Performance Testing & Validation

MSS deliver facilities fully tested, certified and validated to the standards set down by the User Requirements and applicable regulations. We offer:

• HEPA Filter Integrity Testing
• Induction Leakage Testing
• Airborne Particle Counts
• Temperature, Humidity and Pressure tests
• Lighting and noise levels
• Room Recovery

In addition MSS can offer full facility validation based on using either client’s existing protocols or new including:

• GMP Review – Including critical process steps, points of product exposure, flows, segregation / cross contamination review and GMP protection / containment levels
• User requirement Specification production
• HAZOP / HAZCON
• Validation Master Plan – Including criticality assessments
• DQ / IQ / OQ / PQ
• Standard / Engineering Operating Procedures – Including cleaning and maintenance regimes and critical spares

MSS can take full responsibility from Design through to Handover of all project documentation or any elements of the process.