Quality Management Center
Welcome to the Quality Management Center, your gateway to a comprehensive suite of resources dedicated to upholding the highest standards of quality and compliance. Here, we empower you with the tools and documentation necessary to ensure excellence in every aspect of your operations with Repligen products.
Repligen facilities operate according to ISO 9001 Quality Management Systems (QMS), with the aim of building quality into every Repligen product.
Immobilized rProtein Solutions SDS - English
Immobilized rProtein Solutions SDS - English (EU, UK)
Immobilized rProtein Solutions SDS - German
Immobilized rProtein Solutions SDS - French
Immobilized rProtein Solutions SDS - Dutch
Immobilized rProtein Solutions SDS - Swedish
AVIPure® - AAV Affinity Resin Safety Data Sheet - English
AVIPure® - AAV Affinity Resin Safety Data Sheet- Chinese
AVIPure® - AAV Affinity Resin Safety Data Sheet - Dutch
AVIPure® - AAV Affinity Resin Safety Data Sheet- French
AVIPure® - AAV Affinity Resin Safety Data Sheet- German
TangenX® PRO Cassette Safety Data Sheet
TangenX® SIUS Cassette Safety Data Sheet
OPUS® Pre-packed Chromatography Column Certificate of Analysis 8.1cm GMP Run Ready – Example
OPUS® Pre-packed Chromatography Column Certificate of Analysis 8.1cm Pre-GMP- Example
OPUS® Pre-packed Chromatography Column Certificate of Analysis Pre-GMP - Example
OPUS® Pre-packed Chromatography Column Certificate of Analysis GMP Run Ready - Example
ISO 9001:2015 Certificate of Registration - US (Bridgewater)
ISO 9001:2015 Certificate of Registration - US (Clifton Park)
ISO 9001:2015 Certificate of Registration - US (Lebanon)
ISO 9001:2015 Certificate of Registration - US (Rancho Dominguez)
ISO 9001:2015 Certificate of Registration - US (Simi Valley)
ISO 9001:2015 Certificate of Registration - US (Waltham, Marlborough, Billerica, Breda)
ISO 13485:2016 Certificate of Registration - US (Auburn)
ISO 9001:2015 Certificate of Registration - Estonia
ISO 9001:2015 Certificate of Registration - Ravensburg
ISO 9001:2015 Certificate of Registration - Sweden
ISO 9001:2015 Certificate of Registration - Six Cross Roads, Waterford, Ireland
ISO 9001:2015 Certificate of Registration - Waterford, Ireland
ISO 9001:2015 Certificate of Registration IDA - Waterford, Ireland
ISO 14001:2015 Certificate of Registration - Sweden
CaptivA HF Certificate of Analysis – Example
TangenX® Flat Sheet Cassettes
SpectraFlo™ Dynamic Dialysis Systems User Guide
Float-A-Lyzer® G2 Ready-to-use Microdialysis Devices
Micro Float-A-Lyzer® Ready-to-use Microdialysis Devices
Tube-A-Lyzer® Dynamic Dialysis System
Spectra/Por® Biotech Grade Dialysis Membranes: Cellulose Ester (CE), Regenerated Cellulose (RC)
Spectra/Por® 1-7 Standard Grade Regenerated Cellulose Dialysis Membrane
KrosFlo® TFDF® Lab System Set-up Guide
KrosFlo® TFDF® Lab System Set-up Guide - Danish
KrosFlo® TFDF® Lab System Set-up Guide - Dutch
KrosFlo® TFDF® Lab System Set-up Guide - French
KrosFlo® TFDF® Lab System Set-up Guide - German
KrosFlo® TFDF® Lab System Set-up Guide - Italian
KrosFlo® TFDF® Lab System Set-up Guide - Spanish
KrosFlo® TFDF® Lab System User Guide
