corresponding to requirements GMP, GDP, GCP, GPP, FDA 21 CFR (Part11), GAMP and HACCP.
WHAT'S INCLUDED
ATHMS includes the following parts:
CS10600 Data Logger is using for data collecting of wireless transducers. This device acts several functions: aggregates and saves information receiving from transducers, provides with data access via Internet using the web interface of the pre-installed software inside, notifies alarms, functions as database server. Data Logger has RS485 port for Y6.05-K-868 Net Coordinator connection. Internet access implements via Ethernet or built-in 4G/LTE modem. Data Logger is fixing inside of a plastic box along with N1-UPS Uninterruptible Power Supply. It’s available to connect up to 8 Y6.05-K-868 Net Coordinators per Data Logger. Data Logger is able to aggregate and save data of up to 30 wireless transducers. Non-volatile memory is able to store information of the period by over than 10 years.
Y6.05-K-868 Net Coordinator serves as a gateway between the wireless transducers and Data Logger. Net Coordinators work as access spots by 868 MHz frequency. The signal covers 50 - 300 meters of area by radius depending on circumstances. Net Coordinators are connecting with Data Logger by RS485 line. One Net Coordinator is possible to serve for up to 12 wireless transducers.
Y-Case Wireless Temperature Transducers with ZigBee 868MHz and Y-Case Wireless Humidity & Temperature Transducers with ZigBee 868MHz designed for placing it in warehouses, on shelvings, shelves, in freezers and refrigerators. Transducers has dual-channel temperature and humidity sensor. It may have one or two more channels for temperature probe connection. An external temperature probe measures temperature of goods inside of a package or inside of a freezer. Transducers are powering by two replaceable batteries and using 868 MHz frequency radio signal for data transfer. Transducers have magnetic holder for comfortable placing.
The shield with the uninterruptible power supply supplies with power CS10600 data logger. It transduces mains power 230 VDC to 24 VDC. The shield contains two replaceable AGM storage batteries (gel-based lead-acid) with capacity 9 Ah for each one to power the data logger and a net of coordinators uninterruptibly during 20 hours in a case when there is no mains power (depends on a number of coordinators on RS485 line).
LOCAL WEB is pre-installed application in Data Logger, which uses WEB HMI interface, developed with web technologies. This application developed to fulfill all necessary functions of the monitoring system in real-time, namely transducer’s data collecting, processing, displaying and archiving, notifying alarms, database storing, user’s action and event logging, access, roles and rights administration, data export, reports and graphs generating, etc. The application requires Internet or Ethernat access and Google Chrome browser to get access for users.
DIAGRAM
PLACING IN THE WAREHOUSE
FEATURES
Advantages
The most budget option for nowadays warehouses with tall and broad zones on shelvings for storage using pallets.
Transducers can be easily mounted or dismounted.
The user is able to place transducers on his own.
Wireless monitoring system is cheaper, because installation is pretty quick and easy.
No need of transducers cabling.
Wireless monitoring system can serve for mapping (critical spots searching).
Disadvantages
Transducer radio signal may be blocked by physical obstacles (pallets, goods, walls, etc) or by radio interference.
Radio signal distance is about 50 - 100 meters indoor without straight visibility between a transducer and a net coordinator.
Battery charge depend on response time (more response time, more discharge).
Actual response time is no more 1 time per minute.
The need to make preliminary engineering inspection for radio signal passage between transducers and net coordinators referring to placement.
The need of cabling RS485 line for net coordinators.
PLACING ON SHELVINGS WITH PALLETS
Triple-channel transducer is using for air temperature and humidity monitoring by shelf storage. A transducer itself with built-in sensor is placing on top of a shelving by magnetic holder (a green mark on an image). An external probe is placing on bottom of a shelving (a red mark on an image), that’s connected to a transducer by M8 connector. An external antenna tips on the highest spot of a shelving by a magnetic holder (a green mark on an image). A transducer with an external probe hides inside of rack to avoid physical damage while loading goods.
