METHODOLOGICAL INSTRUCTIONS on the use of the product … · 2020. 7. 8. · 1 . Certified...

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Certified translation from Ukrainian into English

STATE SANITARY AND EPIDEMIOLOGICAL SERVICE OF UKRAINE

METHODOLOGICAL INSTRUCTIONS on the use of the product “Antichlor Lux” for the purpose of disinfection,

pre-sterilization cleaning and sterilization of medical products

Kyiv - 2015

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Organization - developer: State Institution “Occupational Medicine Institute of National Academy of Medical Sciences of Ukraine” Methodological instructions are intended for health facilities and other organizations, which perform disinfection works. Local health authorities are allowed to replicate these Methodological instructions in the required number of copies.

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AGREED AND APPROVED

By the Acting Chief Sanitary Inspector of Ukraine

/signature/ S.V. Protas

December, 18 2015

No 636-2015

Official seal: Ukraine – State Sanitary and Epidemiological Service of Ukraine

– Identification code 37508109

METHODOLOGICAL INSTRUCTIONS on the use of the product “Antichlor Lux” for the purpose of disinfection,

pre-sterilization cleaning and sterilization of medical products

1. GENERAL PROVISIONS 1.1. Full product name - disinfectant “Antichlor Lux” (Technical

Specifications of Ukraine 20.2-38890446-001: 2015 “Disinfectants”. Technical Specifications”)

1.2. Manufacturer – “Trade Market Group” LLC (Ukraine) 1.3. Composition of the product, content of active and auxiliary substances,

mass,%: 9,0%-dodecylbispropylene triamine (1,3 -propanediamine), 15,0 - alkyldimethylbenzylammonium chloride (active agents).

1.4. Form and physical and chemical properties of the product. “Antichlor Lux” is a homogeneous, transparent, concentrated liquid with a weak characteristic odour, which is highly soluble in water. Aqueous solutions of the product are transparent, colourless and odourless. Work solutions of the product have good detergent, deodorant, wetting, emulsifying properties, do not cause metal corrosion, do not damage objects made of corrosion-resistant metals, thermostable and thermolabile materials, glass, rubber, natural rubber, synthetic leather, polymeric materials, latex, teflon, polyamide, macrolon, polystyrene, polyethylene, soft and solid polyvinyl chloride, plexiglass (acrylic glass), polyester, silicone, alginate, wood, tile, porcelain, a faience on the surface of medical devices and equipment with varnish-coloured, galvanic and polymeric coatings, do not discolour and do not reduce the strength of the fabric, do not fix contamination of organic origin on the surface of medical products, are

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well washed off, do not leave plaque and spots on the surfaces of objects subject to treatment. The agent is not compatible with anionic surface active agents and soaps.

1.5 Product application. “Antichlor Lux” is intended for: - for carrying out the current, terminal, preventive disinfection and deep

cleaning in case of presence of causative agents of nosocomial infection, infections of bacterial nature (including tuberculosis), viral infections: influenza, parainfluenza, bird influenza virus, swine influenza virus А (Н1N1), rotavirus, poliovirus (poliomyelitis), common-source hepatitis, parenteralviral hepatitis В, С, AIDS/HIV virus and fungal (candidiasis, dermatomycosis, moldfungi) etiology, spores, in the foci of infectious diseases, health care institutions and medical and preventive treatment facility of all profiles, including children's hospitals and day patient facility, departments of neonatology, chamber blocks and special care baby units, procedure rooms, operating rooms, first-aid rooms, surgical, therapeutic, paediatric, obstetric, gynaecological, physiotherapy departments of medical and preventive treatment facility, maternity hospitals, outpatient departments, dental clinics and offices, hospitals, ambulance stations, health centres, feldsher's stations and feldsher-midwife stations, centres for organ transplantation, medical units and medical aid stations, emergency stations, departments of morbid anatomy, sanatoria, disease screening and prevention centres, convalescent centres, social welfare institutions, sanitary inspection rooms, forensic medicine institutions, medical profile centres, clinical, microbiological, biochemical, bacteriological, virological and other specialized diagnostic laboratories;

- for disinfection, combination of disinfection and pre-sterilization cleaning (in manual and mechanized way in ultrasonic cleaning plants) and sterilization of medical products from various disposables and reusable materials, including flexible and rigid endoscopes and their auxiliary tools, surgical, gynecological, dental instruments, dental materials (including pick up impressions of alginate, silicone, polyester resin, dentoprosthetic models, dental bridges, dental crowns, articulators, etc.), probes of all kinds, catheters, heads of supersonic diagnostic apparatus, temperature-sensitive materials for anesthesia, masks, flexible and rigid tubes, hoses for anaesthesia-respiratory apparatus;

