explaning about quality of raw materials used in cosmetics

1. QUALITY OF RAW MATERIALS USED
IN COSMETIC MANUFACTURE
PRESENTED BY
KALYANI.A
M.PHARMACY(PHARMACEUTICAL ANALYSIS)
KRUPANIDHI COLLEGE OF PHARMACY
BANGALORE

2. CONTENTS
• INTRODUCTION
• RAW MATERIALS
• QUALITY OF RAW MATERIALS
Aim and Objectives of Quality Control
Responsibility of Quality Control
physical and chemical parameters
Advantages of Quality Control
• Sensory analysis
• Rheology
• SAXS

3. INTRODUCTION
DEFINITION:
• The word cosmetics is derived from Greek KOSM TIKOS means skilled in
ordering, arranging and decorating.
• According to FDA
• Substances intended to be rubbed , poured, sprinkled, or sprayed on, introduced
into ,or otherwise applied to the human body, for cleansing, beautifying, promoting
attractiveness or altering the appearance
• Many cosmetics are designed for use of applying to the face, hair and body.

4. RAW MATERIALS
• 1) Antibacterial agents and preservatives
• 2) Colorants
• 3) Skin feel agents
• 4) Hydrating substances
• 5) Ceramides and lipids
• 6) Moisturizers
• 7) Thickeners
• 8) Uv filters
• 9) Skin whitening: ellagic acid
• 10) Skin whitening: new hydroquinone combination
• 11) Alpha hydroxy acids
• 12) Surfactants
• 13) Anti-irritants for surfactant based products

5. • 14) Seawater salts
• 15) Silicones-A key ingredient in cosmetic and toiletry formulations
• 16) Antioxidants
• 17) Dexpanthenol
• 18) Hair conditioners

6. Quality of raw materials:
• Quality does not merely mean the goodness of a finished product. Of course, the
quality of a finished product is the ultimate objective of a company; this is also
what the consumers expect from the product. However, in order to achieve the
desired quality in the finished product, it is essential that the whole plan, starting
from the purchase of raw materials to the stage where the ultimate product reaches
the consumers, has to contribute towards building quality into the product.
• Even after the product has reached the consumer, the reactions have to be fed back,
so that the product enjoys continuous sales. Quality embraces all spheres of activity.
In any organization, the quality function involves all departments and all groups of
personnel. No Quality Assurance Department or Manager will be in position to
build and control quality. To build quality, each and every personnel; right from
Managing Director to Attender need to contribute.

7. Quality of raw materials:
• Thus distinct meanings may be given to “Quality”. viz: quality of design, and
quality of conformance. Quality of design refers to the differences in the
specifications for the same and use. On the other hand, quality of
conformance relates to the ability to hold the specified quality of design.
Quality control procedures are primarily concerned with the quality of
conformance, though quality control techniques have helped in improving
upon the design.

8. Aim and Objectives of Quality Control :
1. To establish standards of quality which are acceptable to consumers.
2. To ensure that the customers are provided with products which conform with the
standard specifications.
3. To locate and identify process faults and defects of products.
4. To ensure that defective items are not used.
5. Evaluation of quality standards of incoming material, product in actual manufacture
and of outgoing product.
6. Judging the conformity of the process to the established standards, and taking suitable
action when deviation are noted.
7. Evaluation of optimum quality obtainable under given conditions.
8. To improve quality and productivity by process control and experimentation.
9. To ensure that defective products are not passed to customer.
10. Developing quality consciousness both within and with out the organization.

9. Responsibility of Quality Control :
1. To prepare plant control programme for the management.
2. To advice production department regarding uniformity of materials, quality aspect and
specifications.
3. To advice manufacturing department, about machinery, instruments and process control.
4. To assist purchase in the valuation of suppliers and defects of incoming materials.
5. To advice and assist in inspection and selection of sampling plan.
6. To assist sales in making use of quality and guarantee.
7. Developing procedure for good vendor-vendee relations.
8. To find losses and their causes.
9. To train quality control personnel in means of preventing defects.
10.To study and experiment special processes for eliminating the defects.
11. To analyse customer’s complaints report and make people quality minded.

10. Raw material quality control:
• The cosmetic raw materials varied in nature. Bureau of Indian Standards has done
commendable work in fixing specification for many raw materials used in
cosmetics. The raw materials which do not have IS standards are normally analyzed
as per I.P., B.P., U.S.P. or CTFA specification. The tests normally involve:
• Physical Parameters: Color, odour, density, refractive index, viscosity, etc.
• Chemical Parameters: Like assay of active ingredients, impurities present, etc.
• Drugs & Cosmetic act specifies the limits of impurities in cosmetic raw materials
like lead arsenic and heavy metals. Soon new specification may be added for other
heavy metals.

