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Training Course
PUM
Rob Klerkx
Instruction plan
1. Introduction and goal setting
2. Definitions
3. Elementary chemistry
4. Hygiene and Safety
5. Anatomy of the skin
6. Quality issues
7. Ingredients and formulas ( theory)
How do we proceed?
• Everyday we take a few sheets
• Who is your trainer? And who are you?
• Goal of our training is:
• to develop some knowledge of the skin and the mechanics of cosmetic
products
• To develop knowledge about safety in handling chemicals
• To understand theoretically the production processes
Who is Rob Klerkx?
• Engineer in Chemical Technology
• MsC. in Biochemistry
• MsC in Strategic Marketing
• Dutch , 64 years
• > 30 years of experience in pharmaceutical/ cosmetical and food-beverage
industry
• Ca 15 project for PUM in Africa, Europe and Asia
• Product Development
• Marketing
• Quality Control and Assurance
• Supply Chain Management
2. Definitions
• Etymology
• Classifications
• Nomenclature
2.1 Etymology
• The word cosmetic arrives from the Greek word
• κοσμητικός (kosmêtikos)
• The kosmos which designs the beauty, the beautiful appearance.
• In the Greek history to define the beauty of an army, which is ready
for the battle, to impress the enemy.
2.2 Legal Definition(I)
• We understand the cosmetically product as:
• A "cosmetic product" shall mean any substance or mixture intended to be
placed in contact with the various external parts of the human body
(epidermis, hair system, nails, lips and external genital organs) or with the
teeth and the mucous membranes of the oral cavity with a view exclusively
or mainly to cleaning them, perfuming them, changing their appearance
and/or correcting body odours and/or protecting them or keeping them in
good condition. All substances or mixtures which are meant to bring into
contact with the superficial parts of the human body ( skin, hair, nails, lips,
genital parts and teeth)
• According CE no 1223/2009 of the EU
Not under this definition are:
• Liquids for the eye and nose with a pharmaceutical goal
• Creams with a pharmaceutical purpose
• All products which are ingested with a cosmetical purpose, these are
defined as food
• Products like tattoos
Definitions (II)
• A product is called:
• Environmental:
• When it respects the environment
• Natural
• When is produced with purely natural components
• Biological
• When the ingredients are not in any way treated by chemistry and do not
contain pesticides
• Vegetal
• When the product is purely and uniquely is made of plants or extracts of
plants
2.3 Nomenclature INCI
INCI: International Nomenclature of Cosmetic Ingredients
Type of raw material INCI Europe INCI USA
Chemistry
Sodium dodecyl sulphate SDS
Simplified chemical name:
Sodium lauryl sulphate SLS
Simplified chemical name:
Sodium Lauryl Sulphate
Vegetal
Argan oil
Shea butter
Botanical name:
Agania spinosa
Butyrospermum parkii butter
Common name:
Argan oil
Shea butter
Colour:
Indigo
CL xxxxx
CL= color index
Xxxxx= number of 5 numbers
CL 73000
Name defined by FDA
D&C Blue no. 6
3. Elementary Chemistry
• What is chemistry?
• Molecular structures
• pH
• Lipids
• Surfactants
• Colloid chemistry
• Emulsions
• Other ingredients
3.1 General Chemistry
• Chemistry
• Study of atoms, ions and molecules and their chemical reactions
• Organic Chemistry
• Study of the chemistry focussed on carbon related organic chemistry
• Inorganic Chemistry
• Study of all other chemical reactions based on elements with the exclusion of
carbon
3.2 Molecular structure
3.2 Molecular structure of butane
General formula C4H10
Semi-developed CH3(CH2)2CH3
Developed CH3-Ch2-Ch2-CH3
Topological formula
Molecular mass 58,12
3.3 Acids and bases
Acid
• Substance which liberates
a proton: H+ in water
• E.g. HCl
Base
• Substance which liberates OH-
ions in water
• E.g. NaOH
• pH= -log[H+]
Ordinary pH scale
3.4 Lipids
Oils, Tri-Glycerides, Fatty Acids
• Vegetal oils en animal fats constitute principally (98%) of tri-glycerides
• Tri-Glycerides are build on glycerol with three fatty acids:
Satured and non-satured fatty acids
Formula Description
Palmetic acid has 16 carbon atoms.
Therefore it is named C16
Most of the fatty acids have between 12
and 20 Carbon atoms
Some fatty acids have one or more
unsatured bonds
e.g. Linoleic acid (C18:2)
Some well known fatty acids
Oxidation of oils
• Hydrolytic rancidity occurs when water splits fatty acid chains away from the glycerol backbone in
triglycerides (ester hydrolysis).
• Usually unnoticed since most fatty acids are odourless and tasteless.
• A particular problem arises with butter, which contains triglycerides with a high content of butyric
acid derivatives and acetic acids.
• Oxidative rancidity is associated with the degradation by oxygen in the air. Via a free radical
process, the double bonds of an unsaturated fatty acid can undergo cleavage, releasing volatile
aldehydes and ketones.
• This process can be suppressed by the exclusion of oxygen or by the addition of antioxidants.
• (Auto)oxidation primarily occurs with unsaturated fats.
• Microbial rancidity refers to a process in which microorganisms, such as bacteria, use their
enzymes such as lipases to break down fat.
• This pathway can be prevented by sterilization.
Cosmetic utilization of vegetal oils
3.5 Surfactants
Tensio actives
Function tensides
• Tenside has a water soluble and a fat soluble part, which gives the
following properties
• Reduction of surface tension
• Cleansing of the skin
• Emulsion of dirt
• Easy removal of dirt
• Promotion of foam
• Water cannot remove
all dirt
• Soap does the job:
• HOW?
May 2014 Robert Klerkx for PUM 25
Active ingredients
Tensio active: Surfactants
• A surfactant works on the surface tension of two phases
• The reduction of surface tension between two immiscible liquids
favours the dispersion of one into the other
• Surfactants have:
• One part lipophilic and a-polar (miscible in fats and oils)
• One part hydrophilic and polar ( miscible in water)
• Example: Sodium lauryl Sulphate
Formation of micelles
Tensio active agents
• Detergents: to solubilize dirt into the water
• Dispersants: to stabilize a suspension
• Emulsifiers: to form and stabilize an emulsion
• Hydrating agents: to increase the penetration speed into the porous
skin
• Foams: to form bubbles in a liquid
Chemistry of Soap
Soap
Hydration
Detergent Breaks away the dirt from the
surface
Emulsifier Formation of micelles
3.6 Colloid Chemistry
3.7 Emulsions
• Emulsions contain water- and oil based ingredients
• Water and oil do not mix
• Result:
• O/W emulsions: oil droplets in water
• W/O emulsions: water droplets in oil
• Emulgators are needed to stabilize these emulsions
• Examples of emulgators
• O/W: soaps, fatty alcohols, PEG-esters of fatty acids
• W/O: fatty esters of polyglycerine, cholesterol
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Emulsions and emulgators
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Commercially, large-scale emulsions are prepared in large volume mixing tanks and refined and
stabilized by passage through advanced colloid mills or homogenizers.
•Pharmacists use different small-scale methods that each require that energy is put into the system
in some form:
–tritration ,
–homogenization,
–agitation,
–heat
•Methods
–Continental (Dry Gum, or 4:2:1)
–English (Wet Gum)
–Bottle (Forbes)
–Beaker Method (see further)
–Auxiliary
Pharmacist’s methods of emulsion
preparation
Beaker method (1)
The most appropriate method for preparing emulsions from surfactants or other non-gum emulsifiers is to
begin by dividing components into water soluble and oil soluble components.
•All oil soluble components are dissolved in the oily phase in one beaker and all water soluble components
are dissolved in the water in a separate beaker.
•Oleaginous components are melted and both phases are heated to approximately 70°C over a water bath.
•The internal phase is then added to the external phase with stirring until the product reaches room
temperature.
•The mixing of such emulsions can be carried out in a beaker, mortar, or blender; or, in the case of creams
and ointments, in the jar in which they will be dispensed.
