TECHNICAL DATA SHEET

TDS-255
Edition: September 3, 2009 Previous Editions: December, 1999 / March 25, 2004 / May 12, 2008 Original Date: May, 1998

Formulating Hydroalcoholic Gels with Carbopol* Polymers

Use of Hand Sanitizing Gels to Reduce Germ Transmission
Hydroalcoholic hand sanitizing gels have found increasing use by consumers and institutional facilities. These gels have gained popularity due to their ability to instantly kill germs and bacteria on the hands without the use of soap and water. These gels can be formulated to provide pleasant sensory and good conditioning on the hands even while providing effective disinfecting performance. Carbopol polymers and other Noveon Consumer Specialties rheology modifiers are the preferred polymers to provide cost-effective and aesthetically pleasing ingredients to thicken and stabilize hydroalcoholic gels. Background: Viruses and bacteria such as Staphylococcus, E.coli, Salmonella, and influenza can cause illnesses and are typically transmitted via person-to-person contact, as well as object to person contact. A simple handshake, touching of a doorknob, pushing elevator buttons, answering a telephone and contacting other common objects in public areas can all be sources of germs. Whether travelling by airplane, bus or train, as well as frequenting public places in general, there is potential exposure to an array of harmful and potential infectious bacteria and viruses. These environments represent an opportunity for rapid spread of harmful microbes. The probability of transmission increases when personal hygiene or hand washing habits are inadequate. Washing hands with water and soap is an effective way to remove visible dirt and reduce the number of germs on your hands. However, it is not always feasible or practical to wash your hands as often as desired. The use of hand sanitizing gels significantly reduces the potential for germ transmission as well as the risks of contamination. These gels can be also used to supplement disinfection of the hands after normal washing with soap and water for additional protection. Formulating a Hydroalcoholic Hand Sanitizing Gel Hydroalcoholic gels basically contain four major ingredients: alcohol, water, rheology modifier and neutralizer. The effectiveness of the sanitizer using alcohol depends on the amount and type of alcohol. The FDA proposed monograph considers the effective concentrations as follows: Ethanol at 60-95 v/v% Isopropanol at 70-91.3 v/v%.

Lubrizol Advanced Materials, Inc. / 9911 Brecksville Road, Cleveland, Ohio 44141-3247 / TEL: 800.379.5389 or 216.447.5000
Lubrizol Advanced Materials, Inc. cannot guarantee how the product(s) will perform in combination with other substances or in the users process. Therefore, no representations, guarantees or warranties of any kind are made as to the suitability of this product(s) for particular applications. End product performance is the responsibility of the user. Lubrizol Advanced Materials, Inc. shall not be liable for and the customer assumes all risk and liability of any use or handling of any material beyond Lubrizol Advanced Materials direct control. The SELLER MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTIBILITY AND FITNESS FOR A PARTICULAR PURPOSE. Nothing contained herein is to be considered as permission, recommendation, nor as an inducement to practice any patented invention without permission of the patent owner.

For further information, please visit www.homecare.noveon.com

Lubrizol Advanced Materials, Inc. is a wholly owned subsidiary of The Lubrizol Corporation * Trademark owned by The Lubrizol Corporation Copyright 2009 / The Lubrizol Corporation

2 Alcohol can destroy the lipid containing cell membrane of bacteria and fungus and denatures proteins and enzymes inside bacteria and fungus. Alcohol kills bacteria and fungus almost instantly upon contact. Noveon Consumer Specialties rheology modifiers are efficient ingredients to provide thickening, stabilization and suspension of these types of formulations. Carbopol polymers are the preferred polymers to provide cost effective and aesthetically pleasing hand sanitizing gels. The use of Carbopol polymers will create thick clear gels that will prevent dripping and will maximize contact of alcohol on the skin for optimum performance. Benefits Quickly kills bacteria when water is not available. Quickly evaporates on application requiring no need for rinsing or drying of the hands. Consumer convenience over ordinary hand washing with soap and water. Emollients, botanical extracts, moisturizers and fragrances can all be incorporated and are compatible -- thus helping to provide additional functional benefits such as conditioning.

Polymer Selection Although all Carbopol polymers can thicken hydroalcoholic systems, several grades offer advantages such as higher clarity, better efficiency, ease of handling and better overall aesthetics for hand sanitizing gels. All three of our Carbopol Ultrez polymers are good rheology modifiers for these gels. A typical hand sanitizing gel contains less than 40 wt% deionized water. Due to this constraint, the low dispersion viscosity, as well as the processing ease, makes the Carbopol Ultrez polymers well-suited for these types of formulations as compared to the more traditional polymer grades. The following table will assist in polymer selection. Carbopol Polymer HSG Viscosity*, >0.2 wt% Clarity Electrolyte Tolerance Smoothness after use Ease of dispersion Balling or Pilling**
Preferred Lower performance
*The HSG Viscosity references the formulation viscosity of the Hand Sanitizing Gel shown in table below **The more checks the less pilling of system occurs

