Vectura: BMS Head End Upgrade
Client: Vectura Group plc
Building Type: Pharmaceutical
In order to comply with stringent 21 CFR Part 11 regulations set out by the American FDA, multinational pharmaceutical manufacturer, Vectura Group plc asked us to propose a new validated Head End Supervisor system that would meticulously record and archive the environmental conditions in their labs and production suites.
Vectura Group is a market-leading pharmaceutical manufacturer that develops and manufactures drugs and inhaled delivery devices for respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD).
Their labs and production suites must maintain strict environmental conditions, including temperature, humidity and pressure, which must also be recorded and archived to comply with the strict 21 CFR Part 11 regulations set out by the American FDA for pharmaceutical products sold in the USA.
Having carried out some service works at their main UK site in Chippenham (including replacing the main BMS controller that had failed, and re-commissioning the whole HVAC BMS), we were asked to propose a new validated Head End Supervisor system that would:
- Record and archive logged data on all controlled conditions and HVAC plant,
- Keep a detailed audit trail of any system changes, when they were carried out and by whom,
- Give them a security-protected graphical interface for end users to monitor and manage permitted elements of the system.
In order to satisfy the User Requirement Specification, and comply with all industry regulations, the client required a highly engineered, robust and fail-safe solution that would provide a technically complex Supervisor that was straightforward for end users to interact with.
Through preliminary meetings, research and development we created documentation that would gain approval of Tridium Niagara ‘N4’ as the software platform. The specific requirements were detailed and rigid so we had to provide evidence that we could satisfy these and meet the standards of 21 CFR Part 11.
Once approved, we created the Head End within the N4 Environment, and developed the considerable volume of supporting documentation. At each milestone in the development process we obtained client approval to keep things moving in the right direction.
Once the software was completed, we carried out on-site integration with the live BMS controller, extensive SAT testing and client witness testing (after generating and gaining approval of the relevant commissioning and testing documents, such as validation plans, system configuration specifications).
There were several challenges with this project as the Head End had to interface with an existing control system. We also needed to decommission an existing Honeywell EBI Head End with the minimum amount of downtime possible.
The new Head End resides on a virtual server as part of the Vectura IT infrastructure and needed to communicate with the HVAC control system and be accessible by network-connected end users. We worked with the Vectura IT team to work through the challenges and maintain system security as well as accessibility.
- The new Head End was successfully installed and integrated, and our extensive software and on-site testing prior to the changeover made sure there was minimal disruption or issues.
- We can now remotely access the system to assist with both scheduled and reactive servicing and maintenance and prevent unnecessary call outs.
- The database of users assigned to the system can now be managed by system administrators.
- As well as historical data being automatically backed up and archived, permitted users can quickly and easily view history graphs and tables.
Vectura now meet the requirements of 21 CFR Part 11, with potential for future expansion of the system to incorporate other buildings on their Chippenham site.