Cleaning Validation Services
We provide a specialist Cleaning Validation service that not only meets but exceeds regulatory requirements.
Through our partner organisations, we offer comprehensive microbiological and chemical testing services.
Our team can either execute your existing protocols or provide specialist services to write and execute documentation in accordance with Good Documentation Practices, including:
• Risk Assessments
• GMP review, gap analysis and PIA readiness preparation
• Master validation plans
• Validation Plans
• Validation reports
What Our Cleaning Validation Services Include
Our cleaning validation services extend far beyond protocol writing and execution. We offer a comprehensive service that includes:
• Troubleshooting CIP & COP systems – from pipework and mechanical systems to process and automation systems – ensuring optimal cleaning performance
• Developing cleaning process methodologies
• Optimising cleaning processes and methods
• Establishing scientifically-based acceptance criteria
• Identifying “worst case” products and creating cleaning matrices
• Implementing fully compliant continued verification programmes
We deliver complete turnkey cleaning validation services, alongside bespoke training courses (available on-site, off-site, or online) and technical support for existing validation teams.
Our expertise helps clients ensure that the implementation of processes and cleaning equipment is conducted in a manner that enables full validation of cleaning operations in accordance with regulatory requirements.
Why choose Blue Hatch for Cleaning Validation:
• Over 40 years’ experience in pharmaceuticals, validation and compliance
• Published works on Cleaning Validation by our specialists
• Complete turnkey project execution, including laboratory testing, or targeted protocol writing and execution
• Integrated approach combining validation, engineering and technical expertise
• Flexibility to work within existing cleaning validation plans, create new validation plans and SOPs, or develop comprehensive cleaning validation strategies
• Full compliance with EU & FDA regulations
• Available as Subject Matter Experts for audits and regulatory inspections
• Can function as independent consultants or supplement your existing teams