The Role of Single Use…
The bioprocessing industry is an ever expanding consumer of cutting edge technology to produce the next blockbuster product. SciLog’s goal has been to produce systems that minimize the risk and time for customers to develop discovery product, clinical trials, and manufacturing processes. SciLog began its efforts with Single Use sensors (pressures, conductivity, and temperature) which lead to new automation methods and manifolds. This trifecta has lead into a synergy called the SciPure 200.
The SciPure 200 is a Single-Use bioprocessing platform for the automation, optimization, and documentation of TFF Applications. The system has been designed to meet cGMP and 21 CFR Part 11 standards for data-collection and security as a standalone device. The SciPure 200 is ideal for:
- Product Development
- Process Development
Via a color HMI touch screen and pre-installed software, built on a robust framework, users have the ability to create and execute discrete or batch operations for filling, concentration, diafiltration, normalized water permeability (NWP). User-selectable end points and alarms enable hands-free operation and ensure safe, consistent process performance. The patented proprietary technology enables the SciPure 200 system to respond to sensor feedback and thus maintain the user-defined flows and transmembrane pressure (TMP) simultaneously. All wetted flow-path manifold components of the SciPure 200 are considered Single-Use consumables.
SciPure 200 Advantage - Automated TFF
- Integrates Three core areas of SciLog expertise:
- Single-Use Sensors,
- Gamma Irradiated Single-Use Manifolds,
- Single-Use Bio-Purification Platforms.
- Automated concentration and diafiltration of biopharmaceutical solutions.
- Automated, comprehensive documentation of all TFF process parameters, optional real-time historic access to that documentation via OPC to parent control systems (SCADA).
SciPure 200: Administration, Documentation & Ease of Use
Administrative users have complete control over user creation and passwords, alarm points, access permissions, log file exports, recipe creation and modification as well as process variables. The SciPure 200 software maintains detailed logs for all parameters and system events for all users. On-board documentation and exported process files are 21 CFR Part 11 compliant. OPC and DeltaV are available options.
SCADA, DCS Disposable TFF System
The engineering team at SciLog has developed a hardware / software configuration that utilizes all of the capabilities of a traditional SciPure system with the communication ability to connect to any parent control system or data historian. Remote control or monitoring is accomplished through an optional OPC DA or OPC HDA connection. The customer/integrator has the choice to use SciLog’s SciSoft TFF purification software or use the system as a SmartPump.
Whether seeking to add to an existing parent control system deployment or initiating a new deployment, SciLog will work with you to accelerate your deployment and assist in determining your licensing needs. This in turn, delivers powerful automation at an affordable price point.