Seppic Hand Hygiene
Seppic Hand Hygiene
European biocide directive (REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL of 22 May 2012) defines in annex V Disinfectant products of type 1 as :
“biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for
the primary purpose of disinfecting the skin or scalp.”
Non-active substances
art 19 (9) - Where a biocidal product is intended for direct application to the external parts of the human body
(epidermis, hair system, nails, lips and external genital organs), or to the teeth and the mucous membranes of
the oral cavity, it shall not contain any non-active substance that may not be included in a cosmetic product
pursuant to Regulation (EC) No 1223/2009.
Ethanol, Isopropanol or propanol (propane-1-ol or n-propanol) at concentrations between 60% - 70% v/v
or a concentration between 520 et 630 mg/g (equivalence obtained by approximation with a mixture of
ethanol and water) and that advises the use of final products that are compliant with NF EN 14476 to
clearly assess Virucidal activity.
Thickener: it must be conform with article 19( 9) - UE Regulation n° 528/2012 (see previous slide) w/w: weight / weight v/v: volume/volume
Labelling
For information1, labelling must contain the following data:
- Gel name : « Hydroalcoholic Gel for hand hygiene - overridded decree »
- Composition : «Ethanol - Glycerin - used thickener»
- Manufacturer
- Manufacturing date and batch number
- Storage condition
- Several indications:
- Only for skin use
‘ Avoid eye contact
- Keep away from children
1
- Inflammable liquid: keep away from heat Data given for information. It must be checked with the local regulation.
SIMULGEL™ 600 SEPIGEL™ 305 SEPIPLUS™ 400 SEPINOV™ EMT 10 SEPIMAX™ ZEN
Liquid Liquid Liquid Powder Powder
Acrylamide/
Polyacrylate-13 -
Sodium Acryloyldimethyl Taurate Polyacrylamide - C13-14 Hydroxyethyl Acrylate/Sodium
Polyisobutene - Polysorbate Polyacrylate Crosspolymer-6
Copolymer - Isohexadecane - Isoparaffin - Laureth-7 Acryloyldimethyl Taurate Copolymer
20
Polysorbate 80
Anionic polymers
Pre-neutralized
SEPIGEL 305™
SIMULGEL™ range SEPIMAX ZEN™
SEPIPLUS™ range
SEPINOV™ range
Electrostatic repulsions
= polyelectrolytes
Ethanol compatibility
SIMULGEL™ 600 SEPIGEL™ 305 SEPIPLUS™ 400 SEPINOV™ EMT 10 SEPIMAX™ ZEN
4% 3% 2% 2% 2.8%
Liquid Liquid Liquid Powder Powder
Acrylamide/
Sodium Acryloyldimethyl Taurate Polyacrylamide - C13-14 Isoparaffin Polyacrylate 13 - Polyisobutene - Hydroxyethyl Acrylate/Sodium
Polyacrylate Crosspolymer-6
Copolymer - Isohexadecane - - Laureth-7 Polysorbate 20 Acryloyldimethyl Taurate Copolymer
Polysorbate 80
Ethanol 95°: 62% w/w Ethanol 95°: 70% w/w Ethanol 95°: >65% w/w Ethanol 95°: 65% w/w Ethanol 95°: >95% w/w
68,2% v/v 76,99% v/v 71,49% v/v 71,49% v/v > 96,7% v/v
Formula: qs polymer for an aqueous gel of 80 000-100 000 mPa.s, x% ethanol 95°, up to 100% Water
Process: prepare the aqueous gel and slowly add the solvent. For the concentrated liquid or powder grades, high shear and /or longer agitation could be necessary.