Beaker method (2)
Oil phase: heated about 5-10 degree above the highest melting point of ingredient (water bath)
•Water phase: heated to the same temperature of oil phase (water bath)
•Add: internal phase into external phase, mix, constant agitation being provided throughout the time of
addition
•Caution:
–not to heat the phase above 85 degree
–rate of cooling determining the final texture and consistency
3.8 Other ingredients
• Soap removes not only dirt, but also skin fat ( sebum)
• We add hydrating agents and moisturizing agents to the soap for
temporarily purpose
• Examples moisturizing agents:
• Lanoline
• Fatty acids
• Fatty alcohols
• Lecithine
• Examples of hydrating agents
• Glycerine
• Glycol
• Sorbeth
• Polyethylene glycol
May 2014 Robert Klerkx for PUM 43
3.8.1 Hydrating agents
3.8.2 Conservation agents
• Goal: to protect a product against micro-biological and mould
contamination.
• But: Sterile shit remains always shit. So do clean first!
natural Semi-natural Synthetic
Poumplemousse Cosgard (benzyl alcohol,
dehydroacetic acid, water)
Benzoate, sorbate
Parabenes
Ureum derivatives
Isothiazolones
Triclosan
Salicylic acid
Heliozimth K
• Cosmetic products may be spoiled by oxidation
• Anti-oxidants take away the oxygen radicals
• Examples of anti-oxidants:
• Vitamine E (Tocoferol)
• Dibutylhydroxytoluene
• Ascorbic acid
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8.3 Anti-oxidants
• Fragrances
• Colouring agents
• Viscosity stabilizers
• Foam stabilizers
• Chemicals to support
claim
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3.8.4 Other ingredients
Other ingredients
Skin conditioner
• Interact by their structure with
the skin and pulls it straight.
Smoothing.
• Collagen- or silkhydrolysate and
milk proteins. Silicon
compounds.
Humidifier
• Every wash removes lipids from
the skin. Therefore the skin will
dry-out too much.
• Therefore we add humidifiers to
reverse partly the removal of
lipids.
• Amino acids, glycerine, milk acid
and sorbit.
Other ingredients
Fragrance
• To stimulate the purchase and
psychological well feeling of
user. Takes away off
flavopunctatus of tensides.
• Mind the possible interaction
with colouring agents.
Colour
• European laws restrict the use of
colouring agents.
• Mind the pH, basic formulation
and stability. concentration
0,0001 - 0,01%
Other ingredients
Pearling
• Give tensidproducts a pearl
mutter shine.
• E.g. glycoldisearate
• With styrol acrylate colymer we
obtain a milky appearance
without pearls.
Organic acids
• To adjust to the pH of the skin 5-
6.
• Often used are wine acid or citric
acid to 0,1-0,5%
• Citric acid helps also as
complexer.
Other ingredients
Complexer
• Catch heavy metals which
promote oxidation like iron and
copper.
• Sodium salt of
ethylendiamintetraacetic acid or
editronacid.
Thickener
• To adjust the viscosity
• Fattyalcoholethoxylate,
fattyacidalkylolamide or salt.
• Mind too much salt will reverse
the thickening and induce
separation.
• To from a gel we use xanthan,
hydroxypropylmethylcellulose.
Chemical operations
• Mixing. Basic operation to blend two or more substances evenly
• Hominization to change the particle size in emulsions and suspensions to prevent
separation
• Dispersion to mix one or more phases of substances into a dispersion liquid. Could be
solid, liquid or gas
• Emulations. To mix two not soluble substances into each other. The outer liquid is called
continuous phase, the other inner phase is called discontinuous phase
• Suspension. To mix into very small, but not molecular parts of a solid into liquids.
4. Hygiene and sanitary protection
• Instructions
• Disinfection en sterilization
• Safety measures
• Sanitary Plan
4.1 GMP ( ISO 22716:2007)
Personnel Hygiene
2.15 Detailed hygiene programmes should be established and adapted to the different needs
within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel.
These procedures should be understood and followed in a very strict way by every person whose duties take him into the
production and control areas.
Hygiene programmes should be promoted by management and widely discussed during training sessions.
2.16 All personnel should receive medical examination upon recruitment. It must be the manufacturer’s responsibility that
there are instructions ensuring that health conditions that can be of relevance to the quality of products come to the
manufacturer’s knowledge. After the first medical examination, examinations should be carried out when necessary for the
work and personal health.
4.1 GMP directives
2.18 Every person entering the manufacturing areas should wear protective garments appropriate to the operations
to be carried out.
2.19 Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal
medication in the production and storage areas should be prohibited. In general, any unhygienic practice within the
manufacturing areas or in any other area where the product might be adversely affected should be forbidden.
2.20 Direct contact should be avoided between the operator’s hands and the exposed product as well as with any
part of the equipment that comes into contact with the products.
2.21 Personnel should be instructed to use the hand-washing facilities
4.2 Three elementary points on hygiene:
• All aqueous products are very susceptible to bacteria- and mould
growth. It is therefore absolutely required to respect a perfect
hygiene:
1. Wash your hands well before you start the production. Wear
protective gloves, caps and masks.
2. Disinfect carefully all production materials:
1. or with boiling water during ten minutes or
2. by using pharmaceutical alcohol >96%. After production clean the
production means carefully.
3. Keep the preparations cool and use it within the week. Use natural
conservatives. And be apprehensive when you smell an off-flavour.
4.3 Safety measures
• The production of creams requires sometimes the heating of certain
phases. Be prudent as not to burn yourselves. It is necessary to wear
safety googles and gloves.
• Your ingredients should all and always be labelled if necessary with
safety instructions.
• In case of the use of alcohol: be careful, it is irritant to the eyes, it is
inflammable and it affects your respiratory tract.
• Certain ingredients contain the risk of allergy for certain persons.
• Always before you start a production: Read the safety instructions
carefully.
4.3 Symbols
4.4 Sanitary Plan
4.4 GMP plan
• Cleaning plan and disinfection plan
• Plan against rodents
• Training plan personnel
• Documentation
• Maintenance
• Hygiene of personnel
• Temperature checklists
• etc
Microbiology
HACCP hazard analysis and critical control points
CCP Hazard Measures Control
Formulation Insufficient conservation Improve formulation Validation
Ingredients Cell count
Toxins
Sterilisation
Audit supplier
Micro control
Analysis
Sterilisation Insufficient Validation Control
Production Insuff conservation Documentation Chemical analysis
Hygiène Contamination Cleaning and CIP hygiene plan
training hygiene officer
Installation Insuff cleaning / dead end Improve installation Hygiene validation
Quality control Faulty results Validation of equipment
and methods
Periodical checks
Logistics Supply of
contaminated products
Tests of system Controlled recall
5. Anatomy and physiology
• Composition of the skin
• Protection against drying out
• Protection against bacteria
• Protection against UV radiation
• Temperature regulation
• Changes of the skin
• Aging
• Disorders
The Skin
May 2014 63Robert Klerkx for PUM
• Adults have about 18000 cm2
of skin which weighs 4,8 kg
with men, 3,2 kg with
women.
• Two types of skin:
• Hairy
• Glabrous
• Composition:
• Epidermis
• Dermis
• Nerves & sense organs
• Hair follicles
• Sebaccous glands
• Appocrine glands
May 2014 Robert Klerkx for PUM 64
Composition of the skin
May 2014 Robert Klerkx for PUM 65
Epidermis
Epidermis Profile
• Different layers with kerotine
• Pigment cells
• Skin color
• by blood
• carotine (yellow)
• pigment cells (melalin)
• Langerhans cells
• Play role in immunity
• Merkel cells:
• Affect sensations
Skin renews every two to four weeks
May 2014 Robert Klerkx for PUM 66
May 2014 Robert Klerkx for PUM 67
Epidermis consists of:
_ Keratine: 58%
_ Fats, lipids: 20%
_ Water-soluble substances: 15%
_ Water 7%
May 2014 Robert Klerkx for PUM 68
The color melanine is produced in the pigment cells in the stratum
basale.
The melanocytes produce melaline and inject this in the young
skincells ( keratocytes)
No way that cosmetic products can do the same job!
