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

Lubrizol Advanced Materials, Inc. / 9911 Brecksville Road, Cleveland, Ohio 44141-3247 / TEL: 800.379.5389 or 216.447.5000
The information contained herein is being furnished combination with other substances or in the User’s process. THE IMPLIED WARRANTIES OF MERCHANTABILITY
for informational purposes only, upon the express condition Due to variations in methods, conditions and equipment OR FITNESS FOR A PARTICULAR PURPOSE. It is the
that the User makes its own assessment of the appropriate used commercially in processing these materials, no User’s sole responsibility to determine if there are any
use of such information. While the information contained warranties or guarantees are made as to the suitability of issues relating to patent infringement of any component or
herein is believed to be reliable, no representations, the information or products for the applications combination of components relating to the supplied
guarantees or warranties of any kind are made as to its disclosed. Lubrizol shall not be liable and the User information. Nothing contained herein is to be
accuracy, suitability for a particular application or the assumes all risk and responsibility for any use or considered as permission, recommendation, nor as
results to be obtained herefrom. Lubrizol Advanced handling of any material beyond Lubrizol's direct an inducement to practice any patented invention
Materials, Inc. ("Lubrizol") cannot guarantee how any control. LUBRIZOL MAKES NO WARRANTIES, EXPRESS without permission of the patent owner.
products associated with this information will perform in OR IMPLIED, INCLUDING, BUT NOT LIMITED TO,
For further information, please visit: www.lubrizol.com/personalcare
Lubrizol Advanced Materials, Inc. is a wholly owned subsidiary of The Lubrizol Corporation
All trademarks owned by The Lubrizol Corporation
© Copyright 2012 / The Lubrizol Corporation
TDS-255
®
Formulating Hydroalcoholic Gels with Carbopol Polymers
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Lubrizol Advanced Materials’ rheology modifiers are Polymer Selection


efficient ingredients to provide thickening,
stabilization and suspension of these types of Although all Carbopol polymers can thicken
formulations. Carbopol polymers are the preferred hydroalcoholic systems, several grades offer
polymers to provide cost effective and aesthetically advantages such as higher clarity, better
pleasing hand sanitizing gels. The use of Carbopol efficiency, ease of handling and better overall
polymers will create thick clear gels that will prevent aesthetics for hand sanitizing gels. All three of our
dripping and will maximize contact of alcohol on the Carbopol Ultrez polymers are good rheology
skin for optimum performance. modifiers for these gels. A typical hand sanitizing
gel contains less than 40 wt% deionized water.
Benefits Due to this constraint, the low dispersion viscosity,
as well as the processing ease, makes the
• Quickly kills bacteria when water is not available. Carbopol Ultrez polymers well-suited for these
• Quickly evaporates on application requiring no types of formulations as compared to the more
need for rinsing or drying of the hands. traditional polymer grades. The following table will
• Consumer convenience over ordinary hand assist in polymer selection.
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.

Carbopol® Polymer Ultrez 10 Ultrez 21 Ultrez 20 980 940

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

Screening Formulation for Carbopol Polymer Comparison

Use Level of Carbopol® Polymer 0.1 wt% 0.2 wt% 0.3 wt% 0.4 wt% 0.5 wt%

Deionized Water (wt%) 39.8 39.6 39.4 39.2 39.0


Ethanol (wt%) 60.0 60.0 60.0 60.0 60.0
TEA (wt%) 0.1 0.2 0.3 0.4 0.5
TDS-255
®
Formulating Hydroalcoholic Gels with Carbopol Polymers
Page 3 of 6

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
Carbopol® Ultrez 10
30
Polymer
Carbopol® Ultrez 21
Polymer
20
Carbopol® Ultrez 20
Polymer
10

0
0.10% 0.30% 0.50%

Polymer Concentration, wt% TS

Viscosity Results: Brookfield RVT, 20 rpm @ 25°C

Viscosity of Hand Sanitizing Gels

25,000

20,000
Carbopol® 940 Polymer
Viscosity, mPa•s

Carbopol® 980 Polymer


15,000
Carbopol® Ultrez 10
Polymer
Carbopol® Ultrez 21
Polymer
10,000 Carbopol® Ultrez 20
Polymer

