Regine Scholtyssek is Microbiological

Expert for Cosmetics in the

Department of Biology/Product
Safety Microbiology at Henkel KGaA.
She is active in the central
department of product
safety/microbiology as a consultant
for microbiological issues within the
Henkel group of companies.
Primarily in charge of Schwarzkopf
& Henkel Cosmetics, Mrs Scholtyssek
is an expert for microbiological
product safety, e.g. quality control,
preservation and efficacy studies of
cosmetic products, as well as
quality aspects of raw materials
and packaging. Additionally, she is
also a consultant for production
sites, especially concerning
production hygiene, GMP issues,
training, Hazard Analysis and
Critical Control Point studies and
audits. Mrs Scholtyssek is a
member of the microbiological
expert group for cosmetics within
the German industry association
Industrieverband Krperpflege und
Waschmittel e.V. and one of
Germanys representative members
in the European Cosmetic Toiletry
and Perfumery Association. She was
formerly head of the
microbiological department of Hans
Schwarzkopf GmbH and joined
Henkel KGaA in 1996.
a report by
Re g i ne S c hol t y s s e k
Microbiological Expert for Cosmetics, Department of Biology/Product Safety Microbiology, Henkel KGaA
Producers of cosmetic products are legally obliged to
comply with the principles and guidelines of Good
Manufacturing Practice (GMP). This requirement
was formulated in the sixth amending directive to the
Cosmetic Products Directive 76/768/EEC.
Compliance with the guidelines of GMP should
ensure that cosmetic products of consistent quality
are produced and tested in line with a defined quality
standard. Although an EC guide to GMP for
cosmetic products does not yet exist, national and
European guidelines are available. At the European
level, publications by the European Cosmetic
Toiletry and Perfumery Association
1
and the Council
of Europe
2
are available. In Germany, the revised
version of GMP for cosmetics
3
was published by the
Industrieverband Korperpflege- und Waschmittel in
1995 and supplemented with a self-assessment
checklist (Checkliste zur Selbstbewertung)
4
in 1997.
S t a r t i ng Ma t e r i a l s S us c e pt i bl e t o
Mi c r obi a l At t a c k
It is known that, depending on their origin and
processing, starting materials may to a lesser or greater
extent be either already contaminated or susceptible to
subsequent microbial contamination. Water-free raw
materials of synthetic origin generally pose few
microbial spoilage problems. Similarly, water-free
synthetic oils, waxes and fats, as well as emulsifiers,
concentrated surfactants and surface-active agents, are
unlikely to support the growth of micro-organisms.
This reassuring state of affairs changes dramatically as
soon as they are mixed with other aqueous
ingredients. Even natural starting materials supplied as
water-free powders or granulates may harbour micro-
organisms, viruses, prions or microbial toxins. Analysis
of such materials may well reveal bacteria, clostridium
spores, staphylococci, moulds and, in particular, fungal
toxins. Furthermore, the possible presence of bacterial
spores cannot be ruled out, since they may even be
present in preparations with a high percentage of
alcohol. Natural raw materials extracted, processed or
supplied as aqueous preparations are particularly
susceptible to microbial contamination. Insufficiently
preserved, these starting materials can support the
growth of gram-negative micro-organisms such as
Enterobacter spp., Escherichia coli (E. coli), Citrobacter spp.,
Pseudomonas spp., etc. when used to manufacture
solutions, dispersions and emulsions.
Re qui r e me nt s t o be S a t i s f i e d by
Pr oduc e r s of Cos me t i c I ng r e di e nt s
The quality of cosmetic products largely depends on
the quality of the starting materials. The guidelines of
GMP for cosmetic products include the requirement
that all starting materials should correspond to the
agreed specifications and consistently be of good
quality. This requirement applies equally to chemical
and physical product parameters and microbial
purity. As described above, cosmetic starting
materials and material mixtures need protection
against microbial contamination during their
transport, storage and use in production.