Triple-channel transducer is using for air temperature and humidity monitoring by shelf storage. A transducer itself with built-in sensor is placing on top of a shelving by magnetic holder (a green mark on an image). An external probe is placing on bottom of a shelving (a red mark on an image), that’s connected to a transducer by M8 connector. An external antenna tips on the highest spot of a shelving by a magnetic holder (a green mark on an image). A transducer with an external probe hides inside of rack to avoid physical damage while loading goods.
PLACING IN REFRIGERATORS
Single-channel and dual-channel temperature transducers are using to check air temperature inside of refrigerators (freezers, refrigerator chests, climate cameras). A transducer itself is placing on the refrigerator body by a magnetic holder. One or two external temperature probes are placing inside of a refrigerator. A cable passes either through a technological hole in a refrigerator (if exists), or through refrigerator’s door corner. If a refrigerator has two cameras with temperature difference, then it’s using two external temperature probes, that’re connected to a transducer by M5 connector (2-15 Model). Installation for a refrigeration room require to make a hole in sandwich-structured composite by two sides, to mount a flange with a cable gland, and to lay an external temperature probe through it.
Such approach has several advantages. Firstly, a transducer with indication placed outside, and it allows to view temperature value without open the door. Secondly, a refrigerator doesn’t obstruct radio signal passage. Moreover, the batteries are not under extreme low temperature.
Brochure
Read also Wired Temperature and Humidity Monitoring SystemSince 2009 year PJSC TERA designs, manufactures and installs wired / wireless automatic temperature and humidity monitoring systems (ATHMS) for the companies being into pharmacological and food industries. Every complete monitoring system successfully passed required validated procedures by TERA’s customers corresponding to requirements GMP, GDP, GCP, GPP, FDA 21 CFR (Part11), GAMP and HACCP.
WHAT'S INCLUDED
ATHMS includes the following parts:
Android-smartphone with 4G mobile Internet, which runs an application to connect to wireless transducers TSP 868 (DVT 868) and to visualize its measurings on the display. The smartphone is mounted into a plastic holder, which can be place on horizontal surface (f.e., to put it on a fridge), and on vertical surface (f.e., to hang it on a wall).
Coordinator T-K-868, which connects using the USB-C jack to the Android-smartphone and serves as a gateway between wireless transducers TSP 868 (DVT 868) and the smartphone. The coordinator works as an access point on the frequency 868 MHz with a coverage radius 50-300 meters depending on signal transmission conditions. One coordinator can administrate up to 12 wireless transducers. The coordinator itself with the smartphone connects to 220V electric mains using a standard USB charge via the second USB-C jack of the coordinator. When electric mains is off, the smartphone automatically switches to the power from own built-in battery and sends emergency message in the cloud that electric mains is off.
Y-Case Wireless Temperature Transducers with ZigBee 868MHz and Y-Case Wireless Humidity & Temperature Transducers with ZigBee 868MHz, which place in a room of storage, on shelving, shelves, in fridges and refrigerators. Transducers may have two internal channels of temperature and air humidity, and additional one or two channels to connect an external temperature transducer with a cable jacks. External temperature transducers can measure temperature of goods inside of a package or inside of a freezer (refrigerator). Transducers work using two interchangeable batteries and use the radio frequency 868 MHz to transfer data. Transducers are equipped with magnetic holders to mount it easily.
Cold Chain Cloud software in the cloud that provides users with WEB HMI interface using web-technologies. The application is developed to fulfill all necessary functions of the monitoring system in real-time, namely transducer’s data collecting, processing, displaying and archiving, notifying alarms, database storing, user’s action and event logging, access, roles and rights administration, data export, reports and graphs generating, etc. The Cold Chain Cloud requires Internet access and Google Chrome browser to get access for users.
DIAGRAM
PLACING IN THE WAREHOUSE
FEATURES
Advantages
This is the most budget option for pharmacies, vaccination centres, a room to storage medicines in hospitals and clinics, rooms to storage food products of restaurants, cafe, etc. Commonly places where the user needs to control one or more spots within one room.
