• Publokationen - Mikrobiologie

    Veränderung beginnt mit Vertrauen

  • Mikrobiologie

    Veränderung beginnt mit Vertrauen

bactologicum
EN
EN

Publikationen

  • Letter to the editor

    Letter to the editor

    Maren Eggers1
    Prof. Dr. Katrin Steinhauer2
    Florin H.H. Brill3

    1Labor Prof. Dr. G. Enders, MVZ GbR, Stuttgart, Germany

    2bactologicum GmbH, Itzehoe, Germany

    3Dr. Brill + Partner GmbH Institute for Hygiene and Microbiology, Hamburg, Germany


    Dear editor,
    The authors noticed a sensitive mistake in the paper S2k- Guideline hand antisepsis and hand hygiene in chapter 5, recommendation 28 [1]. The claims used for activity against viruses are misspelled and may lead to misleading interpretations of the claims. This is likely due to a translation failure from German to English. Consequently, we would like to give the correct claims in Table 1.

  • Validation of Disinfectants in Pharmaceutics based on European Standard Test Methods

    Validation of Disinfectants in Pharmaceutics based on European Standard Test Methods

    Prof. Dr. Katrin Steinhauer1,2,
    Dr. Maren Grütters3

    1bactologicum GmbH, Itzehoe, Germany

    2Faculty of Mechanical Engineering, Kiel University of Applied Sciences, Kiel, Germany

    3Schülke & Mayr GmbH, Norderstedt, Germany


    Abstract
    In the production area, especially in areas for the manufacture of pharmaceuticals, it is the task of the companies manufacturing according to GMP to iden- tify contamination risks in the course of production and to implement an effective contamination control strategy (CCS). In this context, cleaning and disinfection processes play a role in addition to the consideration of the manu- facturing process, the spatial conditions, the personnel, and the associated personnel hygiene. In this context, European Norm (EN) methods for determining the effectiveness of disinfectants can be adapted for the validation of disinfectants in the GMP environment. In this way, the required proof of the efficacy of the disinfectants used on the in-house specific surfaces can be demonstrated in a systematic, application-related, and needs-based manner. This includes both the surfaces available on site and the in-house flora, i.e., the specific microorganisms detected at the production site.

  • Benefits and Limitations of Species Identification

    Benefits and Limitations of Species Identification

    Dr. Frank Mertensa,
    Prof. Dr. Katrin Steinhauerb,c


    aVAAM-Fachgruppe Qualitätsmanagement

    bbactologicum GmbH, Itzehoe, Germany

    cFaculty of Mechanical Engineering, University of Applied Sciences, Kiel, Germany


    Abstract
    Microbial contaminants can have a huge impact on product safety. Thus, microbiological testing is required for many products and production processes. Good production hygiene is of the utmost importance for contamination control of pharmaceutical manufacturing processes for sterile and non-sterile drugs. In Chapter 5.1.4 the European Pharmacopeia suggests microbiological limits for final products. However, for environmental monitoring there are no detailed requirements for specific organisms. The question arises, to what level an isolate from the manufacturing environment should be identified. How beneficial is species identification? Is it always necessary to have a name for an isolated contaminant in production processes? This article discusses the need for identification of microbial contaminants in pharmaceutical production environments, especially in the light of the information required to establish an appropriate disinfection regime. In the context of contamination control and production hygiene measures, the need for unconditional identification using high-tech methods is reflected.

  • Use of the European standardization framework established by CEN/TC 216 for effective disinfection strategies in human medicine, veterinary medicine, food hygiene, industry, and domestic and institutional use - a review

    Use of the European standardization framework established by CEN/TC 216 for effective disinfection strategies in human medicine, veterinary medicine, food hygiene, industry, and domestic and institutional use - a review

    Astrid Boltena,
    Verona Schmidtb,
    Katrin Steinhauerc,d

    aBODE Chemie GmbH, Hamburg, Germany

    bChemische Fabrik Dr. Weigert GmbH & Co. KG, Hamburg, Germany

    cbactologicum GmbH, Itzehoe, Germany

    dFaculty of Mechanical Engineering, University of Applied Sciences, Kiel, Germany


