Tofflon OSD High Containment Wet Granulation Line: Empowering Safe and Compliant High-Potent Drugs Production

In the production of High-Potent drugs, containment performance directly determines production safety and compliance levels. Tofflon's OSD High Containment Wet Granulation Line can stably meet the production standards for highly toxic and potent drugs at OEB4  and OEB5 levels. It builds a full-chain containment protection system from multiple dimensions including charging/discharging control, material transfer, equipment sealing, sampling and testing, cleaning and disinfection, and explosion-proof protection, laying a solid foundation for safe HPAPI production through 6 core technical highlights.

Containment Granulation Line - Production

OEB4-5, Capacity 30L ~ 150L

Containment Granulation Line - Lab & Scale up

OEB5, capacity 1L~30L

1. Contained Charging & Discharging Control 

When connecting IBCs to the granulator and dry mill, split butterfly valves (SBV/AB Valve) are adopted for rigid sealed connection. The valve discs fit closely during charging and discharging, and materials are transferred between equipment through sealed pipelines, achieving complete dust-free transfer and effectively avoiding operator exposure and dust leakage risks.

Split Butterfly Valve

2. Vacuum Contained Material Conveying

The high shear mixer, fluid bed dryer and dry mill are connected by integrated sealed pipelines. Materials are always in a closed environment throughout the entire production process of mixing, granulation and drying, fundamentally eliminating dust emission.

3. Contained Sampling System Configuration

Equipped with a dedicated contained sampling device that can be directly connected to PE bags, ensuring that sample collection is fully free of exposure. It not only protects the personal safety of operators, but also maintains the integrity and accuracy of samples, fully complying with cGMP requirements; the online contained sampling design can accurately match the containment protection standards of OEB levels.

4. Efficient and Compliant Cleaning Solution

Adopting WIP offline pre-wetting process, which can effectively soften residual materials on the inner wall of equipment. Combined with CIP online circulation cleaning system and conductivity detection function, it accurately controls the cleaning effect, ensures that the cleaning verification between batches meets the standards, and satisfies the needs of industry compliant production.

5. Safe Part Changeover Protection Design

The exhaust dust collector adopts dynamic back-blowing technology and BIBO (Bag-In/Bag-Out) structure design. The equipment is integrally designed with a modular layout, which can realize quick part replacement, minimize material residue, and reduce the contact risk between operators and hazardous materials.

6. Equipment Sealing & Safety Monitoring

Airbag sealing technology is adopted at the equipment connection parts, and real-time pressure and flow monitoring devices are configured to dynamically monitor the sealing status of the system, ensuring the safety and stability of the entire production process.

Relying on mature technical design and full-process containment protection, Tofflon's OSD High Containment Wet Granulation Line empowers global pharmaceutical companies with professional strength, creating efficient, safe and compliant oral solid dosage form production solutions, and boosting the high-quality development of the pharmaceutical industry.