Sartorius, FYM312732, Linkit® AX 1000 Aliquoting System

The Linkit® AX Aliquoting Solution is ideal for aliquoting small quantities of process fluids - quickly, even, and consistently from batch to batch.

The Linkit® AX Aliquoting Solution is ideal for aliquoting small quantities of process fluids – fast, even, and reproducible batch-to-batch in applications such as small-batch media preparation in cell & gene therapy operations.
The plug-&-play concept, combined with a ready-to-use patented manifold design, minimizes operator effort and error and consistently distributes fluid between the 10 bags with an accuracy of ±5.1%. The solution is designed to address the pain points of manual filling and aliquoting applications without the need to heavily invest in big and complex equipment.
Reach higher throughput
Fast filling performance with a unique flow-through fluid design of the main hub.
Work confidently with more automation
QApp guides the operator during a filling operation, ensuring batch-to-batch repeatability.
Simplify Aliquoting Operations
Fully assembled, compact, and small footprint solution - no need to handle bulky and complicated traditional manifolds.
Go paperless with compliant batch records
Full end-to-end traceability in compliance to FDA directive 21 CFR part 11 and EU Annex 11.
To support you in your regulatory needs, specific documentation is available upon request:
Validation guide
Extractables guide
Technical drawing
Inspection guide
Product compliance statement
Instructions for use

Specifications
Applications:
Application Area: Aliquoting
Process Step: Media Preparation; Aliquoting; Buffer Preparation

Compliance Information:
Compliance: USP <88> Class VI; USP <85>; USP <788>; USP <87>; ISO 10993-5

Connections (Physical):
Connector Inlet: AseptiQuik® G
Connector Outlet: Sealed + Plug
Disconnection Method: Quickseal® on 1/4" OD
Inlet Line: 3/8" AseptiQuik® G + 3/8" ID TPE (Tuflux® TPE) 0.5 m (20")
Outlet Line: 3/32" ID PVC (Tygon® ND100-65) + 1/8" ID TPE (Tuflux® TPE)

Dimensions:
Dimensions: 520.7 mm × 520.7 mm × 597 mm

Features:
Purging Method: Bag purge (500 mL Flexsafe®)

Operating Conditions:
Operating Conditions - Temperature: Room temperature

Product Information:
Brand: Linkit® AX
Container Type: 10 × 1000 mL Flexsafe® bag manifold
Distribution accuracy between bags: ±5.1 %
Filling Accuracy: For single lot: ±5.9 %; For multiple lots: ±7.3 % @3σ
Pack Size: 1

Sterility/Purity:
Delivery Condition: Sterile
Sterilization Method: Gamma Irradiation (25 kGy – 45 kGy)

Volume:
Volume: 1000 mL