• Protects the body against mechanical shocks
• Feeds the epidermis
• Contains
• Blood
• Nerves
• Hair follicles
• Sweat glands
May 2014 Robert Klerkx for PUM 69
Dermis
• Contains:
• Collagen 75%
• Elastin 4%
• Ground substance
• Fibroblasts
• Secrete collagen and elastin
• Mast cells
• Secrete histamine, which causes inflammation pain and itching
May 2014 Robert Klerkx for PUM 70
Dermis
• Sense organs
• Touch
• Warmth
• Sweat: by evaporation of fluids: chilling
• Cold
• Gooseflesh: Hair follicles rise ( air cushion) , skin contracts
• Pain
• Sweat glands:
• Control body temperature
• Excretion of water and salts
• Evaporation: ( 6-7 burst per minute)
• Environmental temperature
• UV light
• Emotional stress
• Rise of body temperature
May 2014 Robert Klerkx for PUM 71
Nerves & sense organs
• Hair is produced by
keratinization
• 120.000 follicles on the
human scalp
• Cycle: 1 to 3 years
• We lose 100 hairs from our
scalp each day
• Difference between scalp-
and pubic/axillary regions and
face of the male hair follicles
• The latter are initiated by
androgens ( male hormone)
• These androgens cause at the
same time baldness with
men.
May 2014 Robert Klerkx for PUM 72
Hair follicles
• Secrete sebum
• Lipid that covers skin
and hair
• Sebum:
• Tri-Glyceride
• Free fatty acids
• Wax esters (squalene)
May 2014 Robert Klerkx for PUM 73
Sebaccous glands
• Axillary, genital and
nipple regions
• Secrete milky
substance
• Supports human
communication
• Different bacteria
between men and
woman produce
different odors
May 2014 Robert Klerkx for PUM 74
Apocrine glands
• Protects body against
• Noxious substances
• Radiation
• Physical shocks
• Keeps body fluid inside (de-hydration)
• Heath control
• Protection against bacteria
• Transmits sexual and social signals, by
• Color
• Odor
• Materials
• Therefore it is important for cosmetic producers to fully understand the
mechanics of the skin
May 2014 Robert Klerkx for PUM 75
Function of the skin
• Aging:
• Starts at 25-30 yrs of age
• Loss of elasticity
• Start of wrinkles
• Reduction of sebum
• Skin becomes dryer
• Natural aging cannot be stopped!
• Stress, unhealthy food, alcohol, smoking, too much sunlight accelerate the process
• Disturbances:
• Washing and bathing remove sebum
• Puberty:
• Production of more sebum, which causes a fatty skin
• Clogging of exit sebaccous glands could cause bacterial growth
• Cellulitus with women:
• There is no remedy
• Diet, massage and sport
May 2014 Robert Klerkx for PUM 76
Changes of the skin
• Cosmetic chemist is not concerned with serious disorders
• Ephalides (freckles), lentigens and moles
• Freckles:
• Harmless, local pigmentation
• (western people): fair or red haired
• Genetically determined
• Vitilogo:
• Patchy depigmentation: often associated with leprosy
• Social stigma
• Caused by auto-immune disorder
• Cannot be treated, but by cosmetic camouflage
May 2014 Robert Klerkx for PUM 77
Disorders of the skin
• Skin consists of three layers
• Epidermis
• Dermis
• Hypodermis
• Outer layer is
impermeable: Outside-
in, but permeable inside –
out
• All our active ingredients
have too large molecules to
penetrate
• We can keep the epidermis
smooth, soft and maintain
humidity level
May 2014 Robert Klerkx for PUM 78
Summary
6. Quality Issues
Quality issues
• Quality Assurance
• GMP
• Traceability
• Labelling
6.1 Quality Assurance
6.2 ISO 22716 (GMP)
• Equipment
• Raw materials
• Environment
• Packaging material
• Buildings
• Personnel
• Critical stage procedures
GMP chain
6.3 Traceability
Some of the important points to be considered on traceability according to ISO 22005 are
1.Top management should have a traceability plan and design the traceability process based on the objectives
of the organisation.
2.The system should be verifiable, applied consistently, results oriented, cost effective, practical to apply,
compliant with local regulations and also with defined accuracy requirements.
3.The traceability objectives of the organisation may include, quality objectives, customer needs, to identify
responsible organisations
4.The organisation should document the flow of all materials and documents should be controlled based on
the documentation procedure
5.The organisation should have production definition, lot definition and batch identification, data management
and recording protocols
6.The information should be retrievable whenever required or when a customer complaint received.
7. The traceability plan shall be implemented by assigning responsibilities for qualified personnel which is
taken care of by top HR management.
Traceability: two ways
Supplier Producer Customers
information
products
6.4 What are the reason to label?
• Supply Chain function
• Protection function
• Information function
• Marketing function
6.4 Labelling of cosmetic products
• The name of the product and the address of the producer
• Country of origin
• The weight or volume at the moment of labelling
• Date of consum
• Instruction how to use
• Production lot number
• Ingredient list
• Instruction acc CE # 1223/2009 for cosmetic products
Practical
Functionality of skincare
• Objective and measurable
• Cleaning
• Make up
• Deodorant
• Sweat reducer
• UV protection
• Objective but hard to measure
• Humidity regulation
• Skin swelling
• Anti-wrinkle
• Skin protection improvement
• Flagrancy
• Effective against skin dirt
• Subjective and not measurable
• Young appearance
• Pleasant feeling
• Improved handle
• Erotic function of fragrance
• Plus the placebo effects of
• Colour, packaging, verbal sayings, name of producer, price, shop, publicity.
7. Ingredients and formulas
• Face Care
• Hand & Food Care
• Sun screen products
• Shampoo
• Creams & Emulsions
Basic and extended facial care:
Basics of care products Extra ingredients
• Oil
• Fat
• Wax
• Hydrating ingredients
• Liposomes
• UV filter
• Anti-oxidants
• Fruity acids (removal of loose
epidermis)
• Allantoine ( smooths dry skin)
• Bisabolol ( calms the skin)
• Plant extracts ( bleed)
• Emulgators
• Preservatives
• Thickener
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• Composition
• Different kinds of products
Hand & Foot care
May 2014 93Robert Klerkx for PUM
• Hand care:
• With our hands we wash and clean
• Products should contain:
• Fatty substances
• Preservatives
• Fragrances
• Foot care:
• Products are meant to clean and refresh the skin
• Feet contain many sweat glands
• Bacteria transfer sweat into sweaty odors
• Creams and balsa slightly acid
• Powders (talcum)
• Baths ( sodiumcarbonate, sodium hydrogencarbonate)
• Deodorants
• Anti-prespiration products ( alumiunsulphate, aluin, salicylic acid)
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Composition
• Effect of sunlight on the skin
• UV radiation
• Function of sunscreen products
• Different kinds of products
Sunscreen products
May 2014 95Robert Klerkx for PUM
Radiation from the sun
Down-side Up-side
• Affects the epidermis
• Destroys the collagen, which renders
elasticity to the skin
• Destroyed collagen renders skin leathery,
wrinkly
• Nicotine has the same effect
• As we grow older, we produce less and less
collagen
• Cosmetic products can only reduce effects by
keeping skin soft and shiny
• Important: Prudent with sun baths!