Wireless transducers can be easily mounted and unmounted on a surface with the magnetic holder. It's easy to transfer the system to another place on demand.
Easy montage, that may be done by a user on his/her own.
Wireless monitoring system can help to map a place by temperature (critical spots researching).
Disadvantages
Transducer radio signal may be blocked by physical obstacles (pallets, goods, walls, etc) or radio interferences.
If there are some physical obstacles between a transducer and a net coordinator, the connection distance may reach up to 100 meters.
Battery charge depends on response time (more response time, more discharge).
Actual response time is no more than 1 time per minute, recommended one is 1 time in 5 or 10 minutes.
A need to pay every month subscription fee to access The Cold Chain Cloud and to have cellular Internet.
PLACING IN REFRIGERATORS
Single-channel and dual-channel temperature transducers are using to check air temperature inside of refrigerators (freezers, refrigerator chests, climate cameras). A transducer itself is placing on the refrigerator body by a magnetic holder. One or two external temperature probes are placing inside of a refrigerator. A cable passes either through a technological hole in a refrigerator (if exists), or through refrigerator’s door (a special transducer provides with an adapter to a flat cable to avoid a gap while closing the door). If a refrigerator has two cameras with temperature difference, then it’s using two external temperature probes, that’re connected to a transducer by M5 connector (2-15 Model). Installation for a refrigeration room require to make a hole in sandwich-structured composite by two sides, to mount a flange with a cable gland, and to lay an external temperature probe through it. The Android-smartphone with the coordinator T-K-868 place in the same room, where fridges (freezes) are, and can work with up to 12 transducers, which measure temperature inside fridges.
Brochure
Since 2009 year PJSC TERA designs, manufactures and installs wired / wireless automatic temperature and humidity monitoring systems for the companies being into pharmacological and food industries. Every complete monitoring system successfully passed required validated procedures by TERA’s customers corresponding to requirements GMP, GDP, GCP, GPP, FDA 21 CFR (Part11), GAMP and HACCP.
WHAT'S INCLUDED
Wireless temperature and humidity monitoring system includes the following parts:
Android-smartphone with 4G mobile Internet, which runs an application to connect to wireless transducers TSP 868 (DVT 868) and to visualize its measurings on the display. Using the smartphone, the system aggregates and transfers in the cloud all of online data about air temperature and humidity in a cargo compartment, goods temperature and GPS coordinates of refridgerator location. A driver can visually observe data of temperature and humidity on the smartphone display while driving. Also the driver can start and finish expedition by pressing a button, thereby to activate and to diactivate alarm signal.
Coordinator T-K-868, which connects using the USB-C jack to the Android-smartphone and serves as a gateway between wireless transducers TSP 868 (DVT 868) and the smartphone. The coordinator works as an access point on the frequency 868 MHz, which can administrate up to 12 wireless transducers. The coordinator itself with the smartphone connects to the car USB charger using a standard USB charge via the second USB-C jack of the coordinator. When the power supply is off, the smartphone automatically switches to the power from own built-in battery.
Y-Case Wireless Temperature Transducers with ZigBee 868MHz and Y-Case Wireless Humidity & Temperature Transducers with ZigBee 868MHz, which place in a cargo compartment of the refrigerator. Transducers may have two internal channels of temperature and air humidity, and additional one or two channels to connect an external temperature transducer with a cable jacks. External temperature transducers can measure temperature of goods inside of a package. Transducers work using two interchangeable batteries and use the radio frequency 868 MHz to transfer data. Transducers are equipped with magnetic holders to mount it easily.
Cold Chain Cloud software is in the cloud that provides users with WEB HMI interface using web-technologies. The application is developed to fulfill all necessary functions of the monitoring system for vehicles in real-time, namely transducer’s data collecting, processing, displaying and archiving, notifying alarms, database storing, etc.
