As required by <USP 1072> clean-room disinfectant validation is required “to demonstrate the efficacy of a disinfectant within a pharmaceutical manufacturing environment”.

What you must do:  Take the time to think through all the parts and pieces that make up your overall cleaning program to ensure the program is effective, practical for every day activities.

Product Selection:  

Alcohols:  Broad-spectrum efficacy against vegetative bacteria.  Typical concentration of 70% used.  Not effective against molds or spores. 

Aldehydes: Powerful and aggressive disinfectants.  However, are highly toxic to personnel and require long contact times for sporicidal claims.  

Sodium hypochlorite (NaOCl) and other chlorine compounds:  Broad-spectrum biocidal activity.  Chlorine solutions are corrosive, unstable over time, and rapidly lose activity.  Typically concentrations for sodium hypochlorite are 500 to 50,000ppm.  A low ppm will be effective against most vegetative bacteria within 10 minutes.  Unfortunately, to kill spores/molds the concentration must be greater.  Good disinfectant – Poor cleaner.  Will not remove soil load.   

Hydrogen peroxide: A potent biocide and environmentally friendly.  Peroxides are deactivated in the presence of soil loads, so pre-cleaning is required to achieve the desired reduction in the microbial population.  Typical concentrations as low as 0.5 percent.  Hydrogen peroxide can be combined with other ingredients to dramatically increase its germicidal potency and cleaning performance.

Phenolics: Broad range of disinfectants that are used on environmental surfaces. Typical concentrations are 2 to 5 percent with contact times of 5 to 10 minutes.  Added detergents are effective in removal of soil loads. 

Quaternary ammonium compounds: Non-irritating and non-corrosive to surfaces.  Typical concentrations of 0.1 to 2 percent and require 10 minutes of contact time to kill microorganisms.  However most are not effective in removing biofilms and leave surfaces with a residue that must be removed after disinfection.

Application Procedure:

 

A spray procedure is a quick way to effectively treat a surface.  However, with many of the disinfectants a pre-clean may be required to remove any soil load.  A wipe procedure is also very effective in mechanically removing microorganisms and is a great addition to any disinfectant cleaning program.

 

How can BioScience help?

 

We can perform the following testing (1) use-dilution tests (screening disinfectants for their efficacy at various concentrations and contact times against a wide range of standard test organisms and environmental isolates); and (2) surface challenge tests (using standard test microorganisms and microorganisms that are typical environmental isolates, applying disinfectants according to your cleaning procedures. 

 

– Liv Graving, Microbiologist and In-Vitro Study Director 

This entry was posted on Monday, August 17th, 2009 at 2:19 pm and is filed under In-vitro, Quality, Regulatory. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.