Sartoclear Dynamics®

Single-use Clarification Technology

Single-use Clarification Systems for up to 2,000 LitersSartoclear Dynamics® is a new single-use technology for harvesting animal cell cultures with high cell densities. Consistent results, ease of use, enormous speed and flexible scalability are the key characteristics of this technology.

Inspired by the plasma industry, Sartoclear Dynamics® is based on the principles of body feed filtration. The ready-to-use clari fication system enables single-use processing up to 2,000 liters. As a result, it replaces centrifuges and the subsequent depth filters in a single step.

Sartoclear Dynamics®

In the past decade, the productivity of fed-batch mammalian cell cultures has risen significantly. Driven by optimized strains and culture media, biomass concentrations have increased from 1 – 3 g/L to 7 – 10 g/L. Such high concentrations challenge depth filters so that capacities have become very limited. Above 500 L a centrifuge seemed to be inevitable in order to reduce costs and waste. With 2,000 L single-use bioreactors available a break-through technology was needed to enable a fully single-use process.

With Sartoclear Dynamics® you can now harvest high cell density cultures up to 2,000 L – providing a maximum flexibility to your facility.

Your Current Clarification Challenge

Sartoclear® L-DrumsDepth filters

Centrifuges | Depth filters

0 – 500 L > 500 L

SpeedThe installation is quick and easy and preparation short since you do not have to preflush the filters. Sartoclear Dynamics® works with high flow rates and saves you the secondary step of depth filtration.

ScalabilityDo not worry about changing the volume of your bioreactor. You can adapt the amount of DE and the number of Sartoclear Dynamics® filtration units to whatever volume and size you may need.

With Sartoclear Dynamics® Scale you can easily determine the optimal ratio of DE to your biomass and linearly scale this to your process application.

ConsistencyThanks to a constant ratio of diatoma-ceous earth (DE) to your biomass, the performance of Sartoclear Dynamics® is predictable. Variable parameters such as cell viability and cell size do not impact your results.

Sartoclear Dynamics® Clarification System

0 – 2,000 L

Our Clarification Solution up to 2,000 L

Single-useSave on an upfront investment in a centrifuge and its high main-tenance costs. The single-use process of Sartoclear Dynamics® is fast, clean, reliable, economical and flexible.

Our Clarification Solution up to 2,000 L

Sartoclear Dynamics® is a complete ready-to-use technology

designed to harvest your bioreactor. Based on the principles of body feed filtration, it is ideal for high cell density cultures of up to 2,000 liters.

Our solution: The addition of a highly porous filter-aid to the feed stream. This increases the permeability of the filter cake and prevents the filter from getting blocked.

BIOSTAT® STR Bioreactor– Ideal for high cell density

cultures– Scalable design– Volume range: 50 – 2,000 L

The Clarification Process with Sartoclear Dynamics®

Palletank with Flexel® 3D bag– Mixing tank with single-use

bag for the suspension and optional pH adjustment

FlexAct®

– Process automation– Pump for even fluid transfer to filters

DE Powder Bag with Celpure® * C300– Prefilled bag with Celpure® C300 – Optimized grade for cell culture

harvests– Ultrapure diatomaceous earth (DE)

for cGMP processing– Sizes: 0.5 – 10 kg

Sartoclear Dynamics®

DE Powder Bag with Celpure® * C300– Prefilled bag with Celpure® C300 – Optimized grade for cell culture

harvests– Ultrapure diatomaceous earth (DE)

for cGMP processing– Sizes: 0.5 – 10 kg

Sartoclear Dynamics®

Powder Transfer System– Innovative zip mechanism for

fast coupling | decoupling of DE Powder Bags

– 8” port for quick powder transfer– Validated, dust-free DE transfer

Filters– High capacity for DE filtration– No pre-flushing – Pilot scale | Production scale– Volume range up to 2,000 L

The powder transfer adapter is mounted on the seal.

The Sartoclear Dynamics® DE Powder Bag and the adapter are connected with a functional zipper.