- for disinfection of endoscopes of high level; - for disinfection of humidicribs in departments of neonatology; - for disinfection of instruments and accessories for hairdressing, manicure,

pedicure, cosmetics at the service-industry enterprises; - for a combination of disinfection and simultaneous cleaning of surfaces of

premises (floor, walls, doors, windowsills, etc.), furniture, furnishings, medical devices, apparatus and equipment, patient-care items (bed-slippers, rubber hot-water bottles, ice bags, drawsheets, etc.), thermometers, hygiene products, laboratory glassware, tableware, cookware, pharmaceutical glassware (including disposable), linen, trolleys for assembly and transportation of linen, containers, racks for storage of linen, toys, sanitary appliances, cleaning facilities, rubber mats, etc.; for disinfection and cleaning of garbage disposal units, chutes and other garbage containers;

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- for disinfection and washing of technological equipment and facilities in food, pharmaceutical, microbiological, biotechnological, perfumery and cosmetic industries;

- on a rolling stock and objects of maintenance of all kinds of transport (hospital transport, emergency trolleys, public, rail, sea, river, road, air transport), railway stations, airports, etc.;

- in sports and recreation centres (sports complexes, swimming pools, etc.), as well as in places of training, competitions, training sessions, public beaches;

- at the objects of municipal-domestic service (hotels, campings, dormitories, apartments, hairdressers, beauty salons, manicure, pedicure, cosmetology clinics, salons, rooms, solariums, baths, saunas, laundries, dry-cleaners, etc.);

- in recreation and entertainment establishments (cinemas, theatres); - public toilets, dry closets, etc.; - industrial enterprises, warehouses and storage facilities, including paper

archives, library repositories, warehouses of food products, medical products, and hygiene products, enterprises of the agro-industrial complex, etc.;

- for disinfection of glassware in medical laboratories; - for disinfection of laboratory equipment (including organic discharge;); - for disinfection on other epidemiologically significant objects, the activity

of which requires disinfection works in accordance with the existing sanitary-hygienic and antiepidemic norms and rules.

1.6 Antimicrobial spectrum. The product Antichlor Lux” has antibacterial (including mycobacterium tuberculosis), virucidal (including common-source hepatitis, parenteral viral hepatitis В, С, AIDS/HIV virus, poliovirus (poliomyelitis), influenza virus А H5N1 (“bird influenza virus”) and Н1N1 (“swine influenza virus”), sporocidal and fungicidal (including pathogens of candidiasis, dermatomycosis, mold fungi) properties.

1.7 Toxicity and safety of the product. Disinfectant “Antichlor Lux” by the acute toxicity parameters according to GOST 12.1.007-76 in case of ingestion meets the 3rd class of hazard - moderately hazardous substance, in conditions of inhalation exposure (in the form of vapour) and in case of contact with the skin meets the 4th class of hazard –low-hazardous substance. In the recommended for the purpose of disinfection concentrations the product does not show skin irritating properties, does not irritate the mucous membranes of the eyes and the upper respiratory tract, does not have a sensibilizing action, mutagenic, embryotoxic, teratogenic, carcinogenic and gonadotropic properties.

2. PREPARATION OF WORK SOLUTIONS 2.1 Technology and conditions of preparation of work solutions. Work

solutions of disinfectant “Antichlor Lux” are prepared in a labelled glass, enamelled

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(without damage to the enamel), plastic utensils or in utensils of any other material by dissolving the appropriate amount of concentrate in tap water at room temperature.

2.2 Calculations for the preparation of work solutions. For preparation of “Antichlor Lux” product solutions of the corresponding concentration, proceed from the following calculations presented in the Table 1.

Table 1. Preparation of «Antichlor» product work solutions

Concentration,% (by the product)

Number of ingredients required for preparation 1 litre of solution 10 litres of solution

Volume of the product, ml

Volume of water, ml

Volume of the product, ml

Volume of water, ml

0,1 1,0 999,0 10,0 9990,0 0,2 2,0 998,0 20,0 9980,0 0,25 2,5 997,5 25,0 9975,0 0,3 3,0 997,0 30,0 9970,0 0,4 4,0 996,0 40,0 9960,0 0,5 5,0 995,0 50,0 9950,0 1,0 10,0 990,0 100,0 9900,0 2,5 25,0 975,0 250,0 9750,0 4,0 40,0 960,0 400,0 9600,0 5,0 50,0 950,0 500,0 9500,0

2.3 Shelf life and storage conditions of the work solution. Shelf life of the

work solutions of the product is 18 days, if stored in a container with a tightly closed lid. The number of lid openings is not regulated and does not affect the quality of work solutions.

3. WAYS OF PRODUCT USE WITH THE PURPOSE OF DISINFECTION,

COMBINATION OF DISINFECTION PROCESSES AND PRE-STERILIZATION CLEANING

3.1. Targets. “Antichlor Lux” product work solutions are used for disinfection

of medical products of metal, glass rubber and polymeric materials (including surgical and dental instruments anaesthetic-respiratory equipment, etc.,); combination of disinfection processes and pre-sterilization cleaning of medical products in medical and preventive treatment facilities (including flexible and rigid endoscopes with auxiliary tools); for disinfection of hairdressing, manicure and cosmetic necessities, for disinfection of surfaces of premises, fitments, medical devices, apparatus and equipment, patient-care items, utensils (including glassware) and dishwashing items, linen, medical products of single use and exhausted bandaging material before its disposal, rubber mats, sanitary appliances, cleaning utensils, medical transport, etc.

