The fit out of a Drug Substance Facility, including associated manufacturing, cleaning, administration/office, warehouse, laboratory and hydronic/hygienic utility areas. The facility manages the process from raw materials to final product testing and shipping.
Challenge
At Moderna, the client set the challenge of saving 17 weeks on the overall construction, commissioning, qualification and validation (CQV) programmes. By establishing an on-site equipment testing facility, the team were able to provide a 10-week saving against the critical path.
The facility allowed the CQV team to start pre-commissioning, Site Acceptance Testing (SAT), calibrations, temperature mapping and other qualification activities for key mobile process equipment prior to full fitout of their final location.
The facility needed to have cleanroom environments, the process needed to provide performance and repeatability and the process-related equipment needed to be compliant with URS (United Registrar of Systems).
Innovation
Whilst Out-of-Place (OOO) testing is performed on a small scale the innovation includes
• Qualified Delta V hardware automation, connected via Starlink
• Using Facilities Qualified Process system in an OOO location, then migrating it back to its permanent servers without loss of qualification
• Multiple bays to allow simultaneous testing, including connections for IT, automation, chilled water, compressed air
• Direct connection to permanent building to transport equipment
• Clean, temperature-controlled environment
• No impact on construction or logistics, but clean, quiet environment to execute CQV
Solution benefits
• Direct programme saving (10 weeks)
• Early quality inspection of equipment, decoupling fault risk from critical path
• Avoided interruption of cleanroom handover activities
• Early troubleshooting of documentation, vendor pre-commissioning and SATs
• Early access to equipment for familiarisation training