PharmNXT Biotech’s Negative Pressure Rigid Wall Isolators system “NXT Rigid-N” is a high-quality containment isolator system, specially designed for creating controlled negative pressure inside the isolator. It also can effectively control & monitor operating parameters and safeguard the operator & the surroundings from highly potent products.

PharmNXT Biotech can successfully design and manufacture the Rigid Isolator for any pharmaceutical process required for R&D and the production scale containment.

Applications:

“NXT Rigid-N” Rigid wall isolators provided very high levels of containment and are used for the following applications in Pharma and BioPharma manufacturing.

API: (Handling Cytotoxicdrugs/ Oncology drugs/Peptides)

    • Reactor Charging
    • Filtration
    • Drying
    • Milling
    • Sieving
    • Micronizing
    • Weighing and Dispensing
    • Packing and repacking
    • R&D testing

OSD and Formulations:

    • Granulation
    • Blending,
    • Drying (Fluid Bed Drier)
    • Tablet pressing,
    • Tablet Coating,
    • Encapsulation and Blister Packing
    • QC, (Pack-off)
    • Weighing and Dispensing

Advantages:

    • 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
    • Controlled environment: Temperature, Humidity, Oxygen, Nitrogen
    • Safe change Push-Push filters for air exchange
    • Integrated WIP/CIP system for the isolator cleaning operation
    • Excellent on-site service

Technical Specifications for negative pressure Rigid Isolator:

    • Manufacturing as per the AGS and ISO requirement
    • Multi-chamber design
    • Controlled Negative Pressure differential pressure environment to achieve contentment up to OEL 5
    • Safety Interlocks and breach alarms for the safety of the operator
    • RTP/continuous liner/SBV/Passbox integration as per the process requirement
    • Auto leak test option available

Testing and Validation:

    • HEPA Filter Integrity: Filter Leak Tests verify the integrity of the Supply and exhaust Push-Push HEPA filters.
    • Velocity and ACPH: Downflow Velocity Tests verify adequate airflow velocities and recommended ACPH of isolator
    • Pressure Leak Test: Isolator leak tested as Class 2 Containment Enclosure for process and pass chambers by ISO 10648-2
    • Particle Count Test: Particle count (Air Cleanliness Tests) verify air cleanliness by ISO 14644-1.
    • Recovery Time Test: It determines the amount of time required for the isolator main chamber to recover to its original state condition in the event of a contamination event.
    • Breach Test: The breach test verifies user protection in case of a glove failure. The unit will become negative pressure with an inward velocity of 0.7 m/s.
    • Differential Pressure Test: It verifies that the isolator is running smoothly with given parameters of differential pressure.

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