Computer System Validation for a pharmaceutical client

Computer System Validation for a pharmaceutical client

Computer system Validation for a pharmaceutical client in Bothell, Seattle. 

PSC Biotech® provided computer system validation service for a client at their facility. 

  • Area: Bothell, Washington
  • Project Type: Computer System Validation


About this Project

OBJECTIVE

Installation and qualification documents for the new UDI Carton Printer and Verification Systems. 

SERVICES

There were different stages in the installation and qualification of documents related to the UDI Carton Printer and Verification systems. We wrote all the User Requirement Specifications (URS’s), FDS’s, IOQ’s and TM’s for the system. In addition, we also created all the Equipment Identification Forms (EID) and Standard Operating Procedures (SOPs). Next, we developed and installed recipes and performed troubleshooting with their automation engineers during the execution phases of the project. Lastly, we trained production personnel on the operation of the UDI Carton Printer & verification Systems. 

PROJECT SUCCESS

The client was very satisfied with the outcome and praised PSC Biotech for its professionalism, expertise and customer-centric approach. The project was completed on time and within budget, and we are very happy with the outcome. 

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Commissioning of a new MSAT lab

Commissioning of a new MSAT lab

Commissioning of the new manufacturing science and technology (MSAT) lab.

PSC Biotech® provided commissioning service for a client at their facility. 

  • Area: Houston, Texas
  • Project Type: Commissioning, Qualification, and Validation


About this Project

OBJECTIVE

To execute commissioning activities in parallel to the completion of construction of the Biosafety Laboratory II. 

SERVICES

PSC Biotech experts were assigned to commission the architectural finish and mechanical completion of the Manufacturing Science and Technology (MSAT) Laboratory. The commissioning took place parallel with the final construction process. This helped our CQV experts to directly start and complete the project. Our experts modified the existing HVAC system. and existing utilities added liquid nitrogen and carbon dioxide piping. This included the subsequential, additional points added to the building and equipment management system. The lab was successfully released for use post-completion, and open construction items were documented  

PROJECT SUCCESS

The client was very satisfied with the outcome and praised PSC Biotech‘s professionalism, expertise, and customer-centric approach. 

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Commissioning of the new apheresis inspection and processing spaces

Commissioning of the new apheresis inspection and processing spaces

Commissioning of the new apheresis inspection and processing spaces.

PSC Biotech® provided commissioning service for a client at their facility. 

  • Area: New Jersey, New York
  • Project Type: Commissioning, Qualification, and Validation


About this Project

OBJECTIVE

To execute the commissioning of the architectural boundary of the specified HVAC serving room.  

SERVICES

The commissioning team successfully completed the modifications to the air handling system according to the client’s specifications and design. They checked the changes to the supply and return ductwork, as well as the new and existing variable air volume boxes. They also verified the new points added to the Building Management System (BMS) and Equipment Management System (EMS). The commissioning was done at the same time as the final construction, which helped the team to address any issues and documentation quickly. 

PROJECT SUCCESS

The project was successfully completed within 2 weeks of protocol execution. The client was satisfied with the outcome of the project. 

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Equipment Installation and Operational Qualification Project

Equipment Installation and Operational Qualification Project

Equipment Installation and Operational Qualification for a Medical Device Client

PSC Biotech® provided equipment installation and operational qualification support for a medical device client.  

  • Area: Washington, D.C
  • Project Type: Installation and Operational Qualification 


About this Project

OBJECTIVE

The objective of this project was to provide installation and operational qualification support for a benchtop autoclave.  

SERVICES

PSC Biotech experts supported the client by verifying the installation of all equipment, controls, and programming necessary to provide consistent sterilization of glass and wrapped items. Our experts ensured the system complied with relevant current good manufacturing practices (cGMP). We also ensured that all documents are available to enable the equipment and associated programmable logic controller to be operated and maintained safely, effectively, and consistently. We calibrated all the equipment prior to operational qualification and verified the operational aspects of the system deemed critical to its satisfactory performance.  

PROJECT SUCCESS

The client is satisfied with the installation and verification and has praised PSC Biotechs professionalism and expertise. We are in the final stages of the project and awaiting pressure loggers to finish the qualification. 

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Engineering Support for a Bio-Pharmaceutical Client

Engineering Support for a Bio-Pharmaceutical Client

Engineering Support for a Bio-Pharmaceutical Client

PSC Biotech® provided engineering support for a Bio-Pharmaceutical client in San Francisco, California.  

  • Area: San Francisco, California
  • Project Type: Engineering

About this Project

OBJECTIVE

This project aimed to provide engineering support for a new filing line. 

SERVICES

PSC Biotech team supported the client by initially reviewing and providing advice on the design documents, i.e., functional specifications (FS), hardware design specifications (HDS), automation concepts, software design specifications (SDS), and computer specifications (CS).  Our experts mapped the critical quality attributes (CQA) against the process parameters identified by the critical process parameters (CPPs), and generated system impact assessment (SIA) and critical component assessment (CCA). We also participated in design review meetings with the equipment suppliers and provided our expert advice on the design elements. Our team drafted the quality events such as change control for new and legacy equipment removal and installation, demolition, and remodeling of good manufacturing practices (GMP) and non-GMP rooms. 

PROJECT SUCCESS

The project was completed, and the client was satisfied with the goals achieved.  

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