KrosFlo® TFDF® Lab System User Guide - Danish
KrosFlo® TFDF® Lab System User Guide - Dutch
KrosFlo® TFDF® Lab System User Guide - French
KrosFlo® TFDF® Lab System User Guide - German
KrosFlo® TFDF® Lab System User Guide - Italian
KrosFlo® TFDF® Lab System User Guide - Spanish
KrosFlo KTF, KPS, TFDF User Guide - English
KrosFlo KTF, KPS, TFDF User Guide - Dutch
KrosFlo KTF, KPS, TFDF User Guide - French
KrosFlo KTF, KPS, TFDF User Guide - German
KrosFlo KTF, KPS, TFDF User Guide - Spanish
KrosFlo® FS TFF Systems Set-up Guide
KrosFlo® FS TFF Systems Set-up Guide - Danish
KrosFlo® FS TFF Systems Set-up Guide - Dutch
KrosFlo® FS TFF Systems Set-up Guide - French
KrosFlo® FS TFF Systems Set-up Guide - German
KrosFlo® FS TFF Systems Set-up Guide - Italian
KrosFlo® FS TFF Systems Set-up Guide - Spanish
KrosFlo KTF, KPS, TFDF User Guide - English
KrosFlo KTF, KPS, TFDF User Guide - Dutch
KrosFlo KTF, KPS, TFDF User Guide - French
KrosFlo KTF, KPS, TFDF User Guide - German
KrosFlo KTF, KPS, TFDF User Guide - Spanish
KrosFlo® KR2i / KMPi TFF Systems with KONDUiT
KrosFlo® TFF System - Auxiliary Scale ACSS-20K
KrosFlo® TFF System - Auxiliary Scale ACSS-60K
OPUS® 36R – 80R Pre-packed Columns Resin Removal
OPUS® 36R Pre-packed Column Non-wood Packaging Guide
OPUS® 36R Pre-packed Column Non-wood Unpacking Guide
OPUS 45cm Unpackaging Instructions
OPUS 45cm Packaging Instructions
OPUS® 45-80R Unpackaging Guide
Unpacking OPUS® 2.5 - 8 Pre-packed Columns
Packaging Instructions OPUS® 10 - 30 Pre-packed Columns
Packaging Instructions OPUS® 2.5 - 8 Pre-packed Columns
OPUS® 5-80R Pre-packed Chromatography Columns User Guide
Uncrating OPUS® 45-60R Pre-packed Chromatography Columns
Uncrating OPUS® 80R Pre-packed Chromatography Columns
Unpackaging OPUS® 10-30 Pre-packed Chromatography Columns
OPUS® Pre-packed Chromatography Columns Connection and Priming
TangenX SIUS Auto-Torque Holders and System User Guide
TangenX® TFF Cassette Air Integrity Testing Application Note
TangenX® SIUS® PD Cassette User Guide
TangenX® SIUS® Cassette User Guide
TangenX® SIUS® Gamma TFF Device User Guide
TangenX® SIUS® Gamma Closed TFF Cassette Set-up Guide
TangenX® PRO Cassette User Guide
TangenX® PRO PD Cassette User Guide
Disc Membrane User Guide
EH10236 TangenX® Hydraulic Pump User Guide
TangenX® PRO PD Low Holdup Volume (LHV) System User Guide
TangenX® PRO PD Cassette Holder Compatibility Guide
TangenX® SIUS® PD Cassette Holder Compatibility Guide
TangenX® PRO Cassette Holder Compatibility Guide
TangenX® SIUS® Cassette Holder Compatibility Guide
TangenX® SIUS® Filter Plate and 4-Bolt Clamp Assembly
TangenX® SIUS® PD Filter Plate and 2-Bolt Clamp Assembly User Guide
XCell ATF® Devices and XCell® Controllers Seismic Anchorage Report
XCell ATF® 1 Device Set-up Guide
XCell® Lab Controller User Guide
XCell ATF® 2 Single-use Device Start-up Guide
XCell ATF® 6 Single-use Device Start-up Guide
XCell ATF® 10 Single-use Device Start-up Guide
XCell® C24:V3 Controller User Guide
XCell ATF® System with C410:V4B Controller
Repligen facilities operate according to ISO 9001 Quality Management Systems (QMS), with the aim of building quality into every Repligen product.
