KNAUER Product Selection Guide 2021
KNAUER manufactures high-end scientific instruments for research, routine analysis, quality assurance, and other applications. Supported technologies include liquid chromatography, precise handling and pumping of liquids up to high pressures, as well as flow-through detection of dissolved substances. Customizable products and solutions are one of our strengths. Made in Germany. Developing devices that help people in the laboratory to gain new insights or facilitate their work. This is the spirit in which KNAUER was founded and continues to drive the company today.
KNAUER manufactures high-end scientific instruments for research, routine analysis, quality assurance, and other applications. Supported technologies include liquid chromatography, precise handling and pumping of liquids up to high pressures, as well as flow-through detection of dissolved substances. Customizable products and solutions are one of our strengths. Made in Germany.
Developing devices that help people in the laboratory to gain new insights or facilitate their work. This is the spirit in which KNAUER was founded and continues to drive the company today.
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<strong>KNAUER</strong> GMP<br />
NEW<br />
<strong>KNAUER</strong> Services for Good Manufacturing Practice for biopharmaceutical industry<br />
<strong>KNAUER</strong> provides equipment for downstream processing in the biopharmaceutical industry such as skids<br />
for the formulation of lipid nanoparticles, or chromatographic systems for mRNA purification or continuous<br />
chromatography. <strong>KNAUER</strong> provides a wide range of services to support our customers and to ensure that GMP<br />
requirements are met.<br />
<strong>KNAUER</strong>’s GMP services are based on our hardware- and software-solutions; encompassing product safety,<br />
quality control and the training of personnel. Risk management, in relation to GMP, is covered by the user:<br />
Risk<br />
Management<br />
<strong>Product</strong><br />
Safety<br />
Personnel<br />
Training<br />
Quality<br />
Control<br />
Further information:<br />
www.knauer.net/gmp<br />
<strong>Product</strong> safety:<br />
Documentation on the compliance of materials used for wetted parts is an important requirement for<br />
product safety. In the bio-pharmaceutical industry, potentially harmful substances must be avoided in liquids<br />
for clinical, cosmetic or food applications. Therefore, any materials of the liquid flow path that come<br />
into contact with the final product must meet certain criteria. According to our end user’s requirements<br />
<strong>KNAUER</strong> can provide compliance with the order (EN 10204-2.1), certificates of compliance on the materials<br />
used for wetted parts, and further documentation from the supplier such as 2.1 certificates.<br />
Overview of <strong>KNAUER</strong> options:<br />
Certificates are available for <strong>KNAUER</strong> products and selected third party products. Contact sales@knauer.net.<br />
Type of certificate/statement Unit of quantity Article number<br />
Declaration of Compliance with order (EN 10204-2.1) for 1 order A0000TDCOO<br />
Declaration of Compliance (EN 10204-2.1) with Certificate and<br />
compliance of material of wetted parts<br />
Declaration of Compliance (EN 10204-2.1) with Certificate and<br />
compliance of material of wetted parts<br />
Declaration of Compliance (EN 10204-2.1) with Certificate and<br />
compliance of material of wetted parts for one pump<br />
Declaration of Compliance (EN 10204-2.1) with Certificate and<br />
compliance of material of wetted parts for one pump head<br />
Declaration of Compliance (EN 10204-2.1) with Certificate and<br />
compliance of material of wetted parts for one valve<br />
Declaration of Compliance (EN 10204-2.1) with Certificate and<br />
compliance of material of wetted parts for one detector<br />
for 1 article with less<br />
than 5 components<br />
for 1 article with 5<br />
or more components<br />
for 1 article<br />
for 1 article<br />
for 1 article<br />
for 1 article<br />
A0000COMS<br />
A0000COM<br />
A0000COMP<br />
A0000COMPK<br />
A0000COMV<br />
A0000COMD<br />
TSE/BSE Statement: Customized order- and article related for 1 article A0000TDTSE<br />
Stepfile per device without functional groups for 1 article A0000IDSTE<br />
Documentation on compliance of material of wetted parts: Compliance<br />
with the order (EN 10204-2.1); Certificate of compliance on<br />
material of wetted parts; Documentation on references (supplier<br />
information of material) and wetted parts (certificates such as 2.1)<br />
customized<br />
A0000TD<br />
GMP | 96
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