The cosmetic and toiletry industries
employ unique microbiology quality assurance systems that are specifically
designed to detect the
presence of microbes in cosmetic and personal care products, and deliver
accurate and timely results. These microbiology systems perform a variety of
typical assays including checking for unpleasant organisms, microbial content
like molds and yeast, preservative efficacy testing, and suitability testing.
Preservative
Efficacy Testing (PET)
This test examines the effectiveness of
antimicrobial preservatives that are added to products in order to prevent the
growth of microorganism; hence, the name antimicrobial efficacy tests. Cosmetics and toiletries
can be contaminated by microbes during manufacture, or subsequent
activities such as the repeated withdrawal of single doses from packages that
contain multiple doses. The PET is performed after ascertaining that the
product has been neutralized, and has minimal contamination (less than
10cfu/gram). It is a mandatory test for all cosmetics and toiletries in the U.S.
The guidelines for PET tests
are provided under USP <51>. Basically, the product used in the test must
contain preservatives for a minimum period of 28 days before it can be used to
determine the number of microbes, which include ATCC established strains of A.
brasiliensis, C. albicans, P. auruginosa, S. aureus, and E. coli. The
microbiology instrument contains built-in software that generates a graph of
log cfu/g against the corresponding time. When the PET test is complete, a
certificate of analysis and report of microorganism properties of each product
are documented for easy reference in the event that certain products are
recalled. Rapid
detection systems allow automated data archiving, easy database
maintenance, and automated generation of reports. Automation increases
efficiency, saves on time, space and disposables, and protects against product
interference.
Suitability
Testing
Guidelines for this test are provided
in USP <62>. It is a mandatory test that seeks to identify the ability of
techniques used to detect particular microbes in a sample product. For
instance, a suitability test can be used to identify whether a particular
neutralizer actually performs its role by inactivating the preservative in the
sample product being tested. Inactivation would cause organisms that are
present in the product, including mold and yeast, to be spotted as they grow.
Rapid detection systems provide an easy, automated, and fast method of
performing suitability tests.
Microbial
Limits
This test examines the content of
microorganisms in products using assays to assess the growth of molds, yeasts
and bacteria. The assay detects mesophilic bacteria, molds, yeast and bacteria
in both raw materials and finished products. Microbial limits test are
basically microbiology
quality assurance tests that investigate whether an ingredient or mixture
is in compliance with the established specification for cosmetics microbiology
quality, like USP monographs, and manufacturer requirements.
The test is simple and fast enough to
be performed on every product. The test comprises two parts that check for
Salmonella species, Pseudomonas aeruginosa, staphylococcus aureus, and E. coli.
The first part, microbial enumeration, is quantitative, and determines the
cumulative number of aerobic microbes, in addition to mold and yeast counts for
each sample. The recommended count for aerobic microbes should be less than
100cfu/g, while that of molds and yeast should be less than 10cfu/g. The second
part is qualitative, test for specified microbes, and checks for the presence
of absence of specific unpleasant microbes in the product.
The use of rapid detection
instruments for microbiological testing in cosmetic and toiletry industries
has a variety of benefits that are not found in traditional methods, including
fast preparation of assays and automation of processes. This reduces product
interference, simplifies operations, increases efficiency, and saves on labor,
space, time and disposables.
Contact Biolumix to learn more
about microbiological testing in the cosmetic and toiletry industries.
Biolumix
3928 Varsity Dr.
Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com
