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Chematic Formulated Detergents

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Ashleigh Burkart Reyes

Chematic formulated detergents clean a wide variety of products in the pharmaceutical, biopharmaceutical, nutraceutical, and personal care industries from process equipment. This deck provides an overview of Chematic Detergent's key features and examples of typical soils they clean the best.

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CHEMATIC DETERGENT OVERVIEW
CHEMATIC® 82/CHEMATIC® 82Euro Key Features: • Highly Alkaline • Can be used across a wide range of temperatures • Low foaming • Effective in hard water • Euro version meets Biodegradation requirements for EU Typical Soils: • APIs • Parenterals/Injectables • Oils & Waxes Considerations: • Not suitable for certain elastomers and soft materials • Manual Cleaning only at low concentrations & temperatures CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 35°C-80°C pH Range for Recommended Concentrations 12.79-13.69 Manual Cleaning Recommended Use Concentrations 0.5%-2% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 12.51-13.07
CHEMATIC® 82:ACMEXAMPLEPRODUCTTYPE:PERSONALCARE M366W: Zinc & Petrolatum Based Product PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 82 Step 2: DI Spray Rinse 70 20 30 1 Improper Cleaning Passing Result
CHEMATIC® 82:ACMEXAMPLEPRODUCTTYPE:VETERINARY Cydectin 10% Veterinary Injectable PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 5% Chematic® 82 Step 3: DI Spray Rinse Step 4: 5% Chematic® 82 Step 5: DI Spray Rinse 70 70 20 70 20 5 30 1 30 1Improper Cleaning Passing Result
CHEMATIC® 82EURO:ACMEXAMPLE PRODUCTTYPE: NUTRACEUTICAL Fish Oil Ethyl Ester PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 82 Euro Step 2: DI Spray Rinse 80 20 60 1 Improper Cleaning Passing Result
CHEMATIC® 82EURO:ACMEXAMPLE PRODUCTTYPE:COSMETIC Shimmer Lip Balm PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 82 Euro Step 2: DI Spray Rinse 60 20 30 1 Improper Cleaning Passing Result
CHEMATIC® 99/CHEMATIC® 99Euro Key Features: • Low Alkaline • Can be used across a wide range of temperatures • Effective in hard water • Euro version meets Biodegradation requirements for EU Typical Soils: • APIs • Tablet Granulations • OSD Pigments and Excipients • Topical Ointments Considerations: • Lower pH allows for manual cleaning with a larger range of concentrations CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 55°C-70°C pH Range for Recommended Concentrations 9.93-10.25 Manual Cleaning Recommended Use Concentrations 0.5%-5% Recommended Temperatures 25°C-60°C pH Range for Recommended Concentrations 9.61-10.24
CHEMATIC® 99:ACMEXAMPLEPRODUCTTYPE:API Loperamide Slurry PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Pre-rinse Step 2: 5% Chematic® 99 Step 3: DI Spray Rinse 50 50 20 5 10 1 Improper Cleaning Passing Result
CHEMATIC® 99:ACMEXAMPLEPRODUCTTYPE:PERSONALCARE 2% CHG (Skin Protectant) PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Pre-rinse Step 2: 1% Chematic® 99 Step 3: DI Spray Rinse 70 70 20 5 30 1
CHEMATIC® 1 Key Features: • Moderately Alkaline • Effective in hard water • Phosphate free Typical Soils: • APIs • Tablet Granulations • Pigments • Cosmetics & Personal Care Considerations: • Manual Cleaning only at low concentrations & temperatures • Automated cleaning must be at or above cloud point due to foam concerns CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 70°C-80°C pH Range for Recommended Concentrations 11.73-12.54 Manual Cleaning Recommended Use Concentrations 0.5%-2% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 11.41-12.02
CHEMATIC® 1:ACMEXAMPLEPRODUCTTYPE:API Letrozole (API) PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 3% Chematic® 1 Step 2: DI Spray Rinse 50 20 15 1 Improper Cleaning Passing Result
CHEMATIC® 1:ACMEXAMPLEPRODUCTTYPE:OTC Anti-bacterial Ointment PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 1 Step 2: DI Spray Rinse Step 3: 5% Chematic® 1 Step 4: DI Spray rinse 70 20 70 20 30 1 30 1 Improper Cleaning Passing Result
