RMS - CUSTOMER CASE - GSK ENVIRONMENTAL MONITORING WITH ROTRONIC RMS

UK PROJECT

Background

BioCTL at GSK in Stevenage, Hertfordshire is one of the key testing centers for GSK R&D and vital for the launch, verification and testing of new and in-development products. They process a large number of test samples and have the capability to undertake many critical tests for wider parts of the GSK organization. All testing is strictly GxP compliant and under high levels of internal and external scrutiny.

Laboratories are therefore under close control which is verified by an independent environmental monitoring system (EMS). Products are also stored long term in several controlled environments including incubators, cold rooms, stability suites and cryogenic storage, all requiring specific monitoring by a fully validated and calibrated system. For many years, the head of validation had been seeking to upgrade the existing EMS. With other facilities on site and other EMS platforms in use he had great insight into the options available and clear expectations for the new system.

The Rotronic UK team worked closely on the project to understand GSK’s requirements, key concerns and needs as well as advising on alternative approaches and best practice based on their wider experience with large, validated EMS projects. This partnership and consultative process ensured that GSK was able to confidently choose the Rotronic Monitoring System (RMS) as their EMS of choice.

Implementation

The project required a range of temperature, humidity and CO2 level instrumentation as well as integrated links to the onsite Building Management System.  A mixture of wireless and LAN based devices was preferred based on criticality and practicality. All devices included local logging as standard together with RMS so that even in the event of communication or power failure no logging data would be lost. The GSK IT compliance department investigated the platform and wireless solutions in detail to ensure they met with the very latest and future IT security needs in line with GSK corporate policies. Using an ‘on premise’ solution ensured GSK could fully manage and monitor the system whilst still providing ease of connectivity through a secure web interface via the GSK intranet.

All instruments were calibrated pre-delivery with ongoing maintenance and calibration contracts in place. Validation work was undertaken in partnership utilizing the Rotronic comprehensive validation document package combined with standard GSK validation procedures. End user and system owner training as well as ongoing guidance and support were all crucial. Again, the partnership approach was key, with all stakeholders fully appreciating that ongoing end user training and clear guidance on best practice is vital for any successful EMS project.

BMS integration ensured that existing alarming processes for engineering teams could be used in combination with email and beacon alerts for end users. Automated reporting was a huge bonus for the laboratory staff ensuring they could access clear summary data with deviations automatically identified without any risk of human error.

Site time was kept to a minimum since there were no additional infrastructure or installation requirements. Devices were connected to existing LAN ports; no additional power supplies or wiring were required. Software configuration was performed offsite and reviewed by the team. Once approved, the database was restored to the client servers and the system went online ready for validation work to commence. The availability of automated validation scripts, enabled alarm and error events to be conveniently simulated, and alarm outputs checked.

Rotronic products installed

• Gateways
• RMS-LOG-868
• RMS-LOG-T30-868
• RMS-ADC-L-R
• CCA Set
• RMS-DO-L-R

Rotronic services provided

• Installation focused on server setup and interface with GSK corporate IT.
• Compliance department rightly investigated the RMS wireless devices in detail, full approval was given after the review
• Calibration of all devices pre-delivery to UKAS/ ISO 17025 standard with a contract for ongoing annual calibrations given to Rotronic UK.
• ‘Soft’ device installation onsite (connection of LAN cables and Velcro mounting)
• Complete system validation. Client used their validation master plan with Rotronic vendor calibration documents included.
• End user and system owner training
• Support and maintenance Service Level Agreement (SLA).

Conclusion

Following this specific and successful GSK project, additional sites and departments are reviewing RMS, including the flexibility to integrate third party devices, as well as options for cloud and ‘on premise’ software which are all proving highly beneficial in meeting the mixed needs of different GSK sites and departments. Due to the mix of high accuracy sensors, resilient data logging, compliant software, and close partnerships we hope to continue to grow the relationship with this key UK customer.

Switzerland Project

Background

GSK had installed Rotronic HygroFlex5/TF5 temperature/ humidity measurement transmitters and interchangeable probes selected for each application in various buildings, via using a contracted building management company; in total about 200 transmitters/probes. They were installed about nine years ago. However, the software provided by the system integrator company was rather complicated to use and GSK was dissatisfied with it. Rotronic heard from a metrologist involved that GSK was looking at alternative monitoring systems on the market and subsequently presented RMS.

Implementation

• RMS-LOG-868 with RMS-HCD-S sensors and PCD differential pressure probes
• RMS-LOG-T30-868 with PT100 sensors
• HF5-EX ATEX certified transmitters/probes integrated in the RMS
• Services such as calibration and commissioning of the system, validation/qualification.

Conclusion

It was a very large project with many stakeholders on both sides and took about two years from the presentation of the system to completion with the implementation of RMS by GSK. The decisive factors were the quality of the Rotronic system and its accuracy, as well as the positive experience that GSK’s project managers previously had with Rotronic products at other companies they had worked for that that specified RMS.

Singapore Project

Background

GSK Singapore is using RMS to monitor their environment plant-wide, from production areas to warehouse/stores and even offices and server rooms. They refer to this system as their Online-TherrmoHygrograph System (OTH). All of the areas are monitoring temperature and humidity; they have a mixture of Hazardous and Non-Hazardous areas. Previously, they were using HW4 software with HL-NT loggers and they had to upgrade to RMS since HW4 and the loggers were being phased out.

Implementation

• RMS-WEB-E mounted on GSK servers
• RMS-LOG-L-D w/ HCD-S for non-hazardous areas
• HF5-EX w/ RMS-ADC-L-R for hazardous areas
• RMS-DO-L-R connected to AD-0001 for alerts in the control room

Conclusion

GSK is happy with how RMS was able to successfully replace their old system with the same specifications and how Rotronic is able to smoothly transition between the old and new system. Bug fixing and workarounds are not unusual for such projects, but these were managed rigorously with support from the Rotronic factory in Switzerland and from the team at GSK.  

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