% v/v given in accordance with equivalence used in JORF “Decree 20th March 2020 : 59,1 % w/w ~ 65 % v/v - Source: https://www.legifrance.gouv.fr/eli/arrete/2020/3/20/TREP2008113A/jo/texte
66% Alcohol w/w 65% Alcohol w/w 65% Alcohol w/w 65% Alcohol w/w 65% Alcohol w/w
0.8%Sepimax Zen 1.6%Sepinov EMT 1.8%Sepiplus 400 2.2%Sepigel 305 2.2%Simulgel 600
10
Manufacturing advices
SEPIPLUS™ 400
SEPINOV™ EMT 10 SIMULGEL™ 600
or SEPIMAX ZEN™ SEPIGEL™ 305 Gradual ethanol addition
or Manufacturing equipment:
Liquid grade
SEPIPLUS™ 400
SIMULGEL™ 600
Process 1 SEPIGEL™ 305
Thickening
Water +
Glycerin Gel
Water +
Glycerin + Gel
Partial Ethanol content (~15%)
A Aqua/Water Up to 100%
Glycerin 3.00% This gel disinfects hands while
Absolute Ethanol (99,7°)* 66.00% moisturizing them.
B SEPIMAX ZEN™ 0.80% SEPIMAX™ ZEN (Polyacrylate Crosspolymer-6)
io ed C AQUAXYL™ 1.00% Pre-neutralized powder polymeric thickener with a MAXIMUM
at ix
n) 3 resistance to electrolytes thanks to its high associative behavior.
nt (f
SEPIMAX ZEN™ allows to thicken and texturize gels with high dosage
& TU
of alcohol, ideal for hand sanitizer. It also imparts rich, velvet and elegant
at IC
skin feel.
rm P
fo UR
COLD
More informations available on seppic.com
PROCESS
All information contained herein is intended merely to demonstrate the utility of SEPPIC products, and should not be construed as granting license to practice any compositions or methods covered by a patent or a A company
9514/GB/01/March 2020 - Hand Sanitizer
patent application. All information contained in this specific technical documentation is believed to be accurate and has been set up by SEPPIC according to its own described methods and processes. SEPPIC however
does not assume any liability or risks involved in the use of its products for the preparation and the assessment of the hereinabove formulation since the condition of use are beyond its control. SEPPIC customer must 15
insure that the duplication of the hereinabove formulation is not infringing any intellectual property rights and that it complies with any regulatory status.
EU07037A I BLUE HYDROALCOHOLIC GEL
Clean hands easily
HYGIENE
Clean Hands
FORMULATION ADVICES: Pilot- 2k g - DUMEK
Introduce water into the main tank, add ethanol and the blue dye, mix.
Sanitizer Add SEPIPLUS™ 400 then mix under vacuum with rotor/stator for 10’.
ADDITIONAL INGREDIENTS :Colorant FDC Blue n°1 (LCW).
COLD
PROCESS More informations available on seppic.com
All information contained herein is intended merely to demonstrate the utility of SEPPIC products, and should not be construed as granting license to practice any compositions or methods covered by a patent or a A company
9514/GB/01/March 2020 - Hand Sanitizer
patent application. All information contained in this specific technical documentation is believed to be accurate and has been set up by SEPPIC according to its own described methods and processes. SEPPIC however
does not assume any liability or risks involved in the use of its products for the preparation and the assessment of the hereinabove formulation since the condition of use are beyond its control. SEPPIC customer must 16
insure that the duplication of the hereinabove formulation is not infringing any intellectual property rights and that it complies with any regulatory status.
EU07613 I TRANSLUCID HYDROALCOHOLIC GEL
HYGIENE
Translucid gel
FORMULATION ADVICES - Laboratory scale - 300 g
Mix SEPINOV ™ EMT 10 with water in a beaker. Add alcohol step
by step.
Sanitizer
More informations available on seppic.com
COLD
PROCESS
All information contained herein is intended merely to demonstrate the utility of SEPPIC products, and should not be construed as granting license to practice any compositions or methods covered by a patent or a A company
9514/GB/01/March 2020 - Hand Sanitizer
patent application. All information contained in this specific technical documentation is believed to be accurate and has been set up by SEPPIC according to its own described methods and processes. SEPPIC however
does not assume any liability or risks involved in the use of its products for the preparation and the assessment of the hereinabove formulation since the condition of use are beyond its control. SEPPIC customer must 17
insure that the duplication of the hereinabove formulation is not infringing any intellectual property rights and that it complies with any regulatory status.
