About this Project

OBJECTIVE

Commissioning, Qualification, Validation (CQV)

SERVICES

PSC® has been an essential service provider to client throughout the development and implementation of a new cell and gene therapy manufacturing facility. PSC® joined the project during the planning phase and conducted critical design review to ensure facility met cGMP expectations upon completion. Our consultants worked closely with architects, engineers, contractors, and equipment vendors to develop system turnover packages to support subsequent commissioning and qualification efforts. PSC® then performed commissioning and qualification of all facility, utility, and process systems to meet GMP production timelines.

PSC® provided project management services to ensure key milestones were achieved for supplying clinical trial material. Scheduling and coordination work was critical to meeting GMP readiness steps, and PSC® further supported system and facility release for production at each stage. PSC® consultants qualified laboratory equipment, including complex instruments with significant CSV involvement. As the facility transitioned to routine operations, PSC® continued supporting requalification of temperature controlled chambers. PSC® also provided technical writers to generate SOPs and perform manufacturing investigations, and provided QC techs to perform environmental monitoring. PSC® remains engaged with the client for qualification of new equipment and continuous improvement projects.

EQUIPMENT USED

  • Kaye Validator
  • Additional SIM for Kaye 2000
  • iRTD-400 Probe
  • LTR-140 Bath
  • HTR-400 Bath
  • Data Loggers
  • Kaye Feed Thru Device
  • Pressure Transducer
  • CLiMET (laser particle counter)
  • Low Pressure Gas Flowmeter
  • CLiMET (Microbial Sampler)
  • Shortridge Air Data MultiMeter
  • Druck Pressure Testing
  • Gas Flowmeter
  • SVMS Steam Quality
  • Thermocouples
  • Scissor Lift
  • Specialized PPE
  • Specialized Tools

PROJECT SUCCESS

PSC® successfully supported the client’s project to develop a brownfield property into a cell and gene therapy manufacturing facility, performing cGMP operations for clinical trial material production within an aggressive timeline. PSC® partnered with the client and multi-discipline team members throughout the project life-cycle to achieve this success.

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