Innovative Techniques for Effective
Cleaning of Time Release Polymers
and Color Coatings
The Golden Rule of Cleaning
Everything is cleaned by using the T.A.C.T. variables
Time
Action
Chemistry
Temperature
How Cleaning is Done Now
• Manual
• Clean-Out-Of-Place – COP
• Clean-In-Place – CIP
Changing One Parameter Will Affect the Others
Chemistry
Temperature
Time
Action
Chemistry
Temperature
Manual
Automated
Time
Action
Removal Mechanisms of Formulated Detergents
Each detergent constituent has one or more roles to play in the
removal of soil…:
– Wetting
Modifying surface tension
– Solubilization
Increasing solubility
– Sequestration
Reacting with ions to prevent insoluble by-products
(e.g., soap scum)
– Saponification
Formation of water soluble salts (alkali hydrolysis)
– Chelation
Using - charges to form stable complexes with + metal
ions
– Emulsification
Creating a stable oil / water mixture
– Degradation
Inactivation through a number of means, usually
hydrolysis or oxidation
Reasons to Improve Cleaning
• Better Cleaning
Compliance
Risk
• Save Time
Throughput & Capacity
Utilization
• Save Money
Less labor, less utilities
& less time
• Improve Safety
Risk
Compliance by personnel
Define Your Goals & Your Constraints
• What are we cleaning?
• Equipment type
• Materials of construction
• Soil types/conditions
• What are the goals?
• Decrease turn around time
• Improve safety
• Improve consistency of cleaning
• What is available to clean with?
•
•
•
•
Utility supply
Water grade (USP, PW, WFI, etc.)
Waste water restrictions (temperature, pH limits)
Equipment or tools (CIP/COP)
Steps to Improve your Cleaning
• Engage External Resources if Needed
• Equipment suppliers – help with cleanability retrofits
• CIP/COP equipment vendors – help with engineering
solutions
• Detergent suppliers – help with process determination
• Create & Implement a Project Plan
• Execute Improvements
• Validate
Cleaning Time Release
and Color Coatings
Challenging Residues
How Can You Improve
Cleaning of Coatings?
• Better Cleaning
• Reduce/eliminate haze and residue
• Improve reliability
• Save Time
• Limit hand wiping & scraping
• Decrease disassembly
• Save Money
• Reduce cleaning time
• Improve Safety
• Use the right pairing of chemistry and engineering
Detergent Selection is Critical:
Selecting the right process & detergent for the soil
• Two Case Studies
• Opadry® & Similar
Colored Coatings
• Eudragit® & Similar Time
Release Coatings
Case Study 1:
Opadry
®
Understand The Residue
Opadry® & Related Color Coatings
Soil Characteristics
• High in particulate soils TiO2, Zinc & Iron Oxides
• May have film formers or polymers to help coat
• Wipe away easily, yet hard to remove in automated
cleaning
Understand The Residue
Opadry® & Related Color Coatings
Cleaning Process Needs
• Keep particulate suspended while rinsing away –
use a formulated detergent with suspending agents
• High temperatures can redeposit particulate in vapor –
use a detergent with a moderate temperature requirement
• Velocities must keep cleaning solution mixing & flowing –
pay attention to equipment engineering
Case Study 1:
Soil - Opadry®II White
Current Process:
• Customer is moving to automated cleaning; looking to
improve cleaning and removal of tenacious haze
• Bohle BFC400 & BFC600 Coating Pans
• Pans are soaked in an industrial cleaner then scrubbed
manually. Microfiber towels tumbled in pan followed by CIP
wash with an acid detergent
• Up to 7 batches produced before thorough cleaning & may sit
up to 3 days
• Current cleaning process takes 18-30 hours
Case Study 1:
Solution – Formulated Detergent
• 5% Formulated Detergent at 50°C, rinse and repeat
• Bulk of the residue removed with first detergent step
• Pre-rinse step removed
• Application is key to successful cleaning
• Increased action of spray device aids in the removal of
the Opadry®II White
• No manual wiping was required to completely remove
residue
• Cleaning time was reduced to 4 hours before drying
Case Study 1:
Opadry II White Residue Prior to Cleaning
®
Conclusions from Case Study 1:
Opadry® II White
Successful Cleaning Is Achieved
• Tumbling wipes are not needed
when:
• Action is provided from spray cart
• Detergent design emphasizes soil
suspension
• Keeping temperature moderate
held soils in solution and
prevented redeposition
• Do not let product dry in lines
before cleaning is initiated
Case Study 2:
Eudragit
®
Understand The Residue
Eudragit® & Similar Time Release Coatings
Soil Characteristics
• Insoluble polymers
• Forms an impenetrable barrier on surfaces
• May be applied in multiple layers or combined with color
coating
Understand The Residue
Eudragit® & Similar Time Release Coatings
Cleaning Process Needs
• Insoluble nature requires special measures –
to permit chemistry to penetrate – use soaking sprays
• Application in multiple layers creates other challenges –
may need to repeat detergent application as successive
layers are penetrated
Case Study 2:
Soil - Eudragit® NE 30D
Current Process:
• CIP equipped coating pan (60 inch O’Hara Fastcoat)
• One run, soil sat in coating pan for 24 hours prior to cleaning
• Current cleaning process uses hot water rinsing, a highly alkaline
cleaner , power washing and manual scrubbing to remove
residue
• Residue does not dissolve; peels & forms balls that clog the
perforations and have to be picked from the equipment
• Process takes a minimum of 8 hours
Case Study 2:
Solution – Formulated Detergent
• Customer ran 4 separate trials using Formulated Detergent
• 4-5% Formulated Detergent at 50°C-60°C through CIP
• Formulated Detergent dissolved the residue – no longer
blocking perforations
• Pre-rinse step was eliminated
• Clean time and manual intervention were significantly
reduced
• Time to clean was 2 hours plus 1 hour dry time – a
reduction of more than 5 hours
Case Study 2:
NE30D Residue Prior to Cleaning
Case Study 2:
NE30D Residue After Formulated Detergent Cleaning
Conclusions from Case Study 2:
Eudragit® NE30D
Successful Cleaning Is Achieved
• Correct chemistry applied with
the right process* can
eliminate need for manual
intervention
• Correct chemistry can dissolve
difficult to dissolve coatings,
preventing blockage
* Beware! Adding other excipients to coating may change the
process recommendations.
Eudragit® Cleaning Solutions
• Variety of Eudragit® functionality requires variety in cleaning
recommendations*:
Eudragit® Series
Detergents
NE Series
Formulated Detergent X
RS Series & RL Series
Formulated Detergent Y
L Series & S Series
Formulated Detergent Z
* Beware! Adding other excipients to coating may change the
process recommendations.
New Technologies
Right Application:
Utilize Application Equipment
to meet your T.A.C.T.
requirements
Right Formulated Detergents:
• Mild pH- EHS Friendly
• Low foaming
• Detectable:
• HPLC
• TOC
• Applications:
• CIP
• COP
• Manual
Value of Cleaning Improvements
Increased production time
Reduce labor cost
Reduce safety concerns
Ease of validation
Reliable cleaning
Reduce contamination and
product quality issues
Conclusion
• Apply the correct T.A.C.T. parameters to improve
cleaning – including the selection of the right
Chemistry
• Set improvement goals and get assistance
• Understand the residue and your cleaning
process constraints to ensure success
• Increase operating efficiencies by using
formulated detergents
Questions?
Kristina Wesley
Dober
[email protected]
630.410.7300
www.dobergroup.com