Allegro™ Connect バッファーマネジメントシステム product photo Primary L

Allegro™ Connect バッファーマネジメントシステム

The Allegro Connect buffer management system provides buffer on demand. It is a flexible system designed for pilot scale, clinical batches and commercial production to ensure that the right buffer is delivered at the right time, providing an efficient, streamlined workflow. The modular system design enables up to six high volume process buffers to be supplied as required, one at a time, directly to the batch unit operation such as chromatography or tangential flow filtration (TFF) based on buffer inline-dilution (ILD) and utilizing a single-use flow path. Multi-column chromatography (MCC) application buffer requirements can also be met by the Allegro Connect buffer management system, delivering a maximum of four process buffers at the same time to the MCC chromatography system.

The standard system comprises of a control unit and two buffer workstations. Buffer concentrates are diluted in-line with water for injection (WFI) at point of use with typical dilution factors of 5x - 20x. These significantly smaller buffer volumes offer a reduced labor cost and alleviate the need for large mixing/hold vessels that take up a large overall footprint. The Allegro Connect buffer management system provides a reduction in capital expenditure.

The Allegro Connect buffer management system alleviates traditional bottlenecks in buffer preparation and provides a solution to the challenges faced as processes become increasingly intensified and the range of biotherapeutics becomes more diverse.








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カタログ・技術資料

Datasheets

ダウンロード: 英語

概要

The Allegro Connect buffer management system provides buffer on demand. It is a flexible system designed for pilot scale, clinical batches and commercial production to ensure that the right buffer is delivered at the right time, providing an efficient, streamlined workflow. The modular system design enables up to six high volume process buffers to be supplied as required, one at a time, directly to the batch unit operation such as chromatography or tangential flow filtration (TFF) based on buffer inline-dilution (ILD) and utilizing a single-use flow path. Multi-column chromatography (MCC) application buffer requirements can also be met by the Allegro Connect buffer management system, delivering a maximum of four process buffers at the same time to the MCC chromatography system.

The standard system comprises of a control unit and two buffer workstations. Buffer concentrates are diluted in-line with water for injection (WFI) at point of use with typical dilution factors of 5x - 20x. These significantly smaller buffer volumes offer a reduced labor cost and alleviate the need for large mixing/hold vessels that take up a large overall footprint. The Allegro Connect buffer management system provides a reduction in capital expenditure.

The Allegro Connect buffer management system alleviates traditional bottlenecks in buffer preparation and provides a solution to the challenges faced as processes become increasingly intensified and the range of biotherapeutics becomes more diverse.






仕様

System Dimensions and Weight

System Capacity
System
Weight 751 kg
Dimensions (W x D x H) 1120 mm x 1120 mm x 1990 mm
Workstation
Weight 171 kg
Dimensions (W x D x H) 1300 mm x 1000 mm x 2000 mm
Bioburden filter trolley
Weight 90 kg
Dimensions (W x D x H) 1200 mm x 1300 mm x 400 mm

Allegro Buffer Management System Specifications

System Capacity Quantity ½ in. Manifold
WFI pump (single-use diaphragm) 1 20 - 1200 L/h
Buffer concentrate pump (single-use diaphragm) 1 1 - 180 L/h
Tubing internal diameter (ID) N/A ½ in. (1.27 cm)
Pressure sensor range 1 0 to 4 barg (2 barg max)
Temperature rating 10 – 40 oC
Inlets Max 6 inlets per system
4 inlets per workstation
Outlets Max 6 outlets per system
4 outlets per workstation
pH probe range and accuracy 1 3-10 pH ± 0.15 pH unit
Conductivity probe range and accuracy 2         0 to 300 mS
± 3% at 1 to 100 000 μS/cm
± 5% at 100 to 300 mS/cm
Workstation liquid level sensor range and accuracy 4 per workstation 20-100 L ± 10%
Manifold installation test port 1
Flowmeter -electromagnetic (option) 2         0 - 20 L/min
(± 1%) of measured value
Pneumatic air supply 1 6 barg
Power supply 1 208 V AC, 50-60 Hz (UL version)
230 V AC, 50-60 Hz (CE version)

Materials of Construction (System/Workstation – Trays/Manifolds)

