Technology & Documentation
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 VI | Filtration | Polish Chrom | UFDF | |
---|---|---|---|---|
Product Flow Rate | ~10 ml/min | ~10 ml/min | ~10 ml/min | ~10 ml/min |
Buffer Flow Rate | 1 to 2 ml/min | 1 to 2 ml/min | ~50 ml/min | ~10 ml/min |
Product Tubing Diameter | 1/8" | 1/8" | 1/8" | 1/8" |
Buffer Tubing Diameter | 1/16" | 1/16" | 1/8" | 1/8" |
Vessel Volume | 0.2 L | 0.2 L | 5 L | 0.2 L |
Purification of 500 L Cell Culture per Day1 (2,500 g mAb / day)
Low pH VI | Filtration | Polish Chrom | UFDF | |
---|---|---|---|---|
Product Flow Rate | ~100 ml/min | ~100 ml/min | ~100 ml/min | ~100 ml/min |
Buffer Flow Rate | 10 to 20 ml/min | 10 to 20 ml/min | ~500 ml/min | ~100 ml/min |
Product Tubing Diameter | 1/4" | 1/4" | 1/4" | 1/4" |
Buffer Tubing Diameter | 1/8" | 1/8" | 1/4" | 1/4" |
Vessel Volume | 2 L | 2 L | 50 L | 2 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 VI | Filtration | Polish Chrom | UFDF | |
---|---|---|---|---|
Product Flow Rate | ~1 L/min | ~1 L/min | ~1 L/min | ~1 L/min |
Buffer Flow Rate | 100 to 200 ml/min | 100 to 200 ml/min | ~5 L/min | ~1 L/min |
Product Tubing Diameter | 1/2" | 1/2" | 1/2" | 1/2" |
Buffer Tubing Diameter | 1/4" | 1/4" | 1/2" | 1/2" |
Vessel Volume | 20 L | 20 L | 500 L | 20 L |
NOW AVAILABLE Pilot Scale PAK System
Demo, lease or purchase The PAK System continuous manufacturing equipment. Receive your custom quote now.
Request quote