492 JOURNAL OF COSMETIC SCIENCE
The physical and chemical requirements for microbial growth include suitable temperature,
pH, a
w ,substrates/nutrients, oxygen (or the proper oxidation/reduction potential), organic
growth factors (which are needed by some bacteria), and freedom from harmful radiation
and chemicals (e.g., preservatives and antibiotics). Cosmetic ingredients and finished
products provide a wide range of organic and inorganic compounds that will support
microbial growth when water is present. Interestingly, the principles of preservation are
just the opposite of the requirements for microbial growth, which means that application
of these principles prevents bacteria from having access to the things they need, and use of
inhibitory agents (i.e., preservatives/biocides) causes their death.11 Use of these principles to
develop adequately preserved products helps manufacturers meet environmental concerns
and consumer demands for products that are free of chemicals recognized as preservatives.31
Preventing unnecessary microbial load, or bioburden, of the process stream is an
important consideration for making products in accordance with GMPs. This is the reason
manufacturers have microbial specifications (i.e., limits) for raw materials—to minimize
the microbial load in order to maintain microbiological control of the process, because
smaller populations of any specific microorganism require shorter times to kill than
larger populations with any given killing treatment (e.g., heat, chlorination, preservatives,
etc.).11Suppliers of cosmetic ingredients control the microbial load by removal of “bad”
components and avoiding contamination of raw materials obtained from natural sources,
including botanicals and materials obtained in mining operations (e.g., talc, clays, and salts).
The time/temperature parameters involved in preparing raw materials that have aqueous
steps in preparation (e.g., plant extracts and protein powders) are controlled to prevent
microbial growth. Finished product manufacturers prevent microbial growth by use of
adequate preservative systems in products and use of validated manufacturing procedures,
often using Hazard Analysis Critical Control Point (HACCP),32 to ensure microbiological
control of each step in manufacturing from receipt and storage of raw materials, cleaning
and sanitization of equipment, production of the product, packaging, product testing,
and storage prior to shipment to the trade.33 Selection of the proper antimicrobials and
concentrations needed are critical for adequate product preservation, and understanding the
characteristics of the ideal preservative provides the basis for this.
THE IDEAL PRESERVATIVE
There has been an evolution of the characteristics of the “ideal preservative” that have been
identified over the past 75 years to incorporate both positive and negative characteristics,
including inactivating microorganisms quickly enough to prevent adaptation, no cross-
resistance with other preservatives or antibiotics, no negative environmental issues, no
adverse effects on the skin microbiome, and sustainability. The ideal preservative is one that
is both safe and effective for killing all types of microorganisms in all types of formulations,
but it has never been found.14 The reason for this is that no single preservative meets all the
characteristics of the ideal preservative, which are:
It should have a broad spectrum of activity, which means that it would be effective
against all types of microorganisms so that it could be used as the only preservative in
a formulation.
It should be effective at low concentrations and be active over the range of pH values
used in cosmetics and drugs.
493 Evolution and Challenges of Sustainability
It should be stable for the expected shelf-life/expiration date of the product.
It should be compatible with other ingredients in the formulation and with packaging
materials.
It should not affect the physical properties of the product (i.e., color, clarity, flavor, odor,
viscosity, texture, etc.)
It should have a suitable oil/water (o/w) partition coefficient to ensure that an effective
concentration remains in the water phase because biochemical reactions and microbial
growth take place in aqueous systems or at the interface of o/w systems.
It should inactivate microorganisms fast enough to prevent microbial adaptation.
It should be safe to use. This applies to workers handling the preservative chemical
during manufacturing and to consumers using products with the preservative over a
period of months or years. Safe to use means that the preservative has no adverse effects
systemically or locally on skin.
It should not induce cross-resistance with other antimicrobial agents or antibiotics.
It should comply with governmental regulations.
It should be sustainable and not have adverse environmental effects.
It should not adversely affect the healthy skin microbiome.
It should be cost-effective to use.
It may be difficult, or even impossible, to have a preservative or a multifunctional ingredient
with antimicrobial action that is effective against all types of microorganisms (to protect
formulations) and that does not adversely affect the healthy skin microbiome. Nevertheless,
knowing the characteristics of an ideal preservative may help provide the basis for selection
of the most suitable antimicrobials to meet preservation requirements for products that are
natural/organic, consumer friendly, environmentally friendly, and sustainable.
THE PRESERVATIVE SYSTEM CONCEPT
The antimicrobial action of a formulation generally is thought to be due solely to the
preservative chemicals used however, preservatives do not act independently of other
ingredients in the formula. The “preservative system” of a product includes specific
chemical preservatives (if present) and the physicochemical composition of the product,
which includes factors such as the pH, a
w ,redox potential, alcohols, surfactant type, and
concentration, chelating agents, antioxidants, lack of nutrients, and interfering materials
(e.g., talc and bentonite) that may affect the preservative efficacy of a formulation, and
protective packaging.33
All ingredients may have more than one function in product formulations. For example,
organic acids may reduce the pH, affect viscosity, change fragrance character, and exert
antimicrobial action QACs may contribute to skin feel or hair conditioning and provide
antimicrobial activity alcohols may help solubilize ingredients and contribute to the
preservative system antioxidants may help preserve fragrance character and product color
and may alsp have antimicrobial action. Types of ingredients that may contribute to the
preservative system of cosmetic and drug products are presented in Table III and are
discussed more fully in sections below.
Adequate protective packaging is an essential part of a product’s preservative system.
Products with conventional preservatives and preservative-free products require protective
packaging to help prevent microbial contamination during consumer use. Different
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