Hygiene plays a special role in the areas of human and veterinary medicine. But also in the food industry and in special occasions in the domestic or public areas, it is important to work with low amounts of microorganisms. Because germs can generate serious illnesses and infections.
Chemical disinfectants prevent disease transmission by surfaces, instruments and other support materials. Antiseptics reduce microorganisms on body surfaces, wounds and tissues - in humans and animals. For each application, different disinfectants or antiseptics are suitable.
To enable users to choose the right product, they must be able to rely on efficacy data. At the same time many ingredients endanger humans, animals and the environment.
Therefore, strict and highly complex specifications apply. Some chemical disinfectants are biocidal products, others are medical devices. For example, surface and hand disinfectants meet both criteria. But no matter for which product, for which area of application and for which country - all regulations require efficacy tests according to specific specifications. These tests are intended to certify that the disinfectants and antiseptics act as indicated by the manufacturer. At the same time, they protect users and patients from possible damage to health. Reduce this risk as a manufacturer and perform your efficacy testings with HygCen.
Disinfections are intended to interrupt disease transmission. For this, the disinfectant used must irrevocably reduce existing pathogens. In principle, there are chemical, chemothermal and physical disinfection methods. The so-called "reduction factor" defines the value that describes the extent of the disinfecting activity. If a certain "microorganism reduction limit" is reached in the laboratory test, a product is considered to show activity. Laboratories give it as a decadal logarithm (lg). It describes how much a disinfectant reduces the number of testing organisms. Depending on the test method, the Ig is between ≥ Ig 2 and ≥ Ig 5, i. over 102 and 105 steps. The result of the disinfection is therefore always dependent on the initial load (bioburden) of the surface.
Biocides are literally substances that destroy life ("bios" = Greek "life", "caedere" = Latin "kill"). The active ingredients and preparations serve to destroy, kill or deter harmful organisms. They eliminate microorganisms or pests (such as woodworms, mice, etc.) chemically or biologically.
Biocides are intended to protect food, building materials (e.g., wood) and other everyday items, and to provide adequate building hygiene. At the same time, their inherent properties endanger humans, animals and the environment (European Regulation (EU) No 528/2012). The current biocide regulation eases the free circulation of biocidal products in the EU. In parallel, the regulation increases the protection of the biosphere. The Biocidal Products Regulation invokes the precautionary principle. Possible dangers must therefore be excluded prior to marketing. All biocidal products are therefore subject to approval. The approval procedure is a two-stage process. First, the biocidal active substances are tested by means of European methods. If the authority approves the tested biocidal active substance, it will be included in the positive list. Only if all the biocidal active substances of a biocidal product are included in this "Union list" can the biocide be tested and approved as a whole. Disinfectants are one of four main groups in the Biocidal Regulation.
The HygCen testing laboratory tests your biocidal products and individual biocidal agents. So the market approval of your disinfectant is nothing in the way.
The EN 14885 standard empowers manufacturers, users and regulatory authorities to assess the activity of chemical disinfectants and antiseptics. The EU standard EN 14885 represents an overview standard. This is required by the highly complex regulation of such disinfecting agents. EN 14885 sets out numerous standards that set out test procedures and licensing requirements for these products. The European standard provides a good overview of the use of chemical disinfectants and antiseptics in all essential areas. This concerns products of human and veterinary medicine as well as those of the food and other industries. In addition, EN 14885 regulates tests of disinfectants for domestic or public use.
Without independent testing, you will not receive market approval in Europe. The European authorities therefore require that an independent testing laboratory confirms the activity and safe use of your product. Regardless of whether your product should have bactericidal, yeasticidal, fungicidal, mycobactericidal, tuberculocidal or virucidal activity: it must be proven by two specific tests. On the one hand by the quantitative suspension test of phase 2, step 1. On the other hand by the quantitative microorganism carrier test of phase 2, step 2.
Numerous national specifications and regulations supplement the European requirements. Nationwide use e.g. many medical facilities for preventive disinfection only preparations with VAH certificate. The Association for Applied Hygiene is a non-profit association that pays particular attention to standard compliant tests. For the VAH listing, a manufacturer must, among other things, produce two test reports, including two reports from two independent, accredited test institutes. After successful admission, the VAH listing will remain valid for three years. Following this, a recertification process must be performed to ensure that the product remains listed. All relevant tests and appraisals have in common that in addition to the European requirements, further requirements must be met.
The DVG (German Veterinary Society e.V.) lists three lists for users:
All products listed in the DVG list for animal husbandry are tested according to the EN test standards that are binding for the respective field of application. Only for the areas for which no Phase 2 / Stage 2 EN test standards have yet been established on porous microcarriers (e.g., efficacy against viruses and parasites) are the DVG guidelines specific to these areas applicable.
DVG-specific quality assurance criteria:
As an accredited testing laboratory, HygCen tests your chemical disinfectants and antiseptics in accordance with all known national and international guidelines and standards. EN 14885 regulates the tests and requirements for all relevant areas of application
We test preparations that are used in hospitals, municipal medical facilities or in the dental field.
