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.
“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
- Weighing and Dispensing
- Packing and repacking
- R&D testing
OSD and Formulations:
- Drying (Fluid Bed Drier)
- Tablet pressing,
- Tablet Coating,
- Encapsulation and Blister Packing
- QC, (Pack-off)
- Weighing and Dispensing
- 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.
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.
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 standards, and the design accommodates cGMP as well as operator ergonomics. These isolators typically provide operator safety up to OEL 5 for handling potent and toxic powers in modern process plants.