3-Aug-2011

Manual process supersedes gas

Abstract

PharmaCleanse managing director, Kevin Kinsey, outlines a safe alternative to formaldehyde gas for biodecontamination of cleanrooms and equipment

With the kill-all properties of formaldehyde comes inherent dangers for everybody involved. Through transportation to preparation, implementation and clean down, it is a constant concern for health and safety.

In the cleanroom industry, an alternative has been sought to reduce or remove the need for formaldehyde for many years. Its volatile nature and potentially lethal gases used to biodecontaminate modern cleanrooms has meant more stringent training and more costly safety equipment for the operatives involved. As recently as February 2003, the US Department of Labor's Occupational Safety & Health Administration issued strong warnings to industry about the short and long-term effects of exposure to formaldehyde. It says formaldehyde exposure is most common through gas-phase inhalation, but it can also occur through skin absorption. Short-term exposure to formaldehyde can be fatal; however, the odour threshold is low enough that irritation of the eyes and mucous membranes will occur before these levels are achieved. Long-term exposure to low levels may cause respiratory difficulty, eczema, and sensitisation. Formaldehyde is classified as a human carcinogen and has been linked to nasal and lung cancer, and with possible links to brain cancer and leukaemia. Now PharmaCleanse has developed a safer alternative to using formaldehyde gas to biodecontaminate cleanrooms or equipment. The six stage series of manual processes avoids the use of potentially harmful gas, but is at least as effective as the traditional formaldehyde method and includes formidable bactericidal and sporocidal stages. Aside from the health and safety aspect, there are also several other benefits to the cleanroom operator. The room does not have to be in total isolation for the typical 24 to 48 hours, systems do not have to be isolated and shut down and the room does not have to be sealed, sometimes leaving unsightly tape marks.

Industry guidelines followed PharmaCleanse operates within the guidelines laid down by the US Food and Drug Administration, British Medical Council, International Standards Organisation and the Orange Guide to name but a few. It adheres in particular to ISO14644-1 covering the cleaning of sterile areas for bacterial and particle removal from class 10 (M2.5) to class 100,000 (M6.5). Complying to the principles of current cGMP, the teams sent in to the cleanroom environments are continually assessed to ensure high standards are maintained and during each clean all the methods and materials used are logged and are fully traceable. PharmaCleanse also offer amber area services, commercial and industrial cleaning programme for the surrounding areas, helping to minimise the risk of contamination.

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