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Angesichts der zunehmenden Digitalisierung und dem Einsatz datenintensiver Methodiken in der Wissenschaft stehen Forschende vor der Herausforderung, stetig wachsende Datenmengen nachvollziehbar zu dokumentieren, langfristig zu speichern und für Dritte nachnutzbar zu machen. Um diesen Anforderungen gerecht zu werden, bietet sich die Nutzung von Software-Lösungen an, welche Forschungsdatenmanagement mit der digitalen Dokumentation von Laborinventar und Experimenten in elektronischen Laborbüchern (engl. electronic lab notebooks (ELN)) verknüpfen.
Die Bestimmung der Nanopartikelgrößen- und -formverteilung nach OECD TG 125 mit einem Differentiellen Mobilitäts Analyse System (DMAS), auch bekannt als SMPS, wird vorgestellt:
- Generelles Messprinzip
- Welchen Durchmesser misst die Methode?
- Welche Partikel kann diese Methode messen?
- Welche Informationen kann diese Methode liefern?
- Wo stößt die Methode an ihre Grenzen?
- Implementierung und Datenauswertung,
- Reporting.
Anschließend wurde eine Q&A-Session für DMAS/SMPS organisiert.
OECD Prüfrichtlinie 125
(2023)
Diese Präsentation ist eine Einführung in die OECD TG 125 zur Bestimmung der Partikelgrößen von Nanomaterialien. Es wird auf die verchiedenen Probleme der Partikelgrößenbestimmung eingegangen wie z.B. verschiedene Oberflächenschichten, Äquivalenzdurchmesser und Verteilungsfunktionen. Gleichzeitig werden die neuen Begrifflichkeiten eingeführt, die in der TG 125 definiert neu werden.
This presentation was held in an OECD Webinar introducing the newly developed and published OECD TG 125 on particle size and size distribution. The presentation is explaining the structure if the TG 125 and addresses all included methods and methodologies in a short and understandable way for the broader public. The presentation includes sections about nano-particles and nano-fibres.
BAM is currently building up a platform of novel nanoRMs relying on iron oxide nanoparticles of different shape, size and surface chemistry. Iron oxide was chosen as a core material because of its relevance to the material and life sciences.
As a first candidate of this series, we present cubic iron oxide nanoparticles with a nominal edge length of 8 nm. These particles were synthesized by thermal decomposition of iron oleate in high boiling organic solvents adapting well-known literature procedures. After dilution to a concentration suitable for electron microscopy (TEM and SEM) as well as for small-angle X-ray scattering (SAXS) measurements, the candidate nanoRM was bottled and assessed for homogeneity and stability by both methods following the guidelines of ISO 17034 and ISO Guide 35.
The particle sizes obtained by both STEM-in-SEM and TEM are in excellent agreement with a minimum Feret of 8.3 nm ± 0.7 nm. The aspect ratio (AR) of the iron oxide cubes were extracted from the images as the ratio of minimum Feret to Feret resulting in an AR of 1.18 for TEM to 1.25 for SEM. Alternatively, a rectangular bounding box was fitted originating from the minimum Feret and the longest distance through the particle in perpendicular direction. This led to AR values of 1.05 for TEM and 1.12 for SEM, respectively. The results confirm the almost ideal cubic shape.
The OECD Working Party on Manufactured Nanomaterials (WPMN) has actively worked towards understanding possible safety issues for manufactured nanomaterials and has contributed significantly to resolving these by developing Test Guidelines, Guidance Documents, Test Reports and other publications with the aim of a safe use of manufactured nanomaterials. To address the specific needs of manufactured nanomaterials, the OECD Test Guideline No. 110 “Particle Size Distribution/Fibre Length and Diameter Distributions” was identified as one of the test guidelines (TGs) to require an update. The current TG 110 (adopted in 1981) is only valid for particles and fibres with sizes above 250 nm. The WPMN prioritised to either update TG 110 to be applicable also to particles at the nanoscale or draft a new nanomaterial specific (TG).
Eventually, it was decided to develop a new TG that covers the size range from 1 nm to 1000 nm, intended for particle size and particle size distribution measurements of nanomaterials. Paragraph 11 provides further justification on the need for such measurements for nanomaterials. This TG overlaps with TG 110 in the size range from 250 nm to 1000 nm. When measuring particulate or fibrous materials, the appropriate TG should be selected depending on the size range of particles tested. In line with TG 110, the new TG for nanomaterials includes separate parts for particles and fibres.