Components Materials
Single-Use Manifold
Tubing Platinum cured silicone
Diaphragm pump head
(1200 L/h and 150 L/h versions)
Polypropylene; EPDM (ethylene propylene elastomer), Santoprene♦
Manifold connectors Polysulfone, silicone
Fittings Polypropylene
Pressure sensor Polysulfone
Flow sensor Polysulfone, Hastelloy C22
pH sensor Silicone (platinum-cured), glass
Conductivity sensor Stainless Steel 1.4435, PEEK (polyetheretherketone), EPDM (ethylene propylene elastomer)
Allegro storage biocontainer bag chamber, 100 L High-density polyethylene (HDPE), Ultra low-density polyethylene (ULDPE)
Gaskets 1½ in. sanitary connection Silicone (platinum-cured)
MPX connector (male) to ½ in. hose barb Polysulfone
Workstation
Workstation tray Polypropylene (non -wetted)
Workstation frame Stainless Steel 1.4301 (304)
Control System Stainless Steel 1.4301 (304)

性能

The Allegro Connect buffer management system has been designed to simplify and improve process buffer workflow by providing ‘just-in-time’ process buffer directly to the unit operation. Valuable floorspace is saved by using in-line dilution of buffer concentrates and water for injection (WFI) at point of use, to meet the target buffer specifications. Buffer workflow is simplified by eliminating the need to prepare and store large volumes of process buffer in advance. Operator workspace is improved with a more compact footprint around unit operations requiring high buffer volumes. Total buffer cost/L is reduced by up to 12%, attributable to a reduction in costs for labor, reagents and capex expenditure. The reduction in the overall footprint of buffer preparation/hold and storage vessels enables up to 75% valuable facility floor space savings.

The system has an additional option for bioburden protection, providing increased assurance against microbial contamination. Each in-specification buffer can be filtered prior to filling the process bag, with up to six single-use capsule filters with automated capsule venting to ensure ease-of-use. Additional protection can be achieved by using single-use manifolds with sterile connectors to maintain a low bioburden.

Designed for Ease of Use

The Allegro Connect buffer management system has undergone extensive user testing, to ensure the system is simple and intuitive to use, fits with operators’ existing workflows, and eliminates the risk of user error.

The system features on-screen visual instructions and shadow-boarding to guide users and ensure correct manifold installations of the single-use systems.

Inline monitoring of buffer concentrates acts as an additional safety check that manual installation activities have been successfully completed.

Quality Standards

A detailed validation turnover package is available for each system according to ASTM 2500 Standards (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment).

Regulatory dossier-comprising:

  • Regulatory compliance ROHS I to ROHS III directives
  • Raw material compliance data (USP Standards)
  • Packaging and packaging waste directive 94/62/EV

Pall automation platform enables compliance with 21 CFR part 11 and follows the GAMP life cycle for software development.

製品カテゴリー

Totes and Workstations

参考情報


The Road to Better Buffer Management

Providing In-Line Dilution of Buffer at Point-Of-Use

Batch Processing One Buffer Supplied at a Time



Continuous Bioprocessing – Multicolumn Chromatography

型式

Automated System, Workstations and Bioburden Filter Trolley

Part Number Description
ACBMSEUPLC PLC 230 V AC, software automation, 2 buffer workstations (maximum 4 buffers)
ACBMSWHPLC PLC 208 V AC, software automation, 2 buffer workstations (maximum 4 buffers)
ACBMSEUIO I/O 230 V AC, DCS ready no automation, 2 buffer workstations (maximum 4 buffers)
ACBMSWHIO I/O 208 V AC DCS ready no automation, 2 buffer workstations (maximum 4 buffers)
ACBMSWS Workstation (concentrate or process), provides capability for additional 2 buffers
ACBMSFSK Flow sensor kit
ACBMSFT Bioburden filter trolley
ACBMSFTWH Bioburden filter trolley (208 V AC)

Single-Use Manifolds

Part Number Description
6431-1417W ½ in. 100 L biocontainer bag
6431-1457D ½ in. 100 L biocontainer bag with Kleenpak® Presto sterile connectors
6431-1417Z ½ in. filter set
6431-1418A ½ in. filter set with Kleenpak® Presto sterile connectors, 1 m tubing
6431-1418B ½ in. filter set with Kleenpak® Presto sterile connectors, 1.5 m tubing
6431-1418C ½ in. filter set with Kleenpak® Presto sterile connectors, 2 m tubing
6431-1418E ½ in. transfer line, 0.7 m tubing
6431-1418F ½ in. transfer line, 1.6 m tubing
6431-1418G ½ in. inlet tube kit 1 m
6431-1418H ½ in. inlet tube kit 1.5 m
6431-1418J ½ in. inlet tube kit 2 m
6431-1418K ½ in. outlet tube kit 1 m
6431-1418L ½ in. outlet tube kit 1.5 m
6431-1418M ½ in. outlet tube kit 2 m
6431-1418N ¼ in. filter bleed line
6431-1420S ½ in. feed including flow sensor
6431-1420T ½ in. feed excluding flow sensor
6431-1420U ½ in. outlet
6431-1420V ½ in. drain control

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