CHEMATIC® 501 Key Features: • Low Alkaline • Effective in hard water • Phosphate free Typical Soils: • APIs • Tablet Granulations • Topical Ointments • Veterinary drugs Considerations: • Low pH allows for manual cleaning with a larger range of concentrations • Automated cleaning must be at or above cloud point due to foam concerns CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 70°C-80°C pH Range for Recommended Concentrations 9.86-9.40 Manual Cleaning Recommended Use Concentrations 1%-10% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 9.86-9.40
CHEMATIC® 501:ACMEXAMPLEPRODUCTTYPE:TABLETGRANULATION Venlafaxine Granulation PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 1% Chematic® 501 Step 2: DI Spray Rinse 60 20 30 1 Improper Cleaning Passing Result
CHEMATIC® 501:ACMEXAMPLEPRODUCTTYPE:VETERINARY Spectrum Dry Blend (Chew) PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 501 Step 2: DI Spray Rinse 50 20 30 1 Improper Cleaning Passing Result
CHEMATIC® 630 Key Features: • Moderately Alkaline • Effective in hard water • Can be used in combination with Chematic® 25 Typical Soils: • Cosmetics & Personal Care • Oils • Viscosity Modifiers • Oral Suspensions • Pigments other OSD excipients Considerations: • Manual Cleaning only at low concentrations & temperatures • Automated cleaning must be at or above cloud point due to foam concerns CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 70°C-80°C pH Range for Recommended Concentrations 10.96-11.86 Manual Cleaning Recommended Use Concentrations 0.5%-3% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 10.59-11.41
CHEMATIC® 630:ACMEXAMPLEPRODUCTTYPE:OTC Mylanta PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 5% Chematic® 630 Step 3: DI Spray rinse 50 70 20 15 30 1 Improper Cleaning Passing Result
CHEMATIC® 630:ACMEXAMPLEPRODUCTTYPE:PERSONALCARE Vacmul Processing Oil PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 5% Chematic® 630 Step 3: DI Spray rinse 70 70 20 5 30 1 Improper Cleaning Passing Result
CHEMATIC® 630:ACMEXAMPLEPRODUCTTYPE:COSMETIC Waterproof Mascara PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 630 Step 2: DI Spray rinse Step 3: 5% Chematic® 630 Step 4: DI Spray rinse 85 85 85 85 60 1 60 1 Improper Cleaning Passing Result
CHEMATIC® 630+CHEMATIC® 25:ACMEXAMPLE PRODUCTTYPE:PERSONALCARE SPF 30 Moisturizer PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 3% Chematic® 630 + 3% Chematic® 25 Step 3: DI Spray rinse 20 70 20 10 30 1 Improper Cleaning Passing Result
CHEMATIC® 640&CHEMATIC® 670 Key Features: • Mild to Moderately Alkaline when used in combination • Can reduce or eliminate the need for peroxide • Chematic® 640 can be used alone, or in combination with Chematic® 670 for more difficult to remove residues • Typically used in a 2:1 ratio Typical Soils: • Cosmetics & Personal Care • Gels • Viscosity Modifiers Considerations: • Manual Cleaning only at low concentrations & temperatures • Automated cleaning must be at or above cloud point due to foam concerns CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 70°C-80°C pH Range for Recommended Concentrations 10.32-10.73 (640) 5.77-5.78 (670) Manual Cleaning Recommended Use Concentrations 0.5%-5% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 10.10-10.68 (640) 5.77-5.78 (670)
CHEMATIC® 640+CHEMATIC® 670:ACMEXAMPLE PRODUCTTYPE:PERSONALCARE SPF 100 Sunscreen PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Pre-rinse Step 2: 3% Chematic® 640 + 2% Chematic® 670 Step 3: DI spray rinse Step 4: 0.5% Chematic® 670 Step 5: DI spray rinse 20 80 20 80 20 10 60 1 60 1 Improper Cleaning Passing Result