11. physical and chemical parameters
• 1. Colour: Shade matching is one of the important aspect of quality control of
cosmetics. Mostly colour matching is done by visual means by colour experts. It is
always a comparison between a standard and sample lot. Visual observation are made
on two films drawn of similar thickness depending on type of products either glass
slides or drawn apparatus is used for producing film of uniform thickness. Colour
matching computers are available nowadays.
• 2. Density - Specific Gravity : Usually specific gravity cups are used which are
calibrated for particular weight of water.
• 3. Viscosity : Different types of instruments are available. Most popular one is
called Brookfield viscometer. This instrument is based on spring which is attached
to spindles. The viscosity is measured based on torque registered on the spring
indicated on the dial. Other viscometers are falling ball viscometer, Gardner tubes
or Fords cup which are based on different principles.

12. • 4. Melting point or boiling point : Usual capillary method is followed for melting point. Boiling
range is also done using normal distillation setup. Now a days instrument to determine M.P./B.P. is
available.
• 5. Hardness - Softness :
This kind of testing is done using penetrometer. A needle penetrates the block of desired mass and the
depth of penetration indicates the hardness. There are other means like break points which are
measured by specialised instrument.
• 6.Foam Tests :
Foam tests are done using cylinder methods and also there are instruments like Ross Miles apparatus
used for measuring foam.
• 7. Accelerated stability tests :
Many cosmetic products are emulsions. Emulsions are prone to degradation. The tendency of
emulsion degradation is usually checked by accelerated tests like storage of products at elevated
temperatures like 40, 45, 50°C or putting them under high stress conditions like centrifugal force and artificial
humidity conditions or exposed to extremely daylight conditions. These tests are also done for non-
emulsion products to assess perfume stability or physical separation or sweating, etc.

13. Raw material quality control
• 8. Chemical tests :
These are usual tests carried out to find out acidity, alkalinity and assay of particular
active ingredient, etc.
• BIS (Bureau of Indian Standards) lays down specification for finished cosmetics as
per Schedule S of Drugs and Cosmetics Act 1940. Perhaps India was the only
country who had standards for Finished Cosmetics.
• Instruments like thin layer chromatography, Gas Liquid chromatograph, High pressure liquid
chromatograph and infrared and ultraviolet spectrophotometers, Skin meter are widely used for
raw material as well as finished product quality control.

14. Raw material quality control
• Microbiological Quality Control:
It is imperative that each manufacturer should ensure products he manufactures are
safe for use by his customers. Many of the bacteria which come from surrounding
environment or coming from raw materials are not safe. Some of the micro
organisms are relatively harmless. Microbiological quality control is aimed to ensure
that all the finished products are free from harmful pathogenic bacteria and other bacteria
are within the limit.
• On (Production) Line Quality Control:
This type of quality control is practiced in large scale assembly type production units
wherein so many different types of products are assembled into final product. Main
aim is to ensure good quality of outgoing goods.
• Procedure involves drawing of random samples from production line at different
intervals and these samples are inspected and if the product quality is found below
the standard. Entire production is taken up for 100% rechecking.

15. Advantages of Quality Control
1. A quality control program, helps in building an information system which assists in fulfilling the
objective of a modern quality program.
2. From the concept of process behaviors, cause-effect relation study and experimentation involved in a
quality program, a better understanding of the processes and product is obtained.
3. Improvement in quality.
4. Increased production under the same set up.
5. Helps in reduction of rework and adjustments.
6. Reduction in cost per unit.
7. Reduction in scrap.
8. Saving in excess use of material.
9. Enable the feed-back of inspection information to the designers, specification writers and
operators and reduction in inspection.
10. Evaluation of scientific tolerances.
11. Maintenance of operating efficiency.
12. Less customer complaints.
13. Quality Consciousness

16. Raw material quality control:
• The quality control of cosmetics is important to ensure the efficacy and safety of
products and its raw-materials. Due to the rapid growth that cosmetic industries have
exhibit all over the world, efficient, low cost and rapid methods to assay cosmetics’
quality control are a priority.
• Some current techniques used by the cosmetic industry can be applied to the
evaluation of cosmetics’ quality control in an efficient manner, such as: rheology,
sensory analysis and small angle X-ray scattering (SAXS).
• Sensory analysis
• Sensory analysis is defined as the examination of a product through the evaluation
of the attributes perceptible by the five sense organs (organoleptic attributes), such as
color, odor, taste, touch, texture and noise, allowing the establishment of the
organoleptic profile of diverse products, including cosmetics.

