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View additional product information for Tube Clamps compatible with CTS™ Rotea™ Single-Use Kit - FAQs (A49127)
40 product FAQs found
The Rotea Protocol Builder Software, which includes the Rotea Process Model and Simulator, is available for download from the Rotea website. Common cell types are already pre-loaded into the software, and custom cells can also be created. The CTS Rotea System can separate cells that have at least 4 µm difference in diameter. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs. Please visit our webpage (www.thermofisher.com/rotea) to see if the CTS Rotea System will work for your cell type, or submit a request for more information using our demo form (https://www.thermofisher.com/us/en/home/global/forms/life-science/rotea-counterflow-centrifugation-system-cell-therapy.html) to get connected with a Business Development Manager.
Thermo Fisher Scientific strives to provide a catalog of tools to support our diverse customers' needs. If magnetic bead separation using the CTS Rotea System is of interest, Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
Ficoll medium has many shortcomings and often does not scale well for cGMP manufacturing. Rotea PBMC isolation protocol takes less time and has been demonstrated to be capable of providing higher cell recovery compared to Ficoll medium. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The CTS Rotea single-use kits are manufactured with DEHP-free PVC. Extractables and Leechables testing was conducted with 20% DMSO for up to 15 min. The CTS Rotea System has not been validated for fill-finish applications. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The CTS Rotea System has been demonstrated to be capable of washing cells from cryoprotectant into media and the reverse. The CTS Rotea System has not been validated for fill-finish applications. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs
The CTS Rotea System has been demonstrated to be capable of processing whole blood and buffy coat input samples. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The CTS Rotea System has been demonstrated to be capable of processing thawed leukapheresis products. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The CTS Rotea System has been demonstrated to be capable of working with a range of cell types. For more information, see the Rotea Application note "Rapid dissociation of PSC spheroids in a closed environment using the CTS Rotea system" (http://assets.thermofisher.com/TFS-Assets/BID/Application-Notes/rapid-dissociation-psc-spheroids-cts-rotea-system-app-note.pdf). Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The CTS Rotea System has been demonstrated to be capable of virus clarification. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The CTS Rotea System has been connected to incubators, bioreactors, and cell factories as part of a closed system. In order to connect to cell factories, off-the-shelf PVC-Cflex adaptors may be required. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
Counterflow centrifugation technology has a range of applications. The CTS Rotea System has been demonstrated to be capable of processing bead diameters ranging from 5 µm-400 µm. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The CTS Rotea System has been demonstrated to be capable of >90% cell recovery and viability over multiple runs. See the Rotea Application note for more info: Automated PBMC isolation and T cell washing and concentration by the CTS Rotea centrifugation system (https://assets.thermofisher.com/TFS-Assets/BID/Application-Notes/automated-pbmc-isolation-t-cell-wash-concentration-cts-rotea-system-app-note.pdf). Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The CTS Rotea System is manufactured in an ISO13485 certified facility, and the CTS Rotea single-use kits are manufactured in a class 7 clean room. The CTS Rotea System software has operator and administrator modes for manufacturing. Thermo Fisher Scientific also offers additional software options to enable customers' 21 CFR Part 11 requirement goals. The official product use statement is "For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products."
Thermo Fisher Scientific is invested in the success of each CTS Rotea System customer and provides support throughout the instrument buying experience. A live-cell demo is performed with the CTS Rotea System for the customer's evaluation. Thermo Fisher Scientific provides initial equipment and software training by trained Field Application Scientists (FAS). Post-sale, remote and field support teams are available for further customer assistance.
The CTS Rotea System is compatible with sterile welded sample ports for process control.
The CTS Rotea System (and single-use kits) is considered as manufacturing equipment, not a medical device. Therefore, instead of a Drug Master File, a Regulatory Support File (RSF), which includes Quality information such as details on tests performed and validation data, is available.
Yes, Extractables and Leachables studies were performed on the CTS Rotea single-use kits and are available in the CTS Rotea Regulatory Support File (RSF).
As the CTS Rotea System is a peristaltic pump operated instrument, there is no technical limit for input volume. Rather, the primary consideration is the total processing time and sample sensitivity. The CTS Rotea System can process 20 L in approximately 8 hrs, which is why the "recommended" input volume maximum is 20 L. Therefore, 5 CTS Rotea systems arranged in parallel would be required to process 100 L in a day. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The entire fluid path on the CTS Rotea single-use kit was evaluated for regulatory requirements, including testing for biocompatibility, endotoxins, extractables, and more. These test results are provided in the CTS Rotea Regulatory Support File (RSF).
All CTS Rotea single-use kits, Luer connectors, and sample port accessories are gamma-irradiated. Pass-fail criteria are provided on the Certificate of Analysis.
Depending on the chosen settings, the volume reduction processing time for 1 L down to 5 mL can be as low as 20 mins with the CTS Rotea System.
