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Get to know The PAK System

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
Flow Kit: Nylon 12 with fused silica windows    |  Product contact materials meet USP Class VI and/or ISO 10993.

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)

Mass Flow Meter  20 g/min to 1500 g/min with density reading (qty. 2)

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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