Microchem Laboratory regularly screens and tests hand sanitizer formulations. Hand sanitizers may be studied under GLP test conditions for submission of data to FDA, or screened for efficacy under non-GLP conditions for research and development.
FDA testing requirements for hand sanitizers are complicated and have not yet been finalized by the agency. To help out our customers who are new to hand sanitizer testing requirements, we put together a page called “Introduction to Hand Sanitizers” that will be helpful. The article walks the reader through the three main components of hand sanitizer efficacy testing, and describes how test requirements vary from one type of ingredient to the next.
Hand Sanitizer Testing Services
Microorganisms Used For Hand Sanitizer Testing
The FDA Tentative Final Monograph (TFM) specifies 23 species of bacteria and 1 species of fungus for use in hand sanitizer testing. In most cases, it is recommended that customers test both the “official” strain of the test microbe as well as a recent clinical isolate. However, due to the tentative nature of the monograph, opportunities may exist to trim down the testing scheme, so long as it remains scientifically defensible. The 24 microorganisms FDA specifies for TFM testing are listed below:
- Acinetobacter species (such as A. baumannii)
- Bacteroides fragilis
- Haemophilus influenza
- Enterobacter species (such as E. aerogenes)
- Esherichia coli (first strain)
- Esherichia coli (second strain)
- Klebsiella pneumoniae
- Pseudomonas aeruginosa (first strain)
- Pseudomonas aeruginosa (second strain)
- Proteus mirabilis
- Serratia marcescens
- Staphylococcus aureus (first strain)
- Staphylococcus aureus (second strain)
- Staphylococcus epidermidis
- Staphylococcus hominis
- Staphylococcus haemolyticus
- Staphylococcus saprophyticus
- Micrococcus luteus
- Streptococcus pyogenes
- Enterococcus faecalis
- Enterococcus faecium
- Streptococcus pneumoniae
Not the test you’re after? Try our Complete Test Menu. If that doesn’t work, give us a call and we’ll see if we can help you out.
Note: “GLP” stands for Good Laboratory Practices, and refers to governmental requirements for laboratories that submit data to EPA or FDA.