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Training course in skincare

1. The document outlines the agenda for a training course on cosmetic product development. It will cover topics like definitions, elementary chemistry, ingredients, formulas, and safety. 2. The trainer, Rob Klerkx, is introduced. He has over 30 years of experience in industries like pharmaceuticals, cosmetics, and food. He will train participants on product development, marketing, quality control and supply chain management. 3. Definitions of key terms are provided, including the etymology of "cosmetic" and legal definitions. Nomenclature standards like INCI are also introduced.

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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 May 2014 Robert Klerkx for PUM 36 Emulsions and emulgators
May 2014 Robert Klerkx for PUM 37
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 May 2014 Robert Klerkx for PUM 45 8.3 Anti-oxidants
• Fragrances • Colouring agents • Viscosity stabilizers • Foam stabilizers • Chemicals to support claim May 2014 Robert Klerkx for PUM 46 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 May 2014 Robert Klerkx for PUM 92
• 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) May 2014 Robert Klerkx for PUM 94 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) May 2014 Robert Klerkx for PUM 97 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 May 2014 Robert Klerkx for PUM 98 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

  • 1.
  • 2.
    Instruction plan 1. Introductionand 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 weproceed? • 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 RobKlerkx? • 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 • Theword 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 thisdefinition 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) • Aproduct 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
  • 13.
  • 14.
    3.2 Molecular structureof butane General formula C4H10 Semi-developed CH3(CH2)2CH3 Developed CH3-Ch2-Ch2-CH3 Topological formula Molecular mass 58,12
  • 15.
    3.3 Acids andbases 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+]
  • 16.
  • 17.
  • 18.
    Oils, Tri-Glycerides, FattyAcids • 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-saturedfatty 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 knownfatty 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.
  • 23.
  • 24.
    Function tensides • Tensidehas 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 cannotremove 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
  • 27.
  • 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
  • 29.
  • 30.
    Soap Hydration Detergent Breaks awaythe dirt from the surface Emulsifier Formation of micelles
  • 31.
  • 35.
  • 36.
    • Emulsions containwater- 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 RobertKlerkx for PUM 37
  • 38.
    Commercially, large-scale emulsionsare 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) Themost 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) Oilphase: 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
  • 42.
  • 43.
    • Soap removesnot 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 productsmay 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 • Colouringagents • 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 • Tostimulate 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 • Givetensidproducts 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 • Catchheavy 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 andsanitary 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 2.18Every 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 elementarypoints 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.
  • 57.
  • 58.
  • 59.
    4.4 GMP plan •Cleaning plan and disinfection plan • Plan against rodents • Training plan personnel • Documentation • Maintenance • Hygiene of personnel • Temperature checklists • etc
  • 61.
    Microbiology HACCP hazard analysisand 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 andphysiology
  • 63.
    • Composition ofthe 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 haveabout 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 RobertKlerkx for PUM 65
  • 66.
    Epidermis Epidermis Profile • Differentlayers 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 RobertKlerkx for PUM 67 Epidermis consists of: _ Keratine: 58% _ Fats, lipids: 20% _ Water-soluble substances: 15% _ Water 7%
  • 68.
    May 2014 RobertKlerkx 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 thebody against mechanical shocks • Feeds the epidermis • Contains • Blood • Nerves • Hair follicles • Sweat glands May 2014 Robert Klerkx for PUM 69 Dermis
  • 70.
    • Contains: • Collagen75% • 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 isproduced 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, genitaland 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 bodyagainst • 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: • Startsat 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 chemistis 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 consistsof 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
  • 79.
  • 80.
    Quality issues • QualityAssurance • GMP • Traceability • Labelling
  • 81.
  • 82.
    6.2 ISO 22716(GMP) • Equipment • Raw materials • Environment • Packaging material • Buildings • Personnel • Critical stage procedures
  • 84.
  • 85.
    6.3 Traceability Some ofthe 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 SupplierProducer Customers information products
  • 87.
    6.4 What arethe reason to label? • Supply Chain function • Protection function • Information function • Marketing function
  • 88.
    6.4 Labelling ofcosmetic 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
  • 89.
  • 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 andformulas • Face Care • Hand & Food Care • Sun screen products • Shampoo • Creams & Emulsions
  • 92.
    Basic and extendedfacial 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 • Differentkinds 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 ofsunlight on the skin • UV radiation • Function of sunscreen products • Different kinds of products Sunscreen products May 2014 95Robert Klerkx for PUM
  • 96.
    Radiation from thesun 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 wavelengthbetween 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 (Sunprotection 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 IngredientFunction1-4 % 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 IngredientFunction % 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 emulsionsby 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
  • 104.
    Aleurites Moluccana SeedOil [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
  • 106.
  • 107.
    Use of calculationsheet 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 MilkLotion 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
  • 109.

Editor's Notes

  • #13 Questions: Do you know what an atom is? Electron, proton, neutron?
  • #94 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.