• Makes us happy
• Needed for
production of
Vitamin D
May 2014 Robert Klerkx for PUM 96
• Visible wavelength between 400 and 800 nm
• UV-A: 320- 400 nm
• UV-B: 280-320 nm
• UV-C: 100- 280 nm ( stopped by atmosphere)
• UV-B browns our body, but ‘burns’ as well
• Reaction of body against UV radiation:
• Thickening of epidermis ( 10x)
• Production of melamine ( in a couple of days)
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UV radiation
• SPF (Sun protection factor)
• SPF 10 means that we may sunbath 10 x longer without sunburns
• SPF 2 takes away 50% of radiation
• SPF 4 takes away 75% of radiation
• SPF 20 takes away 95% of radiation
• Sunscreen contains
• Filters ( 4-aminobenzoic acid)
• Pigments ( titan oxide and other oxides)
• Anti-oxidants
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Function of sunscreen products
Composition of shampoo
Ingredient Function1-4 %
Water Diluent 50-70
Primary surfactant Washing 15-30
Secondary surfactant Foaming agent 1-4
Gum Viscosity 0-5
Humidifier Hydration 1-5
Chelating agent Binding of calcium 0-1
Acid pH 2
Base pH
Parabens e,g Conservation
Dimethicone, silicones Conditioner
Active agents
Additives (oil,)
Preparation of shampoo (example)
Phase A Ingredient %
Distilled water water 66
Primary surfactant SLES 20
Gum NaCl 3
Humidifier Glycerine 2
Phase B
Additives Avocado oil 2
Secondary surfactant Cocoamido propyl betain 4
Chelating agent EDTA 1
Acid Citric acid 0.4
Phase C
Base NaOH 18%
Conservation agent Acnibio 0.1
Conditioner Dimethicone 1
Active agents - -
Fragrance Verveine 0.7
Total 100
Composition of emulsions
Ingredient Function %
Water Watery phase 60-85
Oils Oil phase < 30
Emulsifier Stability 5-10
Emollient Keep water on the skin
Humidifier Increase retention of the skin
Conservation Anti bacteria, anti fungicide
Anti oxidant Against rancidity
Fragrance
Colouring
Additives
Preparation of emulsions by HBL
Hydrophilic-Lipophilic balance
Value HLB Application
Lipophile
1 - 3 Anti- foam
3 - 8 Emulsions Oil/water
7 - 9 Humidant
8 - 18 Emulsion Water/Oil
11 - 15 Detergent
Hydrophile 15 - 18 Solubilizer
Aleurites Moluccana Seed Oil [7] Grape (Vitis Vinifera) Seed Oil [7]
Almond Oil NF [6] Hybrid Safflower (Carthamus Tinctorius) Oil [9]
Anhydrous Lanolin USP [10] Isopropyl Myristate [11.5]
Apricot Kernel Oil [7] Isopropyl Palmitate [11.5]
Avocado (Persea Gratissima) Oil [7] Jojoba (Buxus Chinensis) Oil [6.5]
Babassu Oil [8] Lanolin [10]
Beeswax [12] Macadamia (Ternifolia) Nut Oil [7]
Borage (Borago Officinalis) Seed Oil [7] Mangifera Indica (Mango) Seed Butter [8]
Brazil Nut Oil [8] Mineral Oil [10.5]
C12-15 Alkyl Benzoate [13] Myristyl Myristate [8.5]
Cannabis Sativa Seed Oil [7] Olive (Olea Europaea) Oil [7]
Canola Oil [7] Oryza Sativa (Rice Bran) Oil [7]
Caprylic/Capric Triglyceride [5] Peanut Oil NF [6]
Carrot (Daucus Carota Sativa) Seed Oil [6] Petrolatum [7]
Castor (Ricinus Communis) Oil [14] PPG-15 Stearyl Ether [7]
Ceresin [8] Retinyl Palmitate [6]
Cetearyl Alcohol [15.5] Safflower (Carthamus Tinctorius) Oil [8]
Cetyl Alcohol [15.5] Sesame (Sesamum Indicum) Oil [7]
Cetyl Esters [10] Shea Butter (Butyrospermum Parkii) [8]
Cetyl Palmitate [10] Soybean (Glycine Soja) Oil [7]
Coconut Oil [8] Stearic Acid [15]
Daucus Carota Sativa (Carrot) Root Extract [6] Stearyl Alcohol [15.5]
Diisopropyl Adipate [9] Sunflower (Helianthus Annus) Oil [7]
Dimethicone [5] Sweet Almond (Prunus Amygdalus Dulcis) Oil [7]
Dog Rose (Rosa Canina) Hips Oil [7] Theobroma Cacao (Cocoa) Seed Butter [6]
Oils and waxes and their HBL
Calcium Stearoyl Lactylate [HLB = 5.1 ± 1] Oleth-20 [HLB = 15.3 ± 1]
Ceteareth-20 [HLB = 15.2 ± 1] PEG-100 Stearate [HLB = 18.8 ± 1]
Cetearyl Glucoside [HLB = 11 ± 1] PEG-20 Almond Glycerides [HLB = 10 ± 1]
Ceteth-10 [HLB = 12.9 ± 1] PEG-20 Methyl Glucose Sesquistearate [HLB = 15 ± 1]
Ceteth-2 [HLB = 5.3 ± 1] PEG-25 Hydrogenated Castor Oil [HLB = 10.8 ± 1]
Ceteth-20 [HLB = 15.7 ± 1] PEG-30 Dipolyhydroxystearate [HLB = 5.5 ± 1]
Cocamide MEA [HLB = 13.5 ± 1] PEG-4 Dilaurate [HLB = 6 ± 1]
Glyceryl Laurate [HLB = 5.2 ± 1] PEG-40 Sorbitan Peroleate [HLB = 9 ± 1]
Glyceryl Stearate [HLB = 3.8 ± 1] PEG-60 Almond Glycerides [HLB = 15 ± 1]
Glyceryl Stearate (and) PEG-100 Stearate [HLB = 11 ± 1]
PEG-8 Laurate [HLB = 13 ± 1]
Glyceryl Stearate SE [HLB = 5.8 ± 1] PEG-80 Sorbitan Laurate [HLB = 19.1 ± 1]
Glycol Distearate [HLB = 1 ± 1] Polysorbate 20 [HLB = 16.7 ± 1]
Glycol Stearate [HLB = 2.9 ± 1] Polysorbate 60 [HLB = 14.9 ± 1]
Isoceteth-20 [HLB = 15.7 ± 1] Polysorbate 80 [HLB = 15 ± 1]
Isosteareth-20 [HLB = 15 ± 1] Polysorbate 85 [HLB = 11 ± 1]
Lauramide DEA [HLB = 15 ± 1] Sodium Stearoyl Lactylate [HLB = 8.3 ± 1]
Laureth-23 [HLB = 16.9 ± 1] Sorbitan Isostearate [HLB = 4.7 ± 1]
Laureth-4 [HLB = 9.7 ± 1] Sorbitan Laurate [HLB = 8.6 ± 1]
Lecithin [HLB = 4 ± 1] Sorbitan Oleate [HLB = 4.3 ± 1]
Lecithin [HLB = 9.7 ± 1] Sorbitan Sesquioleate [HLB = 3.7 ± 1]
Linoleamide DEA [HLB = 10 ± 1] Sorbitan Stearate [HLB = 4.7 ± 1]
Methyl Glucose Sesquistearate [HLB = 6.6 ± 1] Sorbitan Stearate (and) Sucrose Cocoate [HLB = 6 ± 1]
Oleth-10 [HLB = 12.4 ± 1] Sorbitan Trioleate [HLB = 1.8 ± 1]
Oleth-10 / Polyoxyl 10 Oleyl Ether NF [HLB = 12.4 ± 1] Stearamide MEA [HLB = 11 ± 1]
Oleth-2 [HLB = 4.9 ± 1] Steareth-2 [HLB = 4.9 ± 1]
Oleth-20 [HLB = 12.4 ± 1] Steareth-21 [HLB = 15.5 ± 1]
Emulsifiers sorted by INCI names
http://www.soapcalc.net
Use of calculation sheet
Day cream
,,/,,/2014 lot #
Composition Function % Weight
Phase A (water) grams
Water 59 294 1. Specify total
volumeGlycerine Humectant 3 15
Phase B (Oil)
Sesame oil Oil 15 75 2. Specify % of
ingredients
except for water
3. Calculate
amount of water
Almond oil Oil 15 75
Wax # 3 Emulsifier 7.5 37,5
Phase C ( Additives)
Cosgard Conservation 0.5 2,5 4. Do not forget
Different emulsions
Cream Milk Lotion
Date / lot# Date / lot # Date/ Lot #
Compositio
n
Function % grams % grams % grams
Phase A
water 60 299 83 413 69 346
Glycerine Humectant 2 10,0 3 15,0 5 25,0
Phase B 50,0
Sesame oil Oil 10 50,0 0 0 10 50,0
Avocado oil Oil 10 50,0 5 25,0 5 25,0
Argan oil Oil 10 0 5 25,0 0 0,0
Cactus oil Oil 0 37,5 0 0,0 5 25,0
Wax no 3 Emulsifier 7,5 3,0 15,0 5,0 25,0
The end

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Training course in skincare

  • 2. Instruction plan 1. Introduction and goal setting 2. Definitions 3. Elementary chemistry 4. Hygiene and Safety 5. Anatomy of the skin 6. Quality issues 7. Ingredients and formulas ( theory)
  • 3. How do we proceed? • Everyday we take a few sheets • Who is your trainer? And who are you? • Goal of our training is: • to develop some knowledge of the skin and the mechanics of cosmetic products • To develop knowledge about safety in handling chemicals • To understand theoretically the production processes
  • 4. Who is Rob Klerkx? • Engineer in Chemical Technology • MsC. in Biochemistry • MsC in Strategic Marketing • Dutch , 64 years • > 30 years of experience in pharmaceutical/ cosmetical and food-beverage industry • Ca 15 project for PUM in Africa, Europe and Asia • Product Development • Marketing • Quality Control and Assurance • Supply Chain Management
  • 5. 2. Definitions • Etymology • Classifications • Nomenclature
  • 6. 2.1 Etymology • The word cosmetic arrives from the Greek word • κοσμητικός (kosmêtikos) • The kosmos which designs the beauty, the beautiful appearance. • In the Greek history to define the beauty of an army, which is ready for the battle, to impress the enemy.
