PharmNXT Biotech’s Xelta CB is a Fully Integrated Single Use Powder Charging Bag with a cost-effective 2D design, high strength and durability manufactured by using pharma-grade antistatic film
 
Xelta CB can be customized as per process needs. Customization gives flexibility to customers who are dealing in a multi-product facility. These bags are designed to handle small volumes for R&D up to commercial scale volumes.

 

 

 

 

Modular Concept

The platform design allows easy customization of the process chromatography system. One or more systems that meet your precise process requirements can be produced by choosing from the required options. You can choose from a variety of sensors and specify the number of valves and ports you need.

Options to choose from:

    • Additional inlet and outlet valves
    • Inline filter housing (1 or 2)
    • Pressure sensor (before filter or after column)
    • Air sensor (after bubble trap, before pump, or both)
    • Additional conductivity and temperature sensors before column)
    • Additional pH sensor (before column)
    • Sampling valve (after column)
    • Position detectors for valves
    • Steam-in-place (SIP)
    • Clean-in-place (CIP)
    • Gradient function (controlled either by flow rate only or by flow rate and conductivity)

Each option includes the required combination of hardware and software modules. All standard features and options have been validated on the platform.

User-Friendly Software:

The control unit uses a simple, user-friendly interface via the touchscreen for data input and programming commands. The system is shielded from unauthorized access with password protection (four levels), and all events and actions (alarms, process steps, manual commands, etc.) are recorded in accordance with cGMP guidelines. The program allows you to operate the system manually or automatically.

The automatic mode has:

    • Multiple operations
    • Configurable fluid paths
    • Control of inlets/outlets and column valve
    • Multiple end conditions
    • Pause and hold alarms
    • Interactive pausing steps
    • Full trend review, trend analysis, and printing from the system are all standard. Data export and configurable interfacing to external software is also included.

Hygienic Design:

All process piping and valves are made from Stainless Steel 316L (ASTM 1.4404) to conform to ASME BPE requirements. Only membrane valves have been used for the process flow path. Block body valves, compact instruments, and other devices have been used to minimize the holdup volumes. Cables and pneumatic lines are run through stainless steel conduits protecting them from damage or contamination.

The NXTchrom system can be cleaned in place with NaOH. The option for automated cleaning in place is available on request which includes a specialized program with additional valves. A Steam in Place system option is also available upon request.

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TECHNICAL INFORMATION

Xelta CB can be customized as per process needs. Customization gives flexibility to customers who are dealing in a multi-product facility. These bags are designed to handle small volumes for R&D up to commercial scale volumes.

Salient Features:
  • Sizes available in 1L, 5L, 10L, 15L, 25L and 40L
  • Sanitary Flange with integrated gasket in 1 1⁄2”, 2”, 3”, 4”, and 6”
  • Optimized cone angle and radius welds for rapid discharge of powder material
  • Longer neck to facilitate alignment with vessel
 
Easy and Trouble-free Powder Charging:
  • Crevice free design utilizing anti-static materials ensure a free-flowing transfer.
  • Transparent material construction allows operators to see how product is transferring.
 
Suitable for Gamma Irradiation application (Sterile)
  • Manufactured in ISO 7 class cleanroom
  • Double packed within a sealed packing sleeve and gamma irradiated.
  • The packing sleeve is easy to tear manually, no cutting tools are required.
 
Reduce cleaning times
  • Single powder transfer bags reduce downtime, cost of cleaning and most importantly eliminates
  • cleaning validation associated with conventional SS transfer solutions.

Description

Specification

Packing

Food grade LDPE film, 100-micron thick, transparent monolayer

End Connection

FDA-compliant LDPE material

Bag Handle

Polypropylene (Various colors)

Manufacturing

Iso class 7 (Grade C) Cleanroom

Connection

Thermally welded Tri-Clamp connection for sizes 1 1⁄2”, 2’, 3” 4” and 6”

Inspection

100% visual inspection.
Daily heat seal verification was performed to verify seal strength.
One unit per lot was pressure tested to verify the integrity of the bag

Packing

Individually packed in a single LDPE sleeve for non-Gamma application
Individually packed in a double LDPE sleeve for Gamma application

Labeling

Each XeltaPCB-2D Powder Charging Bag is clearly labeled with the lot number,
Manufacturing date, Expiration date (For Gamma) and specification detail to allow
traceability.

Sterilization (Optional)

Gamma irradiated

Compliance

Compliant with Commission Directive 2002/72/EC and its amendments for
plastic materials that come into contact with food material
Compliant to relevant sections of United States FDA 21CFR
Compliant to EP 3.1.3
No animal-derived ingredients
Resistant to most common solvents (see data book for list)

 

 

 

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