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STATEMENT OF FORMULA Product Name : ASEAN FACIAL WATER
Ingredient Function % w/w Acacia Senegal Gum Extract Skin-Conditioning 10.0 Butylene Glycol Skin-Conditioning 2.0 Perfume (Rose ver 1) Fragrance 0.5 Sodium Benzoate Preservative 0.3 Methylparaben Preservative 0.1 Water Solvent q.s.to 100
Total 100 The supplier of the perfume (Rose ver 1) is Max Fragrance Co. Ltd.. Part I . B Qualitative and Quantitative formula in INCI or ACD approved nomenclature.
For Fragrance material, name and code number with the identity of the supplier.
Part III. A Qualitative and Quantitative formula in INCI or ACD approved nomenclature.
Should specify function of each raw material / ingredient.
Manufacturing Procedure
Product Name: ASEAN Facial Water
Manufacturer Name: ASEAN Thailand Co., Ltd.
Address: 64846 Big Street, Bangkok, Thailand 18445
Description of the Process: 1. Add Phase 1 ingredients into Main Mix Tank and mix to dissolve completely. 2. Add Phase 2 to Main Mix Tank and mix to dissolve completely. 3. Add Phase 3 to Main Mix Tank and mix. 4. Transfer bulk product to storage tank.
Ingredient List:
Phase Ingredients Phase 1 Butylene Glycol, Methylparaben, Water,
Phase 2 Acacia Senegal Gum Extract, Sodium Benzoate
Phase 3 Perfume
Part III. B Manufacturing
- Manufacturer contact details: name, country and address of manufacturer, assembler and packager
- Summary of the manufacturing process
FINISHED PRODUCT SPECIFICATIONS PRODUCT NAME: ASEAN FACIAL WATER
SPECIFICATION
RELEASE CRITERIA
ANALYTICAL METHOD NUMBER
Appearance A yellowish, clear lotion 1476468
Odor Match to standard 2846466
pH 4.0 – 6.0 1649686
Specific Gravity 0.99 - 1.05 2987147
Microbial Content Test
(a) Total Plate Count
(b) Specific bacteria not to be
found
- E.Coli
- Pseudomonas aeruginosa
- Staphylococcus aureus
- Candida albicans
<= 100 cfu /g
Not Detected /0.1 ml sample
Not Detected /0.1 ml sample
Not Detected /0.1 ml sample
Not Detected /0.1 ml sample
9184535
9413173
Part III. C Specification and test methods of the finished product
ASEAN COMPANY
Analytical Method # 1476468
Appearance
PRINCIPLE AND SCOPE This method describes the procedure to be followed in comparing the physical appearance of a material with the physical description for that material in its given specification.
PROCEDURE Open the sample and observe the actual material. If the material is adequately described by the specification, report as "PASS." If the material differs from the description given in the specification, report as "FAIL."
ASEAN Company
Analytical Method# 9184535
Microbial Content Test Specific Bacteria Identification
PRINCIPLE AND SCOPE This testing method has been prepared for checking the existence of specific bacteria in cosmetics by
incubating the samples. After the cultivation, the growth of microorganisms or micro tubes is investigated.
