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Specifications

General

Dimensions   53” W  x  31” D  x  33” H (65” height with cart)

Flow Rate Range
Option 1: 0.3 ml/min to 240 ml/min (low flow pump)
Option 2: 1.3 ml/min to 1.7 L/min (high flow pump)

Tubing Diameters Accepted  1/16”, 1/8”, 3/16”, 1/4”

Pressure Limit  4 bar (58 psi)

Equipment 4 buffer pumps, 4 product pumps, 20 pinch valves, and 20 buffer inlet valves

PurSync Automation Control Package
Synchronous operation of four sequential purification stages per system, and up to four systems in series.

  • Control schemes for low pH viral inactivation, TFF for single pass concentration and diafiltration, viral and other filtration, and chromatography.
  • Inline buffer adjustment based on pH, conductivity, or volumetric ratio on inlet and outlet of purification stages. Pressure control for each purification stage.
  • Automated startup and shutdown, including priming, sanitization, equilibration, and storage.

Materials of Construction
Polycarbonate vessel and polypropylene tubing manifolds with fused silica windows

Instrument

Pressure 60 psi max (qty. 8)

UV Sensors Any two specified wavelengths from 185nm to 2600nm (qty. 4)

pH range 0 to 14 (qty. 8 max)

Conductivity Range and Accuracy  0.02 mS/cm to 500 mS/cm (qty. 8 max)

Flow Meter  Choice of mass flow meters or ultrasonic flow meters (qty. 8 max)

Scales  Floor scales with 450kg capacity (qty. 0-2), bench scales with 10kg capacity (qty. 4-6)

Other

Electrical Requirements   120 VAC, 20A

Required Air Supply   90 psi

PLC   Rockwell CompactLogix™ 5480

21 CFR Part 11 Compliant Automation

System Sizing

Purification of 50 L Cell Culture per Day1 (250 g mAb / day)

Low pH VIFiltrationPolish ChromUFDF
Product Flow Rate~10 ml/min~10 ml/min~10 ml/min~10 ml/min
Buffer Flow Rate1 to 2 ml/min1 to 2 ml/min~50 ml/min~10 ml/min
Product Tubing Diameter1/8"1/8"1/8"1/8"
Buffer Tubing Diameter1/16"1/16"1/8"1/8"
Vessel Volume0.2 L0.2 L5 L0.2 L

Purification of 500 L Cell Culture per Day1 (2,500 g mAb / day)

Low pH VIFiltrationPolish ChromUFDF
Product Flow Rate~100 ml/min~100 ml/min~100 ml/min~100 ml/min
Buffer Flow Rate10 to 20 ml/min10 to 20 ml/min~500 ml/min~100 ml/min
Product Tubing Diameter1/4"1/4"1/4"1/4"
Buffer Tubing Diameter1/8"1/8"1/4"1/4"
Vessel Volume2 L2 L50 L2 L
1 Assumes 5 g/L cell culture media with 3.5X concentration factor over first capture step.

Purification of 5,000 L Cell Culture per Day (25,000 g mAb / day) | Commerical Scale System

Low pH VIFiltrationPolish ChromUFDF
Product Flow Rate~1 L/min~1 L/min~1 L/min~1 L/min
Buffer Flow Rate100 to 200 ml/min100 to 200 ml/min~5 L/min~1 L/min
Product Tubing Diameter1/2"1/2"1/2"1/2"
Buffer Tubing Diameter1/4"1/4"1/2"1/2"
Vessel Volume20 L20 L500 L20 L

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