Expedited Qualification

Xcellerex provides Expedited Qualification of Systems (EQS) with all XDR bioreactors to accelerate integration, commissioning, and validation. Our bioreactors and related process equipment arrive at your facility with the following work completed and documented:

Scope:

Full detailed specification package

Factory Acceptance Test protocols and reports

Operating and Maintenance Manuals

Standard Operating Procedures as templates for your use in developing your own SOPs

Training records for your operators

Executed IQ/OQ Protocols

Execution:

Design, build and commission your systems with Xcellerex Engineering at Xcellerex' facility

Operate your equipment with your operators through qualification, training and as an option, engineering runs

Refine the operational features and functionality to meet your operating requirements

Transfer the equipment to your facility, prepared on a parallel timeline with the equipment

Objectives and Benefits:

Reduced qualification required at your facility to reach GMP manufacturing capability

Assurance that the system you require for operational excellence is the system that is delivered

Zero impact on your facility during commissioning, training and initial qualification activities

Because the Xcellerex team regularly validates systems for our own use, we can help to smooth the process of integrating XDR systems into your facility.