IQ/OQ for Peptide Synthesizers

PurePep® custom peptide, process and new modality services

Peptide synthesizers from Gyros Protein Technologies have been a trusted part of contract manufacturing, pharmaceutical, and biotechnology laboratory and production facilities for decades. With more peptides moving through the clinic to the market, many of these instruments are now being used in cGMP environments required to meet high regulatory standards.

Installation qualification and operation qualification (IQ/OQ) support services verify and document that your instrument is supplied, installed, and operating according to GPT specifications. GPT-certified field service engineers inspect critical components, ensure that your systems function properly and reproducibly during automated synthesis operations, and provide documentation to help you meet regulatory requirements.

Trust your peptide synthesizer qualifications to the company that designed your system. Request your quote for qualification services today!

Overview of Services:

IQ Services include a careful inspection and documentation of instrument installation, including:

  • Inspecting vital system components (e.g. nitrogen and vacuum pressures, valve operations)
  • Ensuring that the instrument is properly installed in the required environment (space, power, ventilation)
  • Documenting details about the computer, system, and software installation
  • Confirming correct system functionality

OQ Services verify and document that the instrument is operating according to GPT’s specifications. The thorough evaluation includes:

  • Documenting essential system information
  • Completing instrument verification and service system tests
  • Completing a a standard synthesis method

Signed documentation is provided to record the completion of the IQ and OQ Services.

Our certified field engineers can also provide re-qualifications annually or according to an instrument user’s requirements. 

IQ/OQ support is currently available for PurePep® Chorus®, PurePep Sonata+, Symphony X, Sonata/Sonata XT, and Prelude X instrument systems.

Please contact us for more information regarding IQ/OQ Service for your instruments. Our experienced team would be happy to discuss.