CHEMATIC® 570 Key Features: • Highly Alkaline • Chlorine Free • Can be used across a wide range of temperatures • Low Foaming Typical Soils: • Proteins • Media & Cell Cultures • Buffer Solutions • Fermentation Residues Considerations: • Not suitable for certain elastomers and soft materials • Manual Cleaning only at low concentrations & temperatures CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 20°C-80°C pH Range for Recommended Concentrations 12.47-13.36 Manual Cleaning Recommended Use Concentrations 0.5%-2% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 12.17-12.74
CHEMATIC® 570:ACMEXAMPLEPRODUCTTYPE:BIOPHARMA Lysis Buffer PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 1% Chematic® 570 Step 2: DI Spray rinse 70 20 2 1 Improper Cleaning Passing Result
CHEMATIC® 570:ACMEXAMPLEPRODUCTTYPE:BIOPHARMA Albumin Product PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 1% Chematic® 570 Step 3: DI Spray rinse 20 45 20 5 15 1 Improper Cleaning Passing Result
CHEMATIC® NE/NM CLEANER Key Features: • Moderately Alkaline • Specifically formulated to remove multi-layer polymer coatings Typical Soils: • Eudragit® NE polymer and associated coating formulations • Eudragit® NM polymer and associated coating formulations • Ethyl Cellulose based coating formulations • Cellulose Acetate based coatings Considerations: • Less effective at very low temperatures • Automated cleaning at low temperatures may generate excess foam • May react with hard water CIP/COP/Spray Recommended Use Concentrations 4%-10% Recommended Temperatures 50°C-70°C pH Range for Recommended Concentrations 11.35-11.55 Manual Cleaning Recommended Use Concentrations 4%-8% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 11.35-11.50
CHEMATIC® NE/NM:ACMEXAMPLE PRODUCTTYPE:SUSTAINEDRELEASECOATINGS Eudragit® NE 30-D Coating Formulation PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 8% Chematic® NE/NM Step 3: DI Spray rinse 30 60 20 15 30 1 Improper Cleaning Passing Result
CHEMATIC® NE/NM:ACMEXAMPLE PRODUCTTYPE: ORALSOLIDDOSAGECOATINGS Ethyl Cellulose Coating PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 4% Chematic® NE/NM Step 2: Scrub Step 3: DI Spray rinse 30 - 20 15 1 1 Improper Cleaning Passing Result
CHEMATIC® RL/RSCLEANER Key Features: • Acidic • Glycol Ether Based • Specifically formulated to remove multi-layer polymer coatings Typical Soils: • Eudragit® RL polymer and associated coating formulations • Eudragit® RS polymer and associated coating formulations Considerations: • Not suitable for certain elastomers and soft materials • Automated cleaning at low temperatures may generate excess foam CIP/COP/Spray Recommended Use Concentrations 4%-10% Recommended Temperatures 50°C-80°C pH Range for Recommended Concentrations 2.50-2.30 Manual Cleaning Recommended Use Concentrations 4%-8% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 2.50-2.30
CHEMATIC® RL/RS:ACMEXAMPLE PRODUCTTYPE:ORALSOLIDDOSAGE Eudragit® RSPO + Valproic Acid PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 4% Chematic® RL/RS Step 3: DI Spray rinse 20 60 20 15 1 1 Improper Cleaning Passing Result
CHEMATIC® L/S &CHEMATIC® 444 Key Features: • Moderately Alkaline • Specifically formulated to remove multi-layer polymer coatings Typical Soils: • Eudragit® L polymer and associated coating formulations • Eudragit® S polymer and associated coating formulations • Eudragit® FS polymer and associated coating formulations • Other Enteric Coatings • Pigments and other OSD Excipients Considerations: • Less effective at very low and very high temperatures • Automated cleaning at low temperatures may generate excess foam CIP/COP/Spray Recommended Use Concentrations 4%-10% Recommended Temperatures 50°C-60°C pH Range for Recommended Concentrations 11.07-11.11 Manual Cleaning Recommended Use Concentrations 4%-6% Recommended Temperatures 20°C-50°C pH Range for Recommended Concentrations 11.07-11.11
CHEMATIC® L/S:ACMEXAMPLEPRODUCTTYPE:PIGMENTEDENTERICCOATINGS Eudragit® L30 D-55 Coating with Yellow Iron Oxide PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 6% Chematic® L/S Step 3: DI Spray rinse 20 60 20 15 45 1 Improper Cleaning Passing Result
