Validation & Qualification | AQUATHERM SWS sterilizer (Syntegon)

Validation & Qualification | AQUATHERM SWS sterilizer (Syntegon)

CQV | Qualification of AQUATHERM SWS sterilizer

On-site and off-site Pre-calibration and Post-calibration Verification of the Thermocouples or Wireless Data Loggers.

  • Area: Greater Kansas City Area
  • Key Account Manager: Monica Short
  • Project Type: CQV

About this Project

OBJECTIVE

CQV – Qualification of AQUATHERM SWS sterilizer (Syntegon)

SERVICES

The client engaged PSC™ to initiate the validation and qualification of a AQUATHERM SWS sterilizer (Syntegon) with a chamber of approximately 2500 ft3. Laboratory and Pharmaceutical Manufacturing equipment validations play a vital role to ensure the quality and effectiveness of the equipment being used for the development of manufactured products.

Our team of engineers efficiently completed the tasks of performing qualifications for the AQUATHERM SWS sterilizer (Syntegon). These tasks included writing and executing a Cycle Development Plan, an Installation and Operation Qualification (IOQ), and a Performance Qualification (PQ). PSC™ consultants performed these studies to cGMP standards. Our team worked closely with client engineers and equipment vendors to ensure that the equipment functioned properly. Equipment validations should be completed by professionals of life science services that offer a diverse team of highly qualified and experienced consultants.

PSC™ can provide on-site and off-site Pre-calibration and Post-calibration Verification of the Thermocouples or Wireless Data Loggers.

validation & qualification

Monica Short

Business Development Manager

sales@biotech.com

validation & qualification

EQUIPMENT USED

  • iRTD-400 Probe
  • HTR-400 Bath
  • Ellab Probes (Wireless Data Loggers)

PROJECT SUCCESS

PSC™ engineers efficiently completed the task of performing qualifications for the AQUATHERM SWS sterilizer (Syntegon). PSC™ continues to remain engaged with the client for continued support, as well as any future equipment qualifications to establish GMP regulations throughout the entire manufacturing facility.

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QA CSV | System Implementation & Upgrading

QA CSV | System Implementation & Upgrading

QA CSV | System Implementation & Upgrading

Implementation & Upgrades
  • Area: Greater St. Louis Area
  • Key Account Manager: Monica Short
  • Project Type: CSV

About this Project

OBJECTIVE

Watson 7.6.1 system implementation and upgrade, including new servers, disaster recovery, computer system validation, and business process remediation.

SERVICES

PSC Biotech® is helping our client, a global leader in testing and laboratory services located at St. Louis, with a Watson 7.6.1 system implementation and upgrade, including new servers, disaster recovery, computer system validation, and business process remediation. PSC™ had to support an aggressive project schedule and a global implementation team to ensured the project milestones were met with no loss to the overall project quality needed in an FDA-regulated environment. PSC™ accomplished this by using an IT-trained QA lead to manage the project from the QA and compliance perspective with one computer system validation resource to review post execution scripts and a Watson LIMS expert to advise and review the business process and standard operating procedures created by the client. This project required full PSC™ review and guidance on the technical details of the project and the entire computer system validation life cycle, including the validation plan, user requirements, testing protocols, and the release of the system with the approval of the final summary report.

Calibration Software

Monica Short

Business Development Manager

sales@biotech.com

Calibration Software

Project Success

This project is an ongoing project and underway to completion.

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Regulatory Affairs | Vaccine Registration

Regulatory Affairs | Vaccine Registration

Regulatory Affairs | Vaccine Registration 

Ongoing Project of Animal Product Registration

  • Area: Greater St. Louis Area
  • Key Account Manager: Monica Short
  • Project Type: Regulatory Affairs

About this Project

OBJECTIVE

Registration of Animal Product

SERVICES

This project is ongoing, PSC Biotech® is helping our client located in St. Louis with registration of their animal product (vaccine) in 3 countries, UK, Australia and New Zealand. This project involved many critical processes such as providing support in terms of building out a regulatory strategy for the registration of the product, developing formats for submission of critical quality, safety and efficacy data and authoring CTD Modules 1-5 for submission to the respective Regulatory agencies as also providing support in post marketing activities and responses to the Regulatory Agencies. The consultants working on this registration project ensured that all the critical information regarding quality, safety and efficacy of the product is covered in the required modules, as well as completing the project within timeline. The client has been very satisfied so far with their registration data being transformed into modular formats, required for submission.

registration

Monica Short

Business Development Manager

sales@biotech.com

registration

Project Success

This is an ongoing registration project and underway to completion. The client has been very satisified with the data gathered so far.

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Quality Assurance | New Product Development Projects

Quality Assurance | New Product Development Projects

Quality Assurance | Product Development

 

New Product Development Projects

  • Area: Greater Greater Richmond Area & Greater Salt Lake City Area
  • Key Account Manager: Thomas Kelland
  • Project Type: Quality Assurance

About this Project

OBJECTIVE

New Product Development of Medical Devices

SERVICES

PSC did multiple projects with this client for their new product development. This included:

  • Design Control work including:
    • Creation of design control templates to be executed by R&D team.
    • Design Control Matrix review and implementation.
    • Design Verification & Validation document review.
    • Creation & Implementation of Design Change Control Program.
    • Creation & Implementation of Design Risk Assessment Program.
    • Creation of incoming good specification sheets.
  • Creation & execution of equipment qualification protocols.
  • Creation of process validation protocols.
  • GxP auditing of manufacturing facilities to various regulations and standards.
  • Quality Assurance staff augmentation at various facilities.
  • Creation & implementation of process sampling program ensuring the manufacturing facilities are adhering to ANSI Z1.4.
  • Rental of calibrated equipment including particle counters and temperature data loggers.
  • Creation and execution of shipping validation protocols.
  • Documentation GAP assessment to determine what procedures and work instructions need to be created to ensure the manufacturing facility was compliant.
new product development

Thomas Kelland

Director of Southwest Operations

sales@biotech.com

“I am writing this letter to recommend the services of PSC Biotech. During the past year, our company has been working with PSC on various activities within the development and implementation of a new medical device product. PSC offers high quality services, and we can say that we have always been satisfied by their work.”

Read Full Letter of Recommendation Here

EQUIPMENT USED

  • Fridges
  • Freezers
  • Thermal Cycler
  • Heat Cabinet
  • Incubator
  • Cleanroom

PROJECT SUCCESS

The client has been very happy with PSC’s work on the project ensuring all Toll Gate Activities were achieved on time and that the product transfer to manufacturing was successful.

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Calibration Software | CSV | Risk Assessment, Qualification, and Validation  

Calibration Software | CSV | Risk Assessment, Qualification, and Validation  

Calibration Software Risk Assessment, Qualification, and Validation  

Testing of Critical Software Activities

  • Area: Greater Durham Area
  • Key Account Manager: Chandler Conley
  • Project Type: CSV

About this Project

OBJECTIVE

Calibration Software Risk Assessment, Qualification Protocols, and Validation Plan Development. 

SERVICES

PSC Biotech® performed a Risk Assessment of critical calibration software functionalities and developed a Validation Plan. Our consultant developed configuration specifications, performance qualification protocols, and test scripts for specification of testing of critical calibration software activities. They completed gap assessments or vendor installation qualification, operational qualification, user requirements, and traceability matrix documentation forms. PSC® generated risk-based testing of the calibration software system and generated a final validation report which included a summary of protocol tests.

Calibration Software

Chandler Conley

Business Development Manager

sales@biotech.com

Calibration Software

Project Success

The project was successfully finished on time and within budget. The company was very happy with the work completed.

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