Welcome to our Lab

The Microbiological Test Laboratory Bad Elster is accredited by the ZLG (Central Authority of the German Federal States for Health Protection with Regard to Medicinal Products and Medical Devices) as test laboratory for medical devices according to European Directive 93/42/EEC and 90/385/EEC and the DIN EN ISO/IEC 17025 standard. It is licensed for performing work governed by the provisions of §144 IfSG (German Infection Protection Act).

Our quality management enables transparent control and monitoring of all work procedures as well as flexible planning, and ensures the high quality of the test results.

All work is performed according to current regulations, and is based in particular on the DIN, EN and ISO standards as well as the European Pharmcopoeia.

Our facility is equipped with modern laboratory rooms with controlled clean room conditions. Our technical equipment is state-of-the-art.

As a small, highly qualified team, we process assignments Europe-wide, customized to your requirements, with personal attention and at short notice.

Our Team

Managing Director
Dipl.-Biol. Elvira Schneider
schneider@mtl-be.de

Head of Laboratory
Dr. rer. nat. Kathrin Zander
zander@mtl-be.de

Office
Mandy Gläß
glaess@mtl-be.de

Our Lab

Services

Testing of medical devices

+ Determination of the population of microorganisms on products (bioburden) in accordance with DIN EN ISO 11737-1

+ Sterility testing according to DIN EN ISO 11737-2
Tests for sterility are performed in accordance with the EC Guide to Good Manufacturing Practice and Ph. Eur. under a Class A biological safety cabinet in a Class B clean room.

+ Testing for bacterial endotoxins (BET) according to Ph. Eur.

Monitoring of production hygiene

+ Determination of the airborne viable microorganism count according to DIN EN ISO 14698

  • Airborne microorganism measurement using active air samplers
  • Determination of airborne the colony count using settle plates

+ Determination of the airborne particle count acc. to DIN EN ISO 14644

+ Detection of microbial contamination of surfaces acc. to DIN EN ISO 14698

+ Personell hygiene

+ Microbiological testing of purified water

Monitoring of hospital hygiene

+ Hygiene testing of ventilation systems in rooms of health care

  • Testing for airborne microorganism count
  • Testing for airborne particle count

+ Determination of the colony count on surfaces

  • Personnel hygiene
  • Surface disinfection testing

+ Testing of sterilizers and sterilization processes using bioindicators

+ Testing of cleaning and disinfection processes using bioindicators

+ Microbiological testing of purified water (DI water)

Quality assurance for reprocessing of medical devices

Cleaning, disinfection and sterilization of medical devices is, in accordance with legal requirements, to be performed using validated procedures in such a way that the success of these procedures is demonstrably ensured and the safety and health of patients, users and third-party persons is not endangered (German Medical Devices Act, Medical Devices Operator Ordinance)

+Performance evaluation within the scope of validation of sterilization processes (DIN EN ISO 17665-1)

  • with moist heat (steam sterilizaion)
  • with low-temperature steam/formaldehyde

+ Performance evaluation within the scope of validation of cleaning and disinfection processes in mechanical reprocessing of medical devices

Biological indicators for sterilization processes

Moist heat sterilization – Sporotest-D

Dry heat sterilization – Steri-Test-H

Steam sterilization of liquids – Steri-Test-L

Biological indicators for disinfection and decontamination

Washer disinfectors (WD) – Desi-Test-R

Human waste containers– Desi-Test-S

Bedframes, bedside tables– Desi-Test-B

Laundry disinfection – Desi-Test-W
(Testkeim S. aureus bzw. Keimzahl 10^7 auf Anfrage)

Surgical shoes– Desi-Test-Shoes

Dishwashers – Desi-Test-G

Multitank-transport dishwashers – MTG-Test

  • no PDF

Verification the reprocessing of thermolabile endoscopes

Chemical indicators (PVP-Hygiene control technology)

Chemical indicators for dry heat sterilization class 5 – Thermocontrol

Chemical indicators for dry heat sterilization class 6 – DRY 180

Chemical indicators for steam sterilization class 5 (incl. PCDs) – PVP-Steam control-Indicators

Chemical indicators for low-temperature steam/formaldehyde sterilization class 4 (incl. PCDs) – PVP-FORM-Indicators

Ordering forms

Download the required forms to your computer, print them out and send them back to us by fax.

Fax-Nummer: +49 (0)37437 2418

Testing of medical devices
Form examination of medical devices.pdf

Bio Indicators-Sterilization
Form sterilization.pdf

Bio Indicator-Disinfection
Form disinfection.pdf

Chemo Indicators
Form chemical indicators.pdf

Hygienic environmental monitoring
Form monitoring.pdf

Contact

Mikrobiologisches Testlabor GmbH Bad Elster
(Microbiological Test Laboratory)
Brambacher Straße 17
08645 Bad Elster / OT Mühlhausen
Germany

Phone: +49 (0)37437 2208
Fax: +49 (0)37437 2418
E-Mail: info@mtl-be.de

    Access route

    Motorway A72 or A9 via connection point Bayerisches Vogtland until exit Plauen Süd, Bundesstraße (Federal Highway) B92 via Oelsnitz to Bad Elster – local district Mühlhausen (direction of Bad Brambach)

    Imprint

    Address
    Mikrobiologisches Testlabor GmbH Bad Elster
    (Microbiological Test Laboratory)
    Brambacher Straße 17
    08645 Bad Elster – OT Mühlhausen
    Phone: +49 (0)37437 2208
    Fax: +49 (0)37437 2418
    E-Mail: info@mtl-be.de

    Chief Executive Officer
    Dipl.-Biol. Elvira Schneider
    Registration court: Chemnitz Municipal Court
    Registration number: HRB 18349
    Tax number: DE 211568713
    Responsible for the contents pursuant to § 6 MDStV (German Media Tax ordinance): Elvira Schneider

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    Privacy

    The Microbiological Test Laboratory Bad Elster takes the protection of your personal data very seriously and adheres strictly to the rules of data protection law. Personal data is only collected to the extent necessary for this web application. Under no circumstances will the data collected be sold or passed on to third parties for any other reason. The data collected will only be processed for the stated purpose.

    The following declaration gives you an overview of how we guarantee this protection and what type of data is collected and for what purpose.

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    CALL

    + 49 (0) 37437 2208

    ADDRESS
    MTL GmbH Bad Elster
    Brambacher Straße 17
    08645 Bad Elster
    – OT Mühlhausen –