Ksep® Systems

Scalable Single-Use Centrifugation Systems

Sartorius patented Ksep® technology is the only current technology that provides significant advantages for users that want to either harvest cells as product or separate cells and debris-free media that contains the product.

Through the balance of centrifugal and fluid flow forces, the Ksep® retains particles, such as cells or microcarriers, as a concentrated fluidized bed under a continuous flow of media or buffer. Ksep® systems are currently being used by top biopharmaceutical companies for diverse bioprocessing applications.

Our current offerings include three models, designed to handle low to very high cell densities and with built-in scalability ranging from 0.1 L to 2000 L. Our high-quality, disposable sets are manufactured using class VI materials and gamma irradiated.

Ksep® Benefits

  • Simple, robust, and scalable centrifugation process with low shear stress
  • Closed system with class VI Gamma irradiated single-use consumables
  • Integrates and/or reduces processing steps and time
  • Very high product recovery (in both Ksep® modalities)
  • Increased product quality in harvest

Our Applications

  • Harvest | Clarification
  • Cell Therapy
  • Vaccine Manufacturing
  • Blood Processing

Functional Principle

The Ksep® Advantages

Bioprocessing

  • Integrates and/or reduces processing steps and time
  • Improves recoveries of both solids and liquids
  • Provides option to selectively remove small particulate impurities, e.g. plastic generated, cell debris
  • Built-in scalability (4-6 fold) for development and manufacturing using the same system
  • Automated with option to run in complete manual mode
  • No hardware change for different applications
  • Handles low to high cell density cultures (0.5 to 150 million cells/mL) equally well
  • Complete supernatant product recovery from slurry

cGMP Manufacturing

  • Closed system with single-use class VI product contact surfaces
  • Simple, robust, and scalable
  • One software for all systems
  • Clog-free and continuous operation

Advanced Cell Handling

  • Imparts low shear on cells and keeps the cells intact
  • Maintains a healthy environment to sustain cell viability
  • Reduces intracellular protein contamination for harvest applications by keeping the cells intact


Our Products

We offer two systems for development and manufacturing. Each system has built-in scalability and is capable of running multiple applications. Both systems are fully-automated (with the option to run manually), robust, simple, and scalable. The system can be operated under sterile conditions and all consumables are delivered pre-sterilized.

All product contact surfaces are composed of Class VI materials. We also provide support for IQ/OQ as per your requirements.

Ordering InformationKsep®400Ksep®6000S
Max g-force

1000 g

2000 g

Max flow rate

114 L/hr

720 L/hr

Volume

400 mL (4x100mL)

6000 mL (6x1000mL)

Cell capacity per cycle

1-80 Billion cells

10-1200 Billion

Processing volumes

10 L - 200 L

50 L - 2000 L


 

Ordering Information Ksep®400 Ksep®6000S
Height 140 cm 179 cm
Length 107.5 cm 225 cm
Width 72 cm 106 cm
Weight 350 kg 2141 kg
Ordering Information Ksep®400 Ksep®6000S
All 3/8" x 1/4" C-Flex 5/8" x 3/8" C-Flex


 

Ordering InformationKsep®400Ksep®6000S
Voltage

208-240V 1Ph

208-240V 3Ph (US) / 400V 3Ph (EU)

Current

20 A

60 A

Process air

N/A

60 psi - 1/2" NPT

Connection

NEMA L6-20

Customer supplied

Chilled water

1/2" NPT
 (optional)

3/4" NPT


 

Our Applications

We are continually working with clients to develop a wide range of additional applications including multi-step cell clarification and microcarrier separation.

Harvest Clarification

Ksep® systems are the first single-use centrifugation systems that are completely closed. These systems are fully-automated and designed to recover >97% of product by efficient product displacement from slurry. In addition, low-shear process ensures reduced downstream contaminiation (due to cellular debris or proteolytic enzymes) and high product quality. Our systems have successfully been implemented for recombinant protein (e.g. mAb) manufacturing using CHO cell culture based processes.

Concentrate-Wash-Harvest

Ksep® centrifuges offer the benefit of concentrating cells, while maintaining high recovery and viability. Additionally, these systems can easily be programmed to remove cell debris, dead cells, and light particulate impurities (e.g. plastic particles from single-use plastic products), while significantly reducing any aggregation of cells. Ksep® systems are truly closed systems as they do not contain any rotary seals (Ksep® 400). Our systems do not contain any filters or membranes so that they can operate without clogging or exerting shear stress. These features are critical for cell therapy manufacturing.

Once captured and concentrated, the cells can be efficiently washed, manipulated, and harvested. Due to built-in plug wash option, Ksep® systems can wash cells and remove contaminants below detection levels in less than 5 minutes with a small amount of media or buffer. This technology is a breakthrough for applications requiring maintenance of cellular integrity during processing. This automated process sequence is currently being used for cell therapy manufacturing, cell banking, vaccine, and large-scale blood realted manufacturing processes.

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Download Datasheet

Ksep® systems solve the problems of traditional centrifugation and filtration-based cell retention systems by providing a gentle processing environment for concentration, wash, and separation of cells.

Datasheet

Ksep® Systems - Advanced, Scalable, Single-Use Automated Centrifugation Systems

PDF | 519.1 KB

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