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3.2. Disinfection methods of the separate objects. Disinfection is carrying out by wiping, irrigation, dipping, and soakage in accordance with the cycles, specified in tables 2-6.

3.2.1. Surfaces in premises (floor, walls, doors, window frames, etc.), fitments (hard furniture) are irrigated or wiped with rag, moistened with product solution. Product waste norm while applying the wiping method makes up 75 ml/m2, while applying the irrigation method - 100 ml/m2 of workable surface.

3.2.2. Surfaces of medical apparatus, devices and equipment are wiped with rags, moistened with product solution, with respective exposition further observation.

3.2.3. Patient-care items (rubber hot-water bottles, ice bags, fever thermometers, drawsheets, etc.), hygiene products are fully dipped in product solution or wiped with rags, moistened with product work solution. After disinfection is finished, they are flushed with running water.

3.2.4. Dishes are cleaned of food debris and dipped into product work solution at the rate of 2 l per 1 set (soup and dinner plates, tea cup, saucer, table and teaspoons, fork, knife). Glassware is dipped into agent solution. After disinfection is finished, the glassware is flushed with water.

3.2.5. Dishwashing items are dipped into product work solution and after disinfection is finished, they are rinsed with water and dried out.

3.2.6. Toys, small at size, are fully dipped into container with product solution; big toys are wiped with rag, moistened with product solution. After disinfection is finished, toys are flushed with water and dried out.

3.2.7. Linen is soaked in product solution at the rate of 4l per 1 kg of dry linen (in cases of tuberculosis -5 l/kg of dry linen). Container with soaked in work solution linen is closed tight with the lid. After disinfection is finished the linen laundered and rinsed.

3.2.8. Surfaces of sanitary appliances are irrigated with work solution or wiped with rag, moistened with product work solution. Product work solution waste norm makes up 75 ml /m2 of surface for one procession - while applying the product with wiping method, 100 ml /m2 of surface for one procession - while applying the product with irrigation method. After the exposition is finished sanitary appliances are flushed with running water.

3.2.9. Rubber mats are wiped with rags, moistened with product solution, or fully dipped into product solution. After disinfection is finished they are flushed with water.

3.2.10. Cleaning utensils are fully dipped into product solution or twice wiped with rag, moistened with product work solution. After disinfection is finished they flushed with water, dried out.

3.2.11. Medical wastes: - used bandage (drapes, cotton plugs, etc.) is dumped into separate container

of product solution of 0,5 % concentration, kept in for 15 minutes, then disposed; - disposable medical products are disinfected in plastic or enamelled (without

damage to the enamel) containers with product solutions of 0,5 % concentration with 15 minutes exposition.

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Processing technology of disposable medical products is identical to non-disposal products processing technology. After disinfection is finished, the products are taken out the container with solution and sent for disposal.

3.2.12. Hairdressing, manicure, pedicure and cosmetic necessities are disinfected with dipping method in containers with product work solution according to cycle, established for dermatomycosis. After disinfection the tools are flushed with water and dried out.

3.2.13. Disinfection of humidicrib is carried out with 0,5% “Antichlor Lux” product solution according to methodology of humidicrib disinfection processing. The waste norms of product for humidicrib processing make up 100 ml/m2 of surface. After processing the humidicrib is closed for the exposition period (30 minutes). After exposition the chamber is opened and all inner sides are carefully wiped with clean rag, opulently moistened in water, then rubbed dry. While humidicrib processing it is necessary to take into account recommendations of humidicrib manufacturer.

3.2.14. Medical transport for contagious patient transportation disinfection is carried out according to processing cycle in case of relevant infection.

3.2.15. Processing facilities is disinfected with wiping method; after disinfection is finished they are flushed with running water.

3.2.16. While preventive disinfection at educational, childcare, pharmaceutical institutions, at municipal-domestic service objects (hotels, campsites, dorms), dining and commercial facilities, at markets, railway stations, welfare offices, sanitary institutions, recreation and entertainment institutions, on transport and objects of its maintaining the product is used according to cycles, specified in the table.

3.2.17. At hairdressing saloons, washing houses, swimming pools, sports complexes the product is used according to cycles, specified in the table.

3.2.18. It is allowed to combine disinfection processes and pre-sterilization cleaning of medical products (including flexible and rigid endoscopes with auxiliary tools) with the use of “Antichlor Lux” product solution according to cycles, specified in the table 7.

