Pharmaceutical-Grade
Passivation Services
Complete IQ/OQ/PQ validation packages with FDA audit-ready documentation. Protecting bioreactors, WFI systems, and process equipment.
Why Passivation Is Critical
Untreated stainless steel surfaces harbor risks that can compromise product integrity and fail regulatory audits.
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Bioburden & Contamination
Surface irregularities trap microorganisms that survive standard CIP cycles.
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Rouge Formation
Iron oxide contamination develops on improperly passivated surfaces.
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Regulatory Issues
FDA 483 observations frequently trace back to inadequate surface preparation.
Process Tanks
Systems We Passivate
From single vessels to complete facility buildouts, we deliver pharmaceutical-grade passivation.
Bioreactors & Fermenters
Complete passivation including internal surfaces, ports, and instrumentation wells.
WFI & PW Systems
Distribution loops, storage tanks, and point-of-use drops requiring USP compliance.
Process Vessels
Mixing tanks, buffer prep, CIP tanks, and storage vessels.
CIP/SIP Systems
Clean-in-Place and Steam-in-Place skids with associated valving.
Chromatography Skids
Precision passivation for columns, buffer vessels, and flow paths.
Clean Steam Generators
Pure steam systems, condensate return, and distribution piping.
The 6-Phase Protocol
Each step documented, validated, and designed for stringent requirements.
Pre-Inspection
Complete surface evaluation including borescope inspection and baseline documentation.
Alkaline Degreasing
Removal of oils and organic residues using pharmaceutical-grade solutions.
Acid Passivation
Citric or nitric acid application promoting chromium oxide layer formation.
High-Purity Rinse
Multi-stage rinse sequence with conductivity verification at each stage.
Surface Verification
Testing to confirm passive layer integrity and corrosion resistance.
Documentation
Complete IQ/OQ/PQ validation with audit-ready reports and certifications.
Protocols Tailored to Your Facility
Every facility has unique requirements, SOPs, and regulatory considerations. We develop custom protocols aligned with your specific procedures.
- โ Adapted to your cleanroom classifications
- โ Aligned with facility-specific SOPs
- โ Customized PPE and gowning requirements
- โ Flexible rinse water specifications
- โ Documentation to your QA standards
System Showing Rouge?
Rouge contamination compromises product purity and signals underlying passivation failure. Our derouging process restores surfaces to pristine condition.
โ ๏ธ Signs You Need Derouging
- Pink/red discoloration in WFI
- Iron particles in filters
- Elevated iron readings
- Surface staining on welds
Before
After
Before
After
Complete IQ/OQ/PQ Documentation
Every passivation includes comprehensive validation packages for audit readiness.
IQ
Installation Qualification
- โ Equipment verification
- โ Material certifications
- โ Chemical COAs
- โ Calibration records
OQ
Operational Qualification
- โ Process parameters
- โ Temperature profiles
- โ Time documentation
- โ Deviation handling
PQ
Performance Qualification
- โ Surface testing results
- โ Rinse water analysis
- โ Visual inspection
- โ Final certification
21 CFR Part 11 Compliant
All documentation meets electronic records and signature requirements for FDA compliance.
Ready for FDA-Ready Passivation?
Get a detailed quote for your pharmaceutical system with complete IQ/OQ/PQ documentation.