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Interpretation of Hygienic requirements for iodine disinfectants (GB 26368-2020)
GUIDE INTERPRETATION | Updated:2023-07-14
    • Interpretation of Hygienic requirements for iodine disinfectants (GB 26368-2020)

    • Yanyue Tie

      ,  

      Yuxin Su

      ,  
    • Sterile Supply   Vol. 2, Issue 2, (2023)
    • DOI:10.11910/j.issn.2791-2043.2023.2.01    

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  • Tie Yanyue,Su Yuxin.Interpretation of Hygienic requirements for iodine disinfectants (GB 26368-2020)[J].Sterile Supply,2023,02(02):56-62. DOI: 10.11910/j.issn.2791-2043.2023.2.01.

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    Iodine is one of the conventional chemical disinfectants. It has been applied to a variety of disinfectant preparations since it was first discovered as a single substance in 1811 by the French pharmacist Bernard Courtois (1777-1838). The application includes iodine aqueous solution, iodine alcohol solution (also known as iodine tincture), glycerin iodohydrin, and iodophor (Povidone iodine, PVP-I), as well as the new compound iodine-containing disinfectants that have emerged in recent years. Iodine-containing disinfectants are frequently utilized in healthcare, daily living, agriculture, livestock farming, and drinking water disinfection.

    Iodine-containing disinfectants come in many varieties, particularly PVP-I. PVP-I’s chemical composition varies depending on the carrier. Many substances can be PVP-I carriers, mainly including three types: nonionic surfactants, such as PVP, PVA, and nonylphenol polyoxyethylene dodecyl ether; cationic surfactants, such as cetyl dimethyl benzylamine and other quaternary ammonium salts; and anionic surfactants, such as alkyl sulfonates. A huge variety of PVP-I products have been approved for market launch in China. There are hundreds of PVP-I reported in the literature, such as PVP-I, PEG-I, POP-I, AES-I, APA-I, NPo-I, PPE-I, PVI-I, CD-I, PVP, WD-D, CS-I, GS-I, etc. It results in the disorder of PVP-I products on the market. The most popular and effective disinfectants are non-ionic surfactants, according to experimental validation and market application research, which can assist standardize the market and strengthen supervision. This kind of surfactant improves iodine solubilization and is less sensitive to pH, which benefits PVP-I stability. It can prepare PVP-I with 200g/L iodine contents and the prepared PVP-I has superior wetting and protective effects on the skin.

    Disinfectants with iodine can be taken in a variety of dose formulations. The active ingredient content, microbiological sterilization effect, and toxicity of disinfectants differ significantly between dosing forms. In terms of the raw materials, utilization, inspection, and storage, developed countries including the United States, Europe, and Australia have set up equivalent safety criteria or regulations for the application of iodine-containing disinfectants.

    Therefore, the mandatory national standard Hygienic requirements for iodine disinfectants (GB 26368-2020) (referred to herein as the “requirements”) was promulgated and put into effect by the previous Ministry of Health (now the National Health Commission of the PRC) in 2011. This requirements lays out in-depth technical specifications for indications of disinfection and clinical usage. The requirements plays an indispensable role to meet the administrative health criteria of the time and to control the quality of this kind of disinfection product.

    There are many different new-type iodine-containing disinfectants on the market now, so PVP-I and iodine tincture are no longer the only options, and the effectiveness of each disinfectant varies greatly. The committee acquired about the technical index requirements, the production process, and the range of raw materials utilized by manufacturers after conducting on-site investigations of manufacturing businesses. It thoroughly investigated the technical indicators, application techniques, and usage scope of currently available products after investigating the approvals and documents acquired for iodine-containing disinfectants in various provinces and cities around the country. Besides, it conducted experimental verification of technical indexes, microbiological sterilization capacity, available iodine content, and raw material identification to determine the reasonableness of the standards and the scientificity of the evaluation methods according to the relevant domestic and international literature. It is discovered that some technical specifications of the original edition cannot meet the market demands as well as the rules and regulations. Therefore, to meet the needs of all parties and further advance the development and standardization of this type of production, this revision integrates feedback from administrative, supervisory, and testing agencies at all levels as well as relevant manufacturing enterprises. It also takes into account the requirements of recently implemented relevant national standards and industry standards.

