DEFENS D1 Antiseptic Skin Agent
Specifications
Purpose and Scope of Application
The purpose of the product “DEFENS D1” is intended for:
for disinfection (antiseptics) of the hands of medical personnel in healthcare institutions.
for hygienic disinfection (antiseptics) of the hands of laboratory personnel of various subordination (clinical diagnostic, microbiological, biochemical, bacteriological, serological, etc.), sanitary transport (including ambulances), in blood transfusion donor points, medical sanitary units, paramedic and medical points;
for hygienic disinfection (antiseptics) of the hands of personnel in communal and household service facilities (hairdressers, beauty salons, SPA centers, manicure, pedicure, massage rooms, cosmetology clinics, salons, solariums, baths, saunas, etc.) before and after working with clients, as well as for treating the client’s skin during manicure, pedicure, tattooing, piercing, and other procedures related to skin damage; for disinfection (sanitary treatment) of skin coverings, treating the skin of the feet to prevent fungal and other infections;
for hygienic disinfection (antiseptics) and decontamination of the hands of personnel in the food processing industry (bakeries, confectionery factories, dairy plants, meat processing plants, beer production, non-alcoholic beverages, mineral waters, etc.), enterprises and institutions of the agro-industrial complex (dairy farms, poultry farms, etc.), perfumery-cosmetic, pharmaceutical, chemical, biotechnology, microbiological industries; for disinfection (antiseptics) of the hands of personnel and visitors in public catering and trade establishments (cafeterias, restaurants, fast food restaurants, shops, supermarkets, markets, etc.);
for hygienic disinfection (antiseptics) of the hands and antiseptic treatment of the skin at home while caring for the sick, infants, elderly people, during travel, in places of increased infectious danger;
for hygienic disinfection (antiseptics) of the hands of personnel and children in preschool institutions, personnel and students of educational institutions of various accreditation levels, workers of disinfection, sanitary-epidemiological, and veterinary services, pharmacies and pharmacy establishments, sanatorium-resort, sports and health institutions of various profiles, social protection institutions (homes for the elderly, disabled), communication establishments and banking institutions; for disinfection (antiseptics) of the hands of personnel and passengers of all types of transport (including railway transport (in passenger cars and other rolling stock, at railway stations and stops) and air transport), objects and subdivisions of the ministries of internal affairs and defense, in penitentiary system institutions, customs and border service employees, and other objects whose activities require compliance with sanitary and hygienic norms and rules.
Purpose and Scope of Application
The product is intended for use in the following areas:
healthcare institutions, laboratories of various subordination, pharmacy establishments, food processing industry enterprises, restaurant and trade establishments (including trade and entertainment), communal and household service facilities (including public transport stops, public places), pharmaceutical, chemical, biotechnology, microbiological, perfumery-cosmetic industries, sports and health institutions, recreation and entertainment establishments, social protection institutions, military units, communication establishments, and banking institutions, educational institutions.hospitals and educational institutions, preschool facilities, transportation (railway, automotive, air, subway, river, sea, etc.).
Advantages and features of the product
Specific biological properties of the product: spectrum of antimicrobial action. “DEFENS D1” has antimicrobial activity against gram-positive and gram-negative bacteria (including pathogens of nosocomial infections, Mycobacterium tuberculosis, multidrug-resistant Staphylococcus (MRSA), enterohemorrhagic Escherichia coli, Pseudomonas aeruginosa, Salmonella, and other antibiotic-resistant bacteria), viruses (including parenteral viral hepatitis (B, C), HIV, papilloma, adeno, polyoma, polio, noro, rota, enterovirus, vaccinia viruses, SARS, herpes viruses, influenza viruses, avian influenza virus A(H5N1), swine flu virus A(H1N1), etc.), pathogenic fungi (including pathogens of candidiasis, dermatophytosis, trichophytosis). The product is highly effective against transient and resident microflora, ensuring quality hygienic and surgical hand and skin antisepsis. The product demonstrates high-quality action in the presence of protein, serum, and blood. The product provides an antiperspirant effect, reducing moisture under gloves, which prevents the release of resident microflora. The product “DEFENS D1” has a prolonged (remnant, residual) antimicrobial action for 3 hours (including under medical gloves). The product provides degreasing skin cleansing, facilitating effective adhesion of surgical film.
Toxicity and safety of the product
“DEFENS D1” is classified as a low-hazard substance (according to the requirements of GOST 12.01.007 76) based on acute toxicity parameters when ingested and applied to the skin (4th class). It does not exhibit skin-irritating and sensitizing properties upon single and multiple applications to the skin. Application of the product to scarified skin does not complicate the healing of artificially applied wounds. The product does not exhibit cumulative properties or specific delayed effects (mutagenic, embryotoxic, gonadotropic, teratogenic, and carcinogenic).
Preparation of working solutions
Methodology and conditions for preparing working solutions
“DEFENS D1” is a ready-to-use product that is used undiluted once.