CHEMATIC® 422 Key Features: • Moderately Alkaline • Specifically formulated to remove multi-layer polymer coatings Typical Soils: • Enteric Coatings • Opadry® Coating • Pigments and other OSD Excipients Considerations: • Less effective at very low and very high temperatures • Automated cleaning at low temperatures may generate excess foam CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 45°C-60°C pH Range for Recommended Concentrations 10.73 - 11.07 Manual Cleaning Recommended Use Concentrations 1%-5% Recommended Temperatures 20°C-55°C pH Range for Recommended Concentrations 10.73-11.02
CHEMATIC® 422:ACMEXAMPLEPRODUCTTYPE:ORALSOLIDDOSAGECOATINGS Opadry® White PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 5% Chematic® 422 Step 3: DI Spray rinse Step 4: 5% Chematic® 422 Step 5: DI Spray rinse 20 55 55 55 55 10 30 1 30 1Improper Cleaning Passing Result
CHEMATIC® 8700&CHEMATIC® 8711 Key Features: • Similar formulas, but different surfactant packages. Chematic® 8711 also contains EDTA • Moderately Alkaline • Multi-purpose Cleaning Typical Soils: • Oils • Greasy Residues • Cosmetics and Personal Care Considerations: • Manual Cleaning at low concentrations and temperatures • Automated cleaning at low temperatures may generate excess foam (Chematic® 8700) CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 60°C-70°C pH Range for Recommended Concentrations 11.02-11.98 Manual Cleaning Recommended Use Concentrations 0.5%-5% Recommended Temperatures 20°C-50°C pH Range for Recommended Concentrations 10.73-11.71
CHEMATIC® 8700:ACMEXAMPLEPRODUCTTYPE:PERSONALCARE Wet Wipe Solution PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 1% Chematic® 8700 Step 2: DI Spray Rinse 70 20 15 1 Improper Cleaning Passing Result
CHEMATIC® 8700:ACMEXAMPLEPRODUCTTYPE:NUTRACEUTICAL Annatto Oil PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 8700 Step 2: DI Spray Rinse Step 3: 5% Chematic® 8700 Step 4: DI Spray Rinse 80 20 80 20 60 1 60 1 Improper Cleaning Passing Result
CHEMATIC® 8711:ACMEXAMPLEPRODUCTTYPE:PERSONALCARE Beef Tallow PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 5% Chematic® 8711 Step 3: DI Spray Rinse 70 70 20 15 60 1 Improper Cleaning Passing Result
CHEMATIC® 7 Key Features: • Highly Acidic • Low Foaming • Can be used across a wide range of temperatures Typical Soils: • APIs • Water Hardness/Scale Residues • Metal Oxides • Tarnishes/ Rouging Considerations: • Phosphoric Acid Based • Manual Cleaning only at low concentrations and temperatures CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 40°C-80°C pH Range for Recommended Concentrations 1.72-1.02 Manual Cleaning Recommended Use Concentrations 0.5%-5% Recommended Temperatures 20°C-50°C pH Range for Recommended Concentrations 1.92-1.26
CHEMATIC® 7:ACMEXAMPLE PRODUCTTYPE:METALROUGING Rouging in Elbow of Stainless Steel Pipe PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 10% Chematic® 7 Step 2: DI Spray Rinse 70 20 60 1 Improper Cleaning Passing Result
OTHERDETERGENTS: Chematic® 9301 & Chematic® 9301-D • Citric Acid Based with Glycol Ethers • Used for Acid Soluble APIs and OSD Coating Products Chematic® 9250 • Citric Acid Based • Used for Acid Soluble APIs, Scale, Corrosion Products & Metal Oxides Chematic® 91 & Chematic® 91 Euro • Hydroxy Acetic Acid Based • Used for Acid Soluble APIs, Scale, Corrosion Products, Metal Oxides & Waxy Residues Chematic® 25 • Peroxide Based Detergent Booster • Used in Combination with Lower Alkaline Detergents (Chematic® 630 & Chematic® 501 • Used for Carbomers, Gels & Viscosity Modifiers
OTHERDETERGENTS: Chematic® 573 • Highly Alkaline • No Surfactant Package • Used for APIs and Alkaline Soluble Biopharma Products Chematic® 4057-CP & Chematic® 4057 M-CM • Moderately Alkaline • Used for Cosmetic and Personal Care, Specifically, Lotions, Creams and Pastes Chematic® 405 & Chematic® 410 • Chematic® 405 is mildly acidic, Chematic® 410 is mildly alkaline • Used for Pigmented Coatings both alone and back to back • Recommended less frequently due to the availability of newer, more effective detergents (Chematic® 422 & Chematic® 444)