Disinfection of medical products made of metal, glass rubber and polymeric materials, including combined disinfection with its pre-sterilization cleaning is carried out in enamelled (without damage to the enamel), glass or plastic containers, closed with the lid. Products, after its usage, using auxiliary tools (injectors, droppers, etc.) are fully dipped into solution and all ducts and cavities are to be filled with it and released from air. Separable products are dipped into product solution in parts. Instruments with locking parts are dipped opened, with few work actions in solution, previously made for its better ingress to inaccessible places of tools. Solution thickness layer above products shall be not less, than 1cm.

3.2.19. Hoses, locking and connective elements, masks, other parts of anaesthetic-respiratory apparatus are dipped into product solution according to processing cycles, using auxiliary tools all ducts and cavities filled with it and released from air. The temperature during exposition is not maintaining. After necessary

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exposition observation the products are washed in the same solution, where the soakage was carried out in with the help of cotton plugs. Scrapers use is prohibited. After disinfection products are flushed in two steps. First, products are flushed with water according to recommendations, specified in the table 8. At the second step all the products are flushed in distilled water. Hoses are wrapped in bedsheets, hung and dried out in such condition. Accessory components are laid out on sterile bedsheets and dried out in closed condition. Hoses and accessory components are kept in aseptic conditions. Equipment surfaces are processed according to paragraph 3.2.2.

3.2.20. Disinfection of endoscopes and auxiliary instruments is carried out in case of manufacturer’s restrictions absence as for chemical agents, containing in product. For cleaning and disinfection, combined with pre-sterilization cleaning of endoscopes and medical instruments for flexible endoscopes one uses the processing technology specified in relevant official documents, paying much attention to cleaning procedure, that precedes disinfection. Disinfection cycles, combined with pre-sterilization cleaning of endoscopes and its auxiliary tools are specified in the table.

3.2.21. After disinfection, products without internal ducts are flushed with water within five minutes. Medical products with internal ducts and cavities are flushed with water within seven minutes fully dipped into water (with correlation of water volume to flushed products scope not less, than 3:1). Ducts and cavities of medical products are flushed by flashing water over them (not less, than 20 ml), with a help of continuous action type injectors or electric suction machine, not allowing flashed water ingress into flushed products containers.

For medical products and its parts, that don’t have direct touch to the patient, it is allowed the two-time, with an interval in 15 minutes, wiping with rag, moistened with product work solution and further exposure according to the specified exposition.

After disinfection medical products are flushed with water within seven minutes. After that products are rinsed with distilled water within 0,5-1 minutes and dried

out with the help of clean textile tissues. Used tissues, flushing waters and containers for flushing are disinfected by boiling

or by one of disinfection products, recommended by the current instructional guidance documents.

3.2.22. Product work solutions for disinfection of medical products, including combined with pre-sterilization cleaning may be used repeatedly. Presence of active agents should be controlled with the help of “Procedure for determining disinfectant “Antichlor Lux”. At the first signs of appearance change of the work solution (turbidity or colour change, deposit or blooming on containers walls, etc.) and in case of concentration reducing of active agents to lower level otherwise specified, product work solution should be replaced immediately to a new, freshly manufactured one. Pre-sterilization cleaning of thermoliable, surgical, dental tools, tools for flexible endoscopes and parts of disassembled rigid endoscopes by “Antichlor Lux” work solution is carried out in container tightly closed with the lid by method of dipping in product solution. Ducts and cavities of surgical and dental tools are fully filled with

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“Antichlor Lux” work solution. While dipping instruments in solution the internal opened ducts of instruments are fully filled with product work solution with the help of sterile continuous action syringe, flowing through the ducts of each instrument not less, than 10 cm3 of solution. A syringe is attached to the tool distal end with the help of nozzle, which, after flowing through of product work solution is removed from tool, not allowing airing in the channel.

3.2.23. Quality of pre-sterilization cleaning of medical products is estimated by hallmarking as for blood residue, according to methods, specified in current methodological official documents. 1 % of simultaneously processed products of one item (but not less, than 3 products) is subjected to control. When revealing blood residue (positive hallmark) the whole group of products, from which the hallmark was taken to control is subjected to reprocessing till the negative result will be obtained.

Table 2. The disinfection cycles by solutions of product “Antichlor” in case of intestinal and droplet infections of bacterial etiology (with the exception of tuberculosis)

Object of decontamination Concentration

of the solution, % (by the product)

Exposure, min

Disinfection method

Surfaces of premises (floors, walls, doors, window frames, etc.), medical transport:

- uncontaminated

- contaminated

0,1

0,3

60

30

Wiping or irrigation

Medical apparatus, instruments and equipment:

- uncontaminated

- contaminated

0,1

0,3

60

30

Wiping

Patient-care items (rubber hot-water bottles, ice bags, fever thermometers, drawsheets, etc.), hygiene products

0,1

0,1

15

30

Dipping, wiping or irrigation

Tableware, cookware, pharmaceutical glassware (including disposable):

- without food residues;

- with food residues

0,1

30

Dipping

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0,1 60

Laboratory glassware:

- uncontaminated

- contaminated

0,1

0,1

30

60

Dipping

Dishwashing items, cleaning utensils 0,1 60 Dipping or soaking

Rubber mats, bath sandals, leather shoes, slippers, wooden ladders in baths, saunas, showers

0,1 60 Dipping, wiping or irrigation

Sanitary appliances (baths, sinks, toilets)

0,1

0,2

60

15

Irrigation or wiping

Garbage disposal units, chutes and other garbage containers

0,1 60 Dipping

Dental materials, dental salivary ejectors, spittoon bowls

0,1

0,2

60

15

Dipping or wiping

Medical products, including flexible and rigid endoscopes and their auxiliary tools, surgical, dental instruments, probes of all kinds, catheters, etc.

0,5

1,0

30

15

Dipping

Table 3. The disinfection cycles by solutions of product “Antichlor Lux” in case

of droplet infections and with parenteral transmission of infections of viral etiology (including common-source hepatitis, parenteral viral hepatitis (В, С), AIDS/HIV virus, poliovirus (poliomyelitis), influenza virus А H5N1 (“bird influenza”), Н1N1 (“swine influenza”)

Object of decontamination Concentration


Exposure, min

Disinfection method

Surfaces of premises (floors, walls, doors, window frames, etc.), medical transport.

0,5

1,0

30

15


Medical apparatus, instruments and 0,5 30 Wiping

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equipment: 1,0 15


0,5

1,0

30

15



0,5

1,0

30

15

Dipping

Laboratory glassware: 0,5 30 Dipping

Dishwashing items, cleaning utensils 0,5

1,0

30

15

Dipping or soaking


0,5

0,1

30

15



0,5

1,0

30

15



0,5

1,0

30

15

Dipping


0,5

1,0

30

15

Dipping or wiping

Medical products from different materials, including flexible and rigid endoscopes and their auxiliary tools, surgical, dental instruments, probes of all kinds, catheters, etc.

0,5

1,0

30

15

Dipping

Table 4.The disinfection cycles of objects by solutions of product “Antichlor

Lux” in case of tuberculosis Object of decontamination Concentration


Exposure, min

Disinfection method


0,1

0,2

60

30

Wiping, dipping

13

0,5 15


0,2

0,5

30

15

Wiping, dipping


0,8

0,2

15

30

Dipping, wiping


0,5

0,2

15

30

Dipping, wiping

Laboratory glassware: 0,5

0,2

15

30

Dipping

Dishwashing items, cleaning utensils 0,5

0,2

15

30

Dipping or soaking, wiping


0,2

0,3

0,5

30

30

15



0,1

0,2

30

30

2-time irrigation with an interval of 15 min., irrigation

Dental material, dental salivary ejectors, spittoon bowls

0,5 30 Dipping or wiping


0,8 15 Dipping

Table 5. The disinfection cycles of objects by solutions of product “Antichlor

Lux” in case of candidiasis. Object of decontamination Concentration of

the solution, % (by the product)

Exposure, min.

Disinfection method


0,2 0,4

30 15


14


0,4 30 Wiping


0,2 0,5

60 30



0,2 30 Dipping

Laboratory glassware: 0,2 30 Dipping



0,2 30 Dipping, wiping or irrigation

Sanitary appliances (baths, sinks, toilets) at 40% protein contamination

0,2 0,2

30 30

2-time irrigation with an interval of 15 min., wiping


0,1 60 Dipping




0,2 30 Dipping

Table 6. The disinfection cycles of objects by solutions of product “Antichlor

Lux” in case of dermatomycosis, mold fungi Object of decontamination Concentration


Exposure, min

Disinfection method


0,1 0,2

60 30



0,2

0,1

30

60

Wiping

15


0,1

0,2

60

30



0,1

0,2

60

30

Dipping

Laboratory glassware: 0,1

0,2

60

30

Dipping



0,2

0,3

30

15



0,2

0,3

30

15



0,2

0,3

30

15

Dipping



Medical products of all kinds from different materials, including flexible and rigid endoscopes and their auxiliary tools, surgical, dental instruments, (including endodontic, rotary, orthopedic instruments, baseplates), probes of all kinds, catheters, etc.

0,3 60 Dipping

Table 7. The disinfection cycles, combined with pre-sterilization cleaning of

medical products (including flexible and rigid endoscopes and their auxiliary tools, surgical, dental instruments, etc.) by solutions of “Antichlor Lux” product

Stages of processing Concentration of the solution,

% (by the product)

The temperature of

the solution, °С

Exposure, min.