    1 Standard revision and drafting principle

    The following principles were adopted for this revision in view of the following reasons: the various kinds of iodine-containing disinfectants that are currently available on the market go beyond conventional disinfectant formulations; iodine-containing cleaning products are still being developed, and their effectiveness varies greatly; to fulfill the requirement of the previous National Health and Family Planning Commission (now the National Health Commission of the PRC) that several disinfection products’ administrative licenses could be suspended and the control and management of disinfection goods should be intensified; to maintain product quality, improve market monitoring, and effectively regulate the production of iodine-containing disinfection producers.

    1. It is formulated following the uniform format prescribed by the National committee on technology and equipment of disinfection technology standardization.

    2. The requirements is revised to be recommended in full. The title is revised from “Hygienic standard for iodine disinfectants” (referred to herein as the “standard”) to “Hygienic requirements for iodine disinfectants”.

    3. The application scope of the requirements is clarified. This requirements applies to iodine tincture, PVP-I and compound iodine-containing disinfectants with available iodine as the main bactericidal ingredient for skin, mucous membrane and hand disinfection.

    4. This revision extensively investigates the requirements of various fields and the opinions or suggestions given during the implementation of the original standard, actively adopts the advanced scientific research results at home and abroad in recent years, expands the coverage of technical content, proposes technical indicators for quality control, outlines the precise usage scope and usage methods, etc. Thus, this revision is conducive to promoting technological progress, improving product quality, benefiting personal health, meeting the needs of disinfectors and users, and regulating the market.

    5. This revision adapts to the new national regulatory requirements for disinfection products and is composed following the Directives for standardization -- Part 1: Structure and drafting of standards (GB/T 1.1-2009).

    2 Basis for each technology

    (i) Standard kind

    The standard kind is adjusted from the original full-text mandatory to the full-text recommended. The health standard of chemical disinfectants is adjusted to be recommended according to the requirements of the cleanup of mandatory standards by the Standardization Administration of the People’s Republic of China.

    (ii) Title

    According to the requirements of the Standardization Administration of the People’s Republic of China and the Standard Appraisement Meeting, the title of the requirements is revised to “Hygienic requirements for iodine disinfectants” to improve its applicability and to facilitate the supervision of disinfection products on the market.

    (iii) Coverage scope

    1. The original standard only covered iodine tincture and PVP-I. Compound iodine-containing disinfectant is added to this requirements.

    Compound iodine-containing disinfectant specified in this requirements is made of iodine, chlorhexidine, quaternary ammonium salts and ethanol as the main bactericidal ingredients.

    This is primarily caused by the fact that iodine-containing disinfectants are no longer just available in traditional disinfectant forms. Instead, new varieties are continuously emerging, with significant variations in disinfection efficacy. This requirements expands the range of iodine-containing disinfectants which only consisted of iodine tincture and PVP-I in the original standard and could not cover the numerous types of compound disinfection products appearing in the market.

    2. The scope of PVP-I is clearly defined as complexed iodine disinfectants consisting of iodine, primary alcohol ethoxylate (AEO), alkylphenol ethoxylates (APEO), PVP, potassium iodide, etc. This definition specifies that PVP-I complexing agents include AEO, APEO and PVP. It also requires qualitative or quantitative determination of these three complexes in the physicochemical indicator testing of PVP-I.

    PVP-I products are much more disorderly in the market currently. Therefore, specifying the complexes facilitates the regulation of the market and steps up monitoring.

    (iv) Raw material requirements

    The requirements of raw material level in the original standard are confusing. Thus this requirements makes the following clear revisions:

    1. The raw materials used include iodine, potassium iodide and ethanol, which need to meet the requirements of pharmaceutical ingredients in Pharmacopoeia of the People’s Republic of China (2015 Edition, Part II).

    2. The complexing agents used in the preparation of PVP-I include AEO, APEO and PVP, and are required to meet the General Rule 0251 “Pharmaceutical Excipients” of Pharmacopoeia of the People’s Republic of China (2015 Edition, Part IV).

