Greenfield Facility Buildout  |  CQV & Engineering Projects

PSC® provided Commissioning, Qualification, Validation (CQV) and Engineering Services for the Clients Sterile Fill/Finish Manufacturing Facility Since its Inception.
  • Area: Greater Los Angeles
  • Project Type: CQV, Engineering,  Manufacturing, Technical Writing, and Quality Assurance

About this Project

OBJECTIVE

CQV, Engineering,  Manufacturing, Technical Writing, and Quality Assurance on Facility

SERVICES

PSC® served as the key consultants for the entire facility and covered engineering and validation in various functional areas. After the facility reached the operational phase, PSC® continues to provide Engineering Managed Services to Facility Engineering, PMO and automation groups. Additionally, PSC® continues to provide consulting services in Validation, Quality Assurance and Manufacturing.

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

The clients commissioning project was a guaranteed maximum lump sump project. PSC® was able to accurately manage the scope of work and performance to meet the companies satisfaction. PSC’s team played a major role in the FDA approval of the clients site in late November 2019. The success of PSC® at the site led to ongoing consulting services expanding into other functional areas with the company, and has kept many of the team members who began their services this client since the inception of the facility. We are still currently supporting them through their validation engineering.

 

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20 Years & Counting of CQV Services

Commissioning, Qualification, and Validation (CQV) services for one of the clients plants since the mid 1990’s to the present.

Cleaning Validation & Decommissioning Project

PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

Sterile Fill/Finish Laboratory Facilities CQV Project

The operations performed included: Filling, Parts Preparation, Formulation, Filling, Process Support Systems and Cleaning.

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