Pfizer Research/Vivarium Facility Building Management System Commissioning & Qualification
We approach our work from a Whole Facility Design Perspective, resulting in elegant, efficient engineering solutions that are practical and reliable, maximizing your long term benefit from your facility.
Challenge
Pfizer needed to bring their existing 400,000 ft2 research lab and vivarium into compliance with current Good Laboratory Practice (cGLP). This effort included the necessity to validate the critical facility systems. Pfizer determined that the facility’s 5,000 I/O point building management system (BMS) was a critical system and retained the services of Hallam-ICS to lead the system commissioning and qualification, working within the constraints of an operating vivarium.
Solution
Following the standards for Good Automated Manufacturing Practice (GAMP 4) established by the International Society of Pharmaceutical Engineers (ISPE), Hallam-ICS proposed a risk-based solution to the commissioning qualification effort. This included leading an interactive Risk Assessment Process to identify the critical system components and development of the Validation Plan.
As part of the solution, Hallam-ICS worked with the System Engineers and Operators to consolidate the original system design documents into asbuilt User Requirement Specifications (URS),
Functional Specifications (FS) and Detailed Design Specifications (DDS). Hallam-ICS prepared and executed commissionin documents, in concert with Pfizer’s QA Group, based on the requirements of these design specifications. The commissioning documents were leveraged to support sebsequent validation (IOQ) work. Hallam-ICS also wrote system Standard Operating Procedures (SOP) that were verified during the OQ. Following IOQ execution, Hallam-ICS wrote the final qualification reports.
At the conclusion of the project, Pfizer achieved cGLP compliance with their Building Management System, benefiting from a comprehensive set of engineering documents, standard procedures, trained staff and a qualified system.
Results
Our team accomplished the following:
-
Achieved cGLP Compliance: Hallam-ICS successfully brought Pfizer’s 400,000 ft² research lab and vivarium into compliance with current Good Laboratory Practice (cGLP) by commissioning and qualifying a 5,000 I/O point Building Management System, ensuring regulatory adherence in an operational vivarium.
Risk-Based Commissioning: Using GAMP 4 standards, Hallam-ICS implemented a risk-based approach with an interactive Risk Assessment Process and Validation Plan, streamlining the qualification of critical BMS components while maintaining operational continuity.
Comprehensive Documentation and Training: Hallam-ICS delivered consolidated design documents (URS, FS, DDS), executed commissioning and IOQ protocols, wrote SOPs, and provided final qualification reports, equipping Pfizer with standardized procedures and trained staff for sustained system performance.