By Christopher Fournier
The choice of a disinfectant is critical for a pharmaceutical cleanroom, not only because of potential losses due to contaminated product, but also because of user safety as well as room turnaround. This selection process is not as simple as it seems, as there are multiple factors that have to be considered when choosing a product for use in a pharmaceutical cleanroom. Just as most processes and products used in a pharmaceutical production facility have to be validated, cleaning and disinfection products are subject to the same process according to FDA and USP (United States Pharmacopeia) standards.
The specific standard the USP uses to regulate cleanroom disinfectants is USP 29 NF-24 <1072>. This standard classifies the biocide and gives clear definitions on decontamination techniques, the use of disinfectants, sanitizing agents, sporicidal agents and sterilants. The final step in the disinfection process is also the most critical, and because of this, it is subject to the most governmental scrutiny. The most effective of these biocides, a sterilant, for instance, is defined by the USP as a chemical agent that destroys all forms of microbiological life. The destruction of bacteria spores is a crucial point of differentiation, as few biocides are registered as effective sporicides at reasonable concentrations. Biocides that are manufactured for use in the United States must be registered with the EPA, which requires manufacturers to submit data demonstrating the effectiveness of the product. In addition to these regulations, biocides used in cleanrooms are subject to FDA and USP guidelines, which classify them, describe their mechanism of action and efficiency, request minimum efficacy levels, and describe how to get the disinfection process validated.
Peracetic Acid (PAA) is one of the few sporicidals that can perform this job safely and effectively. The key reason for this is that PAA is an effective sporicide at very low concentrations (less than 1%). Adding to the case of PAA is that the chemical is also listed in <1072> classification as a validated cold sterilant. So, it represents a doubly effective chemistry. When you consider that the only other chemicals validated as both a sporicidal agent and sterilant by the USP <1072> are hydrogen peroxide (H2O2), which is deployed in a vapor form and at high concentration (far over 10%), and Ethylene oxide, you understand the need for a more user-friendly option. PAA at 0.015% concentration in a liquid form can be used for daily low level biodecontamination in aseptic rooms replacing bleach (toxic and corrosive), quaternary ammonium, or other low-level biocides.
Advantages Of PAA
PAA has additional benefits which increase its value as an ideal cleanroom sporicidal agent, including:
The chemical is fully biodegradable (breaks down into oxygen, water, and acetic acid).
It leaves no residual on the surfaces after it evaporates.
It can be validated as a sterilant even at a very low concentration level.
It can be used in both liquid and/or vapor (dry fog) form, is fully compatible with modern cleanroom materials, and is available at a pharmaceutical grade chemical purity level.
FDA and USP guidelines play a big part in developing pharmaceutical activities in facilities all over the world. Developing effective, compliant disinfection procedures for the facilities is where the users of disinfectants sometimes get in trouble. The best course of action for users to save time and money is to follow the recommendations set forth by the USP <1072>, getting the right efficacy, and simplifying the protocols. When considering the risk vs. the benefits, PAA is one of the better choices for cleanroom disinfection, and it is now being used by more and more biopharma companies.
Christopher Fournier is the VP of marketing for Mar Cor Purification. He graduated from SUNY Syracuse with a focus in environmental sciences. Fournier has been involved in water, filtration, and disinfection products for the pharma market for over 15 years with a number of respected international companies including Millipore, US Filter, and General Electric.