Clamps keep the plastic film in position and protect the rails during powder transfer.

Safe and Clean Powder TransferWith Sartoclear Dynamics®, the DE is directly mixed into the cell culture fluid. The innovative powder transfer system ensures a fast and dust-free transfer of the DE.

*Celpure® is a trademark of Advanced Minerals

The Reality Check

Cell Culture Fluid– 1,000 Liters – Chinese Hamster Ovary (CHO) line – 10% Wet Cell Weight (WCW)– Viability 80% – Viable Cell Density (VCD)

30 Mil. Cells/mL

Preconditioning– 2M acetic acid– pH reduced

to pH 5.0

Adding DE– DE | biomass

ratio 25%– 25 kg

Celpure® C300 added in total

Transfer of cell culture fluid

1 hour 45 minutes 10 minutes

Preconditioning Adding diatomaceous earth (DE)

Recommended Step: Cell Culture PreconditioningIn order to achieve ideal results and to use as little DE as possible, we recommend preconditioning the cell culture fluid. You can either add flocculants or lower the pH. This will create aggregates that are too big to migrate into the filter cake. This way, the cake stays permeable and the DE | biomass ratio can be reduced to about 25%.

Best results were reported using organic acids such as 2M acetic acid to lower the pH to 5. A minimum precipitation time of 45 min between acid addition and filtration should be respected.

0

5

10

15

Particle Number (%)

0.1 1 10 (µm)Particle size

pH 5pH 7

Filtration Results– Final turbidity: 8 NTU – Recovery: 92% – DNA Removal: 93%

How much DE do I need? Adding Diatomaceous Earth (DE) for FiltrationAdding diatomaceous earth to the filtration process has two purposes: Its porous structure keeps the filter cake permeable and it sieves out sub-micron particles to protect subsequent membrane filters.

The amount of Celpure® C300 you mix into your cell culture is relative to your biomass. Based on a large number of tests with many different cell cultures we recommend the following DE | Biomas (WCW) ratios.

Body Feed Filtration– Filtration area:

16 + 0.21 m2 = 3.36 m2 – Flow rate: 300 L/m²/h

Body feed filtration

1 hour

Adding diatomaceous earth (DE)

15

50

DE | Biomass (WCW) ratio (%)

30

pH 5 pH 7

Specifications and Ordering Information

*Celpure® is a trademark of Advanced Minerals

B Adapter for Bag Hoist

Dimensions H + W + D (cm) 140 + 95 + 6 Weight 12 kg

1 Sartoclear Dynamics® Scale 20 for Small-scale Harvesting and Testing

Filtration area 21 cm²

Max. cake height 41 mm

In and oulet 3” Tri Clamp

4 Sartoclear Dynamics® DE Bags

Content Celpure® C300*Weight (kg) 0.5 1.5 5 10 Dimensions H + W (cm) 95.0 + 31.5 145.5 + 73.0Materials of ConstructionFilm LDPE medical gradeFolding plate PolyethyleneHandles HDPEExternal clamp PolyamideZip PolyethyleneSafety (for all plastics with direct and indirect fluid contact)Endotoxins < 0.25 EU/mL Extractables Current USP for WFIBiosafety Biocompatibility

USP<88> Plastic Class VI

5 Sartoclear Dynamics® KIT

Pack. Dimensions H + W + D (cm) 49.5 + 63.0 +19.5KIT Content Materials of Construction1 + Powder Transfer Adapter Film: LDPE medical grade

8” TC Ring: HDPEZip: Polyethylene

1 + Filter Line Filter: Sartopure® PP2 Tube: SiliconeConnector: Polycarbonate

1 + Zipper Polyamide4 + Clamps for Powder Transfer Steel with silicone lipsSafety (for all plastics with direct and indirect fluid contact)Endotoxins < 0.25 EU/mL Biosafety Biocompatibility

USP<88> Plastic Class VI

A Electrical Bag Hoist Dimensions H + W + D (cm) 254 + 112 + 65 Maximum height (incl. adapter) 3.40 m Battery 100 – 240 VWeight 72 kg Maximum transportable weight 20 kg

