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)

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.

Totes and Workstations

Fluid Control

Regulatory/Quality Documentation

• Accelerator Documentation Center

• Application Note: Production of In-Specification Buffer on Demand for Batch Processes

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

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

The Allegro™ Connect buffer management system provides just in time buffer delivery for unit operations, by in-line dilution of concentrates at point of use. Improvement in product titers and process intensification increases the number and volume of process buffers required. The in-line dilution system has been designed to meet increasing process demands by enabling saving on floorspace, capex expenditure and reduction in overall buffer cost per liter as compared to buffer made in-house.