Kairos

COMPANY POLICY                                                                                                               

Kairos company llc has recently established its headquarters in Milan and a production site in the province of Verona. The company was born as a new entrepreneurial venture from the commercial spin-off of a company operating for about 10 years in the market and dedicated to research, development, production (with its own authorized workshop), control and marketing of products disinfectants, antiseptics, detergents, sanitizers and cosmetics. Products are intended for the social-health sector in particular for hospitals, dental and assistance practices (R.S.A., nursing homes, communities accommodation, school environments and sports centers, etc.) for the most part PMC (Medical Presidium Surgical) and Medical Devices. The production bases its roots on a wide knowledge, in addition to experience in research and development as well as in production. The Scientific Manager has stood out previously holding the position of Technical Director (Qualified Person), Manager Quality Assurance, Head of the Chemical Laboratory at the New pharmaceutical company Farmec s.r.l., for more than ten years; for some years, the function of Research and Development Manager in another company in the sector, Esoform S.p.A .The idea that led to the founding of the production activity about 10 years ago and today of the spin-off of the commercial sector, is to develop the acquired knowledge, to set up a competitive reality and innovative in terms of new products, new manufacturing and organization technologies company. the technical director himself in his many years of experience in industrial companies in the disinfection sector e antisepsis has taken stock of the difficulties and problems experienced.One of the set objectives is to design and organize the various business processes efficiently and technologically advanced, in order to be able to meet the new needs of competitiveness, while ensuring the quality of the product and service provided to the customer and in compliance with mandatory regulations on the subject. With the new company it is now intended to improve and develop the relationship with both private and public customers, managing to garantee 360-degree commercial assistance based on everyone's needs.

The company places itself in the market of:

• disinfection
• antisepsis
• personal hygiene

with the aim of developing and producing increasingly innovative formulations, capable of preventing, and somehow stop, the spread of infections, thus ensuring quality improvement of patients' lives, especially in the socio-health sector.

BRIEF HISTORY                               

Microorganisms, precisely because of their fast and simple life process, acquire more and more quickly resistance to the usual means of killing, put in place by man, see ad for example, the development of new sources of infection (prions) or the increasingly consolidated nesting of antibiotic-resistant microorganisms (MRSA = methicillin resistant Staphylococcus aureus, VRE = Enterococcus Vancomycin Resistant). To face these new challenges it is necessary  “running with the same speed of reproduction of microorganisms ", developing many new strategies of aggression, based on in-depth knowledge of the means available, sometimes even of natural origin. After thorough design, installation and operational validation of the premises, equipment and production processes, the company's Quality Management System has been structured in accordance with international standards ISO 9001 and ISO 13485 obtaining recognition compliance of this approach by the notified body KIWA CERMET (0476). Thanks to this acknowledgement, the company can adopt the CE marking on its medical devices, namely, on disinfectants for invasive and non-invasive medical-surgical instruments and devices for dressing, non-sterile, having followed the procedure relating to the EC declaration of conformity of referred to in Annex II of Directive 93/42 / EEC and subsequent amendments and additions. Thanks to this initial recognition, from a technical and scientific point of view, the company intends to take care of people hygiene, antisepsis and 360 ° disinfection, basically adopting strategies that are here below.