For the part of this TG which addresses particles, several methods applicable to nanomaterials were reviewed and included to take into account developments since 1981 when the TG 110 was adopted. This TG includes the following methods: Atomic Force Microscopy (AFM), Centrifugal Liquid Sedimentation (CLS)/Analytical Ultracentrifugation (AUC), Dynamic Light Scattering (DLS), Differential Mobility Analysis System (DMAS), (Nano)Particle Tracking Analysis (PTA/NTA), Small Angle X-Ray Scattering (SAXS), Scanning Electron Microscopy (SEM), and Transmission Electron Microscopy (TEM). The method Single Particle Inductively Coupled Plasma Mass Spectrometry (sp-ICP-MS) could not be sufficiently validated within the interlaboratory comparison (ILC) carried out for the different methods in this TG (see also paragraph 6 for further details on the ILC). Applicability of sp-ICP-MS is strongly limited to nanomaterials with high mass values in combination with a sufficiently high particle size. However, the general method ICP-MS is widely used and the sp-mode for the size measurement of specific nanomaterials was successfully performed in ILCs elsewhere. The method is therefore included in the Appendix Part C of this TG, which further details the limitations of sp-ICP-MS.
For measuring the diameter and length of fibres, analysing images captured with electron microscopy is currently the only method available. This TG includes Scanning Electron Microscopy (SEM) and Transmission Electron Microscopy (TEM).
To test the validity of this TG, an ILC was performed. Test materials were chosen to reflect a broad range of nanomaterial classes, e.g. metals, metal oxides, polymers and carbon materials. Where possible, well-characterised test materials were used.
Additionally, the test materials were chosen to reflect a broad range of sizes representing the size range 1 nm to 1000 nm. Specifically for fibres, a broad range of aspect ratios was included (length/diameter of 3 to > 50). Some of the test materials used are commercially available and further references are given in the validation report of the ILC. Sample preparation for physical chemical characterisation is critical for all listed methods. Due to the differences between individual nanomaterials and due to the wide range of individual material properties it is impossible to have a generic protocol to obtain the best possible sample preparation for every nanomaterial. Therefore, a generic protocol on sample preparation is not part of this TG. Information on sample preparation is given in the paragraphs 25-29, 33, 34 and 39 for particles and in paragraphs 159) for fibres. Further information on sample preparation of nanomaterials for physical chemical characterisation can be found in the OECD Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials and elsewhere.
In this research project, a new OECD Test Guideline (TG) for the determination of “Particle Size and Particle Size Distributions of Nanomaterials” was developed as the existing OECD TG 110 is considered to be outdated in terms of applicable size range (not covering sizes <200 nm) and methods. By its scope with an applicable size range from 1 to 1000 nm the new Test Guideline (TG PSD) covers the whole nanoscale. The TG PSD is applicable for particulate and fibrous nanomaterials. The prescribed, pairwise measurement of fibre diameter and length in the TG PSD allows for the first time to differen-tiate fibres with regard to their size-dependent hazard properties. Measurement instructions for each included method were validated within two separated interlaboratory comparisons, as a distinction between near spherical particles and fibres when applying the methods has to be made.
Besides information on content and structure of the TG PSD, this final report outlines essential steps, considerations and organisational aspects during the development of the TG. Insights into the selec-tion, preparation and prevalidation of test materials used in the interlaboratory comparison are given. Finally, main results of the interlaboratory comparisons and their impacts on the TG PSD are pre-sented.
Many studies have already shown that viruses can spread via aerosol particles. An aerosol is a mixture of air with solid or liquid particles dispersed in it. To understand the role of aerosol particles as a transmission path of SARS-CoV-2, knowledge of the different processes in an Aerosol is therefore of particular importance. With this paper, GAeF would like to contribute to a better understanding of the term “aerosol” and the relevant aerosol processes. In the context of this paper only the essential basics will be discussed. For a deeper understanding of the partly complex processes, please refer to the literature mentioned at the end of the paper.
The paper summarises a large number of studies on the formation of virus-laden aerosol particles and their spread. Based on this, it can be concluded that exhaled aerosol particles may play a prominent role in the spread of viruses in the corona pandemic. Finally, this paper discusses possible measures to reduce the spread of aerosol particles. The measures discussed are based on the current public debate including ventilation, air purifiers, HVAC systems and masks. Advice is given on the correct and sensible use of these measures.
