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Presented By

Vikram Viswajit Mishra,


M.Pharm 1st sem
Branch –Pharma tech
 Introduction
 Microbiology in Cosmetics
 Conditions of use & exposure
 Clinical consequence of
microorganism
 Preservatives used in cosmetics
 Predicting long term
Preservative Efficacy
 Conclusion
 References
 The word itself produces glow  whenever you
think about it. By its definition, it modifies
the look. But before coming to market it has
to go a long way and after reaching to
customer also it has to pass many issues.
 Cosmetic products have to be safe for the

consumers and, if relevant, for involved


professionals (i.e. hairdressers, beauticians).
 A number of adverse effect due to growth of
microorganism is found in cosmetics.
 These includes discolouration of the product,

odour or gas rheological properties of viscous


products,etc
 Decomposition may occur in such cosmetics

after months
 Yeast growth may also take place in cosmetic

preparations.¹
 Organisms commonly isolated from poorly
preserved water-based products include
Enterobacter,Staphylococcus and Bacillus species,
Pseudomonas,
 Gram-negatives are most common and, as they
have very diverse metabolic capabilities, can
survive in a wide range of environments.
 A study of shampoo products 60 % of samples
were contaminated with Gram negatives, 22% of
samples of sun care products in use on a beach
contained Candida species.¹
The following parameters have to be considered:
 Class of cosmetic product(s) in which the ingredient
is used
 Method of application (e.g. rubbed-in, sprayed,
applied and washed off, etc.)
 Concentration of ingredient in product
 Frequency of application
 Total area of skin contact
 Site of contact (e.g. mucous membrane, sunburnt
skin);
 Duration of contact (e.g. rinse-off products, leave-
on products)
 Type of consumers (e.g. children, people with
sensitive skin)²
• Skin irritation
• Skin Sensitization: Cosmetic products are
often used in areas exposed to environment
• Photo Irritation
• Photo Sensitization: For products applied on
the face or scalp
• Eye tolerance¹
Potential pathogens have been found in
cosmetics .The more vulnerable members of
society neonates, the elderly, people with
debilitating diseases or those undergoing
drug therapy
 The eye is particularly vulnerable to infection

E.g.
 Contamination of talc with Clostridium tetani,
 Infection of neonates with P.aeruginosa from

contaminated cleansing solution¹


 The assessment of the safety of any cosmetic
product clearly relates to the manner of use.
 The possible interaction between different
ingredients will usually be evaluated on the basis
of experience (similarities, published data on
related compounds, theoretical considerations,
etc.) and may be controlled using  in vitro testing
and/or skin compatibility tests.
 In vitro testing may be carried out to complement
available information with the necessary use of
appropriate benchmarks.
 Chemical Preservation: These are widely used.
These chemical are used at a conc. of less than 1%
e.g. Benzoic acid, sodium benzoate
 Manipulation of pH:The pH for cosmetics is within
the range of 3.5-9.0.Manipulating of pH limits
microbiologic growth
 Limitation of water content: It is commonly used in
cosmetics whose primary components are oils
waxes and contains less water. Water activity
should be maintained below 0.85.³
 Use of hostile raw materials:Materials like
propylene glycol at a conc of 25-50% is used
as hostile agents for microbial growth
 Aseptic Manufacturing:the product should be

manufactured in accordance to GMP


 Packaging Design: the design of a packaging

should be such that it does not allow asny


interaction between the product and the
environment.
 It should be free from toxic irritants
 Should be stable to heat and prolonged

storage
 Be free from gross incompatibility
 Be effective against a wide range of

microorganism
 Be readily soluble at it’s effective conc.
 Be without odour or colour
 Be able to retain it’s activity in the presence

of metallic salts
 Organic acids: Organic acids like benzoic
acids are used as preservatives .compounds
having 9,10 or 11carbon atoms like
monochloroacetic acid and propionic acids
are used as antifungal activity.
 Aldehydes: Benzaldehyde and cinnamic

aldehyde are widely used in cosmetics


 Essential oils: Essential oils are used in

cosmetics due to their antiseptic properties.


E.g Sandalwood oil
 Phenolic compounds: They are widely used as
antimicrobial agents phenol derivatives are used
like
p-chloro-m-xylenol- used in formulation like
deodrants,shaving creams
O-phenyl phenol- these are used to eliminate
odour, taste and colour grade
 Mercury Compounds: It is used to a limited extent

 Surface active agent: they are widely used as

preservatives like quaternary ammonium


compounds.
 By microbial growth under ideal conditions the
efficacy of the preservative system can be
assessed. Methods are as follows
A. Initial microbiological challenge test:
These determine the type and the minimum
conc. of the preservatives required. Preliminary
tests are conducted like pH change or colour
change
B. Quick Challenge test: this test is used with
bacteria and fungi for growth inhibition. The
steps involved are
• Preparation of product samples
• Preparation of inocula for bacteria and yeast
• Preparation of inocula for moulds
C. Repeat Challenge test: This test is conducted
to predict the susceptibility of a number of
products to microbial contamination
D. The official Method: It involves involves
inoculating test samples using aratio of
inoculum to 20ml
E. CTFA Method
 Shampoos
 Skin irritation Test: Consists of Draize Test in
Rabbits. For shampoos it is for 4hrs.
Alternatively Human Patch test may be carried
out
 Skin sensitization test: Magnusson and
Kligman Guinea Peg Maximization Test should
be carried out
 Eye Irritancy Test: Draize Test in rabbits is also
conducted. Eye irritating potential of a
substance is evaluated on ability to injure
cornea.⁵
 Sunscreen:
Sun Protection Factor(SPF):
It is the ratio between the time needed to
achieve erythematic on protected skin by the
time required to get it unprotected.
This is applied on human beings. In this
method at least 2 persons are irradiated by
medium vapour lamp generating light as
mostly 290-400nm.⁵
 As a protection to both the cosmetic products and the
cosmetic users, adequate microbiological controls are
an important part of a cosmetic testing .Contamination
of the deionizer water utilized in production can be
minimized by ultraviolet radiation..
1. Dr B.F. Perry, Procter & Gamble Technical Centres Ltd.
2. AEAN PIF Guidelines
http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/h
ealth_products_regulation/cosmetic_products/files_1.Par.3
4738.File.dat/Guidelines%20for%20Product%20Information
%20File%20(PIF).pdf
3. Poucher’s Perfumes Cosmetics and Soaps.pg 657-659
4. Cosmetics Technology Pg270-298

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