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

Agenda

1. Cleaning of Lumen instruments – major challenges and solutions.

2. Process Challenge Devices for cleaning verification – focusing on complex instruments

3. Q&A

CLEANING OF LUMEN INSTRUMENTS

SECTION 01

4

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

5

Internal cleaning – it is all about the flow

• Erosion

• Dilution

• Mechanical Displacement

• Dynamic Pressure

6

At the boundary of the flowing fluid…

http://www.mcor.net/mcorabilities/mcorabilites-for-pumps-fluid-flow/cavitation-solution/

7

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 !

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

PCDsfor cleaning verification

SECTION 02

What is behind the idea of PCDs for cleaning verification?

There is no mathematical formula linking cleaning method to actual removal of contamination!

???

11

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.

12

Simulating realistic cleaning

Three critical things to consider:

Test soil

Cleaning challenge

Evaluation method

13

Test Soils

What affect test soils!

Composition

Surface preparation

Application method

Replicability

How do synthetic test soils go beyond visual inspection???

14

Different instruments create different challenges

15

Four Dimensional cleaning challenge

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

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

VeriTest Blue – Protein Sensitive Reagent

• Quantitative test

• Direct method

• Quick result

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

THANK YOU!

#FightDirty

@BeyondClean

…find out more at aseptium.com