DISINFECTANTS FOR ENVIRONMENTAL SURFACES AND ANTISEPTICS FOR INTEGRAL SKIN

REGULATION

In this context, the reference standard at European level is represented by Directive 98/8 / EC the so-called Biocides Directive and subsequent regulations or implementation directives of variation that is revolutionizing the whole world of environmental disinfectants and antiseptics for intact skin. This whole guideline has been since its start and is still the subject of careful study e evaluation by the Scientific Director, who interfaces with the various regulatory bodies (European Commission, ISPRA and Ministry of Health) in addition to obtaining notification of 11 active ingredients with biocidal activity is constantly updated on how to prepare the Dossier Technician for obtaining the registration of the products themselves. In Italy there is currently the regulation on Medical Surgical Devices which will in any case be a short supplanted by the directive indicated above with a European significance. According to this directive all products for environmental disinfection as well as for personal hygiene must be, on the basis of use (e.g. community, domestic, food, veterinary etc.) included in the different types of product (Product Type) and therefore registered as biocidal products. For this registration, it will be necessary to prepare a technical dossier based basically on the chemical-physical, microbiological (biocidal activity), toxicological and eco characteristics toxicological both of the active ingredient adopted and of the formulation. Indeed the active ingredient used in the formula must necessarily be among those notified and reported in Annex I, IA and IB of the Directive itself. Some of the active ingredients present in the various environmental and unsupported disinfectant formulations at European level, have already seen their ban on their use following some decisions of the European Commission for withdrawal from the market (e.g. cetylpyridinium for personal antisepsis PT01). For as regards the active ingredient, all the tests necessary to obtain the above data can be avoided by submitting the letter of access by the manufacturer of the same active ingredient and which has been recognized as notifier by the commission European, while as regards the formulation a series of efficacy tests will have to be performed based on the application of use. Disinfectants and antiseptics, being of the new generation are subjected to a program of evaluation of the biocidal activity performance, by means of execution of in vitro tests according to current legislation in its two phases, i.e. suspension test (phase 2 / step 1) and on support (phase 2 / step 2) as defined by the UNI EN 14885 standard. In other words, the Lines Guide, reported on the European Standards, currently in force, state that the recommendations of use for chemical disinfectants and antiseptics are supported by the results of efficacy tests, performed according to the protocols envisaged by the European Standards, relating to the single type of activity claimed. The following table shows the reference standards necessary to claim the biocidal activity in the various disinfectant and antiseptic products. 

COSMETIC PRODUCTS                   

For this category of products, Law 11 October 1986 n. 173 and subsequent decrees legislative amendments, among which the Regulation will assume particular importance in the near future (EC) 1223/2009 (entered into force 11 July 2013). The company in this area produces and markets the following product categories:

• Emulsions, lotions, gels and oils for the skin (hands, feet, face, etc.)
• Preparations for baths and showers (salts, foams, oils, gels, etc.) and
• Products for external intimate hygiene.

In developing formulations the guiding principles constantly adopted are:

use of allergens-free parfums: all liquid soaps used for personal and intimate hygiene have a pleasant scent due to blends of essences completely free of allergens or sensitizing ingredients; ational use of extracts of plant origin: the cleaning and / or sanitizing effect of Myriel formulations is the result of the skilful combination of a synthetic component, which ensures good efficacy, and a natural component that strengthens the activity, by means of effect:

• moisturizing (Betaine: extract obtained from Sugar Beet Molasses)
• softening, protective, refreshing, (extracts of Calendula, Mallow and Linden)
• soothing, bacteriostatic and fungistatic (Tea Tree Oil or MelaleucaAlternifolia Extract)

Selection of anionic and amphoteric surfactants with little or no irritating potential: the key idea that distinguishes these formulations is that the balanced combination between synthetic ingredients, with enhanced sanitizing effect, and elements provided by mother nature, allows to obtain a good cleaning result with a beneficial effect on the skin surface. Making his own, the ancient and wise maxim of Horace "in medium stat virtus" (the value lies in medium) each formulation developed by our Laboratory represents the right conjugation between natural and synthetic. 

ATTENTION TO THE ENVIRONMENT               

More and more in recent years the attention of the various manufacturers of active and formulated ingredients, above all in the field of detergency, has focused on the adoption of eco-compatible ingredients, that is, having a reduced environmental impact. Even our company in the selection of its ingredients, especially those intended for cleansing and / or decontamination of surgical medical instruments and body hygiene, focuses its attention on this type of ingredients, although this strategy is the most expensive of all other things being equal. The guiding principle in this selection is that "so that nature and the ecosystem in general continue to guarantee satisfactory levels of quality of life, they must be respected "

AFTER SALES ASSISTANCE                                                                                     

In addition to the above guarantees, our company is able to offer customers, even a after-sales assistance service, consisting of training courses at our headquarters or at the customer's office on the following topics:

Current regulations on the subject of biocidal products (Directive 98/8 / EC and subsequent amendments);

Current regulations on the subject of medical devices (Directive 93/42 / EC and subsequent amendments); REACH Regulation; Regulations on the hazard classification of preparations (Regulation 1272/2008 / EC); Chemical Risk; Theoretical-practical courses on the correct use of disinfectants and antiseptics; Physico-chemical and microbiological characteristics of the biocidal active principles; Biocide efficacy test according to European guidelines (EN Standards); Consultancy for setting up the Hospital Infection Control Program Hand antisepsis guidelines; Practical rules for the use of sanitizing products.

All this activity is ensured by the company's Scientific Manager, given the consolidated experience acquired on the various topics listed above. The advice given can also be of a telephone nature and embrace all the cases or problems encountered with the use of the different products.