Engineering | Documentation Support for the B1 Exit Program

Engineering | Documentation Support for the B1 Exit Program

Engineering Support for the B1 Exit Program

PSC® Provided Engineering Consulting Services

  • Area: Greater Los Angeles Area
  • Project Type: Engineering

About this Project

OBJECTIVE

Client required engineering support for the B1 Exit Program Documentation Support Project. 

SERVICES

PSC® provided engineer consulting services for the B1 Exit Program Documentation Support Project. The work for this project entailed performing assessments and modifying 3200 Non-GMP documents and/or drawings, 153 documents that needed addressing before shut down, and 14 documents that needed addressing after shut down. 

EQUIPMENT USED

  • “FPC50W – Isolator (Watson Marlow-Ziel)
  • FlexPro 50 – Isolator (Groninger – Ziel)
  • Steris Autoclave (27 cu ft. production)
  • Santimatic COP washer
  • Seidnator (2)
  • Innova Deneste
  • USP water, Pure steam, Compressed air, Nitrogen, AHUs, Water for Injections. -Not tools used 

PROJECT SUCCESS

PSC® hired two Senior Engineers to execute the successful completion for this project over the course of 1,114 hours. 

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

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

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Engineering | Facilities, Utilities & Process Equipment

Engineering | Facilities, Utilities & Process Equipment

Engineering | Facilities, Utilities & Process Equipment

Providing Validation Support to Keep the Facility Operational.
  • Area: Greater Los Angles Area
  • Project Type: Engineering

About this Project

OBJECTIVE

Engineering Validation

SERVICES

PSC® has been providing engineering and validation services at the San Dimas facility since 2014. When the La Verne facility startup projects began, PSC® has been providing validation support to keep the facility operational. PSC® covers all aspects of facilities, utilities and process equipment qualification and validation across the entire facility.

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® has been providing engineering and validation services since 2014.

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Greenville Facility Buildout

Greenville Facility Buildout

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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