Specifications of hand sanitizers

Alcohol based hand sanitizer itself is a bactericidal , then why , absence of microbial contamination is included in its specifications ?

There are chances of presence of microbes in the form of spores in the hand sanitizer.This is beacause the conditions are adverse as the alcohol present in the hand sanitzer itself is bactericidal. Spores can not be easily destroyed by thr hand sanitizer. But when the effect of alcohol is subsided or when alcohol is removed after appying the sanitizer on surfaces or on hands then those spores become active and can grow in favourable conditions. Therefore, control of microbial contamination is essential and hence it is included in the specifications of hand sanitizers.
Simlarly, the antiseptic solutions or the bactericidal / disinfectant solutions used in sterile manufacturing areas must be “Sterile” means there must be absence of microbes in the antiseptic or bactericiedal / disinfectant solutions used for disinfection of sterile areas.


Thanks @sunilrbudhkar … Does the BioLumix (Rapid Micro Testing Method ) analyse microbial contamination present in form spores ?

In the literature , it is stated that , " BioLumix is unsuitable for sterile injectable products ,whose purity is guaranteed by kill steps involving heat or chemicals (and sterilizing filtration ) . Can you explain the reason behind this ?

As per my knowledge BioLumix is suitable for testing of raw materials (Non-sterile) and laboratory or process area surfaces rather than testing sterile products. This might be because volumes required for testing sterile product batches would be too high for the BioLumix system.

The BioLumix system detects microorganisms by monitoring changes in color or fluorescence changes in a microbial liquid growth medium. The color changes resulting from microorganism metabolism are checked at defined intervals.

Thank @sunilrbudhakar . As you rightly said , if , alcohol based hand sanitizer ( containing 62.5 % Ethanol ) has microbial contamination , it will be in form of Bacterial Spores only & Bacterial Spores do not have any metabolic activity . Moreover , the sample of the product to be added in the ready to use test vial of BioLumix , will contain alcohol & until the effect of alcohol is subsided or removed , the spores will not be active & hence no metabolic activity . Thus , testing of microbial contamination in hand sanitizer containing 62.5% Ethanol , by BioLumix is not an appropriate method . Do you agree with the above conclusion ?

Yes, I agree with you.

You must be aware that for performing microbial limit tests (bioburden) in pharmaceutical products containing preservatives, then in such cases first preservative effect in the product must be removed or nullified by adding suitable reagents / substances such as Tween-20 or Tween-80 solutions (Polysorbate-20 or 80). Only then we can perform microbial limit tests. Otherwisw we can get false negative results.

Alcohol effect should be removed by Dilution or Polysorbate 80 before testing

PDA TR 70:

Thanks , Dr. Ahmed… But , if we neutralize by dilution , is it possible that we do not get "Thresh hold Detection level " within due time ?

i saw in the USP there is no requirement for microbial analyses in rubbing alcohols, Hand sanitizers and rubbing alcohol are almost the same with content of 70% alcohol.

Alcohols cannot inseminate spores which is a possible microbial contamination in alcohol. Hence, the specification.