  • 7. 2.2 Legal Definition(I) • We understand the cosmetically product as: • A "cosmetic product" shall mean any substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition. All substances or mixtures which are meant to bring into contact with the superficial parts of the human body ( skin, hair, nails, lips, genital parts and teeth) • According CE no 1223/2009 of the EU
  • 8. Not under this definition are: • Liquids for the eye and nose with a pharmaceutical goal • Creams with a pharmaceutical purpose • All products which are ingested with a cosmetical purpose, these are defined as food • Products like tattoos
  • 9. Definitions (II) • A product is called: • Environmental: • When it respects the environment • Natural • When is produced with purely natural components • Biological • When the ingredients are not in any way treated by chemistry and do not contain pesticides • Vegetal • When the product is purely and uniquely is made of plants or extracts of plants
  • 10. 2.3 Nomenclature INCI INCI: International Nomenclature of Cosmetic Ingredients Type of raw material INCI Europe INCI USA Chemistry Sodium dodecyl sulphate SDS Simplified chemical name: Sodium lauryl sulphate SLS Simplified chemical name: Sodium Lauryl Sulphate Vegetal Argan oil Shea butter Botanical name: Agania spinosa Butyrospermum parkii butter Common name: Argan oil Shea butter Colour: Indigo CL xxxxx CL= color index Xxxxx= number of 5 numbers CL 73000 Name defined by FDA D&C Blue no. 6
  • 11. 3. Elementary Chemistry • What is chemistry? • Molecular structures • pH • Lipids • Surfactants • Colloid chemistry • Emulsions • Other ingredients
  • 12. 3.1 General Chemistry • Chemistry • Study of atoms, ions and molecules and their chemical reactions • Organic Chemistry • Study of the chemistry focussed on carbon related organic chemistry • Inorganic Chemistry • Study of all other chemical reactions based on elements with the exclusion of carbon
  • 14. 3.2 Molecular structure of butane General formula C4H10 Semi-developed CH3(CH2)2CH3 Developed CH3-Ch2-Ch2-CH3 Topological formula Molecular mass 58,12
  • 15. 3.3 Acids and bases Acid • Substance which liberates a proton: H+ in water • E.g. HCl Base • Substance which liberates OH- ions in water • E.g. NaOH • pH= -log[H+]
  • 18. Oils, Tri-Glycerides, Fatty Acids • Vegetal oils en animal fats constitute principally (98%) of tri-glycerides • Tri-Glycerides are build on glycerol with three fatty acids:
  • 19. Satured and non-satured fatty acids Formula Description Palmetic acid has 16 carbon atoms. Therefore it is named C16 Most of the fatty acids have between 12 and 20 Carbon atoms Some fatty acids have one or more unsatured bonds e.g. Linoleic acid (C18:2)
  • 20. Some well known fatty acids
  • 21. Oxidation of oils • Hydrolytic rancidity occurs when water splits fatty acid chains away from the glycerol backbone in triglycerides (ester hydrolysis). • Usually unnoticed since most fatty acids are odourless and tasteless. • A particular problem arises with butter, which contains triglycerides with a high content of butyric acid derivatives and acetic acids. • Oxidative rancidity is associated with the degradation by oxygen in the air. Via a free radical process, the double bonds of an unsaturated fatty acid can undergo cleavage, releasing volatile aldehydes and ketones. • This process can be suppressed by the exclusion of oxygen or by the addition of antioxidants. • (Auto)oxidation primarily occurs with unsaturated fats. • Microbial rancidity refers to a process in which microorganisms, such as bacteria, use their enzymes such as lipases to break down fat. • This pathway can be prevented by sterilization.
  • 22. Cosmetic utilization of vegetal oils
  • 24. Function tensides • Tenside has a water soluble and a fat soluble part, which gives the following properties • Reduction of surface tension • Cleansing of the skin • Emulsion of dirt • Easy removal of dirt • Promotion of foam
  • 25. • Water cannot remove all dirt • Soap does the job: • HOW? May 2014 Robert Klerkx for PUM 25 Active ingredients
  • 26. Tensio active: Surfactants • A surfactant works on the surface tension of two phases • The reduction of surface tension between two immiscible liquids favours the dispersion of one into the other • Surfactants have: • One part lipophilic and a-polar (miscible in fats and oils) • One part hydrophilic and polar ( miscible in water) • Example: Sodium lauryl Sulphate
  • 28. Tensio active agents • Detergents: to solubilize dirt into the water • Dispersants: to stabilize a suspension • Emulsifiers: to form and stabilize an emulsion • Hydrating agents: to increase the penetration speed into the porous skin • Foams: to form bubbles in a liquid
  • 30. Soap Hydration Detergent Breaks away the dirt from the surface Emulsifier Formation of micelles
  • 32.
  • 33.
  • 34.
  • 36. • Emulsions contain water- and oil based ingredients • Water and oil do not mix • Result: • O/W emulsions: oil droplets in water • W/O emulsions: water droplets in oil • Emulgators are needed to stabilize these emulsions • Examples of emulgators • O/W: soaps, fatty alcohols, PEG-esters of fatty acids • W/O: fatty esters of polyglycerine, cholesterol May 2014 Robert Klerkx for PUM 36 Emulsions and emulgators
  • 37. May 2014 Robert Klerkx for PUM 37
  • 38. Commercially, large-scale emulsions are prepared in large volume mixing tanks and refined and stabilized by passage through advanced colloid mills or homogenizers. •Pharmacists use different small-scale methods that each require that energy is put into the system in some form: –tritration , –homogenization, –agitation, –heat •Methods –Continental (Dry Gum, or 4:2:1) –English (Wet Gum) –Bottle (Forbes) –Beaker Method (see further) –Auxiliary Pharmacist’s methods of emulsion preparation
  • 39. Beaker method (1) The most appropriate method for preparing emulsions from surfactants or other non-gum emulsifiers is to begin by dividing components into water soluble and oil soluble components. •All oil soluble components are dissolved in the oily phase in one beaker and all water soluble components are dissolved in the water in a separate beaker. •Oleaginous components are melted and both phases are heated to approximately 70°C over a water bath. •The internal phase is then added to the external phase with stirring until the product reaches room temperature. •The mixing of such emulsions can be carried out in a beaker, mortar, or blender; or, in the case of creams and ointments, in the jar in which they will be dispensed.
