pawel de sternberg stojalowski dublin 2018 · 7 internal cleaning mechanics –continuity principle...
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C L E A N I N G O F H O L L O W I N S T R U M E N T S , V E R I F I C A T I O N A N D P C D S
Pawel de Sternberg Stojalowski
Dublin 2018
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Agenda
1. Cleaning of Lumen instruments – major challenges and solutions.
2. Process Challenge Devices for cleaning verification – focusing on complex instruments
3. Q&A
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CLEANING OF LUMEN INSTRUMENTS
SECTION 01
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External vs Internal cleaning
• Different, independent processes
• Success of one does not guarantee
success of the other
• Need of dedicated tests to evaluate each process
• Evaluate each process in every washer
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Internal cleaning – it is all about the flow
• Erosion
• Dilution
• Mechanical Displacement
• Dynamic Pressure
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At the boundary of the flowing fluid…
http://www.mcor.net/mcorabilities/mcorabilites-for-pumps-fluid-flow/cavitation-solution/
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Internal cleaning mechanics – Continuity Principle et al.
• Volume of flow rate remains constant
• Volume flow rate = Area x Velocity
𝐴1𝑉1 = 𝐴2𝑉2
𝐴1 = 𝜋𝑟12
𝜋𝑟12𝑉1 = 𝜋𝑟2
2𝑉2
Example r1 = 3mm
r2 = 1mm
V1 = 100mm/s
V2 = 900mm/s
It is a squared relationship!https://courses.lumenlearning.com/boundless-physics/chapter/deformation-of-solids/
Law of Conservation of Mass in Fluids
• Laminar vs. Turbulent flow
• No slip condition
• Consider lumen size !
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The need for ultrasonics - its not magic, it’s beautiful physics!
Cleaning uniformityGood penetrationRemoves contamination locally!Penetrate lumen walls*
Most importantly:
Ultrasonic washer 1 ≠ Ultrasonic
washer 2
https://www.researchgate.net/profile/Claus_Dieter_Ohl/publication/242514089_Bubble_Dynamics_Shock_Waves_and_Sonoluminescence/links/54deb70f0cf2953c22afb362/Bubble-Dynamics-Shock-Waves-and-Sonoluminescence.pdf?origin=publication_detail
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PCDsfor cleaning verification
SECTION 02
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What is behind the idea of PCDs for cleaning verification?
There is no mathematical formula linking cleaning method to actual removal of contamination!
???
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Verification of instruments vs PCDs
INSTRUMENTS
• Impractical
• Compromise integrity of a set
• High cost
• Disruptive
• Time consuming
PROCESS CHALLENGE DEVICES (PCDs)
• Mimic real environment*
• Integrity of set assured
• Process not disrupted
• Saves time and resources
• Practical
Ideally we would like to verify every single instrument but that is too costly and impractical.
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Simulating realistic cleaning
Three critical things to consider:
Test soil
Cleaning challenge
Evaluation method
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Test Soils
What affect test soils!
Composition
Surface preparation
Application method
Replicability
How do synthetic test soils go beyond visual inspection???
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Different instruments create different challenges
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Four Dimensional cleaning challenge
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Internal cleaning PCDs – I told you it is all about the flow
It is all about the flow of water through the
instrument: the more realistic the flow the
more accurate the PCD.
Inside the capsule: exemplary flow
Optimised flow
Not-Optimised flow
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But how do we know if it is really clean?
What test do we need?
- Sensitive (at least 5µg protein)
- Quantitative
- Direct
… and ideally quick!
What works?
1. Fluorescence (ProReveal)
2. Protein sensitive reagent
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VeriTest Blue – Protein Sensitive Reagent
• Quantitative test
• Direct method
• Quick result
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Aseptium’s VeriTest Family
Different Cleaning Challenges
• VeriTest Tag
Natural protein test soil
• VeriTest Multi
4 Dimensional Cleaning
• VeriTest Lumen & FlexE
Different size lumens
• VeriTest Blue
Protein Sensitive Reagent
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THANK YOU!
#FightDirty
@BeyondClean
…find out more at aseptium.com