scipure 200 automated single use TFF system with weighstationThe 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
  • Bio-Manufacturing

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

  1. Integrates Three core areas of SciLog expertise:
    • Single-Use Sensors,
    • Gamma Irradiated Single-Use Manifolds,
    • Single-Use Bio-Purification Platforms.
  2. Automated concentration and diafiltration of biopharmaceutical solutions.
  3. 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.

ETL, RoHS, WEEE, CSA

SciPure 200 Product Information

SciPure Models & Specs
Part Numbers: 900-200-7 900-200-7 HF 900-200-8 900-200-8 HF
Foot Print 30" x 48.5" 30" x 48.5" 30" x 48.5" 30" x 48.5"
Single Use Yes Yes Yes Yes
Flow Range (L/min) 0.25-8 0.5-16 1-20 1-40
Recommended Pump Head Piston, Cam Profile 1 Piston, Cam Profile 2 Peristaltic Peristaltic
Recommended Membrane Area (m2) 0.1-1.5 0.1-2.5(5) 0.1-2.5(5) 1-5
Filter Type Flat Sheet Flat Sheet Flat Sheet Flat Sheet
Flow Path Flex Tubing, Single-Use Flex Tubing, Single-Use Flex Tubing, Single-Use Flex Tubing, Single-Use
Typical Hold-up Volume < 500 mL < 500 mL < 500 mL < 600 mL
High Pressure Limit 60 PSI 60 PSI 30 PSI 30 PSI
Pressure Measurement 3 Sensors Included 3 Sensors Included 3 Sensors Included 3 Sensors Included
Automated TMP Pressure Control 1 No No No No
Automated TMP Pressure Control 2 Yes Yes Yes Yes
Optimized for Microfiltration No No Yes Yes
Conductivity Measurement 2 Sensor Included 2 Sensor Included 2 Sensor Included 2 Sensor Included
Temperature Measurement 2 Sensor Included 2 Sensor Included 2 Sensor Included 2 Sensor Included
Inlet Pump Manufacturer Quattro Quattro Watson Marlow Watson Marlow
Inlet Pump Model 1200SU - 3° Cam 1200SU - 5° Cam 701RE 701RE Duplex
Diafiltration Pump Manufacturer Watson Marlow Watson Marlow Watson Marlow Watson Marlow
Diafiltration Pump Model 620R 620R 620R 620R
Permeate Pump Manufacturer Watson Marlow Watson Marlow Watson Marlow Watson Marlow
Permeate Pump Model 620RE4 (Optional) 620RE4 (Optional) 620RE4 (Optional) 620RE4 (Optional)
Integrated Diafiltration Pump Yes Yes Yes Yes
Permeate Flow Meter Option Option Option Option
Permeate Flow Control Yes, Option Yes, Option Yes, Option Yes, Option
Inlet Flow Control Yes Yes Yes Yes
Total # of Automated Valves (Standard) 1 1 1 1
Diafiltration Pump Solution Access (Option) 2 2 2 2
Concentration Mode Yes Yes Yes Yes
Diafiltration Mode Yes Yes Yes Yes
Manual Mode Yes Yes Yes Yes
Fill Mode Yes Yes Yes Yes
NWP Mode Yes Yes Yes Yes
Batch Mode (ex. Conc, Diafil, Conc) Yes Yes Yes Yes
Parameters Collected/Displayed 28+ 28+ 28+ 28+
User-Definable System Alarms Yes Yes Yes Yes
Color, Touch Screen HMI Yes, 19" Yes, 19" Yes, 19" Yes, 19"
Stack Light Status Indicator Yes Yes Yes Yes
Multiple User Accounts Yes Yes Yes Yes
Multiple Permission Levels Yes Yes Yes Yes
Multiple Recipe Storage Yes Yes Yes Yes
On-Board Data Collection Yes, 40 GB Yes, 40 GB Yes, 40 GB Yes, 40 GB
On-Board Trending Yes Yes Yes Yes
GMP Compliance Yes Yes Yes Yes
DeltaV Software Option, Available Yes Yes Yes Yes
OPC Software Option, Available Yes Yes Yes Yes
SciLog Multiplexing System Option Available
Input Voltage 208 1P US, 208 3P US, 240 1P EU, 480V 3P US
Current Required 20AMP
Pneumatic Requirements 85PSI Dry, Clean Air or Nitrogen

 

1 Method 1 - Via Rate Manipulation

2 Method 2 - Via Proportional Control Valve in Retentate Line