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Microbiological Testing – Sterile Products

Labor LS 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. 

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 LS 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

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

Stability Storage

To test the stability of their products, we offer our customers a comprehensive package of services.

To test the stability of their products, we offer our customers a comprehensive package of services. We take care of the entire logistics, from collection (to be agreed separately) and storage (including or excluding analytics) up to the return and disposal of our customers' samples.
We create precise stability reports, test plans as well as test matrices and implement necessary storages even at short notice. As part of our comprehensive storage concepts, we guarantee the compliance with the highest security levels. Our climate cabinets and chambers, for example, are equipped with emergency generators and are continuously controlled by two monitoring systems.
We can offer the following climatic conditions for your stability tests:

  • -20 °C
  • -80 °C
  • 5 +/- 3 °C
  • 25 °C, 60 % relative humidity
  • 30 °C, 65 % relative humidity
  • 40 °C, 75 % relative humidity
  • 30 °C, 75 % relative humidity
  • 25 °C, 40 % relative humidity
  • 40 °C, 25 % relative humidity (starting end of 2015)
  • Special conditions are possible on request

Your Contact Person:

Dr rer nat Joanna Ruppel
Pharmacist
+49(0)9708/9100-451
joanna.ruppel@labor-ls.de

Dr rer nat Marcus Kehrel
Pharmacist
+49(0)9708/9100-439
marcus.kehrel@labor-ls.de

Identification of Microorganisms

In many areas of the manufacture of pharmaceuticals, medical devices, food and cosmetics as well as in the context of hygiene checks, the fast and reliable identification of microorganisms is of crucial importance in quality assurance.

In many areas of the manufacture of pharmaceuticals, medical devices, food and cosmetics as well as in the context of hygiene checks, the fast and reliable identification of microorganisms is of crucial importance in quality assurance. The demands placed on the quality control of products are ever-increasing, the associated production processes are getting more complex and the requirements on the production environment, more rigid. Labor LS conducts the correct identification of microorganisms such as bacteria, yeasts or molds with the following procedures:

  • Biochemical identification (“Bunte Reihe”, VITEK™/API™ systems)
  • Molecular mass-spectrometric methods (MALDI-TOF MS)
  • Molecular biological methods (16S rDNA sequencing of bacteria and 28S / 26S rDNA sequencing of yeasts and moulds)

Our core competence lies in extensive plausibility checks: all results are checked by the skilled eyes of our experienced experts. Only when the cultural morphology as well as the Gram staining results and the identification results of the system used are consistent and cogent examination is completed and released. Results are forwarded to you as soon as possible. In addition this special service guarantees qualitative and reliable results.  

Another important part of identification of organisms is the area of mold identification up to species level. Based on long experience in identification of molds as well as extensive trainings for our technicians, we provide an enclosing service of cultural- and microscopical  identification.

Your contact person:

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

L+S Strain Collection

If requested, Labor LS will deposit identified microorganisms in the L+S strain collection. The isolates are thus available for testing, validation or comparison purposes at a later time.

If requested, Labor LS will deposit identified microorganisms in the LS strain collection. Thus, isolates could be used for additional tests like validation or comparison purposes at a later time. In accordance with the requested retention period, we offer different ways of storing domestic microorganisms, such as the classical agar slant, cryo-preservation as well as long term storage as lyophilisate (freezedried). Furthermore we store a large number of strains, recorded by national reference centres.

Your contact person:

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

Mycoplasma Detection

Microbial contaminations of cell banks by mycoplasma species lead to enormous production losses during production of biotechnological active substances in cell culture bioreactors.

Microbial contaminations of cell banks by mycoplasma species lead to enormous production losses during production of biotechnological active substances in cell culture bioreactors.
In these processes, the reproduction and spread of mycoplasmas usually occurs undetected: mycoplasmas belong to the smallest described bacteria. With a size of 0.2 - 2 µm, they are not visible under the light microscope and they pass through conventional bacteria filters. Furthermore, during their growth in the cell culture, they do not induce the clouding of the cell culture medium typical for microbial contamination nor initiate a colour change of the medium due to a change in pH.
 
For initial testing of your production cell line as well as routine in-process controls, we offer a rapid test method, based on the nucleic acid amplification technique (NAT) according to Ph. Eur. 2.6.7, for investigation of mycoplasmas.

In the context of release tests, the NAT is described in the pharmacopoeias as an alternative to the traditional methods. For products with limited shelf life, e.g. ATMPs, the rapid test is the only option for the detection of mycoplasmas in a timely manner.
 
Product-specific validations are performed according to your requirements and in consultation with the competent authorities.

Your contact person:

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

Suitability Testing of Culture Media

For customers who do not have the opportunity to subject their culture media to a receiving inspection, Labor LS tests these media according to the common pharmacopoeias and the respective customer's individual specifications.

For customers who do not have the possibility to perform receiving inspections of their culture media, Labor LS will test media in accordance with common pharmacopoeia regulations, as well as individual customer specifications, e.g. use of specific in-house isolates. We offer extensive experience and expertise in the field of culture media production.

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 LS 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 LS 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 LS 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 LS 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

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 LS 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 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

In-Use Tests

In-use tests simulate the application of a product in order to determine its microbiological or chemical-physical stability in real-life conditions and, if necessary, its shelf life after opening.

In-use tests simulate the application of a product in order to determine its microbiological or chemical-physical stability in real-life conditions and, if necessary, its shelf life after opening. The focus is often on medicines and cosmetics in multi-dose containers, where product removal is a microbiological risk and where the potential contamination with pathogenic microorganisms during use poses a possible health risk.

Labor LS creates test plans for this purpose and develops a test design adapted to the product and its use. For certain products, the test design may include, in the simulation, microbiological flora occurring specifically at the application site. Quality evaluation tests in the context of in-use tests may be sterility tests, microbial purity tests, tests for adequate preservation or chemical-physical tests.

General requirements for in-use stability tests of human and veterinary pharmaceuticals are specified in the corresponding CPMP and CVMP guidelines of the EMA (European Medicines Agency). In accordance with the cosmetics regulation for certain cosmetic products, a “period after opening” (PAO) needs to be specified.

Guidelines:

  • CPMP/QWP/2934/99 Note for Guidance on In-Use Stability Testing of Human Medicinal Products
  • EMA/CVMP/424/01 Note for Guidance on In-Use Stability Testing of Veterinary Medicinal Products (Excluding Immunological Veterinary Medicinal Products)
  • CPMP/QWP/159/96 corr Note for Guidance on Maximum Shelf-Life for Sterile Products for Human Use after First Opening or Following Reconstitution

Your contact person:

Dr rer nat Carola Matthies 
Graduate Biologist

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

News

Spendenübergabe zur Aktion "Spende statt Weihnachtskarten"

Im Zuge des Versands von Weihnachtsgrüßen an unsere Geschäftspartner hatten wir...


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Events

European Microbiology Conference 2018

24.-26. April 2018, Wien (ECA Academy)


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20. Pharmatechnik-Konferenz

24. April 2018, Düsseldorf (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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