    PMID: 36157383 PMCID: PMC9487781 DOI: 10.3205/dgkh000417

    Abstract
    Die SARS-CoV-2-Pandemie verdeutlicht die Notwendigkeit wirksamer Präventionsmaßnahmen für bekannte und neu auftretende Krankheitserreger. Wenn man mit Krankheits- oder Verderbniserregern konfrontiert wird, insbesondere wenn sie noch nicht gut erforscht sind, sind sofort wirksame Hygieneprotokolle erforderlich. Im medizinischen Bereich sind wirksame Präventionsmaßnahmen von entscheidender Bedeutung, um efährdete Patienten vor Infektionen zu schützen. Ebenso sind in Produktionsbereichen wirksame Hygienemaßnahmen erforderlich, um Waren vor Verderb oder mikrobieller Verunreinigung zu bewahren. Mit Hilfe der vom Europäischen Komitee für Normung (CEN) erarbeiteten Normen im Bereich der Desinfektion und Antisepsis können wirksame Hygienemaßnahmen kurzfristig und bedarfsgerecht etabliert werden. Auf der Grundlage eines breiten Portfolios von Normen/Labortests werden Wirksamkeitsauslobungen begründet, die speziell die Besonderheiten bei der Anwendung mikrobizider Formulierungen im Fokus haben. In der Übersichtsarbeit wird das Konzept der Verwendung standardisierter Surrogat-Testorganismen erläutert und das standardisierte europäische Methodenportfolio zur Auslobung der mikrobiziden und viruzider Wirksamkeit, die Spezifität der Auslobung und ihre Relevanz für Maßnahmen zur Infektionsprävention veranschaulicht sowie die Relevanz der Testmethoden der Europäischen Normen im Hinblick auf die gesetzlichen Anforderungen erläutert. Abschließend wird die Systematik des standardisierten Methodenportfolios des Technischen Komitees 216 des CEN erläutert, das von großem Nutzen ist, wenn wirksame Strategien zur Bekämpfung oder Verhinderung von mikrobiell oder viral bedingten Infektionen, Kontaminationen oder Verderb unmittelbar erforderlich sind.

  • Efficacy of octenidine- and chlorhexidine-based wash-mitts against Candida albicans and Candida auris – a comparative study

    Efficacy of octenidine- and chlorhexidine-based wash-mitts against Candida albicans and Candida auris – a comparative study

    F. Gugscha, C.K. Tana, D.Y. Ohb, L. Paßvogelb, K. Steinhauerac

    abactologicum GmbH, Itzehoe, Germany
    bSchülke & Mayr GmbH, Norderstedt, Germany
    cUniversity of Applied Sciences, Kiel, Germany

    Summary

    Background

    Management of outbreaks of the newly emerging pathogen Candida auris may include use of antimicrobial wash-mitts for decolonization. However, currently there is little clinical evidence to support the wide adoption of ‘whole-body decolonization’ as part of the protocol to effectively manage C. auris outbreaks. The aim of this study was to investigate the chemical tolerance of C. auris compared with the surrogate test organism Candida albicans as established in the European Standards (EN).

    Methods

    Two commercially available antiseptic-impregnated wash-mitts based on either chlorhexidine digluconate (CHG) or octenidine dihydrochloride (OCT) were studied. Comparison of susceptibility of C. auris and C. albicans was investigated based on the standardized test protocol EN 13624. Experiments were conducted using the impregnation liquid squeezed from the wash-mitts at a contact time of 30 s at different concentrations between 0.5% and 97% in the presence of low organic soiling.

    Findings

    Yeasticidal efficacy according to EN 13624 was found for the OCT wash-mitts at 30 s at ≥10% concentration with C. albicans. In comparison, reduction ≥4 log10 was found at a much lower concentration of ≥1% for both C. auris strains. For the CHG wash-mitts, efficacy against C. albicans was below 2 log10 reduction at 97% concentration within 30 s. Efficacy against the two C. auris strains was around 3 log10 reduction.

    Conclusion

    Both C. auris strains were found to be significantly more susceptible when compared with C. albicans. Data also demonstrate that not all antiseptic-impregnated wash-mitts are equally effective against C. auris with OCT having a higher efficacy compared with CHG.

  • Long-Term Biocide Efficacy and Its Effect on a Souring Microbial Community.

    Long-Term Biocide Efficacy and Its Effect on a Souring Microbial Community.

    Shi X, Oliveira DAF, Holsten L, Steinhauer K, de Rezende JR.
    Appl Environ Microbiol. 2021 Aug 11;87(17):e0084221. doi: 10.1128/AEM.00842-21. Epub 2021 Aug 11.
    PMID: 34160245
    Free PMC article.