Contaminated starting materials introduced into
production can severely load, or even overload, a
products preservative capacity, such as to render it
ineffective. Therefore, an essential condition for the
manufacture of cosmetics is the use of starting
materials containing the lowest possible level of
microbes where possible, fewer than 10 colony-
forming units (cfu) per gram. Furthermore,
specifications must be accepted by the supplier that
guarantee the absence of potentially pathogenic
micro-organisms, as well as other bioactive material,
as mentioned in Table 1. Moreover, the compatibility
of the ingredients and the packaging must be
ensured. The supplied containers must be clearly
identifiable and bear the following information:
product name, batch number, number of items, gross
Good Manuf act ur i ng Pr act i ce f or Pr oducer s of Cos met i c I ngr edi ent s
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Reference Section
1. COLIPA, Cosmetic Good Manufacturing Practice, 1988 and 1994, Brussels.
2. Council of Europe, Guidelines for Good Manufacturing Practice of Cosmetic Products (GMPC), 1995 Strasbourg.
3. Industrieverband Krperpflege- und Waschmittel e.V. (1992 and 1995), Leitlinien zur Herstellung kosmetischer Mittel,
Kosmetik GMP, Frankfurt a.M.
4. Industrieverband Krperpflege- und Waschmittel e.V. (1997), Checkliste zur Selbstbewertung, Kosmetik GMP,
Frankfurt a.M.
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Good Manuf act ur i ng Pr act i ce f or Pr oducer s of Cos met i c I ngr edi ent s
weight and tare. From this requirement with regard
to quality, packaging and labelling it is clear that
producers of cosmetic ingredients must also comply
with the principles and guidelines of GMP. Aspects
such as the quality of the cosmetic ingredients,
product and storage stability, adequate preservation
and the compatibility of cosmetic ingredients and
packaging are all checked during the development
stage and appropriate specifications of the cosmetic
ingredients are defined. Production should be carried
out in compliance with GMP to ensure that the
defined level of quality is maintained and not
impaired in any way by the production process.
Ma i n Re qui r e me nt s of GMP
The GMP guidelines indicate that production
should be carried out by qualified personnel in
suitable premises with suitable equipment.
Measurement and control instruments should be
calibrated and serviced regularly. A comprehensive
system of records should be established to provide
documentation of the consistent good quality of
production, storage and testing. All activities during
production and testing should be recorded for each
product and batch. Comprehensive documentation
of the preparation and filling operations for each
batch and the associated results of the quality testing
of intermediate, bulk and finished products, as well
as appropriate reserve samples, should enable the
production history of each batch to be traced
seamlessly if a complaint is received (see Table 2).
Like cosmetic products, cosmetic ingredients must
be produced in a clean and rigorously hygienic
environment to exclude any form of
contamination. Production premises, equipment,
instruments, storage tanks, containers, etc. should
accordingly be maintained to a high standard of
cleanliness. The equipment, containers and storage
tanks used for production should be clearly labelled
to minimise the risk of mix-ups between starting
materials or batches.
Qua l i t y of S t a r t i ng Ma t e r i a l s / S t or a g e
Special attention should be paid to the production of
cosmetic ingredients that are susceptible to
microbiological attack. Such ingredients must be
handled with great care. Since they are usually
preserved, the production process must be designed
to ensure that the preservative action is not impaired
at any stage of production or during storage.