    3. The water used for production must be purified.

    The raw material requirement in the original standard is to adopt the raw material in pharmaceutical grade, chemically pure grade or above. These levels of reagents are small packages, which do not apply to the production line of enterprises. Considering that iodine-containing disinfectants are generally applied for hand, skin and mucous membrane disinfection, this requirements specifies that all raw materials should meet the requirements of pharmaceutical raw materials and excipients in Pharmacopoeia of the People’s Republic of China (2015 Edition). This requirements facilitates regulating the manufacturers of disinfectants containing iodine, stabilizing product quality, and reinforcing market supervision.

    (v) Technical requirements

    1 Physicochemical indicators

    For PVP-I and compound iodine-containing disinfectant physical and chemical indicators, the available iodine content range should be 1~10 g/L (or the upper and lower limits of the range does not exceed the value of 90%~110% of the product specification).

    The pH range for PVP-I and compound iodine-containing disinfectant is specified as 2-4 (or an upper and lower limit range not exceeding ±1 of the value indicated in the product specification).

    Limits for Pb, As and Hg are added. Iodine-containing disinfectants are mainly used for the disinfection of hands, skin and mucous membranes General requirements for skin disinfectant (GB 27951), General requirements for hand disinfectant (GB 27950) and General requirements for mucosa disinfectants (GB 27954) specify the limits for Pb, As and Hg, and are consistent with the limits in the Safety and Technical Standards for Cosmetics (2015 Edition).

    The content range and pH range of PVP-I are appropriately widened.

    The identification or determination requirements for PVP-I complexes are added for the reason that the current PVP-I products are much more disordered on the market and thus specifying complexes can help regulate the market and reinforce supervision.

    Content requirements of PVP-I powder in available iodine are added. This is due to, on the one hand, the PVP-I products on the market are disordered at present and thus specifying its available iodine content may contribute to regulating the market and boosting supervision. On the other hand, the diluted solution of this disinfectant should comply with the Pharmacopoeia of the People’s Republic of China (2015 Edition, Part II) on the available iodine content requirement of solid PVP-I since it is primarily used for clinical applications such as disinfecting surgical hands and forearms, surgical incision sites, the skin of injection and puncture sites, skin of umbilical cord sites of newborns, and mucosal rinsing disinfection.

    2 Microbiological sterilization indicators

    It is specified that the indicator strains for microbiological sterilization include Staphylococcus aureus (ATCC 6538), Escherichia coli (8099), Pseudomonas aeruginosa (ATCC 15442), and Blastomyces albicans (ATCC 10231).

    The action time of microbiological sterilization should comply with the General requirements for hand disinfectant (GB 27950), General requirements for skin disinfectant (GB 27951), and General requirements for mucosa disinfectants (GB 27954).

    The amount of disinfectant used in the test (concentration and time) should follow the dose indicated in the product specification. Suspension quantitative method is preferred for sterilization tests. if the suspension quantitative method cannot be applied (e.g., directly using the disinfectant stock solution or the liquid is viscous), the carrier quantitative method is available. The action time and sterilization log value of the carrier quantitative sterilization test are specified.

    (vi) Application scope

    1. It is specified that iodine tincture applies to the disinfection of surgical sites, skin at injection and puncture sites, and skin at the umbilical cord site of newborns, but does not apply to the disinfection of mucous membranes, broken skin, and sites sensitive to alcohol.

    2. It is specified that PVP-I and compound iodine-containing disinfectants apply to the disinfection of surgical hand and forearm, surgical incision, the skin of injection and puncture sites, skin of newborn umbilical cord, mucous membrane rinse, and hygienic hand.

    3. It is specified that the application scope comprehensively includes the standard, the manufacturer’s instructions, and the qualified scope tested by the third-party inspection agency recognized by health administrative departments.

    (vii) Usage

    1. The concentration is not limited because new iodine-containing disinfectants and compound iodine-containing disinfectants are emerging and have synergistic effects with other ingredients to improve disinfection efficacy, instead of traditional disinfectants on the market.

    2. Iodine-containing disinfectants for hand and mucous membranes are not specified in this requirements for the action time and usage but should be referred to General requirements for hand disinfectant (GB 27950), General requirements for skin disinfectant (GB 27951), General requirements for mucosa disinfectants (GB 27954) and product manuals given by manufacturers.

    3. The requirements specifies that the usage of PVP-I and compound iodine-containing disinfectant is to rinse or wipe the disinfection site of the mucous membrane directly according to the usage concentration required by the manufacturer’s instructions.

