Considerations for Choosing a Cleanroom Disinfectant

To ensure the quality of the products they produce, pharmaceutical, biopharmaceutical and medical device manufactures must disinfect as well as clean the cleanrooms in which their products are made. The choice of disinfectant and the frequency of disinfectant rotation, which includes a sporicidal agent, are based on an Environmental Monitoring Program and Quality Risk Assessment (QRM) at each manufacturing site. It is essential that disinfection selection be based on Environmental Monitoring results.

Some considerations when choosing an anti-microbial agent include:

The efficacy of the disinfectant or sporicidal agents against the microorganisms present in the facility as determined by the Environmental Monitoring Program.

Contact times required to kill the microorganisms. The shorter the contact time, the greater the chance for compliance. If a long contact time is required, the surface must be re-wetted, leading to increased chemical costs. Contact times under 5 minutes are ideal, as they do not usually require re-wetting of the surface.

One step cleaning and disinfecting. The EPA states: ”An antimicrobial agent identified as a “one-step” cleaner-disinfectant, cleaner-sanitizer, or one intended to be effective in the presence of organic soil must be tested for efficacy by the appropriate method(s) which have been modified to include a representative organic soil such as 5% blood serum.”3  Some commonly used sporicidal agents such as sodium hypochlorite (bleach) and some hydrogen peroxide/peracetic acid blends are effective only on pre-cleaned surfaces. Pre-cleaning adds both chemical costs and labor costs to the disinfecting process and downtime to the facility... Continue Reading Here!