A crucial requirement for the production of cosmetic
ingredients with a low micro-organism content is the
use of starting materials with a low micro-organism
content. Incoming goods checks should therefore
examine the micro-organism content of critical
materials, as well as conformity with the defined
chemical and physical specifications. Storage areas
should be clean and dry and the stored materials
should be clearly identifiable. The GMP guidelines
also indicate that quarantined and released materials
should be clearly separated and labelled. Next to the
supplied starting materials, the micro-organism count
of the production water, in particular, is of crucial
importance. In terms of volume, production water is
Table 1: Microbial Risk Factors for Human
Health from Contaminated Cosmetics
Organisms Possible Symptoms
Gram-positive bacteria
Staphylococcus aureus pus, sepsis
Streptococcus pyogenes ditto
Enterococcus spp. infections
Clostridium tetani tetanus
Clostridium perfringens gas gangrene
Gram-negative bacteria
Pseudomonas aeruginosa conjunctivitis, pus, infections
Klebsiella spp. conjunctivitis, infections
Enterobacteriaceae enteritis
Fungi
Candida albicans conjunctivitis
Candida parapsilosis conjunctivitis
Malassezia furfur dermatomycosis
Trichophyton spp. dermatomycosis
Trichoderma inflammations
Aspergillus spp. allergic reactions
Source: M Heinzel (1999), Antimicrobial and Preservative Efficacy, Eds: Elsner,
Merk and Maibach, Cosmetic Controlled Efficacy Studies and Regulations,
Stuttgart: Springer Verlag, pp. 275290.
Table 2: Documentation in Conformity with GMP
Organogram with defined responsibilities. In-house processes
Process-related working procedures. Formulations
Production procedures
Batch-related production and filling reports. Quality testing records
Cleaning and disinfection instructions. Documentation of work performed. Hygiene plan
Waste disposal plan
Records of calibration and maintenance of control and measurement instruments
Documentation of personnel training courses
Source: http://www.scf-online.com/english/issue22/gmp_22_e.htm
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Reference Section
often the main component of a formulation and for
this reason it should be subjected to regular checks of
its micro-organism content. If necessary, a number of
measures (bacterial filtration, ultraviolet (UV)
irradiation, ozonisation, etc.) can be taken to reduce
the micro-organism count to an acceptable level.
The named methods can be monitored physically or
chemically and should preferably incorporate an
alarm system so that measures can be initiated
immediately if any deviation from a threshold value
is detected.
Re qui r e me nt s Conc e r ni ng
Pr oduc t i on Pr e mi s e s
In the premises used for the production of cosmetic
ingredients, the production areas should be clearly
separated from all ancillary areas. All surfaces in the
production areas should be smooth, permitting easy
and effective cleaning and disinfection. Windows and
doors should be kept closed, to keep out dust, soil,
birds, rodents, insects, etc. External ventilation
systems should be fitted with appropriate filters and
inspected at regular intervals. In particular, it is
advisable to check the micro-organism content of the
air regularly, if fluidised bed systems are used. For
most production areas, counts of less than 500cfu/m
3
are acceptable. In ventilation systems for storage
tanks, it is advisable to use filters that are
impermeable to both dust and micro-organisms. In
addition, drums and small containers in the filling
area should be protected from dust and soil during
storage and filling.
Cl e a ni ng a nd Di s i nf e c t i on
Equipment used for production, filling and storage
should be cleaned and disinfected regularly, to
prevent microbial contamination. Written cleaning
and disinfection procedures should be drawn up for
this purpose, indicating the products to be used and
the necessary concentrations and exposure times.
Cleaning and disinfection operations should be
documented. Cleaning and disinfection measures can
only be carried out effectively if the production
equipment is capable of being cleaned. This means
that it must be designed so that it can be emptied
completely and has no dead (non-rinsable) sections.
The cleaning and disinfection agents must access all
parts of all the surfaces that come into contact with
the product. Equipment that does not meet these
basic requirements can only be satisfactorily cleaned
by dismantling the critical sections.
