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Microbiology – Non-Sterile Products

Depending on product and category, non-sterile products need to fulfil certain minimum requirements for microbiological purity in order to become marketable. For this purpose, specifications for product groups have been defined in the common pharmacopoeias and standards, in which the permitted total load of replicable microorganisms is stipulated.

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 L+S AG 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 L + S AG 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 L+S AG 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

Microbiological Water Analysis

Depending on the purpose, water must meet specific microbiological quality requirements. Labor L + S AG provides microbiological water analyses according to the German Drinking Water Ordinance

Depending on the purpose, water must meet specific microbiological quality requirements. Labor L + S AG provides microbiological water analyses, next to microbiological analyses, all chemical analyses for water used in pharmaceutical applications. These analyses are carried out according to the requirements of the current pharmacopoeias.

We do not only analyse water samples, but also perform complete qualifications of water systems for the pharmaceutical industry.

Your contact person:

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

Container Closure Integrity

A condition for the protection of the products is the ideal packaging protecting the product against microbiological and other contamination and practically preventing a change in the product quality through environmental conditions.

A condition for the protection of the products is the ideal primary packaging protecting the product against microbiological and other contamination and practically preventing a change in the product quality through environmental conditions. Container closure integrity testing is the method for testing the functionality of the primary packaging.

Labor L+S AG offers two methods: microbiological testing (microbial immersion testing) as well as dye ingress testing. Due to our extensive equipment, know-how and a variety of preparation options we are capable of conducting an individual test design for our customers.

The development of a specific test method is tailored to the specific product requirements, taking into account the closure system, product formulation and the mode of application.  In addition to the applicable guidelines (USP <1207 >, International Standard ISO 8362-2 Annex C, ISO 3826-1 Annex C, ISO 15747 Annex C, PDA Technical Report No. 27, FDA Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products) and pharmacopoeias, we also rely on the experience from numerous studies.

 

Your contact person:

Dr rer nat Carola Matthies 
Graduate Biologist

+49(0)9708/9100-160
carola.matthies@labor-ls.de

Industrial Hygiene

Whether in the production of pharmaceuticals, food, cosmetics, medical devices or at the hospital: the compliance and review of microbiological standards and processes are key prerequisites for the optimal industrial hygiene.

Hygiene is a subject that concerns all of us. Whether in the production of pharmaceuticals, food, cosmetics, medical devices or at the hospital: the compliance and review of microbiological standards and processes are key prerequisites for the optimal industrial hygiene.
With the QVPlus quality seal, Labor L+S AG offers its customers the complete range of services for the microbiological qualification and validation of production systems. This includes the production of documents, the testing of disinfectants as well as various validations and qualifications, for example, of equipment and premises. Further plus points of our QVPlus service portfolio are additional modules such as crisis counselling as well as hygiene trendings and trainings. This way, our customers may individually select the services they need from professional components and combine them in a way that best suits them:

  • Qualification of clean rooms and production rooms [Q]
  • Creation and planning of hygiene registers and monitoring [Plus]
  • Determination of the domestic microbiological flora and subsequent storage of domestic microorganisms [Plus]
  • Validations of filling processes, service life and sterilisation methods [V]
  • Employee training and qualification [Q]
  • Cleaning validations [V]
  • Validation of disinfectants [V]
  • Conduct of audits and inspections [Plus]
  • Crisis counselling [Plus]
  • Creation and review of hygiene plans, work instructions etc. [Plus]
  • Identification of microorganisms [Plus]

The brand quality sign summarises the unique performance promise we make to our customers.

Your contact person:

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

Disinfectant Tests

Manufacturers of disinfectants have to prove the effectiveness of their products. Labor L + S offers a variety of methods to investigate the disinfectant efficacy according to standard methods for surface- and instrument-disinfectant

 

Manufacturers of disinfectants have to prove the effectiveness of their products. Labor L + S offers a variety of methods to investigate the disinfectant efficacy according to national and European standard methods for surface- and instrument-disinfectants. Moreover, our service portfolio includes efficacy tests on human volunteers for products for hygienic hand washing and hygienic / surgical hand disinfectants.

  • With the help of standardised test methods, we ensure valid results at all times as well as reliable data and consistent quality. Due to our membership in the DIN committee we are always up to date for our customers.
  • Via our approved consultant at the VAH (Association for Applied Hygiene), we create certificates for the listing of disinfectants for our customers. Furthermore, we provide transcriptions and translations of your certificates or test reports.

Even when using already listed disinfectants, customers from the pharmaceutical industry are required to prove the efficacy of the used disinfectants on customer-specific surfaces and against their environmental test strains. In this context we offer our customers the following services:

  • Practice-related validation of disinfectants for the determination of disinfectant efficacy.
  • With the help of standardised test methods, we ensure valid results at all times as well as reliable data and consistent quality. Due to our membership in the DIN committee we are always up to date for our customers.
  • Together with our customers we create the basis for sustainable data and an optimal qualification/validation status—even after completion of the initial qualification/validation.
  • Everything from one source: from the identification of environmental isolates and the storage of customer-specific microorganisms in our strain collection up to test performance and consulting — Labor L + S AG offers its customers all-inclusive service solutions.

Your contact person:

Anastasija Schlicht
Graduate Biologist
+49(0)9708/9100-190
anastasija.schlicht@labor-ls.de

Approved consultant at the VAH (Association for Applied Hygiene) and member of the DIN committee

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 L+S AG 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

Biological Assay

Complex active substances or products that need to be classified and examined according to their biological activity are assayed according to the requirements laid down in the Ph Eur.

Complex active substances or products that need to be classified and examined according to their biological activity are assayed according to the requirements laid down in the Ph Eur.

With its wide range of testing methods and its product-specific consulting expertise, Labor L+S AG is the ideal partner for assays. The high quality of our statistical analysis increases the precision and reliability of our results.

  • Microbiological assay of antibiotics (API and pharmaceuticals)
  • Detection of antibiotic activity by microbiological analysis
  • Biological assay of heparin by coagulation deceleration (clotting assay)
  • Biological assay of heparin via anti-factor IIa activity and anti-factor Xa activity
  • Biological assay of thrombin
  • Assay of protamine sulphate
  • Microbiological assay of vitamins

Your contact person:

Dr rer nat Nadine Frölich
Graduate Biochemist

+49(0)9708/9100-588
nadine.froelich@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 L+ S AG as well.

For the MIC determination, Labor L+S AG 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

Impressionen vom Tag der offenen Tür

Am 7. und 8. Juli wurde der Neubau der Labor L+S AG eingeweiht. Mehrere Tausend...


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Events

Low Endotoxin Recovery/Masking (Hands-on Laboratory Training Course)

27. - 28. Februar 2018, München (ECA Academy)


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Transfer analytischer Methoden und Verfahren (A19)

25. -27. April 2018, Mannheim (Concept Heidelberg)


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Contact

Labor L+S AG

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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