BioBLU^® c HNQ Single-Use Bioreactors

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BioBLU c HNQ Single-Use Bioreactors are rigid- walled stirred-tank bioreactors for the cultivation of human and animal cells. They are suitable for use in clinical and commercial manufacturing.
The scalable BioBLU c HNQ portfolio enables for a more than 100-fold cell expansion (working volume range of 320 mL – 40 L).

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Caratteristiche

HNQ stands for Harmonized for Next-Generation Quality, highlighting our commitment to delivering products that carry harmonized certificates and Validation Guide documents. The BioBLU HNQ series represents a leap forward in customer facing quality documentation, supporting our customers' equipment qualification and process validation activities.

The BioBLU c HNQ Single-Use Bioreactors for cell culture applications at a glance:

BioBLU c HNQ Single-Use Bioreactors: For the scalable cultivation of mammalian and insect cells in suspension, on microcarriers, or as cell aggregates. BioBLU c HNQ Single-Use Bioreactors are available in different sizes for more than 100-fold scalability.
• BioBLU 1c HNQ (working volume 320 mL – 1,25 L)
• BioBLU 3c HNQ (working volume 1.25 – 3.75 L)
• BioBLU 10c HNQ (working volume 3.3 L – 10 L)
• BioBLU 50c HNQ (working volume 18 – 40 L)

BioBLU 5p HNQ Single-Use Bioreactor: For the cultivation of adherent cells and for perfusion processes in a fixed working volume of 3.75 L. This packed-bed bioreactor is preloaded with Fibra-Cel^® Disks, a solid growth support matrix.

Suitable for use in clinical and commercial manufacturing
• BioBLU HNQ Single-Use Bioreactors are available with LOT-speciﬁc Validation Guide, irradiation certiﬁcate, and the sterile- and endotoxin test report.
• We offer a uniﬁed solution package of bioprocess controllers, bioreactors, bioprocess SCADA software, and services that together support compliance of bioprocesses with GMP requirements.

Warning! Not approved for applications in medical diagnostics or therapy! The single-use vessel has not been developed for applications in medical diagnostics or therapy. It is not medical equipment within the meaning of Regulation (EU) 2017/745. Do not use the single-use vessel for medical or therapeutic applications.

Bioreactor body and head plate

• Dimensions: Standard bioreactor dimensions and impeller size of the BioBLU c Single-Use Bioreactors allow efficient mixing and mass transfer, and scalable results.
• Equipment: BioBLU Single-Use Bioreactors are assembled with sparger, overlay, gas filters for inlet and exhaust as well as penetrations for pH, DO, and temperature sensors, liquid additions, sampling, and harvest. All head plate ports are clearly marked for ease of use. Spare Pg 13.5 ports can be equipped with single-use septa, tri-ports and compression fitting adaptors for more flexibility.
• Tubing: Weldable and easy to connect tubing offer in-field flexibility and ease of use.
• Motor: Sealed magnetic drive with fully enclosed bearings maintains vessel sterility.
• Exhaust Treatment: Effective liquid-free exhaust condensation (Peltier) or electric heater band.
• Sterilization: BioBLU c HNQ Single-Use Bioreactors are delivered sterile. Irradiated by > 25 kGy (X-ray). SAL-level 10^-6 for X-ray irradiated BioBLU Single-Use Bioreactors.

Impellers designed for cell culture applications

• All BioBLU c HNQ bioreactor sizes are available with pitched-blade impellers for cell culture applications.
• BioBLU 5p HNQ bioreactors are equipped with the Eppendorf-exclusive packed-bed impeller, pre-loaded with Fibra-Cel Disks.

Non-invasive sensor technology reduces the contamination risk

• Temperature: The temperature sensor is inserted into the thermowell (RTD port) allowing non-invasive temperature measurement.
• Dissolved oxygen (DO): The gas-permeable membrane of the DO sensor port prevents direct contact of the sensor with the culture medium.
• pH: BioBLU c HNQ Single-Use Bioreactors are equipped with non-invasive optical pH sensing technology from PreSens^®. Eppendorf provides optical pH modules for the use of optical pH measurement on bioprocess control systems that are not equipped with this technology. The bioreactors can be equipped with standard pH sensors as well.