Av oi da nc e of Cr os s - c ont a mi na t i on
The co-transport of micro-organisms must be
prevented when transporting raw materials,
packaging and products out of the unclean zone to
the clean zone. To avoid such cross-contamination,
appropriate quality assurance measures should be in
force along the entire transport route through the
factory. Every stage of the manufacturing process
should be subject to analysis for potential sources and
routes of contamination and, when necessary,
operational-specific instructions created and put into
practice. Copies of these instructions should be
distributed proactively to production staff in the form
of training sessions. Moreover, the establishment of
the following plant-specific rules of personal hygiene
is advisable:
employees should be instructed about washing and,
if necessary, disinfecting their hands, especially after
using the toilet or before touching objects or
materials that come into contact with the product;
suitable work clothing should be worn;
no smoking, eating or drinking should occur in
the workplace; and
rules of behaviour should be established governing
illness or injury, coughing and sneezing, etc., so
that at least the minimal requirements of personal
hygiene are satisfied and, in this way, personnel-
related sources of risk are minimised.
F i l l i ng of F i ni s he d Pr oduc t s / F i ni s he d
Pr oduc t Che c ks
Filling equipment, like production equipment,
should be regularly cleaned and disinfected. To
Figure 1: General Design Requirements for
Cleaning Production Equipment
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Good Manuf act ur i ng Pr act i ce f or Pr oducer s of Cos met i c I ngr edi ent s
avoid contamination, the drums and other
containers used must have a low micro-organism
content. Special protective measures should be
taken, in particular when filling tank trucks. Tank
trucks should be properly cleaned and steam-
treated before they are filled. Insistence on the
provision of a cleaning certificate has proven
worthwhile. Tank trucks cannot usually be filled in
clean areas, and such operations are generally
performed outdoors. For this reason it is advisable
to use a disinfected filler hose and to fit the
manhole of the tank truck with a special cover to
keep out soil.
Sensitive cosmetic ingredients should be subjected to
microbiological checks before they are released for
delivery. Samples should be taken from the full
containers or tank trucks under very clean conditions.
Sterilised sampling equipment should be used. The
documented test results and reference samples should
be available, in case complaints are received.
Doc ume nt a t i on a nd Pe r s onne l T r a i ni ng
To avoid potential sources of error, it is advisable to
draw up specific procedures for the individual
production areas. The content and purpose of these
procedures should be explained to production
personnel during training courses, in order to achieve
acceptance of the described measures. The guideline
shown in Box 1 can be used as a basis for
systematically safeguarding the production process.
As well as the aforementioned documentation of all
defined processes, documentation of personnel
training courses has also proven worthwhile. When
an audit is carried out, only comprehensive
documentation can prove what measures were taken
to protect cosmetic ingredients.
Box 3: Gui de l i ne s f or S a f e g ua r di ng t he Pr oduc t i on of
Cos me t i c I ng r e di e nt s
1. Draft hygiene measures for storage, manufacture and filling areas
2. Draft rules for personnel behaviour, specified for each production area
3. Draft hygiene measures for the handling of starting materials
Instructions on procedures for incoming goods and storage of goods delivered in drums and sacks
Hygiene measures for weighing starting materials, handling instruments and containers and proper
labelling, as well as instructions on handling cracked containers
4. Measures and checks for monitoring production water
Checks (physical, microbiological) to monitor the water quality and the efficiency of the method
used to reduce the micro-organism count in the production and filling areas and in the zones
where containers and equipment are cleaned
5. Production premises
Define the frequency with which cleaning and disinfection have to be carried out on equipment
used to produce cosmetic ingredients and to transfer them to intermediate storage tanks
Draw up a cleaning procedure, specifying the method, the products to be used, their
concentrations and the exposure times
Draw up a code of behaviour for personnel who handle products that are susceptible to
microbiological attack
Define maximal residence times for batches that are susceptible to microbiological attack
6. Filling Area
Define the frequency with which cleaning and disinfection have to be carried out on
filling equipment
Draw up a cleaning procedure, specifying the method, the products to be used, their
concentrations and the exposure times
Hygiene measures when handling drums, containers, etc.; hygiene measures when filling
tank trucks
7. Measures for microbiological product release
Source: http://www.scf-online.com/english/issue22/gmp_22_e.htm