Freestead Process Technology

Performance Testing and Re-qualification

As a Pharmaceutical or Biotech company operating in accordance with good manufacturing practices (GMP), you appreciate the importance (and the regulatory requirements) of periodic performance testing and equipment re-qualification.

Re-validation - vital for continued compliance
 

As the mechanism whereby vital Process Equipment is assessed to demonstrate its continuing fitness for purpose and compliance with system standards, re-validation is an essential part of your servicing programme. For your dedicated Freestead service engineering team, the requirements of re-validation come as second nature - carefully planned and executed in conjunction with thorough preventative maintenance and detailed understanding of your equipment and related upstream and downstream processes.
 

Perfectly positioned to support your operational integrity

At Freestead, with nearly 40 years of understanding, installing and servicing Pharma Process Equipment as diverse as Autoclaves, Lyophilisers, Pure Steam and WFI Systems, we are perfectly positioned to understand how performance testing and re-qualification influence the operational integrity and ultimate profitability of your production facility.

Testing and re-qualification - supporting consistent demonstration of compliance

As we work in a professional partnership together, you’ll quickly appreciate how Freestead experience, knowledge and attention to detail can help you meet the requirements of your validation department and regulatory authorities. We understand the testing and re-qualification that enables you to consistently demonstrate compliance with the relevant standards.

After years in the Pharmaceutical and Biotech industries, we understand what is at stake and the importance of re-validation to ensure that system changes are captured and that the system is inspection-ready when your validation department or the regulatory authorities come calling.

We will prepare a validation master plan together with the relevant operating and re-validation procedures for approval prior to carrying out performance testing and re-qualification. Which can include the following:

  • Operational Set Points
  • Operational Values, (conductivity, flow rates, pressures, temperatures, velocity)
  • Alarm Testing
  • Cycle Performance Testing
  • Steam Quality Testing
  • Temperature Mapping
  • Calibration
  • Control Functions Verifications
  • Leak Detection
  • Integrity Testing
  • Water Quality Testing
  • Pressure Vessel Testing

Performance testing and re-qualification - we’ve got it covered so you enjoy a quiet life.

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GMP Servicing and Technical Support for the Pharmaceutical and Biotechnology industries

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© Freestead Process Technology Limited 2015. All rights reserved.   Unit 1, Havyatt Business Park, Havyatt Road, Wrington, North Somerset, BS40 5PY

Telephone +44 (0) 1934 862 561   Facsimile +44 (0) 1934 863 554   E-mail service@freestead.co.uk   www.freestead.co.uk