Wireless Thermal Validation System

The wireless validation data logger  has undergone more than 18 years of experience and refinement, and has already shown a very high level of maturity. Its performance indicators are at the international leading level, and it is very reliable under harsh conditions for temperature verification. The product has been widely recognized by industry customers.

FEATURES

• Only Replace the Battery Twice in 12 Years: Relying on world-leading battery technology and low power performance technology, data recorder only needs the battery to be replaced twice during its 12-year product life cycle. This eliminates customers' concerns about battery life, significantly improves work efficiency, and greatly reduces operating costs.

• High accuracy Integrated Full Laser Weld Sealing: Exclusively using integrated full laser weld sealing technology, the data recorder completely avoids the possibility of water ingress in harsh conditions, greatly enhancing the product's durability and reliability, and almost eliminating the obvious risk of water damage within the industry.

• Long term resistance to extreme temperature and pressure shocks: With the support of multiple advanced core technologies, data recorder achieves the industry's smallest size while still possessing stronger durability, better shock resistance, and the ability to withstand extreme voltage and pressure shocks, ensuring long-term stability and durability, thus eliminating all potential risks during use for customers.

APPLICATION

• Steam Sterilizer, Water-Cascade Sterilizer, Rubber Stopper Washing Machine, Freeze Dryer

• Constant Temperature and Humidity Chamber, Ultra-low Freezers

• Dry Heat Sterilizer , Tunnel Oven, Cold Room

• Workshop, Food equipment and products
  
  

SYSTEM STRUCTURE

SPECIFICATION

Small Size Wireless Temperature logger

Remark:

Enforced probe, bendable probe, flexible probe, very small probe are available.    

Small Size Wireless Temperature & Humidity Logger

Small size Wireless Temperature & Pressure Data Logger

Wireless CO2 Data Logger

Quantus Wireless Temperature logger

The data logger designed specifically for lyophilized vials is currently the world's smallest temperature datalogger specialized for the pharmaceutical industry

Real Time Wireless Temperature Data Logger

Remark:

Enforced probe, bendable probe, flexible probe, very small probe are available.  

Real Time Wireless Humidity & Temperature Data Logger

Real Time Wireless Temperature & Pressure Data Logger

Real Time Wireless CO2 Data Logger

Reader Station

Reader Station is used to communicate with the logger from the PC and toperform operations such as previewing, downlinking work tasks and uploading logged data to the logger.

Thermal Barrier

Provides temperature protection for the main body of the wireless logger when the operating environment of the wireless logger exceeds 150° C during thermal validation of dry heat (tunnel/oven), etc.

Freeze Dryer Heat Transfer Block

Provides fixation and thermal conductivity for the wireless logger probe during freeze dryer thermal validation.

Silicone Cover

Reader Station is used to communicate with the logger from the PC and toperform operations such as previewing, downlinking work tasks and uploadinglogged data to the logger. Provides vibration protection for wireless loggerswhen performing thermal validation on rubber stopper washing machine, etc.

Carrying Case

Wireless logger, reader station, andaccessories can be placed in the carrying case for easy portability.

Software

Power 3000 Thermal Validation System Software

Designed based on the needs of the pharmaceutical industry, in line with industry standards and regulatoryrequirements, with simple and easy-to-use software interface. Meets all requirements of national regulatory regulations such as FDA 21 CFR Part 11 and EU GMP. It features login and three-level permission management, audit trails, and electronic signature functions to ensure compliance in validation work. The system’s functional modules are clearly divided and easy to operate, with comprehensive and visually rich reports, allowing users to complete validation easily and professionally.

Complete and Secure Data

• Data integrity and security are our top priorities.

• The software uses advanced security standards, including encryption technology and access control, toprotect sensitive information. All recorded data is stored in a secure, encrypted, and tamper-proofelectronic record format.

• It provides secure automatic and manual backup functions, as well as optional backup and restore settings.Users can back up and restore the entire system data according to their needs, or back up and restoreimportant data or reports individually.

Compliance with FDA 21 CFR Part 11

• User Management: Three-level user permission management. The system allows different roles to beassigned to each user, with different functions and workflows allocated according to their roles.

• Electronic Signatures: Each user ID is assigned a unique electronic signature to ensure a one-to-onecorrespondence between the signature and the user. During critical operations such as creation and review,the system automatically generates electronic signatures, timestamps, and other identifiers for easyrecognition, tracking, and retrieval.

• Audit Trails: Foundation for system security and process traceability. The software records key loginformation during user operations. Audit trails can be queried in detail based on operation time, type, andother criteria. Each operation log includes detailed information on the type of operation, content, andtimestamp.

Calibration

• Single-point or multi-point calibration.

• Various calibration modes are available, enabling manual, semi-automatic, or fully automatic calibration.

• In fully automatic calibration mode, automatic communication with standard probes, dry wells, liquid baths,etc., is possible to complete calibration automatically.

• Supports multi-stage compensation and calibration for wireless recorders.

• Features post-calibration verification.

Verification

• Supports the verification of multiple types, such as temperature, humidity, pressure, and carbon dioxide,with verification channels that can be expanded indefinitely.

• Supports three verification methods: wired, wireless, and hybrid (wired and wireless).

• Supports various verification start and stop methods.

• Can perform real-time verification of multiple devices without limiting the number of verifications.

• Wired verification allows real-time observation of verification data trends, lethality calculations,temperature statistics, etc.

• During wireless verification, the software can run in the background while being closed.

Reports

• Supports the verification of multiple types, such as temperature, humidity, pressure, and carbon dioxide,with verification channels that can be expanded indefinitely.

• Generates original, unalterable calibration and verification data.

• Calibration data can be split into multiple reports as needed.

• Verification data can be divided into multiple cycles and stages.

• Report display content can be flexibly filtered to show important information.

• Different parameters can be set to specifically calculate F0, FH, A0 values, etc.

• Can calculate cold spots, hot spots, uniformity, and fluctuation during phases.

• Verification report calculations are comprehensive and meet various calculation needs.

• Data can be backed up and restored individually.

• Can export files in different formats such as PDF and Excel.

• Detailed report filtering functionality