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|Grade Standard||Bio-Tech Grade|
Decontaminating pharmaceutical manufacturing facilities is essential for producing safe and pure drugs. The most commonly used decontaminant in the industry has been sublimated formaldehyde. In June 2004, however, the International Agency for Research on Cancer classified formaldehyde as carcinogenic to humans.
The US and most world health organizations now recognize formaldehyde as a carcinogen or a possible carcinogen for humans. Although some companies still use formaldehyde, the pharmaceutical industry is looking for alternative decontaminants.
Chlorine dioxide is a broad-spectrum biocide with the advantage that bacteria, fungi, and viruses do not build up a natural resistance. Chlorine dioxide has emerged as popular replacement of formaldehyde. Chlorine dioxide offers the most thorough decontamination possible in the safest manner without producing any carcinogenic by-products. With these entire advantages, chlorine dioxide decontaminates the vessels, reactors, headspace, process tanks, and filtration units. Chlorine dioxide effectively reduces the downtime.
With the recent and quite sudden withdrawal from sale of clear soluble phenolics, as a result of the European Biocidal Products Directive, many laboratories have been involved in a rapid search for suitable alternative disinfectants.
One such alternative is chlorine dioxide, already well-established in hospitals for instrument decontamination and hard surface disinfection, and now finding an increasing role for decontaminating equipment, reactors, vessels, filtration units and processing tanks in the pharmaceutical formulation units.