EU07614I SPRAYABLE HYDROALCOHOLIC GEL
HYGIENE
All information contained herein is intended merely to demonstrate the utility of SEPPIC products, and should not be construed as granting license to practice any compositions or methods covered by a patent or a A company
9514/GB/01/March 2020 - Hand Sanitizer
patent application. All information contained in this specific technical documentation is believed to be accurate and has been set up by SEPPIC according to its own described methods and processes. SEPPIC however
does not assume any liability or risks involved in the use of its products for the preparation and the assessment of the hereinabove formulation since the condition of use are beyond its control. SEPPIC customer must 18
insure that the duplication of the hereinabove formulation is not infringing any intellectual property rights and that it complies with any regulatory status.
EU07612I THICK HYDROALCOHOLIC GEL
HYGIENE
All information contained herein is intended merely to demonstrate the utility of SEPPIC products, and should not be construed as granting license to practice any compositions or methods covered by a patent or a A company
9514/GB/01/March 2020 - Hand Sanitizer
patent application. All information contained in this specific technical documentation is believed to be accurate and has been set up by SEPPIC according to its own described methods and processes. SEPPIC however
does not assume any liability or risks involved in the use of its products for the preparation and the assessment of the hereinabove formulation since the condition of use are beyond its control. SEPPIC customer must 19
insure that the duplication of the hereinabove formulation is not infringing any intellectual property rights and that it complies with any regulatory status.
EU06371A I HYDROALCOHOLIC GEL
HYGIENE
Minimalist Sanitizer
Gel texture for easy handling
A Aqua/Water Qs 100%
Ethanol 90°* 67,00%
B SEPIGEL™ 305 3,00% Liquid polymer, easy to use, with good compatibility with solvents such
as ethanol, SEPIGEL™ 305 (Polyacrylamide - C13-14 Isoparaffin - Laureth-7) allows
the formulation of minimalist gels. It has a creamy feel and produces very
easily gels with a soft texture.
COLD
PROCESS More informations available on seppic.com
All information contained herein is intended merely to demonstrate the utility of SEPPIC products, and should not be construed as granting license to practice any compositions or methods covered by a patent or a A company
9514/GB/01/March 2020 - Hand Sanitizer
patent application. All information contained in this specific technical documentation is believed to be accurate and has been set up by SEPPIC according to its own described methods and processes. SEPPIC however
does not assume any liability or risks involved in the use of its products for the preparation and the assessment of the hereinabove formulation since the condition of use are beyond its control. SEPPIC customer must 20
insure that the duplication of the hereinabove formulation is not infringing any intellectual property rights and that it complies with any regulatory status.
Concern Due to Excess
Sanitization
Water
Oil
Water
Optical microscope
Electronic
x400
microscope after
polarized light
cryofracture
SIMULGEL™ EG 0.5%
Dominant elastic network Up to
Preservative
(rheometer measurement with oscillation protocol)
Aqua/Water Up to 100%
MONTANOV™ 202
G’: elastic modulus G’’: viscous modulus
forms
the best dominant
Viscosity D7 25000 mPa.s 25000 mPa.s 35000 mPa.s 4000 mPa.s 300 mPa.s
elastic network 25
Stability RT Stable M6 Stable M6 Stable M6 Separation D7 Stable M6
in comparison to the other
Stability 40°C Stable M6 Stable M6 Stable M6 Separation D1 Separation M2
tested emulsifiers!