If the pathogenic setting changes the target cell density or size, the g-force may need to be re-optimized. One of the unique advantages of the CTS Rotea System is the CellCam that allows users to visualize the cells in the cone and modify the counterflow centrifuge parameters live during a protocol step. The CellCam allows the user to optimize the g-force parameters with direct feedback on how the cells are responding. If the pathogenic settings do not change the cell density or size, then there may be no need to modify the counterflow centrifuge parameters. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
Counterflow centrifugation physics are based on density, which generally trends with cell diameter. The CTS Rotea System is capable of separating dead cells from healthy cells due to the reduced cell density of dead cells. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The output concentration range is 5-300 x 10E6 cells/mL. The output volume is customizable due to the peristaltic pump; the minimum achievable output volume is 5 mL. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The Rotea System was designed and tested in room temperature (RT) conditions (minimum recommended temperature: 59 degrees F/15 degrees C). Considerations for operating the Rotea System in a cold room are as follows:
-Hardening of tubing due to lower temperature
-Negative impact on bubble sensor detection
-Negative impact on moisture sensor detection
-Risk of condensation in internal parts
When connecting to the CTS Rotea single-use kits, here are the PVC tubing dimensions to consider:
- 0.160 inches OD (outer diameter)
- 0.116 inches ID (inner diameter)
DEHP-free PVC was chosen as the tubing material of choice due to the historical data from being used in the blood banking industry. DEHP-free PVC is widely used and compatible with industry standard tube welder products.
Calibration of the peristaltic pump is recommended for the CTS Rotea System to ensure optimal flow rate performance. Users can calibrate the peristaltic pump as needed using the Rotea GUI software. Annual Planned Maintenance services with Thermo Fisher Scientific's Global Service and Support team are also recommended for proactive support of customers' CTS Rotea Systems.
Yes, this can be done through elutriation. The CTS Rotea System can separate dead cells which are smaller and less dense than healthy cells. Through this process, the CTS Rotea System is able to create a new population of healthy cells, effectively increasing the cell viability. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
Platelet removal is very easy using the CTS Rotea System and happens during the loading step of the Leukopak when the PBMCs are being collected in the chamber. Platelets, due to their smaller size, are elutriated as other cells are concentrated in the cone.
RBCs can be partially removed with the CTS Rotea System through modifying the flow rate and g-force. For complete RBC removal, the use of lysis buffer is recommended. Lysis buffer is effective in eliminating RBCs during Leukopak processing, while maintaining >90% cell recovery for target cells. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
Yes, but this would depend on the cell type/size, concentration, and supernatant. This would be a typical concentration step except that the supernatant would be collected and the cells would be concentrated and removed. Concentrated cells can be outputted with very little carryover. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The CTS Rotea instrument itself is not 21 CFR Part 11-compliant as it does not store any data that requires the compliance. To enable customers seeking 21 CFR Part 11 compliance, Thermo Fisher Scientific is developing Rotea SAE and Cellmation software options to provide additional security, auditing, and e-signature functionality. Additionally, the CTS Rotea System can be connected to a Laboratory Information Management System (LIMS) or Manufacturing Execution System (MES) via an OPC-UA interface to meet customers' site needs.
The Rotea single-use kit's CFC chamber capacity is 10 mL and can hold up to 5 x 10E9 T-cells. For larger cells, the capacity would be slightly lower. When processing greater than 5 x 10E9 cells, the chamber can be filled and emptied in loops. For example, 4 loops would process 20 x 10E9 cells. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
It depends on the cell type/size. The processing speed is dependent on the size of the cells being concentrated but typically would be between 50 mL/min (for smaller cells) and 120 mL/min (for larger cells). The chamber may need to be emptied 10-20 times depending on the number of cells in the media. This means that a 20 L batch could take from 3-6 hours to process with a single CTS Rotea System. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The CTS Rotea System's counterflow centrifuge technology is extremely gentle on cells, due to low shear forces exerted on cells. It is capable of flow rates of 5-160 mL/min. Higher flow rates generate greater shear force, which translates to additional stress on the cells. Each cell type is different in its sensitivity to shear stress, which is why process optimization is so important to each CTS Rotea System user. Generally speaking, higher flow rates are inversely proportional to cell recovery. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
We recommend the Standard single-use kit for all first-time CTS Rotea System users. The flow rate range of 5-110 mL/min is the ideal processing speed for smaller cells (<15 µm). On the other hand, the Hi-Flow single-use kit is capable of flow rates of 30-160 mL/min, which may be more suitable for hardier cells or applications where >90% cell recovery is not required. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The CTS Rotea System is capable of generating a maximum of 3,000 g. The maximum g-force is measured at the tip of the cone. It is important to note that the Rotea System does not pellet cells in the cone, rather cells are suspended in a fluidized bed during centrifugation.
The maximum flow rate is dictated by the type of single-use kit being used. The Standard kit flow rate range is 5-110 mL/min and the Hi-Flow kit flow rate range is 30-160 mL/min. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The recommended input volume range is 50 mL - 20 L and the recommended input concentration range is 0.2 M to 20 M cells/mL. If the input material is very concentrated, it may require dilution prior to processing with the CTS Rotea System. A very dilute input may require a longer time for establishing a fluidized bed of 5 x 10E7 cells. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
A minimum of 5 x 10E7 cells is required to form a fluidized bed, which is required for concentration, separation, and buffer exchange. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.
The CTS Rotea System is generally agnostic to cell type and can concentrate cells/beads/aggregates from 5-300 µm in diameter. Cells smaller than 5 µm are too small to be concentrated, but can be separated through elutriation from target cells. Preliminary studies have shown that the CTS Rotea System is capable of processing aggregates, 100-300 µm in diameter. Thermo Fisher Scientific recommends that customers use protocol optimization and workflow validation testing to meet their process needs.