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Chematic Formulated Detergents

  • 2. CHEMATIC® 82/CHEMATIC® 82Euro Key Features: • Highly Alkaline • Can be used across a wide range of temperatures • Low foaming • Effective in hard water • Euro version meets Biodegradation requirements for EU Typical Soils: • APIs • Parenterals/Injectables • Oils & Waxes Considerations: • Not suitable for certain elastomers and soft materials • Manual Cleaning only at low concentrations & temperatures CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 35°C-80°C pH Range for Recommended Concentrations 12.79-13.69 Manual Cleaning Recommended Use Concentrations 0.5%-2% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 12.51-13.07
  • 3. CHEMATIC® 82:ACMEXAMPLEPRODUCTTYPE:PERSONALCARE M366W: Zinc & Petrolatum Based Product PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 82 Step 2: DI Spray Rinse 70 20 30 1 Improper Cleaning Passing Result
  • 4. CHEMATIC® 82:ACMEXAMPLEPRODUCTTYPE:VETERINARY Cydectin 10% Veterinary Injectable PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 5% Chematic® 82 Step 3: DI Spray Rinse Step 4: 5% Chematic® 82 Step 5: DI Spray Rinse 70 70 20 70 20 5 30 1 30 1Improper Cleaning Passing Result
  • 5. CHEMATIC® 82EURO:ACMEXAMPLE PRODUCTTYPE: NUTRACEUTICAL Fish Oil Ethyl Ester PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 82 Euro Step 2: DI Spray Rinse 80 20 60 1 Improper Cleaning Passing Result
  • 6. CHEMATIC® 82EURO:ACMEXAMPLE PRODUCTTYPE:COSMETIC Shimmer Lip Balm PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 82 Euro Step 2: DI Spray Rinse 60 20 30 1 Improper Cleaning Passing Result
  • 7. CHEMATIC® 99/CHEMATIC® 99Euro Key Features: • Low Alkaline • Can be used across a wide range of temperatures • Effective in hard water • Euro version meets Biodegradation requirements for EU Typical Soils: • APIs • Tablet Granulations • OSD Pigments and Excipients • Topical Ointments Considerations: • Lower pH allows for manual cleaning with a larger range of concentrations CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 55°C-70°C pH Range for Recommended Concentrations 9.93-10.25 Manual Cleaning Recommended Use Concentrations 0.5%-5% Recommended Temperatures 25°C-60°C pH Range for Recommended Concentrations 9.61-10.24
  • 8. CHEMATIC® 99:ACMEXAMPLEPRODUCTTYPE:API Loperamide Slurry PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Pre-rinse Step 2: 5% Chematic® 99 Step 3: DI Spray Rinse 50 50 20 5 10 1 Improper Cleaning Passing Result
  • 9. CHEMATIC® 99:ACMEXAMPLEPRODUCTTYPE:PERSONALCARE 2% CHG (Skin Protectant) PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Pre-rinse Step 2: 1% Chematic® 99 Step 3: DI Spray Rinse 70 70 20 5 30 1
  • 10. CHEMATIC® 1 Key Features: • Moderately Alkaline • Effective in hard water • Phosphate free Typical Soils: • APIs • Tablet Granulations • Pigments • Cosmetics & Personal Care Considerations: • Manual Cleaning only at low concentrations & temperatures • Automated cleaning must be at or above cloud point due to foam concerns CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 70°C-80°C pH Range for Recommended Concentrations 11.73-12.54 Manual Cleaning Recommended Use Concentrations 0.5%-2% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 11.41-12.02
  • 11. CHEMATIC® 1:ACMEXAMPLEPRODUCTTYPE:API Letrozole (API) PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 3% Chematic® 1 Step 2: DI Spray Rinse 50 20 15 1 Improper Cleaning Passing Result
  • 12. CHEMATIC® 1:ACMEXAMPLEPRODUCTTYPE:OTC Anti-bacterial Ointment PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 1 Step 2: DI Spray Rinse Step 3: 5% Chematic® 1 Step 4: DI Spray rinse 70 20 70 20 30 1 30 1 Improper Cleaning Passing Result