Methods of application of the product for disinfection
Objects of application
The product “DEFENS D1” is used for hygienic and surgical disinfection (antiseptics) of the hands of medical and service personnel in healthcare facilities of all profiles, for rapid disinfection of surfaces, medical devices, including non-critical instruments, gloves, and other objects, for hygienic disinfection of hands and skin at home, for disinfection (sanitary treatment) of skin surfaces, treatment of foot skin to prevent fungal and other infections, for hygienic disinfection and decontamination of the hands of personnel in various fields of activity mentioned in p. 1.5.
Methods of disinfecting objects with the product
Hygienic disinfection (antisepsis) and decontamination of hands are aimed at removing acquired pathogenic microflora (transient flora). To interrupt the transmission chain of infectious disease pathogens, hygienic disinfection (decontamination) is recommended before handwashing. For precise hygienic dosing of the product and to avoid the risk of cross-infection, it is recommended to use wall-mounted elbow dispensers, medfixes, or infusion holders. Before performing manipulations – apply 3 ml of “DEFENS D1” to dry hands and rub it in.within 15 seconds. After performing the manipulations: in the case of clean hands – apply 3 ml of the “DEFENS D1” product to dry hands and rub for 15 seconds; in the case of dirty hands – remove contaminants from the surfaces using a disposable wipe, and then treat the hands by rubbing 3 ml of “DEFENS D1” for 15 seconds. During the hygienic disinfection (decontamination) of hands, the hand processing technique must be followed. After disinfection, hands should not be washed, wiped, or dried.
Quick disinfection of surfaces, medical devices, including non-critical instruments, gloves, and other objects is carried out by wiping or spraying (if a sprayer is available) the objects with “DEFENS D1”, keeping the surface (product, instrument, etc.) moist for 15 seconds. The consumption rate of the product should not exceed 30 ml/m2. After the exposure time is completed, rinsing the product is not necessary.
Precautions when working with the product
Necessary protective measures for skin, respiratory organs, and eyes when working with the product. No need for protective measures for skin, respiratory organs, and eyes.
General precautions when working with the product. The “DEFENS D1” product is intended for external use only. Do not use for treating mucous membranes, and avoid contact with eyes. The product is dangerous if swallowed, so avoid its entry into the stomach. The product is flammable; disinfection work is prohibited in rooms with open flames and heat sources. In case of accidental spillage of a large amount of the product, ensure intensive ventilation of the room. The spilled product should be collected with sand or another non-flammable material that absorbs liquid well. The cleaned surface should be rinsed with water.
Disposal methods
Batches of “DEFENS D1” that have expired or non-conforming batches due to storage condition violations must be returned to the manufacturer for recycling.
Signs of acute poisoning. First aid measures in case of poisoning
Signs of acute poisoning. Not noted.
First aid measures in case of acute (respiratory) poisoning with the product. None.
First aid measures in case of the product getting into the eyes. Rinse eyes with plenty of running water. If necessary, consult a doctor.
First aid measures in case of the product getting into the stomach. It is recommended to rinse the mouth with water and drink a large amount of water. Do not induce vomiting! If necessary, consult a doctor.
Packaging. Transportation. Storage
Packaging of the product. The “DEFENS D1” product is packaged in canisters from 5 l to 20 l, as well as in containers from 50 ml to 1 l with dispensers. By agreement with the manufacturer, the range of packaging may be changed or supplemented.
Transportation conditions. The product is transported in the manufacturer’s packaging by all types of transport according to the rules for transporting the relevant category of goods.
Storage term and conditions. The “DEFENS D1” product should be stored in the manufacturer’s airtight packaging at a temperature of +5°C to +30°C in covered unheated storage rooms, protected from moisture and direct sunlight, away from open flames and heat sources, separately from flammable materials and substances, in places inaccessible to children. The storage room for the product must be equipped with one of the fire extinguishing means. The shelf life of the product is 3 years from the date of manufacture.
Methods of quality control of the product
Controlling indicators and standards. The disinfectant “DEFENS D1” is controlled forthe following quality indicators: appearance, color, smell, hydrogen index (pH).
Determination of appearance, color, and smell.
The appearance and color of the product are determined visually. The product is made in a transparent form. The smell is evaluated by organoleptic method.
Determination of the hydrogen index (pH) of the product.
The concentration of hydrogen ions (pH) is determined by potentiometric method in accordance with GF XI, issue 1, page 113 “Determination of pH”.
Technical Specifications
| Parameter Name and Unit of Measurement | Parameter Value |
|---|---|
| Main components / active substances | Benzalkonium chloride 0.15 %
|
| Additional components | Glycerin (for skin hydration) |
| Release form | Ready-to-use liquid solution |
| pH | ≈ 5.5 ± 1.5 |
| Scope of application | Hygienic and surgical hand/skin treatment, disinfection of surfaces (non-critical) |
| Activity / spectrum | Effective against bacteria, viruses, fungi |
| Stability / prolonged action | Maintains antimicrobial action for up to ~ 3 hours |