Soaking of products by full dipping

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into the work solution and filling their cavities and ducts with it:

- in case of bacterial (except tuberculosis), nosocomial infections, virus infections and candidiasis; - in case of tuberculosis; - in case of dermatomycosis, mold fungi,

0,2 0,5 0,2 0,2 0,3

Not regulated

30 15 30 15 60

Washing each product in the same solution, where it was soaked, using scraper or brush, rubber and plastic products (including endoscopes)- using cotton-gauze pack or textile napkin (gauze wipe), ducts- using syringe;

- products of simple configuration without locking parts, ducts, cavities; - products with locking parts, ducts and cavities; - flexible and rigid endoscopes and their auxiliary tools

In solutions of appropriate concentration

0,5

1,0

2,0-3,0

Rinsing with potable water (locking parts, ducts, cavities of products –using a syringe or an electric suction machine)

Not rated 3,0-5,0

Rinsing with distilled water (ducts – using a syringe or an electric suction machine)

Not rated 0,5-1,0

Drying (the ducts are dried using air) - To complete moisture removal

Table 8. The disinfection cycles of anaesthetic-respiratory equipment (including

masks, hoses, tubes, etc,) by solutions of “Antichlor Lux” product in case of bacterial infections (including tuberculosis), pathogens of nosocomial infections, viral infections and candidiasis; in case of dermatomycosis, mold fungi

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Stages of processing Concentration of the solution, %, by

the product

Exposure, min.

Soaking of products by full dipping into the work solution and filling their cavities and ducts with it:

0,3 0,5

60 15

Washing each product in the same solution, where it was soaked: - the outer surface using cotton-gauze pack or textile (gauze wipe) napkin; - internal and open ducts using a syringe

In solution of appropriate concentration

5,0

Rinsing with potable water - 5,0 Rinsing with distilled water - 0,5 Drying - To complete

moisture removal

Table 9. The disinfection cycles of objects during deep cleaning in medical and

preventive treatment facility by solutions of “Antichlor Lux” product. Object of decontamination Concentration

of the solution, %

(by the product)

Exposure, min.

Disinfection method

Children's hospitals, obstetric and gynecological clinics, maternity hospitals, department of neonatology, chamber blocks and special care baby unit, pediatric departments

0,1

0,2

60

30

Wiping

Somatic, surgery departments, medical treatment rooms, dental clinics and offices, clinical laboratories

0,1

0,2

60

30


Antitubercular medicated products 0,2 15 Wiping or irrigation

4. APPLICATION OF THE “ANTICHLOR LUX” PRODUCT FOR

STERILIZATION OF MEDICAL PRODUCTS. 4.1. For sterilization of medical products (including dental instruments and

materials, flexible and rigid endoscopes and their auxiliary tools) from different

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materials (metals, rubber, glass, plastics) 2,5%, 3,0 %, 4,0 % (by the product) product solutions are used.

4.2. Before sterilizing the products by “Antichlor Lux”, it should be carried out their pre-sterilization cleaning by any product, registered in Ukraine and approved for use in medical and preventive treatment facility for this purpose, and rinsing from the remnants of this product with potable water in accordance with the instruction for the use of a specific product.

4.3. Sterilization of medical products by “Antichlor Lux” should be carried out in sterile plastic, glass or enamelled (without damage to the enamel) containers, which are closed with lids, at full dipping of products into the solution, ensuring thorough filling of all ducts and cavities of products with solution. For better filling of the ducts with the product and for more complete removal of air bubbles syringes, pipettes, or other auxiliary equipment are used. Dismountable products are dipped into the solution in disassembled form. Sterilized products should be freely placed in a solution container; the thickness of the solution layer over the products should be not less than 1 cm.

Sterilization is carried out at a room temperature of not less than 20°C. The mode of sterilization of medical products is listed in the table No 10.

Table 10. The modes of sterilization of medical products by solutions of “Antichlor

Lux” Sterilized products Concentration

of the work solution (by the product),

%

Exposure, min.

Application method

Thermolabile products made of metals, rubbers on the basis of natural and silicone rubber, glass, plastics (including surgical, gynecological instruments, dental instruments and materials, flexible and rigid endoscopes and their auxiliary tools, etc.)

2,5

3,0

4,0

60

30

15

Dipping

4.4. During sterilization, all manipulations are carried out, adhering to aseptic

conditions, using sterile containers for water, water and tools, as well as sterile gloves to protect the skin of hands.

4.5. After sterilization, the products are taken out of the solution, removing it from the ducts, transferring it to a sterile container with sterile water for washing the residue of the disinfectant.

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The washing is carried out by means of double (10 minutes each) dipping of products into the water at a ratio of the volume of water to the volume occupied by products, not less than 3:1. The sterile water is passed through the ducts of the products during 3-5 minutes using a syringe or an electric suction machine for each wash (not less than 20 cm3), preventing the ingress of water into a container with washed products.

Containers and water used for washing sterile products from the residue of the disinfectant are pre-sterilized by the vapour method at a temperature of 132°C during 20 minutes.

4.6. Sterile products washed from residue of the disinfectant are taken out of water, placed in a sterile sheet, water remaining in ducts is removed using a sterile syringe or other device, the products are transferred to a sterile sterilization box, set out in with a sterile sheet. The shelf life of sterilized products is not more than three days.