An aerosol is always dynamic, as particles are newly formed, transported in or with the air, removed from the air or change in the airborne state. Aerosol particles have sizes between approx. 0.001 and several 100 micrometres (and not < 5 μm as currently defined in many publications) and spread relatively quickly with air currents, even over longer distances. Larger aerosol particles sink to the ground, depending on their size and density, while small aerosol particles can remain in the air for a very long time (see Section 3). Every person emits liquid aerosol particles of various sizes through breathing and when speaking, coughing and sneezing (see Section 4). If a person is infected with a virus, such as SARS-CoV-2, these aerosol particles can contain viruses that can be released into the air and inhaled by other people. SARS-CoV-2 has a size of 0.06 to 0.14 micrometres, but the exhaled liquid aerosol particles are larger. The liquid aerosol particles can shrink by evaporation, depending on the ambient conditions (see Section 3.3). Particle size is relevant for particle transport and particle separation. The highest risk of infection exists in closed indoor spaces, as aerosol particles can accumulate there.
Here in particular, appropriate measures must be taken to reduce the concentration of aerosol particles (see Section 5).
Against the background of aerosol science, the GAeF classifies the current measures to contain the pandemic as follows:
• In principle, no measure can work on its own! According to the current state of knowledge, the interaction of the most varied measures is the best way to minimise the risk of infection.
• Keeping distance is important, because with increasing distance, directly exhaled viruses are diluted and the probability of infection decreases. The often prescribed minimum distance can be used as a guide, but it should be increased and supplemented by other measures (see below), especially for longer meetings and also indoors with reduced air movement.
• Masks help to filter some of the exhaled particles (and viruses). This reduces the concentration of exhaled particles (and viruses) in a room and thus the risk of infection. It should be noted here that the exhaled aerosol particles are relatively large due to adhering moisture and can therefore also be efficiently retained by simple masks. However, since these particles shrink with longer dwell time in the room air, simple mouth-nose masks are less efficient for self-protection. Respiratory masks are required for this purpose, which show a high degree of separation even for fine particles, e.g. of classes FFP2, N95 or KN95. These are efficient for both self-protection and protection of others unless they have an exhalation valve. Masks with an exhalation valve, on the other hand, are only for self-protection and therefore contradict the solidarity concept that fellow human beings are protected by collective mask wearing. Face shields which are used without additional masks are largely useless with regard t• aerosol particles, as the air with particles (and viruses) flows unfiltered around the shields. In everyday clinical practice, facial shields are worn in addition to masks to prevent droplet infection via the mucous membranes of the eyes. Mobile or permanently installed Plexiglas barriers are also largely ineffective against the spread of aerosols indoors. These can only prevent the smallscale spread of an aerosol in the short term, e.g. in the checkout area of a supermarket, but offer no protection in the longer term. Face shields and Plexiglas panels essentially serve as spit and splash protection against large droplets.
• Outdoors, there are practically no infections caused by aerosol transmission. However, droplet infections can still occur, especially in crowds, if minimum distances are not observed and/or masks are not worn. In closed rooms, ventilation is essential to replace the exhaled air in a room with fresh air from outside. Frequent airing and cross-ventilation is just as effective as leaving the window open all the time. From an energy point of view, however, it is more efficient to ventilate the room, especially in winter. CO2 monitors can help to monitor indoor air quality. They indicate when it is necessary to ventilate and when the air in a room has been sufficiently changed during ventilation. However, they can only be used as an indicator and even if the proposed CO2 limit concentrations are met, they do not prevent direct infection by people in the immediate vicinity.
• Air purifiers can make a useful contribution to reducing the concentration of particles and viruses in a room. When procuring air purifiers, care must be taken to ensure that they are adequately dimensioned for the room and application in question in order to significantly reduce the particle and virus load. The air throughput of the unit is more important than the pure efficiency of the filter. For energy and cost reasons, the use of highly efficient filters can even be counterproductive. Permanently installed ventilation systems can also be useful, provided they filter the air to reduce the particle and virus load in a room. To avoid infections, it is advisable to operate them with 100 % fresh air if possible.
From the point of view of the Gesellschaft für Aerosolforschung, there is a considerable need for research, especially at the interdisciplinary borders to research fields of epidemiology, infectiology, virology, ventilation technology and fluid mechanics. The implementation of targeted studies should be made possible at short notice with special funding and research programmes.
This paper was written originally in German by members of the Gesellschaft für Aerosolforschung and is supported by a large number of international aerosol experts. Both the English and German version as well as all images in the paper are available for free download at the following link: https://www.info.gaef.de/positionspapier. The “Gesellschaft für Aerosolforschung e. V.” must be named as the source, whenever an image is used.