    4. The requirements specifies that PVP-I powder should be applied by diluting it with purified water and rinsing or wiping the disinfected parts according to the dilution method required by the manufacturer’s instructions.

    5. All usage methods specified in the requirements are carried out following the applicable national disinfection standards or norms, or following the product’s instructions with the use concentrations and action time tested by independent inspection organizations recognized by the relevant authorities. Specific dosage examples will not be given. This revision integrates with the disinfection application standards. All batch products are included in the usage scope of this requirements.

    (viii) Test methods

    1 Determination method of available iodine content (Appendix A)

    The determination of available iodine is divided into chemical titration and potentiometric titration, of which chemical titration is preferred due to its simplicity. The potentiometric titration should be carried out according to the laboratory’s specific conditions concerning “General Rule 0701” of the Pharmacopoeia of the People’s Republic of China (2015 Edition, Part IV).

    2. The determination of Pb, As and Hg is added and the methods are carried out regarding the physicochemical test methods of the Safety and Technical Standards for Cosmetics (2015 Edition).

    3. The identification methods of PVP-I complexes are added (Appendix B, C, D).

    The determination of PVP should refer to Appendix B for quantitative determination, and AEO and APEO should refer to Appendix C and Appendix D for identification.

    3 Difficulties and priorities in use

    (i) Terms

    1. Iodine tincture and PVP-I are more clearly defined than in the original standard.

    The iodine tincture refers to an ethanolic solution of iodine and potassium iodide.

    PVP-I is a complex iodine disinfectant made of iodine, AEO, APEO, PVP and potassium iodide. The iodine complex composed of iodine, AEO and APEO is polyoxinol-iodine, and the complex composed of iodine and PVP is PVP-I. This definition specifies that PVP-I complexing agents include AEO, APEO and PVP. In addition, the qualitative or quantitative determination of these three complexes is required in testing the physicochemical indicator of PVP-I.

    2. The definition of compound iodine-containing disinfectant is added.

    All compound disinfectants with available iodine, chlorhexidine, quaternary ammonium salt, and ethanol as the main bactericidal ingredients are classified in this category.

    (ii) Raw materials requirements

    This revision makes clear requirements for all raw materials.

    1. The raw materials used include iodine, potassium iodide and ethanol, which need to meet the requirements of pharmaceutical ingredients in Pharmacopoeia of the People’s Republic of China (2015 Edition, Part II).

    2. The complexing agents used in the preparation of PVP-I include AEO, APEO and PVP, and are required to meet the General Rule 0251 “Pharmaceutical Excipients” of Pharmacopoeia of the People’s Republic of China (2015 Edition, Part IV).

    3. The water used for production must be purified.

    (iii) Technical requirements

    1 Appearance indicators

    The iodine tincture should be a reddish-brown clarified liquid, without precipitation and with an iodine and ethanol odor. PVP-I should be a yellowish-brown to reddish-brown clarified or viscous liquid, without precipitation and with an iodine odor. The compound iodine-containing disinfectant should be a reddish-brown clarified liquid, without precipitation and with an iodine odor.

    2 Physicochemical indicators

    (1) For the physicochemical indicators of PVP-I and compound iodine-containing disinfectant, the content range of available iodine should be 1-10 g/L (or the upper and lower limits should not exceed 90%-110% of the labeled value given by the product specification); the pH range of PVP-I and compound iodine-containing disinfectant should be 2-4 (or the upper and lower limits should not exceed ±1 given by the product specification); the content range and pH range of PVP-I and compound iodine-containing disinfectant are appropriately widened.

    (2) The limitations of Pb, As and Hg are required. Pb≤10 mg/kg, As≤2 mg/kg and Hg≤1 mg/kg.

    (3) The identification and determination of PVP-I complexing agents are required.

    (4) The content of available iodine in PVP-I powder is required. If PVP-I is a solid powder, the available iodine content should be 9.0% to 12.0%.

