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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.
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
Technical Specifications:
- 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 a 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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