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Microbiology – Non-Sterile Products

The determination of the total microbial count and/or the detection of specified microorganisms are the cornerstones of microbiological purity tests of non-sterile products. Labor LS is one of the largest independent providers of microbiological product testing across Europe.

Using a wide range of test equipment and laboratory capacities as well as working with experienced staff, our experts can examine even large sample volumes, delivering the highest inspection quality at relatively short processing times.

Microbial Enumeration Test

The microbiological quality and safety of a product depends on the number of viable microorganisms found in it (e. g. bacteria and fungi). To this end, the total aerobic microbial count needs to be determined.

The microbiological quality and safety of a product depends on the number of viable microorganisms found in it (e. g. bacteria and fungi). To this end, the total aerobic microbial count needs to be determined.

In the field of non-sterile products, Labor LS tests a wide range of pharmaceuticals, medical devices, cosmetics and purified water/process water as well as various intermediates in the context of in-process controls. Such tests are carried out according to the requirements of pharmacopoeias, standardised procedures, customer-specific test procedures or ISO standard 11737 (sterilization of medical devices).

Suitability tests and method transfers are made in consultation with our customers. In addition, Labor LS operates a laboratory for processing Zytostatics and other active pharmaceutical ingredients (APIs).

Your contact person:

Christine Weiß
Graduate Ecotrophologist
+49(0)9708/9100-716
christine.weiss@labor-ls.de

Test for Specified Microorganisms

Next to determining the total aerobic microbial count in pharmaceuticals, medical devices, cosmetics and recycled water, it must be ruled out, in order to ensure the quality and the specifications of pharmacopoeias and standards,

Next to determining the total aerobic microbial count in pharmaceuticals, medical devices, cosmetics and process water, it must be ruled out, in order to ensure the quality and the specifications of pharmacopoeias and standards, that certain pathogenic microorganisms or microorganisms with specific contamination profiles (indicator organisms such as E. coli) are present in a product. For this purpose, we perform the test for detection of specified microorganisms — for example Salmonella, pseudomonads or staphylococci — in accordance with the current pharmacopoeias (Ph Eur, USP, JP) as well as according to DIN EN ISO and customer-specific test procedures.

Your contact person:

Christine Weiß
Graduate Ecotrophologist
+49(0)9708/9100-716
christine.weiss@labor-ls.de

Test on the efficacy of antimicrobial preservation

The controlled quality and microbiological safety of a product are mandatory requirements for its safe use. The preservation system is an essential aspect of a product's microbiological safety and safety evaluation.

The controlled quality and microbiological safety of a product are mandatory requirements for its safe use. The preservation system is an essential aspect of a product's microbiological safety and safety evaluation.

Labor LS has extensive expertise in testing the efficacy of antimicrobial preservation. We perform preservation challenge tests on the basis of the European, US and Japanese pharmacopoeias. We do not only examine according to the common regulatory requirements, but also develop and implement specific formulation methods.

  • Test on the efficacy of antimicrobial preservation according to DIN EN ISO 11930 (for cosmetic products) and DIN EN ISO 14730 (lens care products)
  • Suitability testing of the microbial count method
  • Development of new methods and implementation of special test procedures for already existing methods
  • Modified test design, depending on the application

Your contact person:

Christine Weiß
Graduate Ecotrophologist
+49(0)9708/9100-716
christine.weiss@labor-ls.de

MIC Determination

The minimum inhibitory concentration (MIC) against microorganisms is generally defined as the lowest concentration of a substance capable of inhibiting the growth of a germ, that means there is no macroscopically visible growth.

The minimum inhibitory concentration (MIC) against microorganisms is generally defined as the lowest concentration of a substance capable of inhibiting the growth of a germ, that means there is no macroscopically visible growth. The MIC test is used in the development of new pharmaceuticals or products to determine the biocidal effect of a substance or product. The minimum inhibitory concentration is, for example, the basis of statements on the effectiveness of antibiotics or the resistance of a specific pathogen. The substance or product to be examined is tested against an application-based range of microorganisms in order to examine, for example, its impact on the typical skin flora or the organotypic flora of a target patient.

The ingredients of the respective formulation can be tested, either individually or in combination, from the same perspective. Also substances or formulations with broadband biocidal effect, which can subsequently be used for different products, can be tested. One example of this is the testing of the possible application concentration of preservatives that are subsequently used in different formulations. To determine the effectiveness of a preservative in the actual formulation, a preservation challenge test is required which is offered by Labor LS as well.

For the MIC determination, Labor LS offers bouillon dilution method, agar diffusion method as well as agar dilution method, tailoring the test to the respective customer's requirements and applications.

Your contact person:

Melanie Braun
Biological Laboratory Technician
+49(0)9708/9100-940
melanie.braun@labor-ls.de

News

LS opts for a future-oriented corporate structure

Press release dated 23 April 2018


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Events

Personal- & Produktionshygiene im Pharma-Umfeld

19. und 20. Juli 2018, Frankfurt (Forum Institut)


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Der Mikrobiologie Compliance Manager - Block 2

10. -12. Oktober 2018, Mannheim (Concept Heidelberg)


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Contact

Labor LS SE & Co. KG

Mangelsfeld 4, 5, 6
97708 Bad Bocklet-
Großenbrach

Fon: +49 (0)9708/9100-0
Fax: +49 (0)9708/9100-36
E-Mail: service@labor-ls.de

Infobox

In our Infobox, we make additional information on our company, our service portfolio and our QM certification available to you in a download. 

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