Environmental monitoring system (EMS) in the manufacture of cosmeticproducts is required for several stages of production, control, storage,and shipping.
When you plan to create your own cosmetics brand, you must, as a brand manager, respect a number of rules in order to guarantee safety to your customer and to comply with European standards for the manufacture of cosmetic products.
But first of all, it is essential to define clearly the type of product you want to manufacture. For the consumer, the boundary between cosmetic product and medicine is sometimes thin, but for manufacturers, the rules are clear. If you manufacture a drug, you must comply with the pharmaceutical industry regulations. If you manufacture a cosmetic product, you must refer to the regulations specific to cosmetics.
In Europe, whether you manufacture your own cosmetic, whether you use a third party for manufacturing or whether you import it, you must comply with European regulation EC n°1223/2009 and good manufacturing practices by respecting the ISO 22716/2007 standard.
If you manufacture your cosmetic product from an ingredient (peppermint leaf, for instance) described by the European Pharmacopoeia, let's say in the manufacture of a medicine, nothing prevents you from controlling it according to the methods described in pharma as long as it meets the GMP standards in cosmetics.
In the USA, you should know that the FDA (Food and Drug Administration), who’s very demanding as a health authority, ensures the same level of control regarding the production of cosmetics as in the pharmaceutical sector, but it is obviously necessary to take into account that certain European cosmetic products are listed in the United States both as a cosmetic and as a drug (for example: a shampoo for dandruff and for psoriasis).
To comply with standards and control authorities, manufacturers use an environmental monitoring system to control certain parameters throughout the manufacturing process.
Environmental monitoring and contamination control are essential at certain stages and are therefore required. For instance, it is necessary to monitor the contamination of people, equipment, raw materials, water, etc.
Let's start with transportation.
During transport, a series of checks must be carried out: batches check and samples purity.
Control of the environment (temperature, humidity, microbes, etc.) containing the raw materials is also necessary to prevent it from degrading or being contaminated. This is what limits the risks to human health and reduces losses.
All the components of cosmetic products are listed in the INCI nomenclature table (Personal care products Council).
It is also essential to regulate and monitor the production environment.
Since the human body comes into direct contact with cosmetic products, ISO 22716 standards require that most cosmetic products being bottled or filled in a clean room environment. These standards are similar to what is required in the pharmaceutical industry for products that are ingested into the body. Some of the cosmetic items covered by the ISO 22716 standard include: Perfumes, masks, washing gels, mascara, concealer, lipstick, creams, etc.
This results, among others, in the disinfection of premises and the protection of personnel (gloves, coveralls, etc.) in order to minimize accidental mixing between raw materials and human flows, or sufficient ventilation to protect products. In the case of a process such as emulsion, it is necessary to control the temperature to obtain the desired texture.
The equipment has a major role to avoid products’ contamination. It must be cleaned and disinfected. Those not in use should be stored in an uncontaminated, dry place. In addition, equipment maintenance operations must not affect product quality.
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