PharmNXT Biotech’s XELTA Pac is a fully Integrated Single Use Powder Charging Bag with a cost-effective 3D design, high strength and durability manufactured by using pharma-grade antistatic LLDPE film.
 
XELTA Pac bags can be customized as per process needs. Customization gives flexibilityto customers who are dealing in a multi- product facility. These bags are designed to handle small volumes 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 Pac bags can be customized as per process needs. Customization gives flexibilityto customers who are dealing in a multi- product facility. These bags are designed to handle small volumes up to commercial scale volumes.
Conventional 2D Powder handling bags have a narrow fill opening and hence making weight adjustments with 2D powder bags is
extremely challenging. XELTA Pac is the most effective solution for conventional 2D powder bag weight adjustment. 
 
XELTA Pac has a bigger diameter at the top opening, which enables easy filling, accurate weight adjustment and easier product discharge. This design has a large fill neck, allowing easier charging/dispensing into the bag. This reduces fill time
and lowers the risk of spillage when filling the bag. 
 
XELTA Pac is suitable for filling and dispensing a wide range of powder volumes. XELTA Pac is an ergonomically designed 3D powder transfer bag for the biopharmaceutical industry with integrated ferrule connections. It is manufactured with pharma-grade antistatic film material assuring fast and complete discharge of material for the bag.

Description

Specification

Packing

FDA-compliant, Food grade LLDPE film, 8 mil thick, transparent monolayers

End Connection

FDA-compliant LDPE material

Bag loop

FDA-compliant, Food grade LLDPE film, 8 mil thick

Connection

Thermally welded Tri-Clamp connection for sizes 2”, 3” 4”, 6” and 8”

Inspection

100% visual inspection.
Daily heat seal verification is performed to verify seal strength.
One unit per lot pressure is 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 XELTA BioPac 3DPowder Charging Bag is clearly labeled with the lot number,
Manufacturing date, Expiration date (For Gamma) and specification detail to allow
traceability.

Sterilization

Gamma irradiated

Compliance

Compliant to relevant sections of United States FDA 21CFR
Compliant with EP 3.1.3
No animal-derived ingredients
Compliant with BSE /TSE statement
Compliant to REACH

 

 

 

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