APPARATUS CRITERIA (SUGGESTED TYPE OR SOURCE)Clean bench
Dry-heat sterilizer capable of maintaining 160 ~ 180 C
High-pressure steam sterilizer capable of maintaining 121 C by pressurizing one
atmosphere
Thermostat, 2 units capable of maintaining 20 ~ 25 C, 30 ~ 35 C respectively
Thermobath capable of maintaining 40 ~ 50 C
pH meter
Microscope capable of using 100-fold objective lens
Stereoscopic microscope magnification being 2 ~ 50-fold
Balance capable of weighing 0.001g ~ 1,000g
Gas burner
Colony counter
Stirrer stirring rod, stirrer beads
Pipette
Inoculating loop inoculating needle, Nichrome wire, and pre-sterilized
plastic
Conradi L-shaped glass, pre-sterilized plastic
Deltoid flask
Rubber plug for deltoid flask rubber-like silicon plug
Test tube
Rubber plug for test tube silicone plug
Metal plug cap
Cotton plug
Messpipette glass product, pre-sterilized plastic product
Messcylinder
Beakers
Slide glass
Glass beads
Spatula
Scissors
Tweezers
PROCEDURE FOR MEASRUREMENT E. Coli. growth and confirmation medium
Lactose bouillon (LB) medium
Meat extract 3.0g
Gelatin peptone 5.0g
Lactose 5.0g
Water 1,000mL
Pseudomonas aeruginossa confirmation medium
Cetrimide agar
Gelatin peptone 20.0g
Magnesium chloride 3.0g
Potassium sulfate 10.0g
Cetrimide 0.30g
Agar 13.6g
Water 1,000mL
Glycerin 10mL
Staphylococcus aureus differntial medium
Vogel-Johnson agar (V-J)
Casein peptone 10.0 g
Yeast extract 5.0 g
D-mannitol 10.0 g
Potassium monohydrogen phosphate 5.0 g
Lithium chloride 5.0 g
Glycine 10.0 g
Phenol red 0.025 g
Agar 16.0 g
Water 1,000 ml
Candida albicans differential medium
Pyocianin detection pseudomonas agar Casein peptone
Meat peptone 10.0g
Potassium hydrogen phosphate 1.5g
Magnesium sulfate 1.5g
Agar 15.0g
Water 1,000mL
Glycerine 10mL
Sample Preparation and Measurement1. E.coli
To 1 g or 1 ml of a sample, add to the medieum to obtain a 10 to 100 ml sample solution. The solution is
then cultured at 30 to 35 C for 24 to 72 hours. The result of the test on Escherichia coli is considered
negative if no red-brick colonies of Gram negative bacteria with reddish precipitation lining the peripheral area
are detected.
2. Pseudomonas aeruginosa
1 g or 1 ml of a sample is weighed out and added to medium containing no bactericides in order to obtain a 10
to 100 ml solution. The solution is then cultured at 30 to 35 C for 24 to 72 hours. If no growth of
microorganisms is observed, the sample is considered to be Pseudomonas aeruginosa-negative.
3. Staphylococcus aureus
1 g or 1 ml of a sample is weighed out and added to containing no bactericides in order to obtain a 10 to 100
ml solution. The solution is then cultured at 30 to 35 C for 24 to 72 hours. If the black colored colony
surrounded with yellow area is not found, the sample is considered to be Staphylococcus aureus-negative.
4. Candida albicans
To 1 g or 1 ml of a sample, add to medium to obtain a 10 to 100 ml sample solution. The solution is then
cultured at 30 to 35 C for 24 to 72 hours. If the black or green colony is not found, the sample is considered
to be Candida albicans-negative.
ASEAN Company
Analytical Method# 9184535
Microbial Content Test Total Plate Count
PRINCIPLE AND SCOPE This testing method has been prepared for measurement of the total number of bacteria and fungi existing in
cosmetics by incubating the samples.
APPARATUS CRITERIA (SUGGESTED TYPE OR SOURCE)Clean bench
Dry-heat sterilizer capable of maintaining 160 ~ 180 C
High-pressure steam sterilizer capable of maintaining 121 C by pressurizing one
atmosphere
Thermostat, 2 units capable of maintaining 20 ~ 25 C, 30 ~ 35 C respectively
Thermobath capable of maintaining 40 ~ 50 C
pH meter
Microscope capable of using 100-fold objective lens
Stereoscopic microscope magnification being 2 ~ 50-fold
Balance capable of weighing 0.001g ~ 1,000g
Gas burner
Colony counter
Stirrer stirring rod, stirrer beads
Pipette
Inoculating loop inoculating needle, Nichrome wire, and pre-sterilized
plastic
Conradi L-shaped glass, pre-sterilized plastic
Deltoid flask
Rubber plug for deltoid flask rubber-like silicon plug
Test tube
Rubber plug for test tube silicone plug
Metal plug cap
Cotton plug
Messpipette glass product, pre-sterilized plastic product
Messcylinder
Beakers
Slide glass
Glass beads
Spatula
Scissors
Tweezers
PROCEDURE FOR MEASRUREMENT Sample PreparationTake the sufficient amount of product, neutralize the preservatives and dilute.