Immobilized rProtein Solutions SDS - English
Immobilized rProtein Solutions SDS - English (EU, UK)
Immobilized rProtein Solutions SDS - German
Immobilized rProtein Solutions SDS - French
Immobilized rProtein Solutions SDS - Dutch
Immobilized rProtein Solutions SDS - Swedish
CaptivA HF Certificate of Analysis – Example
LONG®R3 IGF-I - Freeze-dried - Certificate of Analysis - Example
LONG®R3 IGF-I - Liquid - Certificate of Analysis - Example
LONG® EGF Certificate of Analysis - Freeze-dried - Example
SpectraFlo™ Dynamic Dialysis Systems User Guide
Float-A-Lyzer® G2 Ready-to-use Microdialysis Devices
Micro Float-A-Lyzer® Ready-to-use Microdialysis Devices
Tube-A-Lyzer® Dynamic Dialysis System
Spectra/Por® Biotech Grade Dialysis Membranes: Cellulose Ester (CE), Regenerated Cellulose (RC)
Spectra/Por® 1-7 Standard Grade Regenerated Cellulose Dialysis Membrane
KrosFlo® TFDF® Lab System Set-up Guide
KrosFlo® TFDF® Lab System Set-up Guide - Danish
KrosFlo® TFDF® Lab System Set-up Guide - Dutch
KrosFlo® TFDF® Lab System Set-up Guide - French
KrosFlo® TFDF® Lab System Set-up Guide - German
KrosFlo® TFDF® Lab System Set-up Guide - Italian
KrosFlo® TFDF® Lab System Set-up Guide - Spanish
KrosFlo® TFDF® Lab System User Guide
KrosFlo® TFDF® Lab System User Guide - Danish
KrosFlo® TFDF® Lab System User Guide - Dutch
KrosFlo® TFDF® Lab System User Guide - French
KrosFlo® TFDF® Lab System User Guide - German
KrosFlo® TFDF® Lab System User Guide - Italian
KrosFlo® TFDF® Lab System User Guide - Spanish
KrosFlo KTF, KPS, TFDF User Guide - English
KrosFlo KTF, KPS, TFDF User Guide - Dutch
KrosFlo KTF, KPS, TFDF User Guide - French
KrosFlo® FS TFF Systems Set-up Guide
KrosFlo® FS TFF Systems Set-up Guide - Danish
KrosFlo® FS TFF Systems Set-up Guide - Dutch
KrosFlo® FS TFF Systems Set-up Guide - French
KrosFlo® FS TFF Systems Set-up Guide - German
KrosFlo® FS TFF Systems Set-up Guide - Italian
KrosFlo® FS TFF Systems Set-up Guide - Spanish
KrosFlo KTF, KPS, TFDF User Guide - English
KrosFlo KTF, KPS, TFDF User Guide - Dutch
KrosFlo KTF, KPS, TFDF User Guide - French
KrosFlo KTF, KPS, TFDF User Guide - German
KrosFlo KTF, KPS, TFDF User Guide - Spanish
KrosFlo® KR2i / KMPi TFF Systems with KONDUiT
KrosFlo® TFF System - Auxiliary Scale ACSS-20K
KrosFlo® TFF System - Auxiliary Scale ACSS-60K
OPUS® Pre-packed Chromatography Column Certificate of Analysis 8.1cm GMP Run Ready – Example
OPUS® Pre-packed Chromatography Column Certificate of Analysis 8.1cm Pre-GMP- Example
OPUS® Pre-packed Chromatography Column Certificate of Analysis Pre-GMP - Example
OPUS® Pre-packed Chromatography Column Certificate of Analysis GMP Run Ready - Example
OPUS® 36R – 80R Pre-packed Columns Resin Removal
OPUS® 36R Pre-packed Column Non-wood Packaging Guide
OPUS® 36R Pre-packed Column Non-wood Unpacking Guide
OPUS 45cm Unpackaging Instructions
OPUS 45cm Packaging Instructions
OPUS® 45-80R Unpackaging Guide
Unpacking OPUS® 2.5 - 8 Pre-packed Columns
Packaging Instructions OPUS® 10 - 30 Pre-packed Columns
Packaging Instructions OPUS® 2.5 - 8 Pre-packed Columns
OPUS® 5-80R Pre-packed Chromatography Columns User Guide
Uncrating OPUS® 45-60R Pre-packed Chromatography Columns
Uncrating OPUS® 80R Pre-packed Chromatography Columns
Unpackaging OPUS® 10-30 Pre-packed Chromatography Columns
OPUS® Pre-packed Chromatography Columns Connection and Priming
TangenX® PRO Cassette Safety Data Sheet
TangenX® SIUS Cassette Safety Data Sheet
TangenX SIUS Auto-Torque Holders and System User Guide
TangenX® TFF Cassette Air Integrity Testing Application Note
TangenX® SIUS® PD Cassette User Guide
TangenX® SIUS® Cassette User Guide
TangenX® SIUS® Gamma TFF Device User Guide
TangenX® SIUS® Gamma Closed TFF Cassette Set-up Guide
TangenX® PRO Cassette User Guide
TangenX® PRO PD Cassette User Guide
Disc Membrane User Guide
EH10236 TangenX® Hydraulic Pump User Guide
TangenX® PRO PD Low Holdup Volume (LHV) System User Guide
TangenX® PRO PD Cassette Holder Compatibility Guide
TangenX® SIUS® PD Cassette Holder Compatibility Guide
TangenX® PRO Cassette Holder Compatibility Guide
TangenX® SIUS® Cassette Holder Compatibility Guide
TangenX® SIUS® Filter Plate and 4-Bolt Clamp Assembly
TangenX® SIUS® PD Filter Plate and 2-Bolt Clamp Assembly User Guide
XCell ATF® Devices and XCell® Controllers Seismic Anchorage Report