We evaluate active substances used in animal transport, production or body disposal.
We test chemical disinfectants and antiseptics for use in tourism & retail, manufacturing industry, office & household and public facilities (crib ...).
The European overview standard applies to products which are to be active against the following microorganisms: vegetative bacteria (including Legionella and mycobacteria), yeasts, bacterial and fungal spores and viruses (including bacteriophages). In addition, EN 14885 also applies to active substances and disinfectants that are currently being developed or are not yet intended for a specific area of application. For each area of application, the tests must demonstrate different levels of reduction of the test organisms. Which standards according to EN 14885 could be relevant for your disinfectant or antiseptic, you will find in our next test.
Phase 1 exams are not used for product claims. Historically, they have only served to differentiate disinfectants from non-disinfectants in general. The term "disinfectant" was previously not protected.
These tests are intended to confirm that a product has a bactericidal, fungicidal, yeasticidal, mycobactericidal, tuberculocidal, sporicidal or virucidal activity. Under simulated practical conditions (in particular conditions) that apply to its intended use. The activity of a disinfectant in the quantitative suspension test is generally tested as follows:
First, we define a base condition that simulates the normal soiling of a surface. These are brought into contact with your disinfectant together with a starting microorganism suspension (in a defined amount e.g. 108 CFU / ml). Then we wait for the specified contact time. Then we immediately stop the further effect of your active substance chemically with a neutralizing agent. Now we bring the mixture diluted to different extents on agar plates and it follows the incubation of the plates. After the microorganism-specific time for growth (e.g. 48h) we read the colony-forming units (CFU). Then we analyze the reduction of the initial amount of organisms. For a product to be classified as bactericidal, the decadic logarithm at ≥ lg 5 must be greater than 105. If your disinfectant does not reach this value, a higher concentration of the active substance or a longer contact time can possibly achieve the desired effect.
The tests should certify that a product has a bactericidal, fungicidal, yeasticidal, mycobactericidal, tuberculocidal, sporicidal or virucidal activity. Unlike Phase 2, Step 1, the product is applied to a surface or skin under simulated practical conditions (e.g, surface, instrument, handwashing and hand sanitizing).
Applicable procedures for this type of test are not yet available, but can be developed in the future..
As part of the regulation of disinfectants and antiseptics, there are numerous other specifications and standards in addition to the standards already mentioned. HygCen tests your chemical disinfectants and antiseptics according to the specifications you desire. In most cases, it is better to test different requirements in parallel at the same time. Use HygCen to determine your optimum testing setup. Avoid expensive additional tests.
The abbreviation of the European Chemicals Ordinance derives from the English title "Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals". Its German title is the European Chemicals Regulation for the Registration, Evaluation, Authorization and Restriction of Chemical Substances. "Regulation (EC) No 1907/2006 requires that chemicals should in principle be manufactured and used in such a way that the negative consequences for humans, animals and the environment are as low as possible. For most of the chemicals used, there are still insufficient data available. Since 2007, the REACH guideline aims to change this situation. At the same time, the introduction of REACH has standardized the chemicals legislation throughout Europe. As a manufacturer, you must ensure that your chemical disinfectants meet the requirements of REACH. We are happy to test your active substances in accordance with the requirements of REACH.
ECHA is the European Chemicals Agency. It advocates the safe use of chemicals. The agency supports companies to comply with applicable laws. Worrying chemicals are under scrutiny. Thus, ECHA places the protection of humans, animals and the environment in the focus of their work. At the same time, the regulatory authority promotes the innovative capacity and profitability of companies in the chemical industry. ECHA sets the benchmarks that chemical disinfectants must meet under certain conditions to show activity. If you have further questions about ECHA, feel free to contact us!
CLP is Regulation (EC) No 1272/2008 on the classification, labeling and packaging of substances and mixtures.
The aim of the CLP (Regulation on Classification, Labeling and Packaging of Substances and Mixtures) is to ensure a high level of protection of human health and the environment. It also seeks to ensure the free movement of goods within the common internal transport of chemicals, mixtures and certain specific products. The CLP regulation is based on the so-called "Globally Harmonized System (GHS) of Classification and Labeling of Chemicals" of the United Nations (UN). The globally harmonized system aims to make the level of protection of human health and the environment more uniform, transparent and comparable. Our experts at HygCen know which specifications your product must observe in accordance with the CLP regulation. Contact us!
Whenever officially ordered disinfection measures are carried out, the RKI list must be used. The disinfectant list of the Robert Koch Institute ensures that the registered active substances and mixtures show activity. People should be protected from communicable diseases. Registered products are simultaneously classified by the Federal Environmental Agency (UBA) as harmless to health and the environment.
In order for the RKI to classify a product as showing activity, the disinfectant must be assessed by expert opinion according to prescribed methods and / or own investigations. The environmental impact assessment is based on the application concentration and the concentration of use of the disinfectant.