16. Medical Biodefense Conference in München Nachlese

16. Medical Biodefense Conference in München Nachlese

16. Medical Biodefense Conference in München Nachlese

Alle 2 Jahre versammelt die MBDC Universitäten, Behörden und staatliche und militärische Forschungseinrichtungen für einen wissenschaftlichen Austausch. Berner International war bei dieser Veranstaltung mit einem Vortrag und Poster im wissenschaftlichen Programm der Konferenz vertreten.

Die 16. Medical Biodefense Conference, die weltweit führende Tagung auf dem Gebiet des Medizinischen B-Schutzes, fand vom 28. Bis 31. Oktober in München statt. Das wissenschaftliche Programm der von dem Institut für Mikrobiologie der Bundeswehr veranstalteten Konferenz deckte ein breites Spektrum medizinischer Biodefense-Themen ab. In Vorträgen und Workshops diskutierten die international führenden Experten aus dem Bereich des medizinischen B-Schutzes u.a. Themen zu medizinischen Gegenmaßnahmen, insbesondere die Entwicklung neuer antimikrobieller Mittel und Impfstoffe.

Berner International war mit einem Vortrag zum Thema „Sichere Handhabung von biologischen Toxinen – Besondere Anforderungen an Sicherheitswerkbänke und Isolatoren“ vertreten. In der Poster Ausstellung präsentierte Berner ein Poster zum Thema „Stand der Technik der Dekontaminierung von Sicherheitswerkbänken, Isolatoren und Luftschleusen“.


Thema: Safe handling of biological toxins – Particular requirements to safety cabinets and isolators


Thomas Hinrichs, Ralf Wörl, Michael Klein, Berner International GmbH

The handling of biological toxins requires the use of a safe work environment. Appropriate protective measures have to ensure that personnel as well as product protection can effectively be implemented. The current legal situation is complex: As an example in Germany, activities pertaining to isolated toxins are regulated by the German Ordinance on Hazardous Substances (Gefahrstoffverordnung). On the other hand, when activities involve the toxin producing organisms, these activities are also subject to the German Ordinance on Biological Substances (Biostoffverordnung).

In any case, the release of toxins or microorganisms into the air constitutes the main exposure route. With regard to occupational safety and health, inhalation of particles or aerosols inadvertently generated during work or as the result of a spill must be prevented.

Safety cabinets and isolators are considered to be the most effective technical measures to minimise this risk. They should provide a secure containment, which prevents airborne particles from escaping or entering the working area. Despite their widespread use, there are so far no regulations which define the particular requirements for these devices when used as a barrier system against biological toxins. In Germany, since 2017, the standard DIN 12980 defines the design and testing procedures of safety cabinets and isolators, which must be used for the handling of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR substances). Moreover, in the related standard DIN EN 12469 basic requirements for microbiological safety cabinets (classes I to III) are specified.

In line with both standards and in view of our own long-term experience, the special requirements for the safe handling of biological toxins should be identified and discussed. The ongoing efforts at federal and European level in connection with the amendment of the DIN EN 12469 make this considerations more topical than ever.


State of the art decontamination of safety cabinets, isolators and air locks


Thomas Hinrichs, Ralf Wörl, Michael Klein, Berner International GmbH

To inactivate microbiological contaminants inside safety cabinets, isolators and air locks the conventional wipe disinfection is not sufficient. In particular, filters but also hard-to-reach areas cannot be reliable decontaminated in this way. Therefore, relevant regulations and standards stipulate that vaporized or nebulized agents should be used for decontamination.

The most common gaseous or aerosolized agents for room decontamination are ethylene oxide, formaldehyde and hydrogen peroxide. All substances are characterized by a high biological effectiveness but differ in regard to conditions of use, exposure time and health risks. An increasingly important aspect is the fact that ethylene oxide and formaldehyde are considered to be carcinogenic. In contrast, hydrogen peroxide is classified as less harmful to human health and to the environment. Mainly due to its low toxicity as well as to its relative ease of use, hydrogen peroxide has become the method of choice in many laboratories and in industrial processes.

Despite the principal advantages of hydrogen peroxide it is still a complex issue to develop a suitable, reproducible and validated decontamination procedure even with this agent. A number of factors like temperature, humidity, vaporisation method, aeration and decomposition have to be taken into account to make the process sufficiently effective, compatible with all materials, less time consuming and safe. Most important becomes the design of the hydrogen peroxide generator for fast and even distribution inside the containment, while avoiding leakage into the environment.

In various regulations, recommendations and standards information on implementation and the correct validation can be found. Nevertheless, many users may not be sufficiently informed about the possibilities and requirements for the decontamination of containments used for microbiological, biotechnological or medical work.

In this presentation we will describe requirements and basic conditions for the decontamination of safety cabinets, isolators and air locks. We aim to provide an overview of the current state of implementation and to give an outlook on future developments.


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