XCell ATF® 1 Device Set-up Guide
XCell® Lab Controller User Guide
XCell ATF® 2 Single-use Device Start-up Guide
XCell ATF® 6 Single-use Device Start-up Guide
XCell ATF® 10 Single-use Device Start-up Guide
XCell® C24:V3 Controller User Guide
XCell ATF® System with C410:V4B Controller
ISO 9001:2015 Certificate of Registration - US (Bridgewater)
ISO 9001:2015 Certificate of Registration - US (Clifton Park)
ISO 9001:2015 Certificate of Registration - US (Lebanon)
ISO 9001:2015 Certificate of Registration - US (Rancho Dominguez)
ISO 9001:2015 Certificate of Registration - US (Simi Valley)
ISO 9001:2015 Certificate of Registration - US (Waltham, Marlborough, Billerica, Breda)
ISO 13485:2016 Certificate of Registration - US (Auburn)
ISO 9001:2015 Certificate of Registration - Estonia
ISO 9001:2015 Certificate of Registration - Ravensburg
ISO 9001:2015 Certificate of Registration - Sweden
ISO 9001:2015 Certificate of Registration - Six Cross Roads, Waterford, Ireland
ISO 9001:2015 Certificate of Registration - Waterford, Ireland
ISO 9001:2015 Certificate of Registration IDA - Waterford, Ireland
ISO 14001:2015 Certificate of Registration - Sweden
Quality Document Search
Welcome to the Repligen Quality Document Search tool. This resource is designed to help you quickly locate the quality and compliance documents related to Repligen products and solutions. Whether you're looking for certificates of analysis, conformance or quality, or any other type of quality-related document, our search tool makes it easy. Simply enter the Lot Number information or Serial Number associated with your Repligen product or solution in the fields below.
Not sure which type of document you're looking for? Click here for a detailed list of the document types included in our search.
WEEE Directive 2012/19/EU + Battery Directive 2006/66/EC
Repligen Statement on WEEE Directive 2012/19/EU + Battery Directive 2006/66/EC
Electrical and electronic equipment (EEE) and batteries contain materials, components and substances that may be hazardous and present a risk to human health and the environment when waste electrical and electronic equipment (WEEE) and batteries are not handled correctly.
Electrical and electronic equipment and batteries are marked with the crossed-out wheelie bin symbol indicating that electrical and electronic equipment and batteries should not be disposed of in the regular household waste stream, but need to be collected separately. In case batteries contain more than 0,0005% mercury (Hg), 0,002% cadmium (Cd) or 0,004% lead (Pb) (by weight), the corresponding chemical symbol is displayed on the battery.
Users need to follow local recycling regulations to reduce adverse environmental impact in connection with disposal of WEEE and batteries and to increase opportunities for reuse, recycling, and recovery of WEEE and batteries. To facilitate this, free collection points may be available in your area or you can contact Repligen to organize collection. Users are responsible for removing personal data from electronic devices prior to disposal. If possible please remove old batteries or accumulators from the electronic device before you return it for recycling.
Repligen Product Take-Back
Please see below for European country-specific recycling options for products that are end of life. If local disposal options are not listed, please contact Repligen at [email protected]. Repligen will work with you to arrange for the environmentally sound treatment of the product.
Repligen is registered as a WEEE and battery producer with the Umweltbundesamt. Repligen fulfills its recycling obligations through membership of a WEEE producer compliance scheme and a battery producer compliance scheme.
WEEE Registration Number: 40893
Battery Registration Number: 40893
Information on the return and collection options for WEEE in Austria is available at: https://secure.umweltbundesamt.at/eras/registerabfrageEAGSammelstelleSearch.do?wfjs_enabled=true
Information on the return and collection options for batteries in Austria is available at: https://secure.umweltbundesamt.at/eras/registerabfrageBATSammelstellenSearch.do
Repligen is registered as a WEEE producer with the Dansk Producentansvar (DPA). Repligen fulfills its recycling obligations through membership of a WEEE producer compliance scheme.