Stability 50°C Stable M1 Stable M1 Separation D7 Separation D1 Separation D7
Similar organization of lamellar phases to epidermis lipids for excellent skin affinity
⬇ Restructuring effect (In Vitro)
l 2 +++
Protocole
ge 14 S 82 68 L 20
am ™ ™ ™ ™ V™ V™ Drying • In Vitro test
re
NO
V
OV OV OV NO NO
lc AN AN AN
tro NT
A
NT NT TA TA effect • Gelatine cells
n NT N N
Co MO MO MO MO MO MO • SEPPIC method 57 CO 010
MONTANOV™
L
+++ Formula
Structuring
EMULSIFIER 5%
effect
LANOL™ 99 20%
Limit skin
dehydration SIMULGEL™ EG 0.5%
Preservative qs 26
Aqua/Water Up to 100%
* Protocole Formula
* * • In Vivo test
EMULSIFIER 3%
* * • 20 volunteers with dry skin (<50 a.u.) LANOL™ 1688 20%
• Single application
SIMULGEL™ EG 0.5%
• Application zone: leg
* * * * • Corneometer CM 825 Preservative qs
** * * 27
* * Aqua/Water Up to 100%
EXTREME CONDITIONS
• In Vivo test
• 50 volunteers with very dry skin (<30 a.u.)
• Single application
• Application zone: leg
• Corneometer CM 825
Formula
* 1min
MONTANOV™ L 3%
* application LANOL™ 2681 5%
All information contained herein is intended merely to demonstrate the utility of SEPPIC products, and should not be construed as granting license to practice any compositions or methods covered by a patent or a A company
9514/GB/01/March 2020 - Hand Sanitizer
patent application. All information contained in this specific technical documentation is believed to be accurate and has been set up by SEPPIC according to its own described methods and processes. SEPPIC however
does not assume any liability or risks involved in the use of its products for the preparation and the assessment of the hereinabove formulation since the condition of use are beyond its control. SEPPIC customer must 29
insure that the duplication of the hereinabove formulation is not infringing any intellectual property rights and that it complies with any regulatory status.
HYGIENE
All information contained herein is intended merely to demonstrate the utility of SEPPIC products, and should not be construed as granting license to practice any compositions or methods covered by a patent or a A company
9514/GB/01/March 2020 - Hand Sanitizer
patent application. All information contained in this specific technical documentation is believed to be accurate and has been set up by SEPPIC according to its own described methods and processes. SEPPIC however
does not assume any liability or risks involved in the use of its products for the preparation and the assessment of the hereinabove formulation since the condition of use are beyond its control. SEPPIC customer must 30
insure that the duplication of the hereinabove formulation is not infringing any intellectual property rights and that it complies with any regulatory status.
HYGIENE
All information contained herein is intended merely to demonstrate the utility of SEPPIC products, and should not be construed as granting license to practice any compositions or methods covered by a patent or a A company
9514/GB/01/March 2020 - Hand Sanitizer
patent application. All information contained in this specific technical documentation is believed to be accurate and has been set up by SEPPIC according to its own described methods and processes. SEPPIC however
does not assume any liability or risks involved in the use of its products for the preparation and the assessment of the hereinabove formulation since the condition of use are beyond its control. SEPPIC customer must 31
insure that the duplication of the hereinabove formulation is not infringing any intellectual property rights and that it complies with any regulatory status.
Hand Wash -
Foaming Range
All information contained herein is intended merely to demonstrate the utility of SEPPIC products, and should not be construed as granting license to practice any compositions or methods covered by a patent or a A company
9514/GB/01/March 2020 - Hand Sanitizer
patent application. All information contained in this specific technical documentation is believed to be accurate and has been set up by SEPPIC according to its own described methods and processes. SEPPIC however
does not assume any liability or risks involved in the use of its products for the preparation and the assessment of the hereinabove formulation since the condition of use are beyond its control. SEPPIC customer must 35
insure that the duplication of the hereinabove formulation is not infringing any intellectual property rights and that it complies with any regulatory status.
HYGIENE
All information contained herein is intended merely to demonstrate the utility of SEPPIC products, and should not be construed as granting license to practice any compositions or methods covered by a patent or a A company
9514/GB/01/March 2020 - Hand Sanitizer
patent application. All information contained in this specific technical documentation is believed to be accurate and has been set up by SEPPIC according to its own described methods and processes. SEPPIC however
does not assume any liability or risks involved in the use of its products for the preparation and the assessment of the hereinabove formulation since the condition of use are beyond its control. SEPPIC customer must 36
insure that the duplication of the hereinabove formulation is not infringing any intellectual property rights and that it complies with any regulatory status.
Thank you !
A company of