Manufacturing Process

During the manufacturing process, contamination can occur through contact by the operators, the manufacturing equipment, and the air. The micro-organisms capable of contaminating a cosmetic from human sources are part of the rhinopharyngal, buccal skin, hair, hand skin, and, in some circumstances, intestinal floras. Among these, fecal streptococci, staphylococci, enterobacteria, and Pseudomonas have sufficient vitality to survive and even to multiply in a product.

The manufacturing equipment is also an important source of contamination, coming from maintenance materials (oils, greases), from poor cleaning and/or disinfection on a regular basis, and from product changeover. The design of the equipment is also participating in this process: a piece of equipment that cannot be totally emptied is critical; the equipment storage conditions must also be optimized to avoid product residues stagnant in the system. The design of cleaning in place (CIP) systems must be carefully evaluated: a CIP that leaves a small quantity of stagnant water together with diluted product will have a negative effect instead of a beneficial one.

Attention must be paid to the air quality of the manufacturing rooms. The number of workers and the importance of their movements contributes to 80% of aerial contamination [37]. Air conditioning contributes to 15% of this contamination, and the room structure (materials used) to 5%. It is thus necessary to fix acceptable levels for the biocontamination of the air and to control the air quality. According to the European Good Manufacturing Practices (GMPs) [38], the limits of the class D rooms should be used (200 organisms/m3).

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