High-Containment OEB 4 / OEB 5 Granulation Line with Isolator for Pharmaceutical Manufacturing
URL 3S Pharma Machinery Inc. supplies advanced Granulation Line with Isolator in Hyderabad, Telangana, engineered for the safe processing of highly potent active pharmaceutical ingredients (HPAPIs), oncology products, cytotoxic compounds, hormones, and allergenic materials.
Designed to achieve OEB 4 and OEB 5 containment levels, our integrated systems provide complete operator protection, product integrity, and compliance with global pharmaceutical manufacturing standards.
The Granulation Line with Isolator combines all critical Oral Solid Dosage (OSD) processing equipment inside a fully enclosed negative-pressure barrier isolator, minimizing operator exposure while maximizing production efficiency and product quality.
Complete Integrated Granulation Line with Isolator:
Our high-containment systems integrate multiple pharmaceutical process machines into a single contained production line.
High Shear Mixer Granulator (RMG)
- Rapid and efficient wet granulation
- Uniform particle size distribution
- Improved powder flow properties
- High mixing efficiency
Fluid Bed Dryer (FBD)
- Uniform drying of wet granules
- 12 Bar pressure-shock resistant construction
- HEPA-filtered drying air
- Energy-efficient operation
Wet / Dry Cone Mill
- Uniform granule sizing
- Dust-free milling operation
- Closed contained process
- Reduced material loss
Vacuum Transfer System
- Fully enclosed powder transfer
- Safe product conveying
- Eliminates manual handling
- Prevents cross-contamination
Blender
Available with:
- IBC Blender
- Fixed Bowl Blender
Provides homogeneous blending prior to tablet compression or capsule filling.
Integrated CIP / WIP Cleaning System
- Cleaning-In-Place (CIP)
- Wash-In-Place (WIP)
- Faster cleaning validation
- Reduced production downtime
Available Batch Sizes:
The Granulation Line with Isolator is available in multiple capacities.
| Batch Capacity | Application |
|---|---|
| 200 g – 2 kg | Research & Development |
| 600 g – 5 kg | Pilot Scale |
| 2 kg – 15 kg | Commercial Production |
Custom capacities can be supplied to meet specific process requirements.
High-Containment Features:
Our Granulation Line with Isolator is engineered for maximum safety and pharmaceutical compliance.
OEB 4 / OEB 5 Containment
- Operator exposure below 1 µg/m³
- Fully enclosed barrier isolator
- High-containment pharmaceutical processing
Negative Pressure Operation
- Operating pressure: –50 to –80 Pa
- Continuous pressure monitoring
- Controlled turbulent airflow
Airbag Inflatable Seals
- Automatic sealing system
- Safety interlocks
- Leak-proof equipment interfaces
Safe Material Transfer
Available options include:
- Continuous PE Liner System
- Alpha/Beta Transfer Valve
- Rapid Transfer Ports (RTP)
Advanced BIBO Filtration
- Bag-In / Bag-Out filter replacement
- F9 pre-filter
- H13 / H14 HEPA filters
- Safe maintenance procedures
Pharmaceutical Hygienic Construction
- SS316L contact parts
- Mirror-polished internal surfaces
- Full-radius corners (≥15 mm)
- Crevice-free sanitary design
Glove Ports
- Safe operator intervention
- Ergonomic operation
- Reduced contamination risk
Automation
- PLC + HMI Control System
- Recipe Management
- Alarm & Data Logging
- Optional 21 CFR Part 11 Compliance
- SCADA Integration
Technical Specifications:
| Parameter | Specification |
| Containment Level | OEB 5 (<1 µg/m³) |
| Chamber Material | SS316L Stainless Steel |
| Operating Pressure | –50 to –80 Pa |
| Air Changes | ≥20 Air Changes/Hour |
| Leak Tightness | ISO 10648-2 Compliant |
| Power Supply | 220V / 50Hz |
| Power Consumption | Approx. 1000W |
| Noise Level | ≤65 dB(A) |
Benefits of Granulation Line with Isolator:
Maximum Operator Protection
Protects operators from exposure to highly potent pharmaceutical compounds during processing.
Product Quality Assurance
Maintains a contamination-free environment for consistent pharmaceutical production.
Global Regulatory Compliance
Designed according to:
- cGMP
- US FDA
- EU GMP
- ISO 10648-2
- ISPE Guidelines
Higher Productivity
Integrates granulation, drying, milling, blending, and transfer into one contained production system.
Compact Footprint
Optimizes cleanroom space while reducing installation costs.
Simplified Cleaning
Integrated CIP/WIP systems reduce cleaning time and improve manufacturing efficiency.
Applications:
Our Granulation Line with Isolator is ideal for:
- HPAPI Manufacturing
- Oncology Drug Manufacturing
- Cytotoxic Product Processing
- Hormonal Drug Production
- Sterile Granulation
- Non-Sterile Granulation
- Oral Solid Dosage (OSD) Manufacturing
- Tablet Manufacturing
- Capsule Manufacturing
- Nutraceutical Production
- Chemical Powder Processing
Complete High-Containment Pharmaceutical Solutions:
URL 3S Pharma Machinery Inc. supplies complete turnkey high-containment solutions for pharmaceutical manufacturing, including:
- Granulation Line with Isolator
- Wet & Dry Granulation Systems
- Roller Compaction Lines
- Tablet Compression Isolators
- Tablet Coating Isolators
- Capsule Filling Isolators
- Vacuum Tray Dryer (VTD) Isolators
- Dispensing & Sampling Booths
- High-Containment Material Transfer Systems
- Pharmaceutical Packaging Containment Solutions
Working with globally trusted OEM partners, we deliver customized containment solutions that combine advanced engineering, automation, and regulatory compliance for pharmaceutical, biotechnology, and nutraceutical manufacturing. Our systems are designed to improve operator safety, protect product quality, and support efficient, GMP-compliant production processes.
Frequently Asked Questions (FAQs):
Q1. What is a Granulation Line with Isolator?
It is a high-containment pharmaceutical system designed for safe granulation and handling of potent drug ingredients.
Q2. What containment level does it offer?
The system is available in OEB 4 and OEB 5 configurations for maximum operator protection.
Q3. Which equipment can be integrated?
It can include an RMG, FBD, Cone Mill, Blender, Vacuum Transfer System, and CIP/WIP system.
Q4. Is it suitable for HPAPI and oncology manufacturing?
Yes. It is ideal for HPAPIs, oncology drugs, hormonal products, and cytotoxic compounds.
Q5. Can the system be customized?
Yes. Batch size, automation, containment level, and equipment configuration can be customized.
Q6. Which industries use this system?
It is widely used in pharmaceutical, biotechnology, and high-potency drug manufacturing facilities.
URL 3S Pharma Machinery Inc. supplies advanced Granulation Line with Isolator in Hyderabad, Telangana, and nearby industrial regions including Warangal, Nizamabad, Karimnagar, Khammam, Ramagundam, Mahbubnagar, Nalgonda, Adilabad, Siddipet, Jagtial, Suryapet, Mancherial, Bhadradri Kothagudem, Jagitial, Medak, Kamareddy, Vikarabad, Peddapalli, Sangareddy, Narayanpet, Wanaparthy, Mulugu, Yadadri Bhuvanagiri, Nagarkurnool, Jayashankar Bhupalpally, Komaram Bheem Asifabad, Bhupalpally, and Mahabubabad.
Call Us:
+91 87582 51079
Email:
info@url3s.com
For more information, please feel free to contact us.
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