ivt san diego 3 10 14

8/12/2019 IVT San Diego 3 10 14

http://slidepdf.com/reader/full/ivt-san-diego-3-10-14 1/30

Improving Facility Appearance and

Cleaning Efficiency in Pharmaceutical

Applications

IVT – San Diego

3.10.14

Presented By:

Fred Pisacane

President

8/12/2019 IVT San Diego 3 10 14


Agenda

• Facility Appearance:• Cycle

• Regulatory

• Aesthetics

• Wiping Rules and Performance:

• Wiper history• What role does the surface have

• Wiping Challenges in the Life Science Industry

• Residue, Rouge, and Rust Remediation/Prevention:

• Proactive• Reactive

• Questions and Answers

8/12/2019 IVT San Diego 3 10 14


Does this look familiar?

8/12/2019 IVT San Diego 3 10 14


8/12/2019 IVT San Diego 3 10 14


What does the cycle look like?

Surfaces Remediated

Residue, Rouge, and Rustremoved. Generally duringtwice/year shutdown using

chemical passivation

8/12/2019 IVT San Diego 3 10 14



Post Remediation:

Visible disinfectantresidues begin to

build creating doubtsabout cleaning

procedures

8/12/2019 IVT San Diego 3 10 14



Post Remediation:

Residues continue tobuild and the first

signs of rougeappear on the

surface

8/12/2019 IVT San Diego 3 10 14


8/12/2019 IVT San Diego 3 10 14



Surfaces Remediated

Residue, Rouge, and Rustremoved. Generally duringtwice/year shutdown using

chemical passivation

8/12/2019 IVT San Diego 3 10 14


The Residue to Rust Cycle:

Costly, Risky & Unpredictable

X = Audit Failure Risk

Jan

Feb

Mar X

Apr X

May X

Jun X Jul

Aug

Sep

Oct X

Nov X

Dec

Acid Passivation

Residue Buildup

Disinfectant Buildup

Disinfectant Buildup

Rouging

Rouging

Rust

Rust

Acid Passivation

Residue Buildup

Heavy Corrosion

Heavy Corrosion

8/12/2019 IVT San Diego 3 10 14


8/12/2019 IVT San Diego 3 10 14


Wipers Used in Clean Rooms

Wiper Type

• Non-Wovens (Sontara)

• Polyester

• Poly/Foam

• Micro Fiber

Strengths/Weakness

• Unit Cost, Absorbency, Tear,

Chemical Resistance/Fibers, Wet

Strength

• Tear Strength, Chemical

Resistance Particles,

NVR’s/Cleaning Efficiency

• Fiber Control, Pickup, fluid

delivery, Conformability/Tear,

Unit Cost

• Cleanliness, Cleaning, NVR’s,

Chemical Resistance/Unit Cost

8/12/2019 IVT San Diego 3 10 14


Poly vs. Microfiber Characteristics

Star-shaped microfiber traps and

removes particles;

where standard

Polyester round fibers

push particles around.

A tighter bundle

means better pick up,

greater absorbency,and superior abrasion

resistance.

Woven Microfiber Wiper

Woven Microfiber

Woven Microfiber Bundle

8/12/2019 IVT San Diego 3 10 14


Residues impact Wiper Performance

Phenol Sodium Hypochlorite

Quaternary Ammonium

8/12/2019 IVT San Diego 3 10 14


Fiber Generation Is A Function Of Surface Roughness

Microfiber

Poly T

PolyP

PolyB

PolyC

25Ra Bleached

SS

35 Ra Bleached SS

Inspected Each Wipe After Wiping Different Surfaces

10 Ra 316LEP 5Ra

8/12/2019 IVT San Diego 3 10 14


Non-Viable Surface Particle

Analysis

Via Q3 Surface Particle Counter

ISO Class 7 suite

5 micron/

CM2

.5 micron/

CM2

Rusted 316L 567 14589

Rouged 316L 456 16783

Stained 316L 4759 200,129

New 316L 34 467Stained Windows 2344 125,167

Cleaned Windows 22 345

8/12/2019 IVT San Diego 3 10 14


8/12/2019 IVT San Diego 3 10 14


Fiber Black Light Inspection

POLYESTER WIPER

COATER POST MICROFIBERCOATER POST POLYWIPE

MICROFIBER WIPER

* Using black light technology

8/12/2019 IVT San Diego 3 10 14


Why Stainless Steel?

• Why is it called “stainless” if it stains?

• Stainless steel is stainless due

to a > 12% chromium content that enables achromium oxide passivation film on the steel.

• Stainless steel will self-passivate as long as it

clean• Once the passivation layer is damaged

stainless will rust

8/12/2019 IVT San Diego 3 10 14


Cleaning versus Disinfection

Cleaning (remove viable and non

viable particles from surfaces)

Disinfection (kill viable

organisms on a surfaces)

Removal of particulatesand microbes from the

surface

Saturate and penetratethe cell wall to kill the

organism

Removal of residues andbuildup that cancomplicate disinfection

Disinfectants need aspecified Contact Time towork

Particulates, residues &irregular surfaces mustbe factored

8/12/2019 IVT San Diego 3 10 14


The micro fiber 1-2um star-

shape characteristic is able to

reach into the micro

scratches on all surfaces.

Giving the microfiber the

ability to remove the sub

.2um particles gathered

within micro scratches.

Contaminants, soil and even

Bleach residue can be lifted

by the micro fiber wipe.

A Clean Surface Is More Easily Disinfected:

Fiber of Woven

Microfiber

Microfiber

Woven

Woven Microfiber

8/12/2019 IVT San Diego 3 10 14


Cleaning Challenges

Soil and disinfectant residues on clean room surfacescomplicate subsequent disinfection cycles.

Is the surface to be disinfected in the same condition aswhen the disinfectant validation took place?

Wiping protocols are very difficult to execute even with

robust training.

Porous surfaces like stainless steel and glass are especiallychallenging

8/12/2019 IVT San Diego 3 10 14


Why Is Facility Appearance a Compelling?

Pain & Suffering

• Audit/Contamination risks

• Risk & Cost of current

process• Acid based passivation

• Poor facility productivity

New Condition

• Audit ready every day

• Cost savings with greatly

reduced risk• EHS is mandated to reduce

hazards

• Audit Ready Conditions no

longer rely on long andcostly shutdowns

8/12/2019 IVT San Diego 3 10 14


Residue And Its Effective Removal

Disinfectant

residue cleaned

with cleanroom

grade microfiber& 70% alcohol

Residues that lead to

corrosion remaining

after the surfaces was

cleaned with

standard clean room

grade polyester

wipers & 70%

alcohol

8/12/2019 IVT San Diego 3 10 14


Processing

Appearance

Harmonized w/

Audit Appearance

During weekly or

monthly

shutdowns

8/12/2019 IVT San Diego 3 10 14


Processing

Equipment can be

maintained Audit

Ready-Every Day

w/ water and 70%

IPA

8/12/2019 IVT San Diego 3 10 14


Processing Tools

brought up to

Audit Ready

Conditions During

Weekly Shut

Downs

8/12/2019 IVT San Diego 3 10 14


In summary:

• Our industry is changing• As requirements change cleaning protocols

have to improve

• Proactive audit ready practices have to beestablished

• Manufacturing is being asked if the facility isaudit ready everyday

8/12/2019 IVT San Diego 3 10 14


Wrap Up…

• Thank you to IVT for bringing in thoughtleaders.

• Thank you to consultants, manufacturers and

distributors who are a resource to the industry

• Questions today or the rest of the week

ivt san diego 3 10 14

Documents