With over 15 years development and commercial experience, ownership of our own Intellectual Property (IP) of a strong stable formulation under the brand name Leucillin, Lyvlee Ltd are experts in the field of Hypochlorous acid (HOCl) based antimicrobials. Leucillin has been developed for the use in cleaning and flushing minor wounds, on skin disinfection, a skin safe, user-friendly solution which dramatically reduces pathogen loads. Leucillin is a is non-cytotoxic, broad-spectrum topical antimicrobial to accompany all dermatological protocols.

With HOCl now a popular choice for topical skincare management, it is vital for optimum efficacy of function and value for money to understand its formulation, limitations and stability challenges; so you know what questions to ask when choosing your HOCl based antimicrobial.

What is Hypochlorous acid?

Hypochlorous acid (HOCl) is a naturally occurring chemical in the mammalian body, produced by white blood cells in response to the detection of invading pathogens. Harnessing the body’s natural defences HOCl antimicrobials kill all known bacteria, viruses and fungal spores from MRSA, Clostridium difficile (C. Diff), E. coli and Salmonella. HOCls many applications mean it’s the perfect replacement for existing standard antiseptic and minor wound care products.

How is your formulation made?

Electrolyis HOCl can be made combining non-iodinated salt, water and electrolysis. Electrolysis is a technique that uses direct electric current to drive an otherwise non-spontaneous chemical reaction, this process has the ability to make concentrations of between 50 - 150ppm. HOCl is inherently unstable, electrolysis method is ideal for generating HOCl on demand i.e. to be used within 48-72 hours. Optimizing electrolysis conditions, such as current density and pH control, can affect the stability and extend its shelf life, with some solutions demonstrating efficacy up to 18 months when stored in ideal conditions. However, it is to be retained that HOCl degrades over the period of its shelf life, therefore a solution with a weaker ppm on production will degrade to a poorer efficacy by the end of its shelf life.

Synthesis Lyvlee Ltd.’s investment in Research and Development has managed to harness and stabilize HOCl using a entirely unique modern method of manufacture. Leucillin has a guaranteed 300ppm strength, considerably greater than electrolysis formulations, an effective shelf life of 24 months, with laboratory stored batches demonstrating vastly extended efficacy and pH stability over many years.

How is HOCl efficacy measured?

The effectiveness of a Hypochlorous product is measured by the strength of Free Available Chlorine (FAC) of the solution. FAC refers to the relationship between the Hypochlorous acid (HOCl) and hypochlorite ion. It is this free, uncombined form of Chlorine that is the active ingredient for effective disinfection, FAC is measured in parts per million (ppm)

A HOCl solution with a higher ppm formula of FAC translates to guaranteeing you a stronger solution, providing a more efficient pathogen kill rate and faster results from the application.

pH Matters!

The positioning of a HOCl solutions’ pH is paramount to efficacy. The pH dictates the free chlorine species present in the aqueous solution. At a pH of between 5-6, the chlorine species is nearly 100% hypochlorous acid (HOCl). As the pH drops below 5, it starts to convert to Cl2 (chlorine gas). Above a pH of 6, it starts to convert to the hypochlorite ion (OCl-). 

Many electrolysis-based formulations sit at a pH 7, this is perfectly safe and efficacious, however it is not optimum for peak efficacy because of the relationship between Hypochlorous and Hypochlorite. Leucillin has been developed and stabilised at a pH 5.5 – 6 which is the natural pH of the skins acid mantle, and the peak efficacy of HOCl.

What Other Factors affect the stability of Hypochlorous acid?

To ensure the effectiveness of HOCl as a disinfectant, it is important to understand and control many factors during manufacture, production, transport and storage to maintain product integrity and activity of hypochlorous acid molecules.

Temperature: too high or too low can accelerate the degradation causing HOCl to break down and lose its antimicrobial effectiveness.

Light: Exposure to sunlight or UV radiation breaks down HOCl molecules, thereby reducing disinfecting power.

Time: HOCl has a limited shelf life decreasing in efficacy over its shelf life.

Metals: Contact with metals, particularly ferrous metals causes rapid degradation of the product, this is a particular consideration during manufacture and bottling.

Organic Materials: HOCl reacts with organic substances such as proteins and other biological materials this again causes rapid degradation.

