The US Food & Drugs Administration (FDA) has issued new draft industry guidance on Cosmetic Good Manufacturing Practices, so now is a good time to be reviewing your water system for compliance.
GMP Compliance - What's your water treatment process?
In particular, the draft guidance states that the water used as a cosmetic ingredient should be of a defined quality standard and should be tested or monitored regularly to verify that it meets the standard set out in the guidance, in terms of chemical, physical and microbiological quality.
Further, the water quality must not be affected by materials of construction used in the water treatment process and distribution system. It should be engineered to avoid stagnation and risks of contamination should be routinely cleaned and sanitized to ensure that there is no biofilm build-up. Let's look at those points in turn.
Currently there is no universal standard for the quality of water used as a cosmetic ingredient, although an increasing number of manufacturers, conscious of the need for traceability are adopting pharmaceutical water standards. Inevitably the standard of choice is the US Pharmacopoeia (USP).
Like the pharmaceutical industry, cosmetic manufacturing is a global business and products manufactured in any country may be destined for sale in almost any other country too. But supplying products into the massive US market means that manufacturing protocols must comply with FDA regulations, so the USP has become the de facto universal water quality standard for the pharmaceutical industry and although the new FDA guidance is not specific on water quality, it is logical that the cosmetic industry should follow suit.
The USP requires purified water at the point of use to have a conductivity of no more than 1.3µS/cm at 25°C and a TOC of no more than 0.5mg/l as C. The two most widely used as a water treatment process for purified water production - ion exchange and reverse osmosis - are both capable of producing water of conductivity less than 1µS/cm but water of this quality readily absorbs atmospheric carbon dioxide during storage and distribution, and this can change its conductivity appreciably.
The solution, which has been widely adopted in the pharmaceutical industry is to produce purified water at a lower conductivity to allow for some carbon dioxide contamination whilst still meeting the 1.3µS/cm specification at point of use. This is not quite as easy as it sounds, because the only technologies capable of consistently meeting better than 1µS/cm conductivity are mixed bed ion exchange and continuous electro-deionisation, and both produce water an order of magnitude better than is needed.
The result is that most manufacturers have adopted a pragmatic approach, setting a conductivity standard for purified water of 0.2µS/cm together with a TOC maximum of 0.5mg/l. On-line monitoring of these two parameters provides an early warning of water quality deterioration, allowing action to be taken before the ingredient fails.
Essentially, the same approach is applied to microbial quality of the water. The pharmacopoeias give a guideline value for total viable bacteria count (TVC) less than 100 cfu/ml in practice most manufacturers set action levels an order of magnitude lower to ensure that the standard is met at point of use.
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