Engineering and CQV Services for Pharmaceutical Client

Engineering and CQV Services for Pharmaceutical Client

Engineering and CQV Services for Pharmaceutical Client

PSC Biotech® provided Engineering, Commissioning, Qualification and Validation services for the client reactor at pilot facility.

  • Area: Texas
  • Project Type: Engineering, Commissioning, Qualification, Validation

About this Project

OBJECTIVE

The goal of this project was to provide Engineering, Commissioning, Qualification and Validation Services for upgrading and qualification for 50 L Reactor at the clients Pilot Manufacturing site.

SERVICES

PSC Biotech supported with the qualification, commissioning, validation, and other Engineering for 50L Reactor. As part of this project, PSC supported the Validation Protocol development, developing Qualification Plan, developing initial qualification documentation, execution, and final reports for different equipment and processes. PSC also supported in developing or updating of relevant SOPs for this project. Apart from Quality Assurance and technical writing support, PSC helped in the smooth planning and execution of the project through its project management expertise.

Project Success

The client was very happy with the smooth execution of all the deliverables as well as PSC’s support with documentation as well as project management aspects within the specified timeframe.

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20 Years & Counting of CQV Services

Commissioning, Qualification, Validation and Engineering services for the clients  facility since its inception.

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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Equipment Validation Support for Container Closure Integrity Testers

Equipment Validation Support for Container Closure Integrity Testers

Equipment Validation Support for Container Closure Integrity Testers

PSC Biotech® provided equipment validation support and Engineering support for the Container Closure Integrity Tester.

  • Area: Texas
  • Project Type: Equipment Validation and Engineering

About this Project

OBJECTIVE

The goal of this project was to provide equipment validation support and Engineering support for one line of the container closure integrity testers for the client.

 

SERVICES

PSC provided support by performing validation on the Container Closure Integrity tester, the tester was checked for leaks on stoppered vials.

PSC supported with protocol development, execution and developing final reports and all relevant documentation for the Validation of the tester.

Additionally, PSC supported in planning and execution of the project through its project management expertise.

Project Success

This project has been completed meeting the client’s timeline. In Process Leak Testers (CCIT) are in production. 

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

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Stability Chamber Qualification

Stability Chamber Qualification

Stability Chamber Validation and Qualification

PSC Biotech® provided Engineering, Commissioning, Qualification, and Validation Services for upgrading and qualification of stability chambers for the client.

  • Area: Texas
  • Project Type: Equipment Validation

About this Project

OBJECTIVE

This project aimed to provide Engineering, Commissioning, Qualification and Validation Services for upgrading and qualification for two stability chambers for the client.

SERVICES

PSC Biotech supported with the qualification, commissioning, validation and other Engineering for two stability chambers. PSC also supported in developing and maintaining all the documents related to this project. Apart from Quality assurance and technical writing support, PSC helped in smooth planning and execution of the project through its project management expertise.

Project Success

This project was completed successfully. PSC Biotech met client and regulatory requirements, delivered results
on schedule and within budget.

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20 Years & Counting of CQV Services

Commissioning, Qualification, Validation and Engineering services for the clients  facility since its inception.

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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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Engineering, Commissioning, Qualification and Validation Services for the Life Science Industry

Engineering, Commissioning, Qualification and Validation Services for the Life Science Industry

Engineering, Commissioning, Qualification and Validation Services

PSC Biotech® provided Engineering, Commissioning, Qualification and Validation Services for upgrading and qualification for Bag Fillers for client.

  • Area: Texas
  • Project Type: Engineering, Commissioning, Qualification, Validation

About this Project

OBJECTIVE

The goal of this project was to provide Engineering, Commissioning, Qualification and Validation Services for equipment on the client manufacturing site.

SERVICES

PSC Biotech supported the qualification, commissioning, validation, and other Engineering for Bag Filler Equipment as well as performing Installation and Operational Qualification as well as completing the Traceability Matrix for the equipment. PSC also supported in developing and maintaining all the documents related to this project. Apart from Quality assurance and technical writing support, PSC helped in the smooth planning and execution of the project through its project management expertise.

 

Project Success

This project has been completed successfully as per client specifications.

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Commissioning, Qualification, Validation and Engineering services for the clients  facility since its inception.

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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 | 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 support our client’s B1 Exit Program Documentation. Our engineers successfully assessed and modified over 3200 Non-GMP documents, on time and on budget, contributing to the successful completion of our clients project.

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Greater Los Angeles Varied Services

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

Greater Los Angeles Cleaning Validation

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

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