ivt san diego 3 10 14
TRANSCRIPT
8/12/2019 IVT San Diego 3 10 14
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Improving Facility Appearance and
Cleaning Efficiency in Pharmaceutical
Applications
IVT – San Diego
3.10.14
Presented By:
Fred Pisacane
President
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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
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Does this look familiar?
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What does the cycle look like?
Surfaces Remediated
Residue, Rouge, and Rustremoved. Generally duringtwice/year shutdown using
chemical passivation
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What does the cycle look like?
Post Remediation:
Visible disinfectantresidues begin to
build creating doubtsabout cleaning
procedures
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What does the cycle look like?
Post Remediation:
Residues continue tobuild and the first
signs of rougeappear on the
surface
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What does the cycle look like?
Surfaces Remediated
Residue, Rouge, and Rustremoved. Generally duringtwice/year shutdown using
chemical passivation
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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
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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
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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
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Residues impact Wiper Performance
Phenol Sodium Hypochlorite
Quaternary Ammonium
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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
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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
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Fiber Black Light Inspection
POLYESTER WIPER
COATER POST MICROFIBERCOATER POST POLYWIPE
MICROFIBER WIPER
* Using black light technology
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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
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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
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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
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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
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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
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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
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Processing
Appearance
Harmonized w/
Audit Appearance
During weekly or
monthly
shutdowns
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Processing
Equipment can be
maintained Audit
Ready-Every Day
w/ water and 70%
IPA
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Processing Tools
brought up to
Audit Ready
Conditions During
Weekly Shut
Downs
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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