DIAGRAM
PLACING IN THE VEHICLE
FEATURES
Advantages:
It allows to switch from using USB data loggers to the online system with minimal human interaction. Compared to USB data loggers it saves human's time taking to collect manually, transfer and read all data by maintain staff.
Using exactly the online system, not the system with downloading (based on USB or Bluetooth data loggers) is recommended to implement by standards of cold chain in pharmacology and food industry.
Using GPS and 4G LTE it allows to receive exact route coordinates of the vehicle and display it on the map.
The smartphone display, which shows temperature measures, allows a driver to react quickly on alarm situations related on temperature regime in the way even in absence of the mobile network.
Easy montage, which lets to move and mount all of parts (transducers and the smartphone with the holder) in another vehicle as necessary.
Wireless transducers can be easily mounted and unmounted by magnetic holder from the vehicle to maintain, to calibrate or battery exchange, etc.
Disadvantages:
Transducer radio signal may be blocked by physical obstacles (pallets, goods, steel walls, etc) or by radio interferences. Before mounting it's recommended to determine in advance the transducer location and its external antenna inside of cargo compartment to search location with the high quality radio signal (RSSI level).
Battery charge depends on response time (more response time, more discharge).
Actual response time is no more 1 time per minute, recommended is 1 time per 5 or 10 minutes.
A need to pay every month subscription fee to access to Cold Chain Cloud cloud software and to have cellular Internet.
Validation of computerized systems regulated by Application 11 GxP EU Manual for pharmaceutical industry. The concept of a computerized system includes: computer hardware, software, peripheral devices, networking system, documentation, and staff, which interact with hardware and software. Besides of documented proof of the system compliance by certain requirements, validation covers whole life cycle of a computerized system - starting with design and ending with decommissioning.
Validation Documents include:
User Requirements Specification (URS)
Project
Functional Specification (FS)
Technical Specification (TS)
Configuration Specification (CS)
SOP manuals for Maintenance and Operating
Availability of the actual project, URS & FS are components for successful pass of the first stage of validation - project qualification (DQ). On a stage of montage qualification (IQ) it’s required to check equipment package, proper installation, package and actuality obtained documents, correspond of using device base in TS, correspond view and correctness device name. On a stage of functioning qualification (ОQ) it’s required to check trained staff, SOP documents, correctness system function fulfill and related equipment. In this case, all conditions of the test must be approached to conditions of real system operation. On a stage of working qualification (РQ) it’s required to check correctness system operation by determined requirements.
Computerized systems of TERA company fully correspond by validated requirements. TERA company also provides with validation services for its customers, which fulfilled by TERA’s staff cooperating with leading expert in validation.
Automatic temperature and humidity monitoring system ATHMS supplied with full of set of required technical documentation. TERA company also provides all of its equipment with required set of metrological documentation (verification and calibration certificates), both by system installation and by its operating furthermore, when interverificating period ends up.
What's included:
User manual on software
Administrator manual on software
Manual on operation for G2-CP Data Logger
Manual on transducers operation
Technical certificate on transducers, data logger and electrical panel
Schematics and list of electrical panel components
Verification or calibration certificates
Cabling and transducer arrangement diagrams
PJSC TERA also provides with serves for creating full set of documents of project stage named Working Documentation.
TERA company has in its disposal own engineering staff, that fulfills montage and launching tasks for customer’s properties. Its staff has obtained corresponding engineering qualification, trained safety rules by fulfill launching procedure and required access occupational safety and health.
Monitoring system deployment divided on several stages: cabling, montage and equipment connection, installation and setting software, staff tutorial, validation. On customer’s properties may be up to 5 staff depending on deployment stage, from montage to validation.
After system commissioning, it’s technically serviced by guarantee and post-guarantee, concluding corresponding agreement. TERA company has its technical support service, that’s using the monitoring system. It has possibility to connect to customer’s monitoring system via Internet, and to solve the issue rapidly.