Storage and storage receptacle are crucial for maintaining efficacy for the duration of shelf life. Leucillin's packaging is RPET plastic (minimum 30% recycled plastic material) containing a UV inhibitor impregnated for light protection. There are no metal component parts used during any part of its manufacture and bottling process, inclusive of its applicator from bottle to skin, this contributes both towards protecting the product and our dedication to sustainability as a business, utilising recycled materials and ensuring an all-recyclable end product. With storage instructions on the bottle label we have made every effort for our customer to maintain the quality and value of their Leucillin formulation.

Understanding log reductions or What is the difference between 99% and 99.99999% efficacy?

Log Reduction stands for a 10-fold (one decimal) or 90% reduction in numbers of live bacteria. For example a wound containing 1 million bacteria after an application of a Log 7 99.99999% (maximum measurable reduction in bacterial load ie. Leucillin) none would survive, using a Log 2, 99% effective, out of your 1 million bacteria 10,000 will still survive to continue to grow and multiply contributing to microbial resistance and rendering the product potentially ineffective.

The higher the log reduction, the more efficacious the solution, therefore the higher bacterial kill rate and the resulting skin disinfection providing an optimum environment for tissue recovery.

Understanding the difference been a medicine and a biocide:

All antimicrobials claiming effectiveness in the reduction of pathogens are regulated as biocides. Products claiming to have a further physiological effect i.e. to treat or restore are categorised as a medicine, only registered medicines can make medicinal claims, therefore requiring a licensed medical professional to prescribe.

Leucillin is a registered biocide, this allows Leucillin's easy access of purchase as an over the counter product, for first aid and all general skin disinfectant applications for both human and animal skincare.

Proving Efficacy as a biocide, EN Standards testing

EN testing is a globally recognised standard to determine disinfectant efficacy of a product, Leucillin has been tested but not limited to the following EN standards with proven >Log 7 efficacy in the reduction of pathogens tested against:

EN13727, EN1656 EN 16437, EN16437, EN1657, EN14476, EN14476:2013 A2:2019 Annex A*

Who are biocides regulated by?

To maintain the integrity of the products purchased for health care purposes, in the UK these are regulated by governing bodies: HSE (Health and Safety Executive), VMD (Veterinary Medicines Directorate, an executive agency, sponsored by the Department for Environment, Food & Rural Affairs) and MHRA (Medicines and Healthcare products Regulatory Agency).

Who is it made by vs. who was it sold by? 

Beware of white label products. Companies producing products under white or private labels are common place, including biocides as well as electrolysis HOCl. As previously discussed HOCl is inherently unstable, relying on many of contributory factors, essential for maintaining its stability as a viable product. From a practical, regulatory and legal perspective, biocides marketed by third party companies have many concerns:

The shelf life of a HOCl product begins at manufacture. If a solution is manufactured for private label; when was it made vs. when was it bottled and distributed? Was a bulk bought quantity bottled at varying stages? Was it stored in temperature controlled, UV protective containers? Did the contract bottler understand the product's instabilities and requirement for specialist equipment? Does the end user packaging protect the product?

And Importantly, as HOCl now begins to appear in the cosmetic industry, Can other ingredients be added to a HOCl solution? The answer can only be NO. Because of HOCls fine balance of stability, any other ingredients, organic, surfactant, colour, fragrance etc. will render the solution completely ineffective as a disinfectant. All these questions are raised based on known issues with products available on the market, and there are products fraudulently claiming HOCl efficacy with added fragrances, colourings and organic components resulting in a solution which contains absolutely no FAC.

Leucillin is British Technology, owned, manufactured, bottled and distributed globally, rigorously tested inhouse and by third party laboratories, with every batch made archived and available for testing. Leucillin is compliant with European Biocidal Products Regulations, is Type 3 Veterinary authorised and is additionally also Type 1 authorised for Human use; not only under the European Biocide Directive through BAuA Germany; and also by The UK HSE which is the appropriate governing body within the UK. Leucillin being developed, owned, manufactured and distributed by Lyvlee Ltd has all the necessary approvals to be sold and marketed. Leucillin in addition to the EBD is authorised by the FDA (USA), Canada Health, Saudi FDA and EPA New Zealand, exported to most European countries, plus Iceland, Canada, America, Singapore, Hong Kong and Saudi Arabia.

For further information or to request Leucillin's safety data sheet which details of all EN pathogen test results please email info@leucillin.co.uk or call 0345 548 9800

REFERENCES:

https://pmc.ncbi.nlm.nih.gov/articles/PMC7315945/

https://www.preprints.org/manuscript/202404.0954/v1

https://hocl.com/hocl-chemistry

https://www.pwtag.org/importance-of-free-chlorine-content-tn60/