F10 HAND RUB: an alcohol-free hand sanitizer for high level waterless hand decontamination
The antimicrobial action of the F10 Hand decontaminating products is based upon the proprietary branded F10 compound. The mechanism of action of F10 is derived from those of each component separately but, in addition, is due to the additive synergistic action of all components combined.
The number of organisms, most commonly present, e.g. S. aureus, MRSA , Proteus spp., Klebsiella spp., Acinetobacter spp. and Clostridium difficile, on intact areas of the skin can vary from 100 to 106/cm2. Bactericidal tests have been carried out in accordance with SANS 636-2001 (South African) Standard having a performance pass criteria of >log3 (>1,000 times) reduction in microbial counts, the AFNOR (French) Standard which is a >log4 (>10,000 times) reduction in microbial counts, the European Union EN Standard which is a >log5 (>100,000 times) reduction in microbial counts, and the AOAC (USA) Standard which is a >log6 (>1,000,000) reduction in microbial counts. MIC in-vitro tests have shown significant depth of performance as these results indicate.
Bactericidal, fungicidal and virucidal tests have been carried out in accordance with SANS 636-2001,AFNOR and EN Standards which require a log3 up to a log5 reduction in microbial counts respectively.
Contact time is a critical factor in surface acting agents. In hand hygiene applications contact times in practice for frequent use can be from 30 seconds to 1 minute but commonly as little as 15 seconds and from 2 to 6 minutes for surgical preparations. In this regard all F10 hand hygiene products have been further tested to GLP Standards and achieved a > log2 (100 times) reduction of gram positive bacteria, e.g. Staphylococcus spp., Clostridium difficile in 15 seconds, to 30 seconds for gram negative, e.g. Pseudomonas spp. and yeasts, e.g. Candida albicans.
The residual effect of hand hygiene preparations should not be relied upon when dealing with high risk patients because of the variability of the potential challenge, 100 – log6 organisms/cm2, and the variability of the residual effect which is directly affected by transient surface contacts. The use of quick acting waterless gels, rubs and foams can overcome the practical difficulties of hand washing and result in better hand hygiene compliance.
In preoperative surgical scrub products a residual effect is desirable. When subjected to a residual test in a GLP laboratory the F10 HAND SCRUB achieved a >99% kill after 2 successive challenges of 5,000,000 Staphyloccocus spp. applied at intervals of 30 minutes, 1 hr, 2 hrs, 3 hrs, for a contact time of 1 minute.
Acute oral toxicity – >5000mg/kg
Acute dermal toxicity – > 5000mg/kg
Acute dermal irritation – graded 0 (non-irritating)
Acute eye irritation – graded 0 on contact with cornea and iris after 24 hrs contact (non-irritating)
DOSAGE AND DIRECTIONS FOR USE
Refer to each specific product label.
Ingestion: Do not induce vomiting, give milk or water to drink
Do not mix with other soaps or chemicals