Laura Yates introduces new Bioclear Daily
There’s nothing as rewarding as a new product launch when you are a Research and Development Chemist. Months of research and analysis which culminate in final accreditation is one of the highlights of our work and the project that has seen Bioclear Daily go from concept to product has taken well over 12 months.
The problem of biofilm formation in dental unit water lines (DUWLs) has long been an issue in dentistry and something that every practice needs to tackle on a constant basis in order to be compliant with HTM 01-05. We already have a very successful product in Bioclear, which eliminates the build-up of biofilm in DUWLs when used regularly. The aim behind Bioclear Daily was to produce a continuous water treatment, which would supplement regular Bioclear, working to control the amounts of planktonic bacteria in the waterline system to prevent biofilm forming in the first place.
We began work behind the scenes on the development of Bioclear Daily back in March 2017, selecting the active ingredients and finding a formulation that would not only do its job, but would also satisfy the demands of a Notified Body to meet the necessary standards of patient and user safety for a Medical Device and therefore carry the CE mark.
Gathering technical evidence
The formulation of Bioclear Daily is based on well-known disinfectant technology that has been successfully used for decades in water disinfection. The active ingredients are present at low levels, which do not give rise to any safety concerns in patients or staff. As Bioclear Daily is a disinfectant CE marked as a Class IIa product, any claims about the product have to be substantiated and we had to gather a lot of evidence to support our claims around the product’s efficacy.
Bioclear Daily has been developed through a programme of laboratory testing to derive optimum performance and user safety, taking into account low toxicity, biocompatibility, biocidal efficacy, biofilm inhibition and materials’ compatibility. Testing carried out at the Eastman Dental Institute confirmed Bioclear Daily does not affect bond strengths of compounds, so will not interfere with restorative dental treatments. Third party microbiological testing confirms the biocidal efficacy of the formulation against Legionella and Pseudomonas bacteria and that it is yeasticidal.
Despite the complex development and testing process to bring Bioclear Daily successfully to market, the beauty of the product is in its simplicity and ease of use. It simply works away in the background without interfering with everyday practice routine. By controlling the planktonic bacteria in the water system in the first instance, Bioclear creates conditions which make it difficult for biofilm to form, resulting in water quality that complies with HTM 01-05 and other local guidelines.
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