PharmNXT Biotech’s flexible isolator system “NXT Flex-N” is a cost-effective solution for high-quality containment and isolation of pharmaceutic applications. These isolators save time and money by allowing you to retrofit existing processing equipment while achieving nanogram containment levels.

All materials meet FDA PharmNXT Biotech’s flexible isolator system “NXT Flex-N” is a cost-effective solution for high-quality containment and isolation of pharmaceutic applications.

 

 

 

 

 

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

All Active Pharmaceutical Ingredients (API’s) are biologically active, even at very low quantities. Therefore, it is vital not to expose operating personnel handling these compounds to levels that would result in adverse biological effects being
experienced.
 
To facilitate this, a containment strategy needs to be employed. When dealing with API’s, it involves preventing hazardous materials from escaping into the workplace and into the surrounding environment. Essentially this involves isolating the product from personnel and the environment. This in turn protects the product itself, personnel working on the process and the surrounding environment.
 
Here at PharmNXT Biotech, we design, manufacture, and install flexible isolators for this exact purpose. Our business is based on the well-known philosophy “contain at source” and we incorporate this into our designs. The “contain at source” philosophy is now the most favored philosophy among containment engineers and all the regulatory bodies.
Applications:
“NXT Flex-N” flexible isolators can attain high levels of containment for the following applications in Pharma and BioPharma manufacturing
 
API: (Handling Cytotoxicdrugs/ Oncology drugs)
  • Drum Sampling
  • Reactor Charging
  • Filtration and Drying
  • Milling and Sieving
  • Micronizing
  • QC, Weighing, and Dispensing
 
OSD and Formulations:
  • Granulation, Blending,
  • Fluid Bed Drier
  • Tablet pressing, Tablet Coating,
  • Encapsulation and Blister Packing
  • Roller Compaction,
  • QC, Pack-off, Repacking, Weighing, and Dispensing
 
Advantages:
  • Compact and ergonomic design according to process requirement
  • FDA-compliant film material with high transparency & tensile strength
  • Stainless steel support structure for instant assembly of the system
  • Retrofit design for existing equipment
  • Eliminates the cost of the expensive plant by reducing capital costs.
  • Ability to rapidly upgrade existing equipment to handle highly potent products.
  • Custom designed to suit the operator’s needs.
  • Improved ergonomics.
  • Allow for safe, effective, and operator-friendly use.
  • Reduced need for PPE.
  • Lower risk of cross-contamination.
  • Protecting the product from contamination.
  • Protecting the operating personnel and the environment
  • Reduced cleaning and cleaning validation costs.
  • Fast turnaround/installation.
  • Low capital and operating costs
  • Manufacturing as per the AGS and ISO requirement
  • Anti-Static and clear flexible Film
  • Gas tight zippers for Airlocks
  • Design to meet up to OEL 5 tor potent molecules
  • Dedicated AHU unit
  • Closed loop control system with differential negative pressure
  • Ergo trail and cGMP design with rugged 316L Stainless Steel
  • PLC/HMI integration for controlled environment
  • Oxygen monitoring/nitrogen inertization
  • Custom-built design: suitable for site requirement
  • Safe change Push-Push filters for air exchange
  • Integrated WIP system for the isolator cleaning operation
  • Multichambered design option
  • RTP/continuous liner/SBV/ integration as per the process requirement
  • Excellent on-site service

 

 

 

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