Specifications

2 Sartoclear Dynamics® Filter 3 Manifold Set

Dimensions H + W + D (cm) 38.7 + 63.4 + 10.5 38.7 + 63.4 + 58.0 Surface area 0.21 m2

Nominal Retention rating 7 – 12 µmConnectionsIn and oulet 1½” Tri ClampDrain and Vent ¼” Hose Barb

Materials of ConstructionHousing ABS (Acrylonitrile Butadiene Styrene) | Glass Fiber

ReinforcedFilter PolyethyleneDrains and Vents ABS

Gaskets SiliconeOperating ConditionsTemperature range 4°C – 40 °CMaximum Operation Pressure

Liquid: 1.5 bar | 21.8 PSI Gaseous: 0.5 bar | 7.2 PS

Maximum allowed back pressure

0.7 bar | 10.2 PSI

Safety (for all plastics with direct and indirect fluid contact)Endotoxins < 0.25 EU/mL Biosafety Biocompatibility

USP<88> Plastic Class VICE Pressure Equipment Directive

Designed according the requirements of the Pressure Equipment Directive 97/23/EC.

Filter Holder

7 Pilot Scale

8 Process Filter Holder

9 Double Process Filter Holder

Capacity 1– 6 1 – 12 1 – 24Dimensions H + W + D (cm)

96 + 133 + 79 91 + 230 + 93 122 + 230 + 93

Weight 160 kg 500 kg 950 kgMaterials of Construction

Stainless steel

Drip pan

Pilot ProcessDimensions H + W + D (cm)

4 + 110 + 67 4 +184 + 70

Materials of Construction

Stainless steel

Ordering Information

Description Order No.

1 Sartoclear Dynamics® Scale 202 filtration units and 100 g of DE per package 29Z-L00001

2 Sartoclear Dynamics® Filter 0.21 m², Void volume | 8.3 L cake volume 29Z-H00001

3 Manifold Set Inlet and outlet adapter plate for body feed and depth filters

29Z-S00001

4 Sartoclear Dynamics® DE Bags0.5 kg 0.5 kg Diatomic Earth in Plastic

Powder Bag with ZIP adapter for dust free powder transfer, 4 pcs

29Z-B00005

1.5 kg 1.5 kg Diatomic Earth in Plastic Powder Bag with ZIP adapter for dust free powder transfer, 2 pcs

29Z-B00015

5 kg 5 kg Diatomic Earth in Plastic Powder Bag with ZIP adapter for dust free powder transfer, 2 pcs

29Z-B00050

10 kg 10 kg Diatomic Earth in Plastic Powder Bag with ZIP adapter for dust free powder transfer

29Z-B00100

5 Sartoclear Dynamics® KITZIP Adapter for Powder transfer to a standard mix bag, Slider, Vent filter, 4 clamps

29Z-K00001

6 Flexel 3D Magmix® Bags100 L Magmix Bag for DE suspension, 2 pcs FMB122965200 L Magmix Bag for DE suspension, 2 pcs FMB123485400 L Magmix Bag for DE suspension, 2 pcs FMB123486650 L Magmix Bag for DE suspension FMB1234871000 L Magmix Bag for DE suspension FMB122973

Accessories Order No.

7 Pilot Filter Holder 2ZGL--0005

Drip pan for Pilot Filter Holder 2ZGL--0008

8 Process Filter Holder 2ZGL--0006

9 Double Process Filter Holder 2ZGL--0007

Drip pan for Process Filter Holder and double Process Filter Holder

2ZGL--0015

A Electrical Bag Hoist 2ZG---0003

B Adapter for Bag Hoist 2ZG---0004

Separation PlateFor serial or parallel filtration on one layer 2ZGL--0013Pressure Safety DevicePrevents excessive pressure during compressed air draining of the filter cassettes 2ZGL--0014

A

B

5

4

6

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2

3

7

8

9

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www.sartorius-stedim.com Spec

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