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.

GMP Servicing and Technical Support for the Pharmaceutical and Biotechnology industries

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Telephone +44(0)1275 463706 Facsimile +44 (0)1275 462509 E-mail service@freestead.co.uk www.freestead.co.uk

Technical Support & Service Contracts
Calibration
Performance Testing & Re-qualification
Steam Quality Testing
Upgrades and On-site Modifications
Temperature Mapping
Spare Parts Supply
Emergency Call-outs
On-Site Equipment Training

WFI Stills
WFI Storage & Distribution Systems
Pure Steam Generators
Pure Steam Distribution Systems
Sanitary Heat Exchangers & POU Systems
Lyophilisers / Freeze Dryers
Autoclaves / Steam Sterilisers
De-Pyrogenation / Dry Heat Sterilizers