5,000

0
0.10% 0.30% 0.50%

Polymer Concentration, wt% TS


TDS-255
®
Formulating Hydroalcoholic Gels with Carbopol Polymers
Page 4 of 6

Neutralization of Carbopol Polymers in Hand systems. There are amine solubility limitations with
Sanitizing Gels high alcohol, low water containing systems. The
solubility of the Carbopol polymer salt changes as the
The key to formulating a hydroalcoholic gel with alcohol level is increased making the choice of
Carbopol polymers is choosing the correct neutralizing agents important. Different choices are
neutralizing agent. Many neutralizing agents provided as a guideline for the different alcohol type
commonly used to neutralize Carbopol polymers in and level.
aqueous systems do not work in hydroalcoholic

Neutralizing Agent Versus Alcohol Level


Maximum
Alcohol Neutralization Ratio*
Trade Name INCI Name Manufacturer Level Base/ Carbopol® Polymer
NaOH (18%) Sodium Hydroxide 20% 2.3/1.0
Potassium
KOH (18%) 30% 2.7/1.0
Hydroxide
TEA (99%) Triethanolamine 60% 1.5/1.0

Tris Amino (40%)** Tromethamine Angus / Dow 60% 3.3/1.0


Aminomethyl
AMP® Ultra PC2000 Angus / Dow 80% 0.9/1.0
Propanol
Tetrahydroxypropyl BASF
Neutrol® TE 90% 2.3/1.0
Ethylenediamine

Triisopropanolamine Triisopropanolamine Dow 90% 1.5/1.0


* 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


Water soluble emollients
Emollients

Carbopol® polymers
Rheology modifier

Alcohol
Disinfecting agent

Fragrance
Botanical Actives

Specialty Silicones
TDS-255
®
Formulating Hydroalcoholic Gels with Carbopol Polymers
Page 5 of 6

Formulation and Manufacturing Guidelines 2. Add the alcohol with slow mixing to de-aerate the
formulation if it was not included in Step 1.
• Typical hand sanitizing gels contain less that 40 3. Add emollients if desired. Keep in mind that the
wt% water. Due to this formulation constraint, a order of addition may be critical to maintain
common concern is how to effectively incorporate product clarity. See “Adding Emollients” for
the Carbopol polymer. The general methods are further information.
outlined as follows, dependent on your choice of 4. Add the appropriate neutralizing agent with gentle
polymer: sweeping agitation and mix until smooth.

Direct Method: The direct method is the traditional • Water Source: Use deionized water. Carbopol
method for dispersing Carbopol polymers. polymers are sensitive to hard water ions,
therefore, the clarity and viscosity may be
Carbopol Ultrez Polymers: This method is made negatively affected if regular tap water is used. If
easy with Carbopol Ultrez polymers since you simply deionized water is unavailable, add a chelating
sprinkle the polymer on the surface of the water. agent such as tetrasodium EDTA at a level of
Allow the polymer to self wet and then begin about 0.05-0.10% (wt/wt%).
agitation. The general procedure is described as
follows: • Adding Emollients: Several commercially
1. Disperse the polymer into the water. Mix until available emollients can be added to the hand
smooth to insure a lump free dispersion is sanitizing gel to compensate for removal of oils
obtained. on the hands by the alcohol. The following water-
2. Slowly add the alcohol with agitation and mix until soluble emollients can be added directly to the
homogeneous. water and polymer dispersion or just before
3. Add emollients if desired. Keep in mind that the neutralization. The use of these emollients from
order of addition may be critical to maintain 0.3-0.5 wt% addition will not impact the final
product clarity. See “Adding Emollients” for product clarity.
further information.
4. Add the appropriate neutralizing agent with gentle
Trade Name INCI Name
sweeping agitation and mix until smooth. Glucam™ E-20 Humectant Methyl Gluceth-20
Glucam™ E-10 Humectant Methyl Gluceth-10
NOTE: If production equipment constraints require SilSense™ Copolyol-1 Silicone PEG-33 and PEG-8
the water and alcohol to be combined before the Dimethicone and PEG-14
dispersion of polymer, the Carbopol Ultrez polymers SilSense™ SW-12 Silicone Ester Dimethicone PEG-7 Cocoate
Hydramol™ PGPL Emollient PEG/PPG-8/3 Laurate
must be dispersed like a traditional polymer. The
Hydramol™ PGDS Emollient PEG-90 Diisostearate
Carbopol Ultrez grade polymers will not self wet in a
solution of water and alcohol.
The Hydramol™ emollients can be added at use
Carbopol Traditional Grade Polymers: These levels from 0.5-3.0 wt% and still maintain good clarity
polymers can be dispersed in either the water or in the system.
alcohol/water mixture. The polymer will swell more
slowly when added to the alcohol/water mixture, so The use of other emollients may impact the final
care must be taken to avoid the clumping and product clarity depending on the solubility profile of
skinning of the polymer during the dispersion that particular emollient. Other emollients, such as
process. isopropyl myristate, may need to be added to the
alcohol and the water/polymer dispersion added to
1. Carefully disperse the polymer in the water or the alcohol/emollient phase to maintain final product
water/alcohol mixture with good agitation. High clarity.
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.
TDS-255
®
Formulating Hydroalcoholic Gels with Carbopol Polymers
Page 6 of 6

