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bioPharmaceuticals

Labor LS is one of the leading independent contract laboratories for the pharmaceutical industry both in Germany and in Europe. For more than 1,000 well-known customers from the industry, we conduct microbiological and chemical-physical tests; we test sterile as well as non-sterile products and meet all the required standards – from legal guidelines to individual customer specifications in the context of industry-relevant procedures.

In this, we strictly comply with GMP conditions and test according to the requirements of the relevant pharmacopoeia (Ph Eur, USP, and JP). In addition to our comprehensive product test services, our customers benefit from our extensive expertise and consulting competencies in pharmaceuticals and medical devices. 

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.
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Microbiological Testing – Non-Sterile Products

Depending on product and category, non-sterile products have to meet specific minimum requirements for microbiological purity in order to achieve marketability. For this purpose, the common pharmacopoeias and standards have defined specifications for product groups, which detail the permitted total amount of revivable microorganisms and groups of usually pathogenic microorganisms that may not be included. 

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Biological Testing

Determining the absence of endotoxin or pyrogen is compulsory for the quality assessment of sterile dosage forms. Similarly as with pharmaceuticals, the absence of endotoxin is one of the criteria for sterile medical devices. Labor LS offers a wide range of biological purity tests for pharmaceuticals and medical devices. These include, for example, tests for endotoxins, tests for pyrogens and monocyte activation tests (MAT) for the control of sterile products. In addition, we determine the biological activity of insulin according to USP <121>.

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Chemical and Physical Testing

A team of around thirty experts and laboratory personnel conducts extensive analytical services for customers from the pharmaceutical and cosmetics industry – always in compliance with the relevant regulations or customer-specific requirements. Whether limit testing, purity tests, identity tests or the determination of content, melting point and osmolality – Labor L+S offers its customers pharmacopoeial test methods, whose range is extensive in terms of both quality and quantity.

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News

LS opts for a future-oriented corporate structure

Press release dated 23 April 2018


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Events

Laborfehler und CAPAs in der Qualitätskontrolle

17./ 18. Oktober 2018, Mannheim (Concept Heidelberg)


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Der GMP Hygienebeauftragte Block 2

17. - 19. Oktober 2018, Leimen (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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