    Abstract
    Reservoir souring, which is the production of H2S mainly by sulfate-reducing microorganisms (SRM) in oil reservoirs, has been a long-standing issue for the oil industry. While biocides have been frequently applied to control biogenic souring, the effects of biocide treatment are usually temporary, and biocides eventually fail. The reasons for biocide failure and the long-term response of the microbial community remain poorly understood. In this study, one-time biocide treatments with glutaraldehyde (GA) and an aldehyde-releasing biocide (ARB) at low (100 ppm) and high (750 ppm) doses were individually applied to a complex SRM community, followed by 1 year of monitoring of the chemical responses and the microbial community succession. The chemical results showed that souring control failed after 7 days at a dose of 100 ppm regardless of the biocide type and lasting souring control for the entire 1-year period was achieved only with ARB at 750 ppm. Microbial community analyses suggested that the high-dose biocide treatments resulted in 1 order of magnitude lower average total microbial abundance and average SRM abundance, compared to the low-dose treatments. The recurrence of souring was associated with reduction of alpha diversity and with long-term microbial community structure changes; therefore, monitoring changes in microbial community metrics may provide early warnings of the failure of a biocide-based souring control program in the field. Furthermore, spore-forming sulfate reducers (Desulfotomaculum and Desulfurispora) were enriched and became dominant in both GA-treated groups, which could cause challenges for the design of long-lasting remedial souring control strategies. IMPORTANCE Reservoir souring is a problem for the oil and gas industry, because H2S corrodes the steel infrastructure, downgrades oil quality, and poses substantial risks to field personnel and the environment. Biocides have been widely applied to remedy souring, but the long-term performance of biocide treatments is hard to predict or to optimize due to limited understanding of the microbial ecology affected by biocide treatment. This study investigates the long-term biocide performance and associated changes in the abundance, diversity, and structure of the souring microbial community, thus advancing the knowledge toward a deeper understanding of the microbial ecology of biocide-treated systems and contributing to the improvement of current biocide-based souring control practices. The study showcases the potential application of incorporating microbial community analyses to forecast souring, and it highlights the long-term consequences of biocide treatment in the microbial communities, with relevance to both operators and regulators.

  • Virucidal efficacy of different formulations for hand and surface disinfection targeting SARS CoV-2.

    Virucidal efficacy of different formulations for hand and surface disinfection targeting SARS CoV-2

    Steinhauer K, Meister TL, Todt D, Krawczyk A, Paßvogel L, Becker B, Paulmann D, Bischoff B, Eggers M, Pfaender S, Brill FHH, Steinmann E. J Hosp Infect. 2021 Jun;112:27-30. doi: 10.1016/j.jhin.2021.03.015. Epub 2021 Mar 23.
    PMID: 33771601
    Free PMC article.

    Abstract
    In the ongoing SARS CoV-2 pandemic, effective disinfection measures are needed, and guidance based on the methodological framework of the European Committee for Standardization (CEN) may enable the choice of effective disinfectants on an immediate basis. This study aimed to elucidate whether disinfectants claiming 'virucidal activity against enveloped viruses' as specified in the European Standard EN 14476 as well as in the German Association for the Control of Viral Diseases/Robert Koch Institute (DVV/RKI) guideline are effectively inactivating SARS-CoV-2. Two commercially available formulations for surface disinfection and one formulation for hand disinfection were studied regarding their virucidal activity. Based on the data of this study the enveloped SARS-CoV-2 is at least equally susceptible compared to the standard test virus vaccinia used in the EN 14476 and DVV/RKI guidelines. Thus, chemical disinfectants claiming 'virucidal activity against enveloped viruses' based on the EN 14476 and DVV/RKI guidelines will be an effective choice to target enveloped SARS-CoV-2 as a preventive measure.

  • Improved method for tuberculocidal and mycobactericidal activity testing of disinfectants based on the European Standard EN 14348.

    Improved method for tuberculocidal and mycobactericidal activity testing of disinfectants based on the European Standard EN 14348

    Brill FHH, Lenz J, Lach C, Radischat N, Paßvogel L, Goroncy-Bermes P, Gabriel H, Steinmann J, Steinhauer K. J Hosp Infect. 2021 May;111:176-179. doi: 10.1016/j.jhin.2021.02.008. Epub 2021 Feb 11.
    PMID: 33582203

    Abstract
    Safe measurements to prevent the transmission of (multidrug-resistant) mycobacteria such as disinfection are essential in healthcare settings. In Europe chemical disinfectants are tested for their tuberculocidal and mycobactericidal efficacy by the internationally accepted test procedure described in EN 14348. However, especially for amine-based disinfectants, invalid results may occur by this procedure due to insufficient neutralization. In this multi-laboratory study the procedure described in EN 14348 was optimized by a combination of chemical neutralization and membrane filtration in order to obtain a valid and secure method especially for amine-based disinfectants.

  • Comparison of the in-vitro efficacy of different mouthwash solutions targeting SARS-CoV-2 based on the European Standard EN 14476.

    Comparison of the in-vitro efficacy of different mouthwash solutions targeting SARS-CoV-2 based on the European Standard EN 14476.

