Azeco Cosmeceuticals

Test on preservative efficacy / Challenge test (Ph.Eur.5.1.3): The following data were obtained as the log-reduction, with a starting inoculation of 106 CFU/g:

t=0

t=2d t=7d t=14d

t=28d

Staphylococcus aureus

6,0

1,5

1,0

1,0

1,0

Pseudomonas aeruginosa

6,0

1,2

1,0

1,0

1,0

Candida albicans

6,0

2,4

1,0

1,0

1,0

Aspergillus brasiliensis

6,0

5,2

1,0

1,0

The results satisfy the Ph.Eur.5.1.3. requirements.

Manufacturing instructions: 1. The equipment is sterilised using peracetic acid and/or ethanol (non-denatured). The ATP count shall be below 100 for the rinse liquid at the outlet of the reactor. If this boundary condition is not met, the sterilisation procedure shall be repeated.

2. The water phase (Phase A) is prepared by combining the ingredients. The water phase shall be alkaline as to (partially) neutralise azelaic acid present in the oil phase. Ignoring to do so will inhibit emulsion formation. The water phase is heated to 70-75°C.

3. The oil phase (Phase B) is made by combining the ingredients and heating to 70-75°C. The oil phase shall be completely clear and has a slight yellowish colour.

4. The oil phase is added to the water phase at 70-75°C while stirring with a planetary mixer. The mixture, that is still unstable, is stirred during 5 minutes (on a laboratory scale). Subsequently the mixture is homogenised using a high velocity rotor-stator mixer at maximum capacity. The pre-emulsion is cooled to 40-45°C and re-homogenised adding the preservative (Phase C). The obtain- ed emulsion is white and is still low viscous. Upon further cooling the viscosity will continue to increase. At 25°C the fragrance is added (Phase D); stirring is continued during 15 minutes. 5. The pH is adjusted to the specifications with an 18% aqueous sodium hydroxide solution. The lotion is kept in quarantine for 5 days and committed for microbiological analysis. After 5 days the analytical data of the lotion may be adjusted to the specifications, if required. After the quarantine period the lotion may be committed for confectioning or transferred to bulk storage, provided it satisfies the specifications. INCI list: Ingredients: Aqua, Azelaic Acid, Betaine, Cetearyl Isononanoate, Cetearyl Alcohol, PEG-20 Glyceryl Stearate, Isopropyl Myristate, Steareth-2, Steareth-21, Diethylhexyl Adipate, Glycerin, Parfum, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Pro- pylparaben, Isobutylparaben. Shelf life: 3 years after production, 12 months after opening. Store at ambient temperature, out of direct sun light. Preferred packaging: tube, 30 ml.

Mussenberg 1 • 6049 GZ Roermond • The Netherlands

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