  • 40. Beaker method (2) Oil phase: heated about 5-10 degree above the highest melting point of ingredient (water bath) •Water phase: heated to the same temperature of oil phase (water bath) •Add: internal phase into external phase, mix, constant agitation being provided throughout the time of addition •Caution: –not to heat the phase above 85 degree –rate of cooling determining the final texture and consistency
  • 41.
  • 43. • Soap removes not only dirt, but also skin fat ( sebum) • We add hydrating agents and moisturizing agents to the soap for temporarily purpose • Examples moisturizing agents: • Lanoline • Fatty acids • Fatty alcohols • Lecithine • Examples of hydrating agents • Glycerine • Glycol • Sorbeth • Polyethylene glycol May 2014 Robert Klerkx for PUM 43 3.8.1 Hydrating agents
  • 44. 3.8.2 Conservation agents • Goal: to protect a product against micro-biological and mould contamination. • But: Sterile shit remains always shit. So do clean first! natural Semi-natural Synthetic Poumplemousse Cosgard (benzyl alcohol, dehydroacetic acid, water) Benzoate, sorbate Parabenes Ureum derivatives Isothiazolones Triclosan Salicylic acid Heliozimth K
  • 45. • Cosmetic products may be spoiled by oxidation • Anti-oxidants take away the oxygen radicals • Examples of anti-oxidants: • Vitamine E (Tocoferol) • Dibutylhydroxytoluene • Ascorbic acid May 2014 Robert Klerkx for PUM 45 8.3 Anti-oxidants
  • 46. • Fragrances • Colouring agents • Viscosity stabilizers • Foam stabilizers • Chemicals to support claim May 2014 Robert Klerkx for PUM 46 3.8.4 Other ingredients
  • 47. Other ingredients Skin conditioner • Interact by their structure with the skin and pulls it straight. Smoothing. • Collagen- or silkhydrolysate and milk proteins. Silicon compounds. Humidifier • Every wash removes lipids from the skin. Therefore the skin will dry-out too much. • Therefore we add humidifiers to reverse partly the removal of lipids. • Amino acids, glycerine, milk acid and sorbit.
  • 48. Other ingredients Fragrance • To stimulate the purchase and psychological well feeling of user. Takes away off flavopunctatus of tensides. • Mind the possible interaction with colouring agents. Colour • European laws restrict the use of colouring agents. • Mind the pH, basic formulation and stability. concentration 0,0001 - 0,01%
  • 49. Other ingredients Pearling • Give tensidproducts a pearl mutter shine. • E.g. glycoldisearate • With styrol acrylate colymer we obtain a milky appearance without pearls. Organic acids • To adjust to the pH of the skin 5- 6. • Often used are wine acid or citric acid to 0,1-0,5% • Citric acid helps also as complexer.
  • 50. Other ingredients Complexer • Catch heavy metals which promote oxidation like iron and copper. • Sodium salt of ethylendiamintetraacetic acid or editronacid. Thickener • To adjust the viscosity • Fattyalcoholethoxylate, fattyacidalkylolamide or salt. • Mind too much salt will reverse the thickening and induce separation. • To from a gel we use xanthan, hydroxypropylmethylcellulose.
  • 51. Chemical operations • Mixing. Basic operation to blend two or more substances evenly • Hominization to change the particle size in emulsions and suspensions to prevent separation • Dispersion to mix one or more phases of substances into a dispersion liquid. Could be solid, liquid or gas • Emulations. To mix two not soluble substances into each other. The outer liquid is called continuous phase, the other inner phase is called discontinuous phase • Suspension. To mix into very small, but not molecular parts of a solid into liquids.
  • 52. 4. Hygiene and sanitary protection • Instructions • Disinfection en sterilization • Safety measures • Sanitary Plan
  • 53. 4.1 GMP ( ISO 22716:2007) Personnel Hygiene 2.15 Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. Hygiene programmes should be promoted by management and widely discussed during training sessions. 2.16 All personnel should receive medical examination upon recruitment. It must be the manufacturer’s responsibility that there are instructions ensuring that health conditions that can be of relevance to the quality of products come to the manufacturer’s knowledge. After the first medical examination, examinations should be carried out when necessary for the work and personal health.
  • 54. 4.1 GMP directives 2.18 Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out. 2.19 Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in the production and storage areas should be prohibited. In general, any unhygienic practice within the manufacturing areas or in any other area where the product might be adversely affected should be forbidden. 2.20 Direct contact should be avoided between the operator’s hands and the exposed product as well as with any part of the equipment that comes into contact with the products. 2.21 Personnel should be instructed to use the hand-washing facilities
  • 55. 4.2 Three elementary points on hygiene: • All aqueous products are very susceptible to bacteria- and mould growth. It is therefore absolutely required to respect a perfect hygiene: 1. Wash your hands well before you start the production. Wear protective gloves, caps and masks. 2. Disinfect carefully all production materials: 1. or with boiling water during ten minutes or 2. by using pharmaceutical alcohol >96%. After production clean the production means carefully. 3. Keep the preparations cool and use it within the week. Use natural conservatives. And be apprehensive when you smell an off-flavour.
  • 56. 4.3 Safety measures • The production of creams requires sometimes the heating of certain phases. Be prudent as not to burn yourselves. It is necessary to wear safety googles and gloves. • Your ingredients should all and always be labelled if necessary with safety instructions. • In case of the use of alcohol: be careful, it is irritant to the eyes, it is inflammable and it affects your respiratory tract. • Certain ingredients contain the risk of allergy for certain persons. • Always before you start a production: Read the safety instructions carefully.
  • 59. 4.4 GMP plan • Cleaning plan and disinfection plan • Plan against rodents • Training plan personnel • Documentation • Maintenance • Hygiene of personnel • Temperature checklists • etc
  • 60.
  • 61. Microbiology HACCP hazard analysis and critical control points CCP Hazard Measures Control Formulation Insufficient conservation Improve formulation Validation Ingredients Cell count Toxins Sterilisation Audit supplier Micro control Analysis Sterilisation Insufficient Validation Control Production Insuff conservation Documentation Chemical analysis Hygiène Contamination Cleaning and CIP hygiene plan training hygiene officer Installation Insuff cleaning / dead end Improve installation Hygiene validation Quality control Faulty results Validation of equipment and methods Periodical checks Logistics Supply of contaminated products Tests of system Controlled recall
  • 62. 5. Anatomy and physiology
  • 63. • Composition of the skin • Protection against drying out • Protection against bacteria • Protection against UV radiation • Temperature regulation • Changes of the skin • Aging • Disorders The Skin May 2014 63Robert Klerkx for PUM
  • 64. • Adults have about 18000 cm2 of skin which weighs 4,8 kg with men, 3,2 kg with women. • Two types of skin: • Hairy • Glabrous • Composition: • Epidermis • Dermis • Nerves & sense organs • Hair follicles • Sebaccous glands • Appocrine glands May 2014 Robert Klerkx for PUM 64 Composition of the skin
  • 65. May 2014 Robert Klerkx for PUM 65
  • 66. Epidermis Epidermis Profile • Different layers with kerotine • Pigment cells • Skin color • by blood • carotine (yellow) • pigment cells (melalin) • Langerhans cells • Play role in immunity • Merkel cells: • Affect sensations Skin renews every two to four weeks May 2014 Robert Klerkx for PUM 66
  • 67. May 2014 Robert Klerkx for PUM 67 Epidermis consists of: _ Keratine: 58% _ Fats, lipids: 20% _ Water-soluble substances: 15% _ Water 7%
  • 68. May 2014 Robert Klerkx for PUM 68 The color melanine is produced in the pigment cells in the stratum basale. The melanocytes produce melaline and inject this in the young skincells ( keratocytes) No way that cosmetic products can do the same job!