Ultrez 10

Ultrez 21

Ultrez 20

980

940

Screening Formulation for Carbopol Polymer Comparison Use Level of Carbopol Polymer Deionized Water (wt%) Ethanol (wt%) TEA (wt%) 0.1 wt% 39.8 60.0 0.1 0.2 wt% 39.6 60.0 0.2 0.3 wt% 39.4 60.0 0.3 0.4 wt% 39.2 60.0 0.4 0.5 wt% 39.0 60.0 0.5

3 Clarity Results: %Transmittance at 420 nm

Clarity of Hand Sanitizing Gels

100 90 80 70 60

Clarity, %T

Carbopol 940 Polymer

50

Carbopol 980 Polymer

40 30 20 10 0 0.10% 0.30% 0.50%

Carbopol Ultrez 10 Polymer Carbopol Ultrez 21 Polymer Carbopol Ultrez 20 Polymer

Polymer Concentration, wt% TS

Viscosity Results: Brookfield RVT, 20 rpm @ 25C

Viscosity of Hand Sanitizing Gels

25,000

20,000

Carbopol 940 Polymer

Viscosity, mPas

Carbopol 980 Polymer

15,000

10,000

Carbopol Ultrez 10 Polymer Carbopol Ultrez 21 Polymer Carbopol Ultrez 20 Polymer

5,000

0 0.10% 0.30% 0.50%

Polymer Concentration, wt% TS

4 Neutralization of Carbopol Polymers in Hand Sanitizing Gels The key to formulating a hydroalcoholic gel with Carbopol polymers is choosing the correct neutralizing agent. Many neutralizing agents commonly used to neutralize Carbopol polymers in aqueous systems do not work in hydroalcoholic systems. There are amine solubility limitations with high alcohol, low water containing systems. The solubility of the Carbopol polymer salt changes as the alcohol level is increased making the choice of neutralizing agents important. Different choices are provided as a guideline for the different alcohol type and level. Neutralizing Agent Versus Alcohol Level Maximum Alcohol Level 20% 30% 60% Angus / Dow Angus / Dow BASF Dow 60% 80% 90% 90% Neutralization Ratio* Base/ Carbopol Polymer 2.3/1.0 2.7/1.0 1.5/1.0 3.3/1.0 0.9/1.0 2.3/1.0 1.5/1.0

Trade Name NaOH (18%) KOH (18%) TEA (99%) Tris Amino (40%)** AMP Ultra PC2000 Neutrol TE Triisopropanolamine

INCI Name Sodium Hydroxide Potassium Hydroxide Triethanolamine Tromethamine Aminomethyl Propanol Tetrahydroxypropyl Ethylenediamine Triisopropanolamine

Manufacturer

* Ratio values indicated above are for mucilages. For the 60% hydroalcoholic gel, divide the base ratio amount by 1.25 **NOTE: The 40% solution should be made from the Tris Amino crystal provided by the manufacturer. We do not recommend using the predispersed solution produced by the manufacturer due to its high impurity content

Check your local regulations while selecting the appropriate neutralizing amine since there are often specific guidelines on the type of amine and impurity level in the amine for these types of formulations. Modification and Formula Enhancements for Hydroalcoholic Gels
Common Formulation additives for Hand Sanitizing Gels
Emollients Water soluble emollients

Carbopol polymers
Rheology modifier

Alcohol
Disinfecting agent

Fragrance Botanical Actives Specialty Silicones

5 Formulation and Manufacturing Guidelines Typical hand sanitizing gels contain less that 40 wt% water. Due to this formulation constraint, a common concern is how to effectively incorporate the Carbopol polymer. The general methods are outlined as follows, dependent on your choice of polymer:

Direct Method The direct method is the traditional method for dispersing Carbopol polymers. Carbopol Ultrez Polymers: This method is made easy with Carbopol Ultrez polymers since you simply sprinkle the polymer on the surface of the water. Allow the polymer to self wet and then begin agitation. The general procedure is described as follows: 1. Disperse the polymer into the water. Mix until smooth to insure a lump free dispersion is obtained. 2. Slowly add the alcohol with agitation and mix until homogeneous. 3. Add emollients if desired. Keep in mind that the order of addition may be critical to maintain product clarity. See Adding Emollients for further information. 4. Add the appropriate neutralizing agent with gentle sweeping agitation and mix until smooth. NOTE: If production equipment constraints require the water and alcohol to be combined before the dispersion of polymer, the Carbopol Ultrez polymers must be dispersed like a traditional polymer. The Carbopol Ultrez grade polymers will not self wet in a solution of water and alcohol. Carbopol Traditional Grade Polymers: These polymers can be dispersed in either the water or alcohol/water mixture. The polymer will swell more slowly when added to the alcohol/water mixture, so care must be taken to avoid the clumping and skinning of the polymer during the dispersion process. 1. Carefully disperse the polymer in the water or water/alcohol mixture with good agitation. High mixing speeds are generally preferred as it prevents agglomeration of the polymer on the surface of the water. Mix until the polymer is hydrated and the dispersion is smooth and free of lumps. 2. Add the alcohol with slow mixing to de-aerate the formulation if it was not included in Step 1. 3. Add emollients if desired. Keep in mind that the order of addition may be critical to maintain product clarity. See Adding Emollients for further information. 4. Add the appropriate neutralizing agent with gentle sweeping agitation and mix until smooth. Water Source: Use deionized water. Carbopol polymers are sensitive to hard water ions, therefore, the clarity and viscosity may be negatively affected if regular tap water is used. If deionized water is unavailable, add a chelating agent such as tetrasodium EDTA at a level of about 0.05-0.10% (wt/wt%). Adding Emollients: Several commercially available emollients can be added to the hand sanitizing gel to compensate for removal of oils on the hands by the alcohol. The following watersoluble emollients can be added directly to the water and polymer dispersion or just before neutralization. The use of these emollients from 0.3-0.5 wt% addition will not impact the final product clarity. Trade Name Glucam E-20 Humectant Glucam E-10 Humectant SilSense Copolyol-1 Silicone SilSense SW-12 Silicone Ester Hydramol PGPL Emollient Hydramol PGDS Emollient INCI Name Methyl Gluceth-20 Methyl Gluceth-10 PEG-33 and PEG-8 Dimethicone and PEG-14 Dimethicone PEG-7 Cocoate PEG/PPG-8/3 Laurate PEG-90 Diisostearate