4.7. Sterilization of thermolabile cosmetological, manicure, pedicure instruments, instruments for tattoo, piercing, etc., is carried out similarly.

4.8. The work solutions of the disinfectant for sterilization can be applied repeatedly throughout the shelf life (18 days), if their appearance has not changed (colour change, clouding in solution, etc.). At the first signs of changing the appearance, the solution should be replaced.

5. PRECAUTIONARY MEASURES WHEN WORKING WITH THE

DISINFECTANT 5.1 Necessary skin, respiratory and eye protection measures when working

with the disinfectant. All works with the product should be carried out in protective clothing, protecting the skin of hands with gloves, avoiding contact with eyes and skin.

5.2 General precautions when working with the product. Persons under the age of 18 years old who have not passed the preliminary or periodic medical examination in accordance with the order of the Ministry of Health of Ukraine “On Approval of the Procedure for conducting medical examinations of certain categories of workers” are not allowed to work with the product. All works with the “Antichlor Lux” disinfectant should be carried out in a room equipped with a general supply and exhaust ventilation or in a well-ventilated room. It is forbidden to eat or smoke during the performing of disinfection. During disinfection work, avoid spraying and contact the disinfectant with eyes and skin. After end of work, face and hands should be washed with soap and water.

5.3. Precautionary measures in the preparation of work solutions and in the conditions of disinfectant use for the treatment of individual objects. It is allowed to prepare work solutions and disinfection of objects with “Antichlor Lux” solutions with concentration of 0.4% or less by wiping, soaking, dipping (in containers closed by the lid) in the presence of patients and persons not directly involved in disinfection activities (patients, including children, schoolchildren, visitors to the recreational and

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entertainment facilities, hairdressing saloons, public transport, etc.) without the protection of the respiratory organs and eyes.

Work on the use of work solutions by irrigation should be carried out in compliance with personal security measures, which provide protection of the respiratory system, skin and eyes - in protective clothing (robe, hat, rubber gloves), in protective spectacles of ПО-2, ПО-3 type or in monoblock, in a respirator of РУ-60М, РПГ-67 type with a cartridge of «В» mark or “Leaflet”. The treatment is carried out in the absence of people.

5.4. Methods of the product disposal. Lots of the product with terminated shelf life and non-conforming, due to violation of storage conditions disinfectant is to be returned to the manufacturing company for processing.

Discharge of spent and unused work solution of the disinfectant into the sewage system without additional dilution and without adding of neutralizers is allowed.

6. SIGNS OF ACUTE POISONING. FIRST-AID MEASURES AT

POISONING 6.1 Signs of acute poisoning. In the event of non-observance of precautionary

measures and violation of the rules of carrying out work with the disinfectant by irrigation, irritation of the skin, eyes and upper respiratory tract may be possible.

6.2 First-aid measures for acute (respiratory) poisoning. The injured person should immediately be taken to fresh air or in a well-ventilated area, rinse a mouth and a nasopharynx with potable water, give a warm drink (tea, milk). Seek medical advice.

6.3 First-aid measures for eye contact. In case of accidental contact of product with eyes, it is necessary to rinse them with running water for 10-15 minutes, dip 1-2 drops of sulfacyl sodium solution and seek medical advice.

6.4 First-aid measures for skin contact. In case of accidental contact of the product with a skin it is necessary to wash the contaminated area with running water. If the agent gets into clothing, it must be removed and the clothing must be washed before re-use.

6.5 First-aid measures for ingestion of disinfectant. In case of accidental ingestion of the disinfectant it is necessary to give the injured person a few glasses of water with 10-20 shredded tablets of activated charcoal. Do not induce vomiting! Seek medical advice.

7. PACKAGING. TRANSPORTATION. STORAGE 7.1. Packaging of the disinfectant. “Antichlor Lux” is packed in glass and

polymer vials, bottles with a capacity of 50 ml to 2000 ml. The permissible error for packing should not exceed ± 0,5% of the packaging volume.

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The disinfectant “Antichlor Lux” can be also packed in polyethylene plastic containers of 0.5 litres to 1000 litres. The permissible error for packing should not exceed ± 1,0% of the packaging volume.

7.2 Conditions of product transportation. The disinfectant “Antichlor Lux” is transported in the manufacturer's packaging by road or rail in accordance with the rules of carriage of the relevant category of goods by road and rail.

7.3 Shelf life and storage conditions. The disinfectant “Antichlor Lux” is stored in a tightly closed package of manufacturer in well-ventilated unheated warehouse premise protected from moisture and direct sunlight at a temperature from 0°С to 40 °С. The disinfectant is stored away from sources of open fire and heat. Guaranteed shelf life is 60 months from the date of manufacture.

8. METHODS FOR DETERMINING THE MASS FRACTION OF ACTIVE

AGENTS OF THE DISINFECTANT “ANTICHLOR LUX”.

