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Microbiological Testing – Sterile Products

Labor L+S AG is one of the largest suppliers of microbiological and biological purity tests for sterile pharmaceuticals and medical devices. Our sterility tests  are conducted in four aseptic isolators and a clean room (class A in B). The combination of about three decades of laboratory experience, the related methodological expertise and our extensive technical equipment cover the full range of testing services for sterile, endotoxin and pyrogen testing

Test for Sterility

Next to production monitoring, sterility tests are the crucial instrument for controlling the microbiological safety of sterile pharmaceuticals and medical devices.

Next to production monitoring, sterility tests are the crucial instrument for controlling the microbiological safety of sterile pharmaceuticals and medical devices. As one of the largest suppliers of sterility tests, we are capable of conducting tests in accordance with the requirements laid down in the common pharmacopoeias (Ph Eur 2.6.1, USP Chapter <71>, JP Chapter 4.06, ISO standards 11137-1/-2 (sterilization of health care products) and 11737-1/-2 (sterilization of medical devices) and other regulations on request).

In addition, we offer our customers a broad range of consulting and control services to support them.

  • Clean room (class A in B)
  • Four aseptic isolators, one isolator specifically designed for the testing of toxic substances such as cytotoxic agents
  • Testing of the entire range of pharmaceuticals and medical devices

Your contact person:

Katharina Schlereth
Graduate Biologist
+49(0)9708/9100-491
katharina.schlereth@labor-ls.de

Media Fill

For the performance of media fills for the validation of your aseptic (filling) processes, we offer you a broad range of support services.

For the performance of media fills for the validation of your aseptic (filling) processes, we offer you a broad range of support services.

  • Preparation of validation plans according to the requirements of the EU GMP Guide, Annex 1
  • Preparation of validation plans for aseptic dispensing operations for individualised products (e. g. cytotoxic preparation in the hospital pharmacy)
  • Incubation of media fills in qualified incubators
  • Evaluation of media fills for microbial growth by qualified personnel
  • Identification of bacteria in case of positive findings and help in troubleshooting

  • Conduct of growth promotion tests on the media fill containers
  • Storage and maintainance of your production isolates in our strain collection for partly necessary downstream investigations
  • Providing test kits for employee qualifications


Your contact person:

Dr rer nat Carola Matthies 
Graduate Biologist

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

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

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

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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