  • 13. CHEMATIC® 501 Key Features: • Low Alkaline • Effective in hard water • Phosphate free Typical Soils: • APIs • Tablet Granulations • Topical Ointments • Veterinary drugs Considerations: • Low pH allows for manual cleaning with a larger range of concentrations • Automated cleaning must be at or above cloud point due to foam concerns CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 70°C-80°C pH Range for Recommended Concentrations 9.86-9.40 Manual Cleaning Recommended Use Concentrations 1%-10% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 9.86-9.40
  • 14. CHEMATIC® 501:ACMEXAMPLEPRODUCTTYPE:TABLETGRANULATION Venlafaxine Granulation PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 1% Chematic® 501 Step 2: DI Spray Rinse 60 20 30 1 Improper Cleaning Passing Result
  • 15. CHEMATIC® 501:ACMEXAMPLEPRODUCTTYPE:VETERINARY Spectrum Dry Blend (Chew) PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 501 Step 2: DI Spray Rinse 50 20 30 1 Improper Cleaning Passing Result
  • 16. CHEMATIC® 630 Key Features: • Moderately Alkaline • Effective in hard water • Can be used in combination with Chematic® 25 Typical Soils: • Cosmetics & Personal Care • Oils • Viscosity Modifiers • Oral Suspensions • Pigments other OSD excipients Considerations: • Manual Cleaning only at low concentrations & temperatures • Automated cleaning must be at or above cloud point due to foam concerns CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 70°C-80°C pH Range for Recommended Concentrations 10.96-11.86 Manual Cleaning Recommended Use Concentrations 0.5%-3% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 10.59-11.41
  • 17. CHEMATIC® 630:ACMEXAMPLEPRODUCTTYPE:OTC Mylanta PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 5% Chematic® 630 Step 3: DI Spray rinse 50 70 20 15 30 1 Improper Cleaning Passing Result
  • 18. CHEMATIC® 630:ACMEXAMPLEPRODUCTTYPE:PERSONALCARE Vacmul Processing Oil PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 5% Chematic® 630 Step 3: DI Spray rinse 70 70 20 5 30 1 Improper Cleaning Passing Result
  • 19. CHEMATIC® 630:ACMEXAMPLEPRODUCTTYPE:COSMETIC Waterproof Mascara PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 630 Step 2: DI Spray rinse Step 3: 5% Chematic® 630 Step 4: DI Spray rinse 85 85 85 85 60 1 60 1 Improper Cleaning Passing Result
  • 20. CHEMATIC® 630+CHEMATIC® 25:ACMEXAMPLE PRODUCTTYPE:PERSONALCARE SPF 30 Moisturizer PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 3% Chematic® 630 + 3% Chematic® 25 Step 3: DI Spray rinse 20 70 20 10 30 1 Improper Cleaning Passing Result
  • 21. CHEMATIC® 640&CHEMATIC® 670 Key Features: • Mild to Moderately Alkaline when used in combination • Can reduce or eliminate the need for peroxide • Chematic® 640 can be used alone, or in combination with Chematic® 670 for more difficult to remove residues • Typically used in a 2:1 ratio Typical Soils: • Cosmetics & Personal Care • Gels • Viscosity Modifiers Considerations: • Manual Cleaning only at low concentrations & temperatures • Automated cleaning must be at or above cloud point due to foam concerns CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 70°C-80°C pH Range for Recommended Concentrations 10.32-10.73 (640) 5.77-5.78 (670) Manual Cleaning Recommended Use Concentrations 0.5%-5% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 10.10-10.68 (640) 5.77-5.78 (670)
  • 22. CHEMATIC® 640+CHEMATIC® 670:ACMEXAMPLE PRODUCTTYPE:PERSONALCARE SPF 100 Sunscreen PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Pre-rinse Step 2: 3% Chematic® 640 + 2% Chematic® 670 Step 3: DI spray rinse Step 4: 0.5% Chematic® 670 Step 5: DI spray rinse 20 80 20 80 20 10 60 1 60 1 Improper Cleaning Passing Result
  • 23. CHEMATIC® 570 Key Features: • Highly Alkaline • Chlorine Free • Can be used across a wide range of temperatures • Low Foaming Typical Soils: • Proteins • Media & Cell Cultures • Buffer Solutions • Fermentation Residues Considerations: • Not suitable for certain elastomers and soft materials • Manual Cleaning only at low concentrations & temperatures CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 20°C-80°C pH Range for Recommended Concentrations 12.47-13.36 Manual Cleaning Recommended Use Concentrations 0.5%-2% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 12.17-12.74