Information on the return and collection options for WEEE in Denmark is available at: https://selfservice.dpa-system.dk/public/search?tab=collection-sites
Repligen is registered as a WEEE and battery producer with the Ademe (Syderep). Repligen fulfills its recycling obligations through membership of a WEEE producer compliance scheme and a battery producer compliance scheme.
Professional WEEE Ubique Identifier: FR043268_05TFKC
Portable batteries Ubique Identifier: FR043616_06SUNP
Information on the return and collection options for WEEE in France is available at: https://quefairedemesdechets.fr/
Information on the return and collection options for batteries in France is available at: https://www.batribox.fr/points-de-collecte/
Repligen is registered as a WEEE and battery producer with the Stiftung EAR. Repligen fulfills its recycling obligations through offering product take-back for professional products and through membership of a Household WEEE compliance scheme and battery producer compliance scheme. Household WEEE (i.e. tablets used to operate Repligen systems) and batteries can be returned at collection points.
WEEE Registration Number: 46315675
Battery Registration Number: 99743672
Information on the return and collection options for Household WEEE in Germany is available at: https://entsorgungsstellen.e-schrott-entsorgen.org/ and https://www.ear-system.de/ear-verzeichnis/sammel-und-ruecknahmestellen#no-back
Information on the return and collection options for batteries in Germany is available at: http://www.grs-batterien.de/verbraucher/mitmachen.html and https://www.stiftung-ear.de/de/startseite
Repligen is registered as a WEEE producer with the Irish EPA and as a WEEE and battery producer with The Producer Register Ltd (WRS-Blackbox). Repligen fulfills its recycling obligations through offering product take-back for professional products and through membership of a battery producer compliance scheme.
PRL Registration Number: 3540WB
Information on the return and collection options for batteries in Ireland is available at: https://www.weeeireland.ie/household-recycling/where-can-i-recycle/
Repligen is registered as a WEEE producer with the Ministero dell'Ambiento (Registro A.E.E.) and a battery producer with the Ministero dell'Ambiento (Registro Pile e Accumulatori). Repligen fulfills its recycling obligations through membership of a WEEE producer compliance scheme and a battery producer compliance scheme.
WEEE Registration Number: IT 21090000013292
Battery Registration Number: IT 21090P00007280
Information on the return and collection options for WEEE in Italy is available at: https://www.cdcraee.it/centri-di-raccolta-comunali/
Information on the return and collection options for batteries in Italy is available at: https://www.raccogliamopiupile.it/
Repligen is registered as a WEEE producer with the Nationaal WEEE Register. Repligen fulfills its recycling obligations through membership of a WEEE producer compliance scheme and a battery producer compliance scheme.
Information on the return and collection options for WEEE in the Netherlands is available at: https://inleverpunten.stichting-open.org/
Information on the return and collection options for batteries in the Netherlands is available at: https://www.legebatterijen.nl/inleveren/waar-inleveren/
Repligen is registered as a WEEE producer with the Registro de Aparatos Electricos y Electrónicos, as a battery producer with the Registro de Pilas y Acumuladores, and as a packaging producer with the Registro de Productores de Producto, Sección Envases. Repligen fulfills its recycling obligations through membership of a WEEE producer compliance scheme, a battery producer compliance scheme, and a packaging producer compliance scheme.
WEEE Número RII-AEE 7795 RD 110/2015
Battery Número REI-RPA 2321 RD 110/2015
Packaging Número RD1055 RPP ENVASES ENV/2023/000029866
Information on the return and collection options for WEEE in Spain is available at: https://punto-limpio.info/
Information on the return and collection options for batteries in Spain is available at: http://www.ofipilas.es/recogida-ciudadano_A.aspx
Repligen is registered as a WEEE producer with the Naturvårdsverket. Repligen fulfills its recycling obligations through membership of a WEEE Producer Compliance Scheme.
Information on the return and collection options for WEEE in Sweden is available at: https://www.sopor.nu/sortera-%C3%A5tervinn/elavfall/ and municipal locations here https://skr.se/tjanster/kommunerlandsting/kommunerlista.1246.html
Information on the return and collection options for batteries in Sweden is available at: https://sopor.nu/sortera-%C3%A5tervinn/elavfall/batterier/
Repligen is registered as a WEEE producer with the UK Environment Agency. Repligen fulfills its recycling obligations through offering product take-back for professional products.
WEEE Registration Number: WEE/AU5923XC
Quality Document Types
Explore quality document types for Repligen products, including certificates of analysis, conformance, and more.
- Certificates of Analysis
- Certificates of Conformance
- Certificates of Quality