Bioprocessing Systems
Installation & Qualification Services


Seamless system integration

We understand the pressure you face to get your systems up and running as quickly as possible, while ensuring all regulatory requirements are met. Through our offering of installation and qualification services, our experienced engineers will partner with you to ensure your equipment is installed, qualified and operational to your requirements – and those of regulators.

Our engineers have unique and intimate knowledge of our systems. Together, with your process expertise, they can install and qualify your system with the highest level of efficiency.  

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Factory Acceptance Testing (FAT)
The first step in your system’s service journey is making sure it is fully-tested for compliance with your technical and functional specifications – before it leaves the factory. This extensive testing off-site helps to ensure quick and easy acceptance once the system arrives at your site.
 
Site Acceptance Testing (SAT)
After your system has been tested at the factory, it makes its way to you. Once it arrives, our engineers will work with you to perform a site acceptance test to ensure that the system’s performance and functionality was not impacted by the transport and installation on site. Enjoy peace of mind, knowing that your system will deliver high performance at every step of your process.
Installation Qualification and Operational Qualification (IQ/OQ)
Once the system has been site accepted, the IQ/OQ is performed. This step is critical in ensuring that your system is fully operational to your exact specifications, and that operation is documented and compliant with all pharmaceutical regulatory requirements.
Performance Qualification (PQ)
The last step in the process is to ensure that the system functions as intended, for your specific process. During our Performance Qualification (PQ), a trained biomanufacturing engineer will prepare the equipment and support both an engineering run and an actual run of your process recipe, giving you the confidence you need to fully qualify and implement your new system.

These services are available as either a stand-alone service or a combination service package depending on your system.
SAT onlyIQ/OQ onlySAT/IQ/OQ Combo
Cogent® μScale TFF System
Cogent® M1 TFF System
Cogent® Labscale TFF System
Cogent® Process-Scale TFF System
Mobius® FlexReady Solution for Buffer and Media Preparation
Mobius® FlexReady Solution for Clarification (CL-2 and CL-3)
Mobius® FlexReady Solution for Virus Filtration (VF-2, VF-3)
Mobius® FlexReady Solution for Chromatography
Mobius® FlexReady Solution for TFF
Mobius® 50L Bioreactor
Mobius® 200L Bioreactor
Mobius® 1000L Bioreactor
Mobius® 2000L Bioreactor
Mobius® MIX
Mobius® Power MIX
IsoPak™ Chromatography Process Columns
QuikScale® Chromatography Columns
Vantage™ Chromatography Columns
CoPrime® Biochromatography Process Scale System
Pod Filter Holders
Viresolve® Magnus Holder
Integritest® 5
Buffer Dilution System


Support & Sales
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