www.pendotech.com Tel: 609-802-1262

Adds automation and data collection to your processes n Complete batch control with pre-programmed recipesn Real time data output and graphing to MS Excel

No limitation on process scale

Ideal for many applications in biopharmaceutical processingn Concentration / diafiltration of proteins and virusesn Cell culture harvest and perfusion processesn Virus removal processes

Copyright © PendoTECH 2007 TFFSS-0

PendoTECH TFF Process Control& Data Acquisition System

A tangential flow filtration (TFF) or cross flow filtration process using a hollow fiber filter module (versus a plate & frame cassette flat sheet device) is represented in Figure 1.

Liquid is fed from a product vessel (or bioreactor) by a recirculation pump to a filter module containing numerous hollow fibers and the liquid flows into the inner cross section of the individual fibers.The wall of the hollow fiber is the filter membrane. As is shown in Figure 2, a certain amount of liquid and liquid components smaller than the pore size of the fiber wall “permeates” through the wall (the filtrate). The filtrate collects in the module shell and the shell has ports for removal of filtrate from the shell (the void area between the fibers is closed at both ends to prevent the liquid that is entering the filter module from going directly intothe shell). The feed pressure (PIN) is higher than the return pressure in (POUT) because of the pressure drop as liquid

TFF/Cross Flow Filtration

Product Information

flows through the narrow fibers and returns to the vessel. There is also a pressure drop across the fiber wall and the filtrate pressure is measured at PF. Monitoring of these pressures is critical to measure process performance and for process control. The cross flow rate is orders of magnitude above the filtrate flow rate and it is this phenomena that prevents a membrane filter from clogging from material that would rapidly clog a membrane filter operating in “normal flow” filtration. In flat sheet devices, even though the geometry of the device is different, the operation of the process is similar. TFF is a very effective process selection in many areas of biopharmaceutical processing. Depending on the process, a filtrate pump may be used to limit the filtrate flow and prevent rapid filter fouling. A throttling valve may be used on the retentate tube to create back pressure to drive liquid through the membrane. In a TFF process, as filtrate is removed, the vessel contents are concentrated. In a diafiltration process, liquid is added to the product vessel as the same rate of filtrate removal.

Figure 2

Figure 1

www.pendotech.com Tel: 609-802-1262 Copyright © PendoTECH 2007 TFFSS-0

Recipe based control - Recipe based control of concen-tration and diafiltration process steps with multiple options for automated diafiltration end point (filtrate weight, conductivity, pH, air in feed line, total flow)No limitation of process scale - Process control by integration of industry standard scales and pumps of all sizes; disposable pressure sensors are available for up to a 1 inch ID flow pathData acquisition - Real-time data output to Excel for both data recording and graphingAlarms - User defined alarm set-points for pressure, TMP, pH, conductivity and time that will shut down the system

Analytical measurements - available with optional conductivity and pH probe inputs with integral conductivity / temperature monitorFiltrate flow meter - available for real time filtrate flow measurement and flux calculationCustomizable system - Other input and output options to create a custom system such as additional analytical inputs and external valve control.Easy set-up and operation - System comes with required interface cables and components for setup - either scales and pumps can be supplied with the system, or existing equipment can be used.

TFF Process Control System Highlights

Detail Specifications

Enclosure Material Aluminum

Optional Conductivity Input 4 wire input (2 wires for 100 ohm Pt RTD)

Enclosure Dimensions (hxwxd) 4.8”x13.8”x10.3” (12.2x35.1x26.3 cm)

Pump Control Speed control: 0-20mA or 0-10V outputStart/Stop: Relay 3 - 48VDC, up to 3A continuous

Digital input with 5V supplyAir Detector Input

Flow Meter Input Digital pulse input with 5V supply

Other 0-20mA or 0-10V inputs/outputs; relaysSpare Inputs / Outputs

Enclosure Weight 5 lbs. (2.3 kg)

PendoTECH Single Use Sensors (-7 to 75 psi)

Standard probe input via BNC connectorOptional pH Input

Pressure Sensor Inputs*

100-240 Volts, 50-60 Hertz, 2 amp maxPower Requirements

*12 foot cable included, other sensors / transducers optional

The control system interfaces with standard process equipment and components such as shown in Figure 3 below. Cables are configured specifically for existing pumps or pumps can be supplied with the system. Standard scale data output cables can be connected to the system. Process pressures are measured in-line with data displayed on the control system. The weight and pressure data are monitored continuously and this along with complete pump control, allow automation of concentration and diafiltration processes and automatic shut-down if an alarm condition occurs.

System Overview

Feed Pump

Flow

Flow

Filter

Scale

Scale

Data

Filtrate Pump

Flow Flow

Pressure Sensor

Buffer Container

Cross Flow

Cross FlowCrossFlow

CirculationPump

Pressure Sensor

Pressure Sensor

Probes: pH, conductivity,

etc.

FlowMeter

Filtrate Container

Real TimeData

Collection

Figure 3

PDKT-PCS-TFF

PDKT-PCS-TFP

TFF Control System with pressure sensor and pump cables

With pH probe input with software for 2-point calibration on system

PDKT-PCS-TFC With input to conductivity transmitter with temperature compensation and calibration

PDKT-PCS-TFB With pH and conductivity input

Part Number Description

Control System Back Panel with Input/Output Connections