  • 24. CHEMATIC® 570:ACMEXAMPLEPRODUCTTYPE:BIOPHARMA Lysis Buffer PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 1% Chematic® 570 Step 2: DI Spray rinse 70 20 2 1 Improper Cleaning Passing Result
  • 25. CHEMATIC® 570:ACMEXAMPLEPRODUCTTYPE:BIOPHARMA Albumin Product PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 1% Chematic® 570 Step 3: DI Spray rinse 20 45 20 5 15 1 Improper Cleaning Passing Result
  • 26. CHEMATIC® NE/NM CLEANER Key Features: • Moderately Alkaline • Specifically formulated to remove multi-layer polymer coatings Typical Soils: • Eudragit® NE polymer and associated coating formulations • Eudragit® NM polymer and associated coating formulations • Ethyl Cellulose based coating formulations • Cellulose Acetate based coatings Considerations: • Less effective at very low temperatures • Automated cleaning at low temperatures may generate excess foam • May react with hard water CIP/COP/Spray Recommended Use Concentrations 4%-10% Recommended Temperatures 50°C-70°C pH Range for Recommended Concentrations 11.35-11.55 Manual Cleaning Recommended Use Concentrations 4%-8% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 11.35-11.50
  • 27. CHEMATIC® NE/NM:ACMEXAMPLE PRODUCTTYPE:SUSTAINEDRELEASECOATINGS Eudragit® NE 30-D Coating Formulation PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 8% Chematic® NE/NM Step 3: DI Spray rinse 30 60 20 15 30 1 Improper Cleaning Passing Result
  • 28. CHEMATIC® NE/NM:ACMEXAMPLE PRODUCTTYPE: ORALSOLIDDOSAGECOATINGS Ethyl Cellulose Coating PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 4% Chematic® NE/NM Step 2: Scrub Step 3: DI Spray rinse 30 - 20 15 1 1 Improper Cleaning Passing Result
  • 29. CHEMATIC® RL/RSCLEANER Key Features: • Acidic • Glycol Ether Based • Specifically formulated to remove multi-layer polymer coatings Typical Soils: • Eudragit® RL polymer and associated coating formulations • Eudragit® RS polymer and associated coating formulations Considerations: • Not suitable for certain elastomers and soft materials • Automated cleaning at low temperatures may generate excess foam CIP/COP/Spray Recommended Use Concentrations 4%-10% Recommended Temperatures 50°C-80°C pH Range for Recommended Concentrations 2.50-2.30 Manual Cleaning Recommended Use Concentrations 4%-8% Recommended Temperatures 25°C-50°C pH Range for Recommended Concentrations 2.50-2.30
  • 30. CHEMATIC® RL/RS:ACMEXAMPLE PRODUCTTYPE:ORALSOLIDDOSAGE Eudragit® RSPO + Valproic Acid PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 4% Chematic® RL/RS Step 3: DI Spray rinse 20 60 20 15 1 1 Improper Cleaning Passing Result
  • 31. CHEMATIC® L/S &CHEMATIC® 444 Key Features: • Moderately Alkaline • Specifically formulated to remove multi-layer polymer coatings Typical Soils: • Eudragit® L polymer and associated coating formulations • Eudragit® S polymer and associated coating formulations • Eudragit® FS polymer and associated coating formulations • Other Enteric Coatings • Pigments and other OSD Excipients Considerations: • Less effective at very low and very high temperatures • Automated cleaning at low temperatures may generate excess foam CIP/COP/Spray Recommended Use Concentrations 4%-10% Recommended Temperatures 50°C-60°C pH Range for Recommended Concentrations 11.07-11.11 Manual Cleaning Recommended Use Concentrations 4%-6% Recommended Temperatures 20°C-50°C pH Range for Recommended Concentrations 11.07-11.11
  • 32. CHEMATIC® L/S:ACMEXAMPLEPRODUCTTYPE:PIGMENTEDENTERICCOATINGS Eudragit® L30 D-55 Coating with Yellow Iron Oxide PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 6% Chematic® L/S Step 3: DI Spray rinse 20 60 20 15 45 1 Improper Cleaning Passing Result