17. • The raw-materials influence directly in what the consumer feels when applies the
cosmetic. The emollients, for example, are raw-materials of marked influence in the
tactile sense
• To perform the sensorial analysis with rigor and organization, the laboratory
destined to it must have the following areas:
A room destined to the analyst
who leads the team (Figure 1a)
A conference room (Figure 1b)
A room for the samples
preparation (Figure 1c)
An area to the analyses with
the volunteers (Figure 1d)
• The laboratory should be located in an easy access place.

18.  The area where the analyses will be performed should be
divided into individual cabins with a window, where the analyst
must offer the samples to the volunteer, sink and faucet, to
the volunteer use when necessary. The cabins must be
ventilated and odor free, to avoid interferences in the
analyses.
The temperature and humidity should be controlled around
22ºC and at 45% of humidity.
It is recommended that the walls and furniture of the rooms
are colored with neutral and light colors to not disturb the
attention of the volunteers and to not interfere in the
attributes analyzed by the vision, such as color and
appearance of the product.
The volunteers should not smoke, should be healthy, with
ease of memorization and communication.

19. • There are four different methods to perform the sensorial analysis that are most
used, they are: affective, discriminative, descriptive and methods to evaluate the
effective of the product.
• The affective methods represent the consumer opinion and evaluate how much
consumers like or dislike a product. It is a quantitative method that is performed in
order to know the consumers preferences
• The discriminative test is better represented by the Triangular test. It allows
differentiating one between three different samples and is very useful in shelf life
studies and in the quality control of cosmetics. The ideal is to perform this
evaluation with twelve to forty volunteers, who will receive the three samples and should
indicate the different one between them

20. • The descriptive tests provide a broad sensory description about the product that is being
evaluated, helping to predict the consumer acceptance and what consumers think about
such product
• The tests to evaluate the effective of the products should be performed in true
conditions of use and the volunteer may use only the product that is being
assessed. These tests could be conduct by the evaluation of dermatologists, by the
evaluation of volunteers, and even, by the measurement of one parameter by un
equipment, such as the equipment that measures hydration, sebum and trans
epidermal water loss, to define if a product is really effective.
• Based on these clinical evaluations, a company could create an efficacy claim to the
product

21. Rheology
• Rheology has been widely used because, by means of this tool, the researcher can
determine physicochemical properties of a product. Constructing a rheogram,
it is possible to check the flow curve, evaluate if there is a yield stress and a
hysteresis area, which appears to be related to the release of drugs and actives. It is
also possible to construct a creep and recovery curve obtaining information about
viscoelasticity of each system.
• Specifically, in relation to the quality control of cosmetics, specifically, rheology
can be applied to help in determining the stability of products by means of the
apparent viscosity measured periodically in a determined period exposing the
samples to stress conditions (high and low temperatures, solar irradiation), and to
monitor the flow characteristics during the shelf life or in the stability assay of a
product.

22. SAXS
• The SAXS technique have being used for the analysis of cosmetics, in order to
evaluate the presence of liquid crystalline structures, called liquid-crystals,
which are known to increase the stability of formulations becoming, therefore,
desirable in cosmetics.
• An initial analysis of the presence of liquid crystals
in a cosmetic emulsion could be done using a
polarized light microscope, but it should be
confirmed and better analyzed by means of
Small Angle X-Ray Scattering.

23. When a microscope slide containing a sample of the system is
studied and it presents structures that reflect the incident light, it is
an evidence of the presence of liquid crystals. So, they should be
submitted to SAXS analysis to confirm this expectation.

24. • The SAXS method requires a synchrotron light source that is formed by means of a particle
accelerator, and using a monochromatic beam, that is used to irradiate the sample. After
that, the scattering of the rays in small angle should be analyzed.
• Liquid crystals can be analyzed by SAXS since they are able to disperse the X-rays
focused on it. In the SAXS line is used an X-rays detector and an multichannel analyzer
to capture the intense of the SAXS measures (I(q)) in function of the modulus of the
scattering vector
• Analyzing the data obtained, the d value obtained represents the distance between the
particles able to scatter the X-rays. It is calculated by the equation: d = 2π / q max,
where q max, is the maximum intensity of scattering.
The relation between the d values obtained indicates the type of arrangement found in
the system

25. REFERENCES
• https://www.ufag-laboralorien.ch/en/cosmetics-analysis-quality-control-of-
raw-materials-and -active-ingredients/
• https://www.pharmatutor.org/articles/quality-assurance-of-cosmetics
• http://cdn.intechopen.com/pdfs/41063/intech-cosmetics-quality-
control.pdf
• http://en.Wikipedia.org/wki/history-of-cosmetics