cosmetic packaging

5/28/2018 Cosmetic Packaging

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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 associationIndustrieverband 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

Reg i n e S c ho l t y s s ek

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 qualityare 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 Association1 and the Council

of Europe2 are available. In Germany, the revised

version of GMP for cosmetics3 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 n g Ma t e r i a l s S u s c ep t i b l e t o

M i c rob i a l A t 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.

Requ i r emen t s t o be S a t i s f i e d by

P rodu c e r s o f C o smet i c I n g r ed i en t 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 chemicaland 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 Manufactur ing Pract i ce for Producer s of Cosmet ic Ingredients

B U S I N E S S B R I E F I N G : G L O B A L C O S M E T I C S M A N U F A C T U R I N G 2 0 0 4

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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 Manufac tur ing Prac t ice for Producers o f Cosmet ic Ingredients

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 R equ i r emen t s o f 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 tracedseamlessly 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 o f S t a r t i n g Ma t e r i a l s / S t o r 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 impairedat 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 materialsshould 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 conjunctivitisCandida 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 reducethe 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.

Requ i r emen t s Con c e rn i n g

P rodu c t i on P r em i s e s

In the premises used for the production of cosmetic

ingredients, the production areas should be clearlyseparated 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/m3

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.

C l e an i n g and D i s i n f e c t i o n

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.

Avo i dan c e o f C ro s s - c on t am in a 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 n g o f F i n i s h ed P rodu c t s / F i n i s h ed

P rodu c t Ch e c k s

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 Manufac tur ing Prac t ice for Producers o f Cosmet ic Ingredients

avoid contamination, the drums and other

containers used must have a low micro-organism

content. Special protective measures should betaken, 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.

Documen ta t i on and Pe r sonn e l T r a i n i n g

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 : Gu i de l i n e s f o r S a f e gu a rd i n g th e P rodu c t i on o f

Co smet i c I n g r ed i en t 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, theirconcentrations and the exposure times

Hygiene measures when handling drums, containers, etc.; hygiene measures when filling

tank trucks

7. Measures for microbiological product release


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