  • 69. • Protects the body against mechanical shocks • Feeds the epidermis • Contains • Blood • Nerves • Hair follicles • Sweat glands May 2014 Robert Klerkx for PUM 69 Dermis
  • 70. • Contains: • Collagen 75% • Elastin 4% • Ground substance • Fibroblasts • Secrete collagen and elastin • Mast cells • Secrete histamine, which causes inflammation pain and itching May 2014 Robert Klerkx for PUM 70 Dermis
  • 71. • Sense organs • Touch • Warmth • Sweat: by evaporation of fluids: chilling • Cold • Gooseflesh: Hair follicles rise ( air cushion) , skin contracts • Pain • Sweat glands: • Control body temperature • Excretion of water and salts • Evaporation: ( 6-7 burst per minute) • Environmental temperature • UV light • Emotional stress • Rise of body temperature May 2014 Robert Klerkx for PUM 71 Nerves & sense organs
  • 72. • Hair is produced by keratinization • 120.000 follicles on the human scalp • Cycle: 1 to 3 years • We lose 100 hairs from our scalp each day • Difference between scalp- and pubic/axillary regions and face of the male hair follicles • The latter are initiated by androgens ( male hormone) • These androgens cause at the same time baldness with men. May 2014 Robert Klerkx for PUM 72 Hair follicles
  • 73. • Secrete sebum • Lipid that covers skin and hair • Sebum: • Tri-Glyceride • Free fatty acids • Wax esters (squalene) May 2014 Robert Klerkx for PUM 73 Sebaccous glands
  • 74. • Axillary, genital and nipple regions • Secrete milky substance • Supports human communication • Different bacteria between men and woman produce different odors May 2014 Robert Klerkx for PUM 74 Apocrine glands
  • 75. • Protects body against • Noxious substances • Radiation • Physical shocks • Keeps body fluid inside (de-hydration) • Heath control • Protection against bacteria • Transmits sexual and social signals, by • Color • Odor • Materials • Therefore it is important for cosmetic producers to fully understand the mechanics of the skin May 2014 Robert Klerkx for PUM 75 Function of the skin
  • 76. • Aging: • Starts at 25-30 yrs of age • Loss of elasticity • Start of wrinkles • Reduction of sebum • Skin becomes dryer • Natural aging cannot be stopped! • Stress, unhealthy food, alcohol, smoking, too much sunlight accelerate the process • Disturbances: • Washing and bathing remove sebum • Puberty: • Production of more sebum, which causes a fatty skin • Clogging of exit sebaccous glands could cause bacterial growth • Cellulitus with women: • There is no remedy • Diet, massage and sport May 2014 Robert Klerkx for PUM 76 Changes of the skin
  • 77. • Cosmetic chemist is not concerned with serious disorders • Ephalides (freckles), lentigens and moles • Freckles: • Harmless, local pigmentation • (western people): fair or red haired • Genetically determined • Vitilogo: • Patchy depigmentation: often associated with leprosy • Social stigma • Caused by auto-immune disorder • Cannot be treated, but by cosmetic camouflage May 2014 Robert Klerkx for PUM 77 Disorders of the skin
  • 78. • Skin consists of three layers • Epidermis • Dermis • Hypodermis • Outer layer is impermeable: Outside- in, but permeable inside – out • All our active ingredients have too large molecules to penetrate • We can keep the epidermis smooth, soft and maintain humidity level May 2014 Robert Klerkx for PUM 78 Summary
  • 80. Quality issues • Quality Assurance • GMP • Traceability • Labelling
  • 82. 6.2 ISO 22716 (GMP) • Equipment • Raw materials • Environment • Packaging material • Buildings • Personnel • Critical stage procedures
  • 83.
  • 85. 6.3 Traceability Some of the important points to be considered on traceability according to ISO 22005 are 1.Top management should have a traceability plan and design the traceability process based on the objectives of the organisation. 2.The system should be verifiable, applied consistently, results oriented, cost effective, practical to apply, compliant with local regulations and also with defined accuracy requirements. 3.The traceability objectives of the organisation may include, quality objectives, customer needs, to identify responsible organisations 4.The organisation should document the flow of all materials and documents should be controlled based on the documentation procedure 5.The organisation should have production definition, lot definition and batch identification, data management and recording protocols 6.The information should be retrievable whenever required or when a customer complaint received. 7. The traceability plan shall be implemented by assigning responsibilities for qualified personnel which is taken care of by top HR management.
  • 86. Traceability: two ways Supplier Producer Customers information products
  • 87. 6.4 What are the reason to label? • Supply Chain function • Protection function • Information function • Marketing function
  • 88. 6.4 Labelling of cosmetic products • The name of the product and the address of the producer • Country of origin • The weight or volume at the moment of labelling • Date of consum • Instruction how to use • Production lot number • Ingredient list • Instruction acc CE # 1223/2009 for cosmetic products
  • 90. Functionality of skincare • Objective and measurable • Cleaning • Make up • Deodorant • Sweat reducer • UV protection • Objective but hard to measure • Humidity regulation • Skin swelling • Anti-wrinkle • Skin protection improvement • Flagrancy • Effective against skin dirt • Subjective and not measurable • Young appearance • Pleasant feeling • Improved handle • Erotic function of fragrance • Plus the placebo effects of • Colour, packaging, verbal sayings, name of producer, price, shop, publicity.
  • 91. 7. Ingredients and formulas • Face Care • Hand & Food Care • Sun screen products • Shampoo • Creams & Emulsions
  • 92. Basic and extended facial care: Basics of care products Extra ingredients • Oil • Fat • Wax • Hydrating ingredients • Liposomes • UV filter • Anti-oxidants • Fruity acids (removal of loose epidermis) • Allantoine ( smooths dry skin) • Bisabolol ( calms the skin) • Plant extracts ( bleed) • Emulgators • Preservatives • Thickener May 2014 Robert Klerkx for PUM 92
  • 93. • Composition • Different kinds of products Hand & Foot care May 2014 93Robert Klerkx for PUM
  • 94. • Hand care: • With our hands we wash and clean • Products should contain: • Fatty substances • Preservatives • Fragrances • Foot care: • Products are meant to clean and refresh the skin • Feet contain many sweat glands • Bacteria transfer sweat into sweaty odors • Creams and balsa slightly acid • Powders (talcum) • Baths ( sodiumcarbonate, sodium hydrogencarbonate) • Deodorants • Anti-prespiration products ( alumiunsulphate, aluin, salicylic acid) May 2014 Robert Klerkx for PUM 94 Composition
  • 95. • Effect of sunlight on the skin • UV radiation • Function of sunscreen products • Different kinds of products Sunscreen products May 2014 95Robert Klerkx for PUM
  • 96. Radiation from the sun Down-side Up-side • Affects the epidermis • Destroys the collagen, which renders elasticity to the skin • Destroyed collagen renders skin leathery, wrinkly • Nicotine has the same effect • As we grow older, we produce less and less collagen • Cosmetic products can only reduce effects by keeping skin soft and shiny • Important: Prudent with sun baths! • Makes us happy • Needed for production of Vitamin D May 2014 Robert Klerkx for PUM 96
  • 97. • Visible wavelength between 400 and 800 nm • UV-A: 320- 400 nm • UV-B: 280-320 nm • UV-C: 100- 280 nm ( stopped by atmosphere) • UV-B browns our body, but ‘burns’ as well • Reaction of body against UV radiation: • Thickening of epidermis ( 10x) • Production of melamine ( in a couple of days) May 2014 Robert Klerkx for PUM 97 UV radiation
  • 98. • SPF (Sun protection factor) • SPF 10 means that we may sunbath 10 x longer without sunburns • SPF 2 takes away 50% of radiation • SPF 4 takes away 75% of radiation • SPF 20 takes away 95% of radiation • Sunscreen contains • Filters ( 4-aminobenzoic acid) • Pigments ( titan oxide and other oxides) • Anti-oxidants May 2014 Robert Klerkx for PUM 98 Function of sunscreen products
  • 99. Composition of shampoo Ingredient Function1-4 % Water Diluent 50-70 Primary surfactant Washing 15-30 Secondary surfactant Foaming agent 1-4 Gum Viscosity 0-5 Humidifier Hydration 1-5 Chelating agent Binding of calcium 0-1 Acid pH 2 Base pH Parabens e,g Conservation Dimethicone, silicones Conditioner Active agents Additives (oil,)
  • 100. Preparation of shampoo (example) Phase A Ingredient % Distilled water water 66 Primary surfactant SLES 20 Gum NaCl 3 Humidifier Glycerine 2 Phase B Additives Avocado oil 2 Secondary surfactant Cocoamido propyl betain 4 Chelating agent EDTA 1 Acid Citric acid 0.4 Phase C Base NaOH 18% Conservation agent Acnibio 0.1 Conditioner Dimethicone 1 Active agents - - Fragrance Verveine 0.7 Total 100
  • 101. Composition of emulsions Ingredient Function % Water Watery phase 60-85 Oils Oil phase < 30 Emulsifier Stability 5-10 Emollient Keep water on the skin Humidifier Increase retention of the skin Conservation Anti bacteria, anti fungicide Anti oxidant Against rancidity Fragrance Colouring Additives
  • 102. Preparation of emulsions by HBL Hydrophilic-Lipophilic balance Value HLB Application Lipophile 1 - 3 Anti- foam 3 - 8 Emulsions Oil/water 7 - 9 Humidant 8 - 18 Emulsion Water/Oil 11 - 15 Detergent Hydrophile 15 - 18 Solubilizer
  • 103.
