Cleaning Validation

We provide a specialist Cleaning Validation service which not only meets but exceeds regulatory requirements.

Through our partner companies we can also offer a full microbiology and chemical testing service.

We can execute the client’s own protocols or we can offer the services of our team of specialist to write and execute documentation according to full Good Documentation Practices:

  • Risk Assessments
  • GMP review & gap analysis and PIA readiness preparation
  • Master validation plans
  • Validation Plans
  • Validation reports

But our cleaning validation services are not limited to just writing and executing protocols, we can offer a full cleaning validation service including:

  • Troubleshoot CIP & COP systems from pipework, mechanical, process or automation systems to ensure your cleaning systems are working correctly.
  • Determine cleaning process methodologies.
  • Optimise your cleaning processes and methods.
  • Determine scientifically based acceptance criteria.
  • Determine “worst case” products and create cleaning matrixes.
  • Create a fully compliant continued verification program.

We can offer a turnkey cleaning validation service, deliver cleaning validation courses (on-site, off-site, on-line) as well as providing technical support to your existing validation teams.

We can assist clients to ensure that the introduction of processes and cleaning process equipment is undertaken in such a manner that your cleaning operations can be fully validated in accordance with regulatory requirements.

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Why choose Blue Hatch for Cleaning Validation

  • We have over 40 years’ experience within pharmaceuticals, validation and compliance.
  • Our specialist have published works on Cleaning Validation.
  • Complete turnkey integrated project execution including lab testing, or just protocol write & execute.
  • Our validation, engineering and technical experts work together to provide you with a holistic service.
  • We can work within your own cleaning validation plans, or can create validation plans plans and SOPs for you, or can develop a full cleaning validation strategy for you.
  • Fully conversant with EU & FDA regulations.
  • Can act as Subject Matter Experts for you for audits and regulatory inspections.
  • Can act as an independent consultancy or as additional resource to your own teams.