    Table 1  Physicochemical indicators of iodine tincture
    ItemIndicator
    Range of available iodine content g/L 18~22
    Ethanol content range Volume fraction(%) 45~55
    pH value 4.0~5.0
    Pb mg/kg ≤10
    As mg/kg ≤2
    Hg mg/kg ≤1
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    Table 2  Physicochemical indicators of PVP-I and compound iodine-containing disinfectants
    ItemIndicator
    Range of available iodine content g/L 1~10 (The upper and lower limits should not exceed 90%-110% of the labeled value given by the product specification)
    pH value 2.0~4.0 (±1.0)
    Pb mg/kg ≤10
    As mg/kg ≤2
    Hg mg/kg ≤1

    Other bactericidal ingredients in compound iodine-containing disinfectants should meet the requirements of label value of 90% to 110% of the average value according to the product specification, and be determined following the relevant standards.

    The three complexes should meet the requirements of the product specification and be determined and (or) identified following the relevant standards.

    If PVP-I is a solid powder, the available iodine content should be 9.0% to 12.0%.

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    3 Microbiological sterilization indicators

    (1) The indicator bacteria strains are vegetative bacteria, including Staphylococcus aureus (ATCC 6538), Escherichia coli (8099), and Pseudomonas aeruginosa (ATCC 15442); the fungus is Blastomyces albicans (ATCC 10231).

    (2) The amount of disinfectant used in the test (concentration and time) should follow the dose indicated in the product specification.

    (3) Suspension quantitative method is preferred for sterilization tests. if the suspension quantitative method cannot be applied (e.g., directly using the disinfectant stock solution or the liquid is viscous), the carrier quantitative method is available.

    (4) The action time for hand disinfection should be ≤1min.

    (5) The action time of microbiological sterilization should comply with the General requirements for hand disinfectant (GB 27950), General requirements for skin disinfectant (GB 27951), and General requirements for mucosa disinfectants (GB 27954).

    Table 3  Technical requirements for microbiological sterilization
    Name of microorganismTest methodAction time (min)Sterilization log value
    Bacterial propagulesa Suspension quantitative method ≤5 ≥5.00
    Carrier quantitative method ≤5 ≥3.00
    Blastomyces albicans (ATCC 10231) Suspension quantitative method ≤5 ≥4.00
    Carrier quantitative method ≤5 ≥3.00

    The amount of disinfectant used in the test (concentration and time) should follow the dose indicated in the product specification. The suspension method is preferred for sterilization tests. If the suspension quantitative method cannot be applied (e.g. directly using the disinfectant stock solution or the liquid is viscous), the carrier method is available.

    The action time for hand disinfection should be ≤1min.

    aBacterial propagules include Staphylococcus aureus (ATCC 6538), Escherichia coli (8099), and Pseudomonas aeruginosa (ATCC 15442).
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    (iv) Scope of application and usage

    1. Iodine tincture is not applicable for the disinfection of mucous membranes, broken skin, and areas sensitive to alcohol.

    2. The use concentration is no longer limited.

    3. Duration and usage of iodine-containing disinfectants for the disinfection of skin and mucous membranes should comply with the General requirements for hand disinfectant (GB 27950), General requirements for skin disinfectant (GB 27951), and General requirements for mucosa disinfectants (GB 27954).

    Mucous membrane disinfection: adopt cotton swab wipe or irrigation method; the active ingredient content should be 500~1000mg/L; the action time should be ≤5min.

    Skin disinfection: adopt the wiping method; the action time should be 1min~5min.

    Injection or puncture site disinfection: the action time should be ≤1min.

    The action time of hygienic hand disinfection should be 1 min. The surgical hand disinfection should be carried out according to the Specification of hand hygiene for healthcare workers (WS/T313) and the action time should be 3 min to 5 min.

    4. Usage of PVP-I and Compound iodine-containing disinfectant: Rinse disinfected areas directly or wipe mucous membranes at the concentration required by the disinfectant manufacturer’s instructions.

    5. Usage of PVP-I powder: Dilute it with purified water according to the dilution method required by the manufacturer’s instructions, and then rinse or wipe the disinfected parts using the diluent.

    In conclusion, this requirements makes direct references to a variety of pertinent national laws, regulations, rules, and normative documents based on evidence-based research, comprehensive consultation, and detailed debate. This standard promotes the development and standardized production of this class of disinfectants by further enhancing the expansion, timeliness, and operability of laws and regulations and covering all technical indications of the listed batch products.

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