Soybean-Casein-Digest Agar (SCDA)
Casein peptone 15.0g
Soybean peptone 5.0g
Sodium chloride 5.0g
Agar 15.0g
Water 1,000mL
Total Plate CountSterilized plates are used in this test method. In order to obtain accurate plate counts, two or more agar
plates are used per dilution level. 1ml or 1 g of a sample, a solution of the sample or a dilution of the sample
solution are sterilely pipetted into the plates. Next, 15 to 20 ml of previously sterilized and molten agar at a
temperature of 40 to 45 � are added to the plates. The mixture is then stirred until it becomes
homogeneous. After solidification of the agar, the plates are cultured under the prescribed conditions of
culture temperature and time.
Bacterial colonies are generally counted after cultivation at 30 to 35 C for at least five days. Fungous
colonies are counted after cultivation at 20 to 25 C for at least five days.
ASEAN Company
Analytical Method # 1649686
pH PRINCIPLE AND SCOPE
The classical definition of pH is -log [H+ (aq)]. For the practical purposes, it can be thought of as the value given by a suitable, properly standardized, potentiometric instrument, which uses an indicator electrode. Measurements are typically made at 25 °C.
APPARATUS CRITERIA (SUGGESTED TYPE OR SOURCE)pH Meter Capable of reading +/- 0.01 pH units Electrode General Purpose
REAGENTS AND SOLUTIONS GRADE & TYPICAL SOURCEWater (if sample dilution is required) Distilled or deionized water
PROCEDURE
Instrument Operation Follow the electrode manufacturer’s instructions to operate the meter.
Operation Before use, the pH meter should be standardized. pH varies with temperature, the variation being greatest with high pH buffers.
Preparation of Samples If no dilution is required in the finished product specifications, the product is to be analyzed at full concentration. If dilution is required, distilled water must be used for dilution unless directed. Analysis Place the electrode in the sample, wait for the reading to stabilize and record the sample pH. Remove the electrode for the sample and immediately rinse with distilled water.
ASEAN Company
Analytical Method # 2846466
Odor
PRINCIPLE AND SCOPE This method describes the procedure to be followed in comparing the odor of a material with the description for that material in its given specification. When there is no written description, the material is compared to a standard. PROCEDURE Prepare the sample for evaluation as is appropriate to that particular material.
The sample is graded versus the approved standard. Carefully sniff the sample and the standard. If the material is matches to the standard, report as "PASS." If the material differs from the standard, report as "FAIL."
ASEAN Company
Analytical Method# 2987147
Specific Gravity
PRINCIPLE AND SCOPE The density of a substance measures its mass per unit volume. The specific gravity of a substance is
the ratio of its mass to that of an equal volume of water at 4°C. Density has units of kg/Liter or g/mL.
Specific gravity, however, is unitless. The principle of the digital densitometer is based on the change
of the natural frequency of a hollow, U-shaped oscillator when filled with different liquids.
APPARATUS CRITERIA (SUGGESTED TYPE OR SOURCE)Digital density meter
Syringes Suitable for density meter tube
PROCEDURE FOR MEASRUREMENT CalibrationThis should be checked using water. Compare the result obtained at the measurement temperature
with the table value given in the instrument manual.
Temperature EquilibrationHigh differences in temperature between oscillator and sample lead to erroneous results. The density
reading will only be valid when the temperature indicated for the oscillator filled with the sample does not
differ by more than + 3°C from the temperature initially displayed for the empty oscillator.
Filling the Sample Tube
Fill the sample to the tube using the suitable syringes. Ensure that there are no air bubbles in the
measuring cell. If the density display does not show properly, the oscillator tube is not properly filled
and the filling procedure must be repeated.
Reading density and specific gravity The display on density meter shows the density of the sample. Specific gravity can be calculated with
the densities of sample and water at the same temperature.
Density of sample
specific gravity = ________________
Density of Water
Stability Assessment
Product Name: ASEAN Facial Water Formula Code/Version: 1689748 -001 ----------------------------------------------------------------------------------------------
The product shelf life is expected to be 2 years with the rationale below.
Rationale: Samples had been stored at 40 C / 75% RH for 6 months. It was confirmed all the results
were within specification. As the confirmatory assessment, samples had been stored at 25
C / 60 % RH for 2 years, with all favorable results within specification.
Part III. D Product Stability Summary Report for product durability below 30 months
- The stability testing data and report or stability assessment to support the
expiry dates