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home Best Technology / FAQs / What’s involved in the passivation validation process?

What’s involved in the passivation validation process?

Within the medical device world there is a need to validate the passivation process.  But what does that mean, and how does that work?

Validation is the process of insuring that the passivation process you use will reproduce repeatable and predictable results every time a batch of parts is run through the process. By validating the process you are able to forego subjecting every part to testing to prove that it is properly passivated.

Typically you will here the validation process broken down into three distinct parts: the IQ, the OQ and the PQ.  Let’s look at each part.

The IQ or Installation Qualification is the first part.  It is developed by describing the machine – what is it? what does it do? etc. It also looks at what the components on the machine are, gauges, switches, PLC, etc.  It provides a description of the machine and its parts – what is it and how does it work?

The OQ or Operational Qualification is the second part. It essentially help you verify the IQ – does the machine operate as it is supposed to?  Do the components do what they are designed to do? etc. – does everything work as intended?

The PQ or Process Qualification is the third part of the passivation test. If the IQ is the theory of how things SHOULD operate and the OQ is the practice of how things DO operate, then the PQ defines how CONSISTENTLY the machine operates.  You create a DOE (Design of Experiments) that tests the equipment at the top end and bottom end of allowable ranges and run parts to verify the results across the entire range of the variables. Now when the machine operates within the specified range of time, temperature and/or acidic concentration you know that your parts will meet the specs. That is the goal of the passivation validation process.

Latest News & Products from Best Technology

Semi-Automated Inline Citric Passivation Solution with Data Tracking

For one medical device manufacturer, the design of a citric passivation solution faced two major challenges: The manufacturing process required performing a water-break test after cleaning parts, before proceeding to passivation. This meant that they could not use a fully automated passivation solution. The system had to have data tracking for quality control purposes. Semi-Automated […]

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  • Industrial Parts Washers
    • Agitated Immersion Heated Parts Washers
    • Inline Conveyor Wash-Rinse-Dry Parts Washers
    • Immersion Inline Parts Washer
    • Spray Cabinet Parts Washers
      • Front Load Spray Cabinet Parts Washer
      • Top Load Spray Cabinet Industrial Parts Washer
    • Vertical Door Pass Through Parts Washer
    • Rotary Drum Parts Washer
    • Powder Coat Prep Equipment
    • Phosphating Lines
    • Pipe Washing Equipment
  • Precision Cleaning Systems
    • Applicable Articles
    • How clean is clean?
    • How Do Ultrasonic Cleaners Work?
    • Ultrasonic Benchtop Parts Cleaner
    • Benchtop Ultrasonic Parts Cleaning Multi-Tank Systems
    • Ultrasonic Cleaning Consoles
    • Automated Ultrasonic Parts Cleaning Equipment Wash-Rinse-Dry
    • Large Scale Automated Precision Aqueous Cleaning for Cellular Manufacturing
    • Agitated Immersion Ultrasonic Parts Washer
    • Machine Shop Parts Washer for Swiss and CNC Precision Parts
    • Immersible Ultrasonic Transducers
    • Vapor Degreasers
  • Passivation Equipment
    • Applicable Articles
    • What is Passivation? How Does It Work?
    • Nitric vs. Citric Acid Passivation
    • CitriSurf – Citric Acid Passivation
    • Benchtop Ultrasonic Passivation Equipment
    • Ultrasonic Automated Passivation Equipment
    • Automated Ultrasonic Passivation System for Medical Device Parts
    • Passivation Wet Bench for Citric / Nitric Acid
    • Cleanroom Space Saving Automated Passivation System
    • Heated Polypropylene Acid Passivation and Rinse Tanks
    • Agitated Immersion Multi-Tank Passivation Systems
    • Automated Chemical Neutralization Tank / Cart
  • Electropolishing Equipment
    • What is electropolishing? How does electropolishing work?
    • Electropolishing Cycle and Current Calculator
    • What is Dry Electropolishing? How does it work?
    • Passivation vs. Electropolishing
    • Table Top Electropolishing Equipment & Electropolishing Machines
    • Electropolishing Wet Benches
    • Large Scale Part Electropolishing Systems
    • Dry Electropolishing Machines
    • EP System – Open Top Wet Bench with Spray Rinse
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    • Alodine Lines
      • What is Alodine / Chem film / Chromate Conversion Coating?
      • Alodine Chem Film Tank Line
    • Mass Finishing Machines
      • Centrifugal Barrel Finishing Machines
      • Spin Dryers / Chip Wringers
      • Vibratory Bowl Polishers
    • Titanium Anodizing Equipment
  • Wet Benches
    • Citric / Nitric Passivation Wet Bench for Stainless Steel & Titanium
    • Electropolishing Equipment in a Wet Bench / Fume Hood
    • Fume Hoods
    • Wet Benches for Semiconductor & FM4910 Applications
    • Quick Dump Rinse Tank
  • Specialty & Custom Industrial Process Systems
    • Automated Chemical Neutralization Tank / Cart
    • Vapor and Dryfilm PTFE Coating Systems
    • Heated Hot Air Parts Dryer
    • Solvent Recovery Equipment
  • Precision Cleaning Chemistries, Solvents & Fluids
    • Why Use a Parts Cleaning Solvent?
    • 3M Novec Engineered Fluids, Fluorinert Liquids, Solvents & Chemicals
    • Solvent Cleaning with 3M Novec Engineered Fluids
    • Thermal Management / Heat Transfer with 3M Novec and Fluorinert Fluids
    • 3M Novec 72DA 73DE Solvent Vapor Degreaser For Medical Device Instruments
    • Solvent Phase-outs
      • AK225 HCFC-225 Phase Out and Replacement with 3M Novec HFE Engineered Fluids
      • Medical Device AK 225 Replacement with 3M Novec Engineered Fluid Solvent
      • nPB Replacement
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