    Steinhauer K, Meister TL, Todt D, Krawczyk A, Paßvogel L, Becker B, Paulmann D, Bischoff B, Pfaender S, Brill FHH, Steinmann E. J Hosp Infect. 2021 May;111:180-183. doi: 10.1016/j.jhin.2021.01.031. Epub 2021 Feb 11.
    PMID: 33582201
    Free PMC article.

    Abstract
    The outbreak of the SARS-CoV-2 pandemic is triggering a global health emergency alert. Until vaccination becomes available, a bundle of effective preventive measures is desperately needed. Recent research is indicating the relevance of aerosols in the spread of SARS-CoV-2. Thus, in this study commercially available antiseptic mouthwashes based on the active ingredients chlorhexidine digluconate and octenidine dihydrochloride (OCT) were investigated regarding their efficacy against SARS-CoV-2 using the European Standard 14476. Based on the requirement of EN 14476 in which reduction of at least four decimal logarithms (≥4 log10) of viral titre is requested to state efficacy, the OCT-based formulation was found to be effective within a contact time of only 15 s against SARS-CoV-2. Based on this in-vitro data the OCT mouthwash thus constitutes an interesting candidate for future clinical studies to prove its effectiveness in a potential prevention of SARS-CoV-2 transmission by aerosols.

  • The European tiered approach for virucidal efficacy testing - rationale for rapidly selecting disinfectants against emerging and re-emerging viral diseases.

    The European tiered approach for virucidal efficacy testing - rationale for rapidly selecting disinfectants against emerging and re-emerging viral diseases.

    Eggers M, Schwebke I, Suchomel M, Fotheringham V, Gebel J, Meyer B, Morace G, Roedger HJ, Roques C, Visa P, Steinhauer K. Euro Surveill. 2021 Jan;26(3):2000708. doi: 10.2807/1560-7917.ES.2021.26.3.2000708.
    PMID: 33478622
    Free PMC article.

    Abstract
    When facing an emerging virus outbreak such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a quick reaction time is key to control the spread. It takes time to develop antivirals and vaccines, and implement vaccination campaigns. Therefore, preventive measures such as rapid isolation of cases and identification and early quarantine of cases' close contacts-as well as masks, physical distancing, hand hygiene, surface disinfection and air control-are crucial to reduce the risk of transmission. In this context, disinfectants and antiseptics with proven efficacy against the outbreak virus should be used. However, biocidal formulations are quite complex and may include auxiliary substances such as surfactants or emollients in addition to active substances. In order to evaluate disinfectants' efficacy objectively, meaningful efficacy data are needed. Therefore, the European Committee for Standardisation technical committee 216 'Chemical disinfectants and antiseptics' Working Group 1 (medical area) has developed standards for efficacy testing. The European tiered approach grades the virucidal efficacy in three levels, with corresponding marker test viruses. In the case of SARS-CoV-2, disinfectants with proven activity against vaccinia virus, the marker virus for the European claim 'active against enveloped viruses', should be used to ensure effective hygiene procedures to control the pandemic.

  • Chemical disinfection in healthcare settings: critical aspects for the development of global strategies.

    Chemical disinfection in healthcare settings: critical aspects for the development of global strategies

    Exner M, Bhattacharya S, Gebel J, Goroncy-Bermes P, Hartemann P, Heeg P, Ilschner C, Kramer A, Ling ML, Merkens W, Oltmanns P, Pitten F, Rotter M, Schmithausen RM, Sonntag HG, Steinhauer K, Trautmann M. GMS Hyg Infect Control. 2020 Dec 23;15:Doc36. doi: 10.3205/dgkh000371. eCollection 2020.
    PMID: 33520601
    Free PMC article.

    Abstract Chemical disinfection is an indispensable means of preventing infection. This holds true for healthcare settings, but also for all other settings where transmission of pathogens poses a potential health risk to humans and/or animals. Research on how to ensure effectiveness of disinfectants and the process of disinfection, as well as on when, how and where to implement disinfection precautions is an ongoing challenge requiring an interdisciplinary team effort. The valuable resources of active substances used for disinfection must be used wisely and their interaction with the target organisms and the environment should be evaluated and monitored closely, if we are to reliable reap the benefits of disinfection in future generations. In view of the global threat of communicable diseases and emerging and re-emerging pathogens and multidrug-resistant pathogens, the relevance of chemical disinfection is continually increasing. Although this consensus paper pinpoints crucial aspects for strategies of chemical disinfection in terms of the properties of disinfectant agents and disinfection practices in a particularly vulnerable group and setting, i.e., patients in healthcare settings, it takes a comprehensive, holistic approach to do justice to the complexity of the topic of disinfection.

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