MANUFACTURING 81
Water quality that is more than skin deep
n Kalpesh Shah – Veolia Water Technologies, UK
Water is one of the most important and widely used ingredients in the production of cosmetic and personal care products. Therefore, ensuring the quality of this vital ingredient is crucial. The European Cosmetics Regulation (EC) 1223/2009 requires that all products manufactured for use in the EU must comply with the ISO 22716 Good Manufacturing Practices (GMP) standard. The GMP guidelines state that water used as a cosmetic ingredient should be of a defined quality and that this should be maintained through regular testing or monitoring of the water. In terms of system design, it states that the water treatment system should be designed to avoid stagnation and contamination and allow sanitisation. It also requires that the materials used in the construction of the treatment system do not affect the quality of the water. The ISO 22716 GMP is also used as a
basis for regulation outside of Europe. In 2008, the International Cooperation on Cosmetics Regulation (ICCR), the group made up of regulatory authorities from Canada, the EU, Japan and the United States, adopted ISO 22716 as the standard for cosmetics manufacturing practice. It is also recognised in Southeast Asia by the ASEAN Consultative Committee for Standards and Quality (ACCSQ).
Setting the standard While there are no specific, universal parameters that must be met for water used in cosmetics, the EC regulations require the product to be safe for its intended use. Therefore, it is up to the manufacturer to define the quality level of water used in its products. The global nature of the cosmetics industry means that there is a competitive advantage to ensuring that the quality standards established for the manufacture of products will allow simple export and sales in a range of international markets.
The primary concern for any business in this sector will be the safety of the products it produces and ensuring the health of customers. As such the focus is most commonly on minimising microbial
April 2020
contamination in the water. As a result, an increasing number of manufacturers are adopting pharmaceutical purified water standards to help ensure the quality, longevity and safety of their products. The most widely used pharmaceutical standards are the European Pharmacopoeia (Ph. Eur), the United States Pharmacopeia (USP) and Japanese Pharmacopoeia (JP). Due to the size of the US market in cosmetics, the USP has become the one of the most commonly adopted purified water quality standards. The USP requires purified water to achieve a conductivity less than 1.3µS/cm (at 20°C), total organic carbon (TOC) of no more than 500 parts per billion (ppb) and a bacterial count of less than 100 CFU per ml. The Ph Eur purified water standard replicates the USP parameters except for a less stringent conductivity level of 4.3µS/cm rather than 1.3µS/cm. There are several water treatment technologies that can be used to achieve this. The most common being ion exchange (IX) and reverse osmosis (RO) coupled with continuous deionisation (CEDI). Distillation, which is used widely for producing very high quality Water for Injection (WFI) is much less common.
Treatment options available Ion exchange has traditionally been the most common technology employed for producing purified water for cosmetic products. It uses specialist resins to remove contaminants from water. The systems control the electric charge of ions in water by attracting non-water ions and replacing them with water ions - removing the solids and leaving pure water. This technology is widely used as it is cost effective and can achieve the conductivity parameters of the Ph Eur and USP standards. However, one of the disadvantages of ion exchange is the need to use chemicals to regenerate the resin beds. These chemicals are hazardous and present a safety risk to operatives. This is a part of the reason why in recent years RO combined with CEDI has replaced IX as the preferred treatment process for producing purified water. Advances in RO technology have resulted in lower cost RO membranes and the development of lower pressure membranes that have reduced operating costs. This, combined with the ability to eliminate the use of chemicals and the effectiveness and reliability of RO in microbial control, means it has become a more attractive option.
PERSONAL CARE EUROPE
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