cosmecs dose forms - capsig · “the food and drug administration has announced that arbonne ......
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Cosme(csDoseForms
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PersonalCareDoseForms
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“LowRisk”Cosme(csISO 29621:2017
ISO 29621:2017 Cosmetics -- Microbiology -- Guidelines for the risk assessment and identification of microbiologically low-risk products
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WaterAc(vity>0.75a
“HighRisk”Cosme(cs:Emulsions
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“The Food and Drug Administration has announced that Arbonne recalled 14,837 units of ‘It’s a Fine Line Liquid Eyeliner’ in black and 3,818 units of the same formula in brown.”
“HighRisk”Cosme(cs:EyelinerpH
Womens Wear Daily 30th Aug 2016
Typically: Iron Oxides Carbon BlackNeutral pH
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High pH is a big challenge for solid soap Very few preservatives are active above about pH 9 Organo-metals eg copper – tin!
Ac(vepHRange
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Grapefruit Seed Extract - myth debunkedRosemary Extract - oxidisedVitamin E Oil - antioxidantGermaben II – pH limit 7.5Germall Plus – pH limit 8.0Optiphen Plus – pH limit 6.0ALLINAPPROPRIATE!
SolidSoapRecommenda(ons?
http://www.soap-making-essentials.com
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Protein+Formaldehydeliberatorse.g. Quaternium-15: Diazolidinyl Urea: Imidazolidinyl Urea:
Dmdm Hydantoin: 2-bromo-2-nitropropane-1,3 Diol.
Preserva(veCompa(bility
Sequence-specific capture of protein-DNA complexes for mass spectrometric protein identification. Wu CH, Chen S et al PLoS ONE (2011)
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Elas(nEyeCream
Identification of Contaminating OrganismsFacial TreatmentStaphylococcus saprophyticus Enterococcus faecium Eye CreamBacillus species – low discriminationEnterococcus faecium
Preserva(veCompa(bility
Product Recall ex Retail Sept 2012 : Unpublished Internal Data
Another example ofProtein complex formation
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FDARecallJan2018 Enterobacter cloacae
Preserva(veCompa(bility–Protein?
Hydrolyzed Wheat Protein Polysorbate 20Methychloroisothiazolinone Methylisothiazolinone
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ISO11930
Neutralisation chart = guidance on incompatibility
Preserva(veCompa(bility
Annex C (informative)
Examples of neutralizers for the antimicrobial activity
of preservatives and washing liquids
Table C.1 — Examples of neutralizers for the antimicrobial activity of preservatives and washing liquids
Preservative Chemical compounds able to neutralize the antimicrobial activity of preservatives
Suitable neutralizers and washing liquids (for membrane filtration methods)
Phenolic substances:
Parabens, phenoxyethanol, phenylethanol, etc.
Anilides
Lecithin
Polysorbate 80
Fatty alcohol ethylene oxide condensate
Nonionic surfactants
Polysorbate 80, 30 g/l + lecithin, 3 g/l.
Fatty alcohol ethylene oxide condensate, 7 g/l + lecithin, 20 g/l + polysorbate 80, 4 g/l.
D/E neutralizing brotha; SDCLP brothb
Washing liquid: distilled water; tryptone, 1 g/l + NaCl, 9 g/l; polysorbate 80, 5 g/l.
Quaternary ammonium salts
Cationic surfactants
Lecithin, saponin, polysorbate 80, sodium dodecylsulphate
Fatty alcohol ethylene oxide condensate
Polysorbate 80, 30 g/l + sodium dodecylsulphate, 4 g/l + lecithin, 3 g/l.
Polysorbate 80, 30 g/l + saponin, 30 g/l + lecithin, 3 g/l.
D/E neutralizing brotha; SDCLP brothb.
Washing liquid: distilled water; tryptone, 1 g/l + NaCl, 9 g/l; polysorbate 80, 5 g/l.
Aldehydes
Formaldehydegenerating agents
Glycine, histidine Lecithin, 3 g/l + polysorbate 80, 30 g/l + Lhistidine, 1 g/l.
Polysorbate 80, 30 g/l + saponin, 30 g/l + Lhistidine, 1 g/l + Lcysteine, 1 g/l.
D/E neutralizing brotha; SDCLP brothb
Washing liquid: polysorbate 80, 3 g/l + Lhistidine 0,5 g/l.
Oxidizing agents Sodium thiosulphate Sodium thiosulphate, 5 g/l.
Washing liquid: sodium thiosulphate, 3 g/l.
Isothiazolinones
Imidazoles
Lecithin, saponin
Amines, sulphates, mercaptans, sodium bisulphite, sodium thioglycolate
Polysorbate 80, 30 g/l + saponin, 30 g/l + lecithin, 3 g/l.
Washing liquid: tryptone, 1 g/l + NaCl, 9 g/l; polysorbate 80, 5 g/l.