  • 104. Aleurites Moluccana Seed Oil [7] Grape (Vitis Vinifera) Seed Oil [7] Almond Oil NF [6] Hybrid Safflower (Carthamus Tinctorius) Oil [9] Anhydrous Lanolin USP [10] Isopropyl Myristate [11.5] Apricot Kernel Oil [7] Isopropyl Palmitate [11.5] Avocado (Persea Gratissima) Oil [7] Jojoba (Buxus Chinensis) Oil [6.5] Babassu Oil [8] Lanolin [10] Beeswax [12] Macadamia (Ternifolia) Nut Oil [7] Borage (Borago Officinalis) Seed Oil [7] Mangifera Indica (Mango) Seed Butter [8] Brazil Nut Oil [8] Mineral Oil [10.5] C12-15 Alkyl Benzoate [13] Myristyl Myristate [8.5] Cannabis Sativa Seed Oil [7] Olive (Olea Europaea) Oil [7] Canola Oil [7] Oryza Sativa (Rice Bran) Oil [7] Caprylic/Capric Triglyceride [5] Peanut Oil NF [6] Carrot (Daucus Carota Sativa) Seed Oil [6] Petrolatum [7] Castor (Ricinus Communis) Oil [14] PPG-15 Stearyl Ether [7] Ceresin [8] Retinyl Palmitate [6] Cetearyl Alcohol [15.5] Safflower (Carthamus Tinctorius) Oil [8] Cetyl Alcohol [15.5] Sesame (Sesamum Indicum) Oil [7] Cetyl Esters [10] Shea Butter (Butyrospermum Parkii) [8] Cetyl Palmitate [10] Soybean (Glycine Soja) Oil [7] Coconut Oil [8] Stearic Acid [15] Daucus Carota Sativa (Carrot) Root Extract [6] Stearyl Alcohol [15.5] Diisopropyl Adipate [9] Sunflower (Helianthus Annus) Oil [7] Dimethicone [5] Sweet Almond (Prunus Amygdalus Dulcis) Oil [7] Dog Rose (Rosa Canina) Hips Oil [7] Theobroma Cacao (Cocoa) Seed Butter [6] Oils and waxes and their HBL
  • 105. Calcium Stearoyl Lactylate [HLB = 5.1 ± 1] Oleth-20 [HLB = 15.3 ± 1] Ceteareth-20 [HLB = 15.2 ± 1] PEG-100 Stearate [HLB = 18.8 ± 1] Cetearyl Glucoside [HLB = 11 ± 1] PEG-20 Almond Glycerides [HLB = 10 ± 1] Ceteth-10 [HLB = 12.9 ± 1] PEG-20 Methyl Glucose Sesquistearate [HLB = 15 ± 1] Ceteth-2 [HLB = 5.3 ± 1] PEG-25 Hydrogenated Castor Oil [HLB = 10.8 ± 1] Ceteth-20 [HLB = 15.7 ± 1] PEG-30 Dipolyhydroxystearate [HLB = 5.5 ± 1] Cocamide MEA [HLB = 13.5 ± 1] PEG-4 Dilaurate [HLB = 6 ± 1] Glyceryl Laurate [HLB = 5.2 ± 1] PEG-40 Sorbitan Peroleate [HLB = 9 ± 1] Glyceryl Stearate [HLB = 3.8 ± 1] PEG-60 Almond Glycerides [HLB = 15 ± 1] Glyceryl Stearate (and) PEG-100 Stearate [HLB = 11 ± 1] PEG-8 Laurate [HLB = 13 ± 1] Glyceryl Stearate SE [HLB = 5.8 ± 1] PEG-80 Sorbitan Laurate [HLB = 19.1 ± 1] Glycol Distearate [HLB = 1 ± 1] Polysorbate 20 [HLB = 16.7 ± 1] Glycol Stearate [HLB = 2.9 ± 1] Polysorbate 60 [HLB = 14.9 ± 1] Isoceteth-20 [HLB = 15.7 ± 1] Polysorbate 80 [HLB = 15 ± 1] Isosteareth-20 [HLB = 15 ± 1] Polysorbate 85 [HLB = 11 ± 1] Lauramide DEA [HLB = 15 ± 1] Sodium Stearoyl Lactylate [HLB = 8.3 ± 1] Laureth-23 [HLB = 16.9 ± 1] Sorbitan Isostearate [HLB = 4.7 ± 1] Laureth-4 [HLB = 9.7 ± 1] Sorbitan Laurate [HLB = 8.6 ± 1] Lecithin [HLB = 4 ± 1] Sorbitan Oleate [HLB = 4.3 ± 1] Lecithin [HLB = 9.7 ± 1] Sorbitan Sesquioleate [HLB = 3.7 ± 1] Linoleamide DEA [HLB = 10 ± 1] Sorbitan Stearate [HLB = 4.7 ± 1] Methyl Glucose Sesquistearate [HLB = 6.6 ± 1] Sorbitan Stearate (and) Sucrose Cocoate [HLB = 6 ± 1] Oleth-10 [HLB = 12.4 ± 1] Sorbitan Trioleate [HLB = 1.8 ± 1] Oleth-10 / Polyoxyl 10 Oleyl Ether NF [HLB = 12.4 ± 1] Stearamide MEA [HLB = 11 ± 1] Oleth-2 [HLB = 4.9 ± 1] Steareth-2 [HLB = 4.9 ± 1] Oleth-20 [HLB = 12.4 ± 1] Steareth-21 [HLB = 15.5 ± 1] Emulsifiers sorted by INCI names
  • 107. Use of calculation sheet Day cream ,,/,,/2014 lot # Composition Function % Weight Phase A (water) grams Water 59 294 1. Specify total volumeGlycerine Humectant 3 15 Phase B (Oil) Sesame oil Oil 15 75 2. Specify % of ingredients except for water 3. Calculate amount of water Almond oil Oil 15 75 Wax # 3 Emulsifier 7.5 37,5 Phase C ( Additives) Cosgard Conservation 0.5 2,5 4. Do not forget
  • 108. Different emulsions Cream Milk Lotion Date / lot# Date / lot # Date/ Lot # Compositio n Function % grams % grams % grams Phase A water 60 299 83 413 69 346 Glycerine Humectant 2 10,0 3 15,0 5 25,0 Phase B 50,0 Sesame oil Oil 10 50,0 0 0 10 50,0 Avocado oil Oil 10 50,0 5 25,0 5 25,0 Argan oil Oil 10 0 5 25,0 0 0,0 Cactus oil Oil 0 37,5 0 0,0 5 25,0 Wax no 3 Emulsifier 7,5 3,0 15,0 5,0 25,0

Editor's Notes

  1. Questions: Do you know what an atom is? Electron, proton, neutron?
  2. Problems are Sweat,  tension, friction, callus, corn, ingrown nails, moulds. Products are baths, lotions, creams, balms, powder, sprays. Creams, balms are to care the feet. After bathing the feet. Bath is the most important foot care. Deo products Powders against smell, sweat and moulds.