  • 33. CHEMATIC® 422 Key Features: • Moderately Alkaline • Specifically formulated to remove multi-layer polymer coatings Typical Soils: • Enteric Coatings • Opadry® Coating • Pigments and other OSD Excipients Considerations: • Less effective at very low and very high temperatures • Automated cleaning at low temperatures may generate excess foam CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 45°C-60°C pH Range for Recommended Concentrations 10.73 - 11.07 Manual Cleaning Recommended Use Concentrations 1%-5% Recommended Temperatures 20°C-55°C pH Range for Recommended Concentrations 10.73-11.02
  • 34. CHEMATIC® 422:ACMEXAMPLEPRODUCTTYPE:ORALSOLIDDOSAGECOATINGS Opadry® White PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 5% Chematic® 422 Step 3: DI Spray rinse Step 4: 5% Chematic® 422 Step 5: DI Spray rinse 20 55 55 55 55 10 30 1 30 1Improper Cleaning Passing Result
  • 35. CHEMATIC® 8700&CHEMATIC® 8711 Key Features: • Similar formulas, but different surfactant packages. Chematic® 8711 also contains EDTA • Moderately Alkaline • Multi-purpose Cleaning Typical Soils: • Oils • Greasy Residues • Cosmetics and Personal Care Considerations: • Manual Cleaning at low concentrations and temperatures • Automated cleaning at low temperatures may generate excess foam (Chematic® 8700) CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 60°C-70°C pH Range for Recommended Concentrations 11.02-11.98 Manual Cleaning Recommended Use Concentrations 0.5%-5% Recommended Temperatures 20°C-50°C pH Range for Recommended Concentrations 10.73-11.71
  • 36. CHEMATIC® 8700:ACMEXAMPLEPRODUCTTYPE:PERSONALCARE Wet Wipe Solution PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 1% Chematic® 8700 Step 2: DI Spray Rinse 70 20 15 1 Improper Cleaning Passing Result
  • 37. CHEMATIC® 8700:ACMEXAMPLEPRODUCTTYPE:NUTRACEUTICAL Annatto Oil PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 5% Chematic® 8700 Step 2: DI Spray Rinse Step 3: 5% Chematic® 8700 Step 4: DI Spray Rinse 80 20 80 20 60 1 60 1 Improper Cleaning Passing Result
  • 38. CHEMATIC® 8711:ACMEXAMPLEPRODUCTTYPE:PERSONALCARE Beef Tallow PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: Water Pre-rinse Step 2: 5% Chematic® 8711 Step 3: DI Spray Rinse 70 70 20 15 60 1 Improper Cleaning Passing Result
  • 39. CHEMATIC® 7 Key Features: • Highly Acidic • Low Foaming • Can be used across a wide range of temperatures Typical Soils: • APIs • Water Hardness/Scale Residues • Metal Oxides • Tarnishes/ Rouging Considerations: • Phosphoric Acid Based • Manual Cleaning only at low concentrations and temperatures CIP/COP/Spray Recommended Use Concentrations 1%-10% Recommended Temperatures 40°C-80°C pH Range for Recommended Concentrations 1.72-1.02 Manual Cleaning Recommended Use Concentrations 0.5%-5% Recommended Temperatures 20°C-50°C pH Range for Recommended Concentrations 1.92-1.26
  • 40. CHEMATIC® 7:ACMEXAMPLE PRODUCTTYPE:METALROUGING Rouging in Elbow of Stainless Steel Pipe PASSING RESULT Detergent Step Temp (oC) Time (min) Step 1: 10% Chematic® 7 Step 2: DI Spray Rinse 70 20 60 1 Improper Cleaning Passing Result
  • 41. OTHERDETERGENTS: Chematic® 9301 & Chematic® 9301-D • Citric Acid Based with Glycol Ethers • Used for Acid Soluble APIs and OSD Coating Products Chematic® 9250 • Citric Acid Based • Used for Acid Soluble APIs, Scale, Corrosion Products & Metal Oxides Chematic® 91 & Chematic® 91 Euro • Hydroxy Acetic Acid Based • Used for Acid Soluble APIs, Scale, Corrosion Products, Metal Oxides & Waxy Residues Chematic® 25 • Peroxide Based Detergent Booster • Used in Combination with Lower Alkaline Detergents (Chematic® 630 & Chematic® 501 • Used for Carbomers, Gels & Viscosity Modifiers
  • 42. OTHERDETERGENTS: Chematic® 573 • Highly Alkaline • No Surfactant Package • Used for APIs and Alkaline Soluble Biopharma Products Chematic® 4057-CP & Chematic® 4057 M-CM • Moderately Alkaline • Used for Cosmetic and Personal Care, Specifically, Lotions, Creams and Pastes Chematic® 405 & Chematic® 410 • Chematic® 405 is mildly acidic, Chematic® 410 is mildly alkaline • Used for Pigmented Coatings both alone and back to back • Recommended less frequently due to the availability of newer, more effective detergents (Chematic® 422 & Chematic® 444)