Biguanides Lecithin, saponin, polysorbate 80 Polysorbate 80, 30 g/l + saponin, 30 g/l + lecithin, 3 g/l.
Washing liquid: tryptone, 1 g/l + NaCl, 9 g/l; polysorbate 80, 5 g/l.
Metal salts (Cu, Zn, Hg)
Organomercurials
Sodium bisulphite, Lcysteine
Sulphydryl compounds, thioglycolic acid
Sodium thioglycolate, 0,5 g/l or 5 g/l.
Lcysteine, 0,8 g/l or 1,5 g/l.
D/E neutralizing brotha; SDCLP brothb
Washing liquid: sodium thioglycolate, 0,5 g/l.a Dey/Engley neutralizing broth.b Soybeancasein digest broth with lecithin and polysorbate 80.
ISO/FDIS 11930:2012(E)
18 © ISO 2012 – All rights reserved
ISO 11930 Cosmetics – Microbiology – Evaluation of the antimicrobial protection of a cosmetic product
Preservative SuitableNeutraliser
Previous Example
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Essen(alOilasaPreserva(veMelaleucaalternifoliainwater/CCTG(oil)mixSurfactantwaspolyoxyl35CastorOil
Par((oningintheProductItself
Melaleuca Oil - a Healthy Natural alternative. James S Rowe John A StatonCosmetics, Aerosols & Toiletries in Australia 1999; 11: (5) 12-15.
Phase WithoutSurfactant WithSurfactant
Oil 100% 20%
Water 0% 80%
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Par((oningintheProduct“substrate”
Chromatography Effect!
Product Recall ex Retail 2001 : Unpublished Internal Data
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Overcome by package design change
Par((oningintheProduct“substrate”
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Dry Herbal extracts
Earth Minerals
Seed Husks
All have potential for high bioburden
“Natural”Ingredients:Spores
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R&DorManufacturingFault?
Exampleof“Headspace”Failure
Damages Claim $A585,357+
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Adsorption
ExamplesofFailures
“The issue was discovered during routine re-testing. The preservative
system in several lots had been compromised.”
CBC News Sep 25th 2013
"The products were tested and found to be contaminated with Pseudomonas aeruginosa, Candida parapsilosis and
Acremonium fungi," the U.S. Food and Drug Administration said.
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Historical:TalcContamina(on
Sydney Morning Herald May 1st 1946
1946
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Five per percent of the talcum powders were contaminated with 104 C.F.U. /gm and none of the body lotions were contaminated to that extent.
Recent:TalcContamina(on
A Study of Microbiological Contamination in Cosmetics and Toiletries in Iraq. Contamination of Talcum Powder and Body Lotion Raghad A. Razooki AJPS, 2010, Vol. 8, No.2
2009
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60 Samples from the market in Nigeria
50 % were contaminated with Staphylococcus aureus, 20 % were contaminated with Clostridium tetani and 7 % were contaminated with Candida albicans.
Present:TalcContamina(on
Microbiological quality assessment of some brands of cosmetics powders…Dashen M. et al J. Microbiol. Biotech. Res., 2011, 1 (2): 101-106
2011
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The ACCC’s survey involved 115 cosmetic products found in shops and online retailers, which were sent for microbiological testing against internationally-set recommended limits.
The ACCC negotiated recalls with suppliers after finding that three products contained unacceptable levels microbial contamination.
AustralianRecalls:Survey2013
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Internet=24%>1000org/g
MarketplaceSurvey
Comar D. Science of Beauty Journal Vol 6 No 1 : 2016
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LargestgroupcontaminatedwasMineralpowders
MarketplaceSurvey
Comar D. Science of Beauty Journal Vol 6 No 1 : 2016
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ACCCRecall:Eyeliner
ACCC 23rd Nov 2017
“If the product comes in contact with eyes it could cause an eye irritation.”
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MIC versus P.E. !
“Natural”Preserva(ves
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Natural Preservative inSunscreen - Zinc Oxide dispersion
RecentExamplesinourlab
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Separation after mold growth
RecentExamplesinourlab
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Ifwehadtheperfectpreserva(ve,wewouldalluseit!
Preservatives for Cosmetics, 3rd Edition Third Edition 2012Dr David Steinberg
ChoosingaPreserva(veCocktail
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ChoosingaPreserva(veCocktail
Industrial Microbiology: An Introduction: Waites M et al
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ChallengingthePreserva(veCocktail
In house stability protocol Eurofins TecConsult
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An(microbialsUsedinPersonalCareProducts• Preservatives can provide benefits in relation to
providing practical shelf life.• • Must never be used to mask poor manufacturing
practices.• • Judicious choice at appropriate content levels does
not impact on the safety of cosmetics.
AustralianSocietyofCosme(cChemists
Position Paper: Antimicrobials Used in Personal Care Products ASCC.com.au
