IN-CAP WIP with Containment System

Integrated Containment Systems for Pharmaceutical Manufacturing

Modern pharmaceutical production environments demand far more than performance alone. Today’s manufacturers require batch flexibility, operational continuity, safety, ergonomics, and above all, containment—to protect both operators and the surrounding environment.

For this reason, the industry has moved beyond the traditional concept of a machine placed inside an isolator. At Dott. Bonapace, we design fully integrated containment systems, where the isolator and machine operate as a single, unified process organism, engineered to meet the highest pharmaceutical standards and reaching the OEB5/OEL<1μg/m3 standard.

Machines Natively Designed for Isolator Integration

Dott. Bonapace machines are designed from the ground up to operate inside isolators, not adapted after installation. This design philosophy ensures seamless integration at every level:

• Mechanical integration
• Functional integration
• Optimized layout and ergonomics

Key solutions include the IN-CAP WIP capsule filling machine and the CPR-18 WIP rotary tablet press. The same concept can be extended to additional pharmaceutical equipment such as blisters, mixers, counting systems, checkweighers, and granulators.

Advanced Containment and Functional Integration

Each integrated system is engineered with a clearly defined containment strategy, including:

• HEPA filtration systems
• Split Butterfly Valves for powder charging and discharge
• Integration readiness for dedusters, metal detectors, and lifters

These components can be supplied directly or coordinated with the end user, ensuring that every system meets specific process and containment requirements while maintaining validation readiness.

WIP (Wash-In-Place) Logic for Safe and Efficient Cleaning

The WIP (Wash-In-Place) logic is one of the core strengths of the system. Machines are designed with:

• Dedicated containment features
• Surfaces and internal geometries optimized for washing
• Easily accessible components for maintenance

Cleaning is performed using spray balls and spray guns, with drying through the same process lines. All operations are carried out without any loss of containment, ensuring faster cleaning cycles, improved safety, and higher operational efficiency.

High-Containment Product Transfer Solutions

Product transfer is fully contained and can be performed using:

• RTP (Rapid Transfer Ports)
• Split Butterfly Valves
• Continuous liners or BIBO systems

The system is modular and open to integration with additional transfer technologies, depending on customer needs or specific process requirements, while always guaranteeing containment continuity.

Centralized Single HMI and Data Integrity

One of the most important features of the integrated system is management through a single HMI. From one centralized interface, operators can:

• Set and monitor machine parameters
• Check system status in real time
• View alarms and trends
• Manage WIP cycles
• Ensure compliance with 21 CFR Part 11

This unified control provides complete visibility of the entire process, making the system simpler to operate, easier to validate, and significantly safer.

IN-CAP WIP Capsule Filling Machine

The IN-CAP WIP is an automatic capsule filling machine designed for high-containment environments. It supports dosing of:

• Powders
• Pellets
• Single tablets and mini-tablets
• Capsule-in-capsule
• Liquids

The machine is compatible with all capsule sizes (000 to 5, including DB Caps) and offers independent, double, or triple station configurations. With over 20 filling combinations available, including patented double powder dosing, IN-CAP WIP delivers exceptional flexibility for pharmaceutical production.

Overall Benefits of Integrated Containment Systems

By adopting an integrated isolator–machine approach, pharmaceutical manufacturers benefit from:

• Greater operational flexibility
• Enhanced process control
• High efficiency and productivity
• Superior operator safety
• Customizable solutions tailored to specific processes