6 The Hydramol emollients can be added at use levels from 0.5-3.0 wt% and still maintain good clarity in the system. The use of other emollients may impact the final product clarity depending on the solubility profile of that particular emollient. Other emollients, such as isopropyl myristate, may need to be added to the alcohol and the water/polymer dispersion added to the alcohol/emollient phase to maintain final product clarity. Clarity (% Transmission @ 420 nm) All polymers suggested for this application have excellent clarity in hydroalcoholic systems. Clarity can be affected by many factors including dispersion techniques, water source, emollient content, formulation pH, type and level of fragrance and/or dye addition. Hydroalcoholic gels made with Carbopol polymers typically have clarity of 92-98 %T. To obtain optimum clarity we recommend the following: Use deionized water. Use Direct Method for Polymer Dispersion. When using self-wetting polymers they should be dispersed in water, not a water/alcohol mixture. Reference TDS-103 for details on dispersing traditional grade Carbopol polymers. Choose the correct neutralizing amine. It is important to insure that the neutralizing amine is compatible with the alcohol. Reference guidelines provided. For maximum clarity, target appropriate pH. We recommend the following pH: For Carbopol polymers such as Ultrez 10, 940 and 980, the optimum pH is typically around 7.0. For Carbopol Ultrez 21 and Ultrez 20 polymers, the optimum pH is 5.8-6.3. We recommend evaluating various pH levels and neutralizing amines to determine which combination provides the best clarity for your specific formulation. Choose a water-soluble emollient. Optimize use level to provide best balance of clarity and conditioning aesthetics. Use water soluble dyes. Examples of appropriate colors are D&C Red #33, D&C Green #5, and FD&C Blue #1. Dyes supplied as powders should be made into dilute (1-3 wt%) solutions and added at the end of the formulation. Addition of oil soluble fragrances. These ingredients should be post added at low levels. A solubilizer such as Polysorbate 20 at about 0.2 wt% may be necessary to insure good clarity. Filtration of end product will maximize final clarity.

Frequently Asked Questions Hand hygiene in healthcare settings. The US Center for Disease Control (CDC) has issued guidelines for hand hygiene in healthcare settings in order to more effectively reduce the spread of hospital-based infections by healthcare professionals. The CDCs guideline, released in October 2002, strongly recommends alcoholbased hand sanitizers as the primary method of hand hygiene among healthcare professionals when hands are not visibly soiled. The World Health Organization (WHO) issued Hand Hygiene in Health Care Guidelines in May of 2009. The following is a link to that document: http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf Safety of direct food contact after using an alcoholic hand sanitizer? Using an alcoholic hand sanitizing gel is generally considered safe. In Canada, workers in the food industry are allowed to use alcoholic hand sanitizing gels since they have been approved by Health Canada. These systems are listed by the Canadian Food Inspections Agency as acceptable nonfood chemical products. In the food service industry, an alcohol sanitizer is considered helpful as an extra hand disinfecting step after washing of hands with soap and water. The FDA has approved Carbopol polymers for indirect food contact when used in hand sanitizers up to 0.5 wt%.

7 Protection in Schools. According to a study issued in October of 2000 in The American Journal of Infection Control, the use of hand sanitizing gels was shown to decrease absenteeism due to illness among elementary school students by 20%. Acceptance of Hand Sanitizing Gels. According to a study published in the July, 2000 issue of Infection Control and Hospital Epidemiology, use of a Hand Sanitizing Gel is accepted by healthcare workers and does not result in skin irritation and dryness when compared to frequent soap and water hand washing. Regulations. Hand Sanitizing Gels may be regulated as drug products. Review your countrys regulations to insure compliance.