Clarity (% Transmission @ 420 nm) Frequently Asked Questions


All polymers suggested for this application have • Hand hygiene in healthcare settings.
excellent clarity in hydroalcoholic systems. Clarity The US Center for Disease Control (CDC) has
can be affected by many factors including dispersion issued guidelines for hand hygiene in healthcare
techniques, water source, emollient content, settings in order to more effectively reduce the
formulation pH, type and level of fragrance and/or spread of hospital-based infections by healthcare
dye addition. Hydroalcoholic gels made with professionals. The CDC’s guideline, released in
Carbopol polymers typically have clarity of 92-98 %T. October 2002, strongly recommends alcohol-
To obtain optimum clarity we recommend the based hand sanitizers as the primary method of
following: hand hygiene among healthcare professionals
when hands are not visibly soiled. The World
• Use deionized water. Health Organization (WHO) issued “Hand Hygiene
• Use Direct Method for Polymer Dispersion. in Health Care Guidelines” in May of 2009.
When using self-wetting polymers they should be The following is a link to that document:
dispersed in water, not a water/alcohol mixture. http://whqlibdoc.who.int/publications/2009/978924
Reference TDS-103 for details on dispersing 1597906_eng.pdf
traditional grade Carbopol polymers. • Safety of direct food contact after using an
• Choose the correct neutralizing amine. It is alcoholic hand sanitizer?
important to insure that the neutralizing amine is Using an alcoholic hand sanitizing gel is generally
compatible with the alcohol. Reference guidelines considered safe. In Canada, workers in the food
provided. industry are allowed to use alcoholic hand
• For maximum clarity, target appropriate pH. sanitizing gels since they have been approved by
We recommend the following pH: Health Canada. These systems are listed by the
 For Carbopol polymers such as Ultrez 10, 940 Canadian Food Inspections Agency as acceptable
and 980, the optimum pH is typically around non-food chemical products. In the food service
7.0. industry, an alcohol sanitizer is considered helpful
 For Carbopol Ultrez 21 and Ultrez 20 polymers, as an extra hand disinfecting step after washing of
the optimum pH is 5.8-6.3. hands with soap and water. The FDA has approved
 We recommend evaluating various pH levels Carbopol polymers for indirect food contact when
and neutralizing amines to determine which used in hand sanitizers up to 0.5 wt%.
combination provides the best clarity for your • Protection in Schools.
specific formulation. According to a study issued in October of 2000 in
• Choose a water-soluble emollient. Optimize use The American Journal of Infection Control, the use
level to provide best balance of clarity and of hand sanitizing gels was shown to decrease
conditioning aesthetics. absenteeism due to illness among elementary
school students by 20%.
• Use water soluble dyes. Examples of appro-
priate colors are D&C Red #33, D&C Green #5, • Acceptance of Hand Sanitizing Gels.
and FD&C Blue #1. Dyes supplied as powders According to a study published in the July, 2000
should be made into dilute (1-3 wt%) solutions and issue of Infection Control and Hospital
added at the end of the formulation. Epidemiology, use of a Hand Sanitizing Gel is
accepted by healthcare workers and does not
• Addition of oil soluble fragrances. These
result in skin irritation and dryness when
ingredients should be post added at low levels. A
compared to frequent soap and water hand
solubilizer such as Polysorbate 20 at about 0.2
washing.
wt% may be necessary to insure good clarity.
• Regulations.
• Filtration of end product will maximize final
Hand Sanitizing Gels may be regulated as drug
clarity.
products. Review your country’s regulations to
insure compliance.

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