8.1. Determination of the mass fraction of alkyldimethylbenzylammonium chloride

8.1.1 Equipment and reagents General purpose laboratory balance of the 2nd accuracy class according to GOST

24104-88 with a maximum weighing limit of 200,0 g. Burette 1-1-2-25 according to GOST 29251-91. Conical vessel КН-1-250-29/32 according to GOST 25336-82 with a polished

stopper. Sulfuric acid according to GOST 4204-77. Chloroform according to GOST 20015-88. Sodium dodecyl sulphate according to Technical Specifications 6-09-64-75; 0,004

n. water solution. Decahydrate sodium sulfate, analytical grade, according to GOST 4171-76. Methylene blue according to Technical Specifications 6-09-29-78. Monohydrate cetylpyridinium chloride with a basic substance content of not less

than 99.0% of the “Merck” (Germany) company production or a reagent of similar qualification under the current normative documentation; 0.004 n. water solution.

Distilled water according to GOST 6709-72. 8.1.2. Preparation of indicator solutions, cetylpyridine chloride and sodium

dodecyl sulfate а) to obtain a solution of the indicator it is taken 30,0 cm3 of 0,1% aqueous

solution of methylene blue, 7,0 cm3 of concentrated sulfuric acid, 110g of decahydrate sodium sulphate and dilute the volume with distilled water to 1.0 dm3;

б) 0,004 n. solution of cetylpyridinium chloride is prepared by dissolving of 0,143g weighted amount of duodecim cetylpyridinium chloride, taken to an accuracy of 0,0002g, in distilled water in a volumetric flask with capacity of 100,0 cm3 with water volumetric dilution;

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в) solution of sodium dodecyl sulfate is prepared by dissolving of 0,116g of sodium dodecyl sulfate in distilled water in a volumetric flask with capacity of 100,0 cm3 with water volumetric dilution.

8.1.3. Determination of the correction factor of solution of sodium dodecyl sulfate The correction factor of the prepared solution of sodium dodecyl sulfate is

determined by two-phase titration with a 0,004 n. solution of cetylpyridinium chloride. For this purpose, 40,0 cm3 of distilled water, then 20,0 cm3 of the indicator and 15,0 cm3 of chloroform is added to 10,0 cm3 solution of sodium dodecyl sulfate. The obtained two-phase system is titrated with a solution of cetylpyridinium chloride on intensive shaking of a flask with a closed stopper until the discoloration of the lower chloroform layer.

Titration is carried out in daylight. The colour of the two-phase system is determined in transmitted light.

8.1.4. Conducting the analysis Weighted amount of “Antichlor” from 7,0g till 10,0g, taken to an accuracy of

0,0002 g, quantitatively is transferred to a volumetric flask with capacity of 50 cm3 and with distilled water volumetric dilution.

In a conical flask with capacity of 250,0 cm3, one adds 5,0 cm3 of sodium dodecyl sulfate solution, then 45,0 cm3 of distilled water, 20 cm3 of the indicator solution and 15 cm3 of chloroform are added. After shaking, we obtain a liquid two-phase system with a lower chloroform layer, painted with blue. It is titrated with the prepared solution of the analyzed sample of “Antichlor Lux” on intensive shaking of a flask with a closed stopper until the discoloration of the lower layer.

Titration is carried out in daylight. The colour of the two-phase system is determined in transmitted light.

8.1.5. Calculation and report The mass fraction of alkyldimethylbenzylammonium chloride (X) is calculated by

the formula

, where

0,00143 –the mass of alkyldimethylbenzylammonium chloride, corresponding to

1,0 cm3 of solution of sodium dodecyl sulfate accurately (С12Н25SO4Nа) =0,004 mol/dm3(0,004 n.), g;

V - volume of titrated solution of sodium dodecyl sulfate, of concentration accurately С(С12Н25SO4Nа) = 0,004 mol/dm3 (0,004 n.), which is equal to 5,0 cm3;

К - correction factor of solution of sodium dodecyl sulfate of concentration accurately С(С12Н25SO4Nа) = 0,004 mol/dm3 (0,004 n.);

50 - dilution coefficient of the analyzed sample; V1-volume of solution of “Antichlor Lux” spent for titration, cm3;

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m - mass of analyzed sample, g. The arithmetic mean of the results of three parallel determinations, the absolute

difference between which does not exceed the allowed difference and is equal to 0,02% is taken as the result of the analysis.

The permissible relative overall error of results is ± 5,0% for the confidence probability Р=0,95.

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Handwriting: Numbered and bound 24 pages Head of the chancery /signature/ Round seal: Ukraine City of Kyiv State Institution “Occupational Medicine Institute of National Academy of Medical Sciences of Ukraine” Identification code: 22948309

Переклад з української мови на англійську мову виконано

перекладачем Бюро перекладів “Ла-Віта” __________Скопюк Ларисою Петрівною/ Translation from Ukrainian into English is made by the translator of Translation Bureau “La-Vita” Larysa Skopiuk

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