Microbiology - Labor Dr. Merk in Ochsenhausen, Germany
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Mircobiology

Medical Device Testing

Labor Dr. Merk & Kollegen offers customized efficacy testing and validation of manual and automatic cleaning and disinfection processes by application of microbiological or biochemical methods.
Our expert teams work in close cooperation with our clients to find optimal solutions for technical improvements to demonstrate microbial safety. With its outstanding knowledge, Labor Dr. Merk & Kollegen designs the most effective studies for the clients, which comply with the latest regulatory requirements (e.g. ISO, EP, AAMI, ASTM).
Moreover, we offer comprehensive expertise ranging from the cultivation to the purification and analysis of more than 60 different bacteria and fungi, which allows Labor Dr. Merk & Kollegen to customize tests and easily cater to individual demands. Additional strains can be established at any time upon customers request.

 

Some examples of our testing portfolio:
> Validation of chemical disinfection or sterilization procedures
> Validation of manual or automatic cleaning and disinfection procedures
> Validation of steam sterilization processes
> Testing for microbial impermeability
> Antimicrobial efficacy of non leaching antimicrobial treated materials
> Preservative properties of pharmaceutical preparations
> Validation of gamma sterilization

Microbiological Safety Testing

Labor Dr. Merk & Kollegen is an excellent partner for microbiological safety studies using a wide range of standardized methods for biopharmaceutical industries and medical device manufacturers, including monitoring of cleanrooms supporting production safety.

 

All microbiological testings that are offered at Labor Dr. Merk & Kollegen are performed according to GLP or GMP guidelines. Leading microbiologists at Labor Dr. Merk & Kollegen, combined with Labor Dr. Merk & Kollegen´s 40 years of experience in the field, provide a unique expertise. The expert teams at Labor Dr. Merk & Kollegen support clients in study designs and discussions with regulatory agencies with respect to validation, interpretation of validation data and overall safety of the product.
Test Method
Standard
Bioburden Determination
Ph. Eur. 2.6.12: Microbiological examination of non-sterile products:
Microbial enumeration tests;
ISO 11737-1: Sterilization of health care products – Microbiological methods –
Part 1: Determination of a population of microorganisms on products
Sterility Testing
Ph. Eur. 2.6.1: Sterility; ISO 11737-2: Sterilization of medical devices.
Microbiological methods. Tests of sterility performed in the definition,
validation and maintenance of a sterilization process
Mycobacteria
Ph. Eur. 2.6.2 Mycobacteria
Mycoplasma
Ph. Eur. 2.6.7 Mycoplasmas
Bacterial Endotoxins
Ph. Eur. 2.6.14 Bacterial Endotoxins

Medical Device Testing

Labor Dr. Merk & Kollegen offers customized efficacy testing and validation of manual and automatic cleaning and disinfection processes by application of microbiological or biochemical methods.
Our expert teams work in close cooperation with our clients to find optimal solutions for technical improvements to demonstrate microbial safety. With its outstanding knowledge, Labor Dr. Merk & Kollegen designs the most effective studies for the clients, which comply with the latest regulatory requirements (e.g. ISO, EP, AAMI, ASTM).
Moreover, we offer comprehensive expertise ranging from the cultivation to the purification and analysis of more than 60 different bacteria and fungi, which allows Labor Dr. Merk & Kollegen to customize tests and easily cater to individual demands. Additional strains can be established at any time upon customers request.

 

Some examples of our testing portfolio:
> Validation of chemical disinfection or sterilization procedures
> Validation of manual or automatic cleaning and disinfection procedures
> Validation of steam sterilization processes
> Testing for microbial impermeability
> Antimicrobial efficacy of non leaching antimicrobial treated materials
> Preservative properties of pharmaceutical preparations
> Validation of gamma sterilization

Microbiological Safety Testing

Labor Dr. Merk & Kollegen is an excellent partner for microbiological safety studies using a wide range of standardized methods for biopharmaceutical industries and medical device manufacturers, including monitoring of cleanrooms supporting production safety.

 

All microbiological testings that are offered at Labor Dr. Merk & Kollegen are performed according to GLP or GMP guidelines. Leading microbiologists at Labor Dr. Merk & Kollegen, combined with Labor Dr. Merk & Kollegen´s 40 years of experience in the field, provide a unique expertise. The expert teams at Labor Dr. Merk & Kollegen support clients in study designs and discussions with regulatory agencies with respect to validation, interpretation of validation data and overall safety of the product.
Test Method
Standard
Bioburden Determination
Ph. Eur. 2.6.12: Microbiological examination of non-sterile products:
Microbial enumeration tests;
ISO 11737-1: Sterilization of health care products – Microbiological methods –
Part 1: Determination of a population of microorganisms on products
Sterility Testing
Ph. Eur. 2.6.1: Sterility; ISO 11737-2: Sterilization of medical devices.
Microbiological methods. Tests of sterility performed in the definition,
validation and maintenance of a sterilization process
Mycobacteria
Ph. Eur. 2.6.2 Mycobacteria
Mycoplasma
Ph. Eur. 2.6.7 Mycoplasmas
Bacterial Endotoxins
Ph. Eur. 2.6.14 Bacterial Endotoxins

Disinfectant Studies

What

 

Combining our proven skill, know-how and experience LMK’s dedicated project teams are experts when it comes to disinfectant processes. Be it antimicrobial activity of non-leaching antimicrobial treated materials, diffusible antimicrobials, antibiotics impregnated on various materials or preservative properties of pharmaceutical preparations – we’ll help you to ensure antimicrobial efficacy.
How

 

According to the physical state of the product, we could offer you modified test procedures. All antimicrobial efficacy tests are performed on the basis of international standards, norms, regulations and guidelines.
Test
Standards
Efficiency of Disinfectants and Antiseptics
DIN EN 1040:2005 Chemische Desinfektionsmittel und Antiseptika – Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung (Basistest) chemischer Desinfektionsmittel und Antiseptika – Prüfverfahren und Anforderungen (Phase 1)
Efficiency of Disinfectants and Antiseptics
DIN EN 1275:2006 Chemische Desinfektionsmittel und Antiseptika. Quantitativer Suspensionsversuch zur Bestimmung der fungiziden oder levuroziden Wirkung (Basistest) chemischer Desinfektionsmittel und Antiseptika. Pruefverfahren und Anforderungen (Phase 1)
Aerial Surface Disinfection Process
NF T 72-171 Determination of bactericidal, fungicidal, sporicidal activity for aerial surface disinfection processes
Antimicrobial Activity Testing of Chemical Disinfectants
DGHM and DVG standard methods Antimicrobial Activity Testing of chemical disinfectants
Antimicrobial Activity of Immobilized Antimicrobial Agents
ASTM E2149 – 10 Standard Test Method for Determining the Antimicrobial Activity of Immobilized Antimicrobial Agents Under Dynamic Contact Conditions
Antimicrobial Products
JIS Z 2801 Antimicrobial products – Test for antimicrobial activity and efficacy
Antibacterial Susceptibility
Kirby-Bauer Test Antibacterial Susceptibility Test – Zone of Inhibition
Why LMK

 

At LMK we combine over 30 years of tried and tested experience with the know-how of leading microbiologists. Moreover, we offer comprehensive expertise ranging from the cultivation to the purification and analysis of more than 60 bacteria and fungi, which allows us to customize tests and easily cater to individual wishes.

Mycoplasma testing & Endotoxin

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Microbial Antigen-/ Vaccine Production

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Anti-Biological Activity Testing

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