Sterility Testing

A central instrument for monitoring the microbiological safety of medicinal products and medical devices is testing for sterility. With over three decades of laboratory experience, Labor LS is one of the largest providers of microbiological and biological purity testing in Europe.

 

Laboratory LS SE & Co. KG has over three decades of laboratory experience. Methodological competence, our extensive equipment and one of the most modern clean room testing facilities make the company one of the largest providers of microbiological and biological purity testing for sterile drugs and medical devices in Europe. We offer our customers the following spatial testing options:

• Clean room (Class A in B)

• 4 aseptic isolators

• 2 of the 4 isolators are specifically suitable for testing toxic substances (e.g. cytostatics)

 

We examine virtually the entire spectrum of sterile drugs and medical devices according to the current technical standards and have established the appropriate methodological solution approaches for each matrix via membrane filtration or direct feeding.

We conduct the sterility test for you in accordance with the respective current specifications of the common pharmacopoeias:

• Ph. Eur. Chapter 2.6.1

• USP Section <71>

• JP Section 4.06

• various ISO standards, in particular pursuant to ISO 11137

• other regulations on request (e.g. Russian Pharmacopoeia, Chinese Pharmacopoeia)

 

In addition to classic sterility testing with the required 14 day incubation time, we have extensive rapid methods for each matrix in our portfolio:

• BACT/ALERT® (7 days incubation time)

• Celsis® ATP bioluminescence (7 days incubation time)

• Solid phase cytometry (1 day processing time)

 

Of course, we would also be pleased to advise you on quality assurance issues in the manufacturing and filling of sterile products.

Further info
Service groups:
Quality assurance
    Further quality assurance


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Image of   Stefan Gärtner

Stefan Gärtner

Labor LS SE & Co. KG

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