RF ValProbe—Wireless Validation System

With the advent of new technologies in the wireless domain from the beginning of this decade, there are several instrumentation and measurement applications which can beneficially exploit this technology. While there are still some challenges with respect to the application of wireless communication for large scale control and automation in a complex process control environment, there are many applications within the industry where it is very much worthwhile to introduce this new technology.

Wireless: Why now in a good manufacturing practices (GMP) environment? Industrial wireless technology is not new, it has been in use in the industry for multiple decades. Legacy wireless systems were used in niche applications but not in broad applications and hence have not been adopted more widely. However, the recent developments of low-cost, low-power radios and self-organising, self healing wireless Smart-Mesh networking software have ignited interest in industrial wireless standardisation.

In a GMP environment, anything which cannot be validated cannot be used. The new technologies have led to reliability, security and ease of usage.

Smart-Mesh network—Key features

Smart Mesh Formation: Each sensor node can act as a router and optimise data routing

Reliability: RF Mesh can provide up to 99.9 per cent transmission reliability. Redundancy introduced through data-storage eliminates risks of repeat runs.

Security: Immune to RF interference, snooping, insertion of invalid data.

Usability: No RF site surveys required. System works out of the box and can be fully validated.

Smart Mesh Network: The technology

Redundant routing is a must have in a real world RF application. A full mesh topology with automatic node joining and healing lets the network maintain long-term reliability. It works without special-purpose routers. Its implementation in the Kaye product line allows up to 100 sensor nodes to be connected in a seamless, reliable and self forming mesh network.

The mesh technology permits nodes to communicate with the base station and each other, correcting for weak RF links and automatically adjusting to dynamic RF environment, e.g. a forklift truck driving into a warehouse blocking a signal. No special knowledge or expertise is required to install or operate the Kaye RF ValProbe.

Frequency hopping

Automatic joining and formation: The Mesh net-work is self forming and self-optimising. Each of the nodes discover neighbors, measure RF signal strength, optimise signal paths, dynamically optimise signal routing and route signal traffic from neighbours. A node may also join as an end node, become a routing node due to changing RF conditions and later revert back to an end node.

The SmartMesh technology combines frequency hopping with Time Division Multiple Access (TDMA). Interference from WiFi and other existing industrial RF networks is removed due to the fre-quency hopping features.

Smart Mesh Network keys to reliability:

• Maintains full path diversity (mesh)
• Frequency hopping to avoid interferences
• TDMA protocol for data reliability and performance
• Full encrypted data with pre-shared keys on RF level

Validation and mapping

The Kaye RF ValProbe system is a wireless thermal validation system that collects temperature and humidity data. The Kaye RF ValProbe system is designed for accurate, convenient, and reliable process validation of environmental chambers and storage areas. These applications include stability chambers, freezers, refrigerators and warehouses. A 2.4-GHz RF mesh network and multiple-redundant data storage support communications and storage of critical validation data, while safeguards guarantee data integrity, storage and compliance with regulatory requirements. The system consists of Kaye RF ValProbe Loggers, a Kaye RF ValProbe Base Station, and Windows-based software for programming and reading the loggers, calibrating loggers, verifying their calibration, and generating reports.

Data from multiple wireless loggers is combined in a single file from which reports are generated. These reports are designed for implementation of 21 CFR Part 11 requirements for electronic records. Users can customise the reports by defining process cycles and specify-ing cycle-based calculations.

Case study: Validating ‘Steam-In-Place’

While the RF ValProbe technology can be deployed in various applications in a GMP setup, it has been used for validating Sterilization-In-Place processes. (SIP).

Safety is of utmost concern in the pharma industry and products are manufactured under strict aseptic conditions. Aseptic guide-lines recommend that while sterilising equipment such as large tanks and immobile piping by the passage of pressurised steam, validation should consider temperature and pressure at various locations in order to identify potential ‘cold spots’.

SIP is widely used for in-line sterilisation of processing equipment in manufacturing of pharma products, dairy products, beverages and in biotechnology. Proper SIP integration with pharma equipment is important for the overall success of the operation.

In the past, wired data-loggers have been used to connect temperature and pressure sensors to the process to validate. However at times, the process lines spread over a large area and are difficult to access due to Clean Room classification. In such cases it becomes difficult to route wired sensors for long connections to data-logger, and for communicating data to wired loggers kept outside the clean aseptic areas.

Monitoring-LabWatch Pro

The Kaye LabWatch system is built as an Enterprise Architecture Model encompassing intelligence and redundancy at multiple levels in the system. Each of the elements in the architecture are robust, complete and independent sub systems. At the primary input of the system lie the extremely accurate calibrated sensor modules (temperature/humidity/CO2/pressure/etc.). These sensor elements feed into the RF Valprobe data loggers or the Netpac modules. The battery operated RF loggers store and forward the real time data from the sensor elements at programmed interval to the RF Base Stations. Up to 30000 samples can be stored on these loggers and can be re-trieved in case of a power failure on the base stations or RF transmission issues. The RF Base stations communicate to the LabWatch server via the industry standard OPC server.

With sophisticated monitoring and reporting features, Kaye LabWatch proves to be an effective turnkey solution for your laboratory, warehouse and stability monitoring needs. The system provides a cost effective way to view and collect real time data for regulatory compliant monitoring of your valuable inventory.

Critical environmental information is provided to assure that your equipment is operating within defined parameters, thereby protecting your assets and providing a ready trail of compliance.

Integrating high quality sensors, latest wire-less and wired technologies for communication and networking abilities into an easy-to-use Information Management Solution, LabWatch combines precision monitoring with effective alarming, hassle-free reporting, and secure data archiving.