A02-MECs-Scale-X Carbo Bioreactor.docx

Minimum Essential Characteristics Scale-X Carbo for Good Manufacturing Practice (GMP) Usage The scale-X™ carbo benchtop system must function in a way as to not disrupt ISO 8 clean room criteria.

Shall be an automated system suitable for adherent and suspension cell culture capable of supporting viral production Non-metallic product-contact surfaces, such as gaskets or elastomers, shall be constructed of USP Class VI materials and be suitable for the processing conditions. Materials shall not shed particles, or any contaminates that could contaminate the products or materials within the vessel Shall allow for readily-assembled sets of single use manifolds for complete fluid management Dimensions not to exceed (W x D x H) 800 × 300 × 500 mm / 31.5 x 11.8 x 19.7 in

High-density fixed-bed bioreactor Shall be single-use and support high cell density culture Shall support growth surface area from 10 m² - 30 m² Shall provide a homogeneous cell culture environment:

· Evenly compacted, structured fixed bed

· Impeller-driven agitation for fast mixing and flexible control of process parameters

Shall be capable of in-line product harvest Shall be capable of plug and play pre-assembled manifolds Shall be capable of automated and integrated process control delivering concentrated bulk harvest

Human-Machine Interface/Programmable Logic Controller (HMI/PLC)

Shall display real-time data

Shall provide a graphical interface that includes pictograms of the process, including valves, pump, agitators and all key parameters.

The system software and design shall be consistent with 21 CFR Part 11 requirements.

Shall ensure all devices on controller (valve, pumps, heaters) are brought into a safety position or stopped if a power failure is detected.

Shall ensure the workstation (laptop)will keep working on battery and the controller to switch off in the event of power failure and without an external UPS.

Process Control Bioreactors shall be capable of simultaneous controlled addition of up to three gasses (O2, CO2, Air) Max. Total gas flow of all three gases together shall be limited to 200 mL/min

Bioreactors shall be capable of introducing and controlling gas flow rates of air and O2 for dispersion in the growth medium

The bioreactors shall be capable of monitoring dissolved O2 via an autoclavable or single-use probe.

The bioreactors shall be capable of monitoring pH over the range of the process (0 – 14).

The system shall be capable of utilizing redundant probes that can be switched during the process

The system shall be capable of measuring the mass of the bioreactor contents for weight-based control

The system shall automatically monitor and control the media temperature with an operational control range of 32-37ºC.

Bioreactor temperature probe shall be capable of monitoring between 0 - 50 ºC, at a minimum.

The system shall meet the following Utility Requirements:

All gas supplies shall be capable of a flowrateup to 200ml/min@ 2 bar pressure