innovative techniques for effective cleaning of time ... · (e.g., soap scum) –saponification...

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

Time

Action

Chemistry

Temperature

Manual

Time

Chemistry

Action

Temperature

Automated

Removal Mechanisms of Formulated Detergents

– Wetting

– Solubilization

– Sequestration

– Saponification

– Chelation

– Emulsification

– Degradation

Modifying surface tension

Increasing solubility

Reacting with ions to prevent insoluble by-products (e.g., soap scum)

Formation of water soluble salts (alkali hydrolysis)

Using - charges to form stable complexes with + metal ions

Creating a stable oil / water mixture

Inactivation through a number of means, usually hydrolysis or oxidation

Each detergent constituent has one or more roles to play in the removal of soil…:

Reasons to Improve Cleaning

• Better Cleaning

• Save Time

• Save Money

• Improve Safety

Compliance

Risk

Throughput & Capacity Utilization

Less labor, less utilities & less time

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 Formulated Detergents: • Mild pH- EHS Friendly

• Low foaming

• Detectable:

• HPLC

• TOC

• Applications:

• CIP

• COP

• Manual Utilize Application Equipment to meet your T.A.C.T.

requirements

Right Application:

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

kwesley@dobergroup.com

630.410.7300

www.dobergroup.com