Integrated Containment Systems for Pharmaceutical Manufacturing

Advanced OEB5 Containment Solutions with the CPR-18 WIP Rotary Tablet Press

In today’s pharmaceutical industry, manufacturing environments must deliver more than high performance. Companies require flexibility, continuous operation, operator safety, ergonomic design, and strict containment control to comply with global regulations.

To meet these demands, modern production has evolved beyond traditional setups where machines are simply placed inside isolators. At Dott. Bonapace, we engineer fully integrated containment systems, where the isolator and the machine function as a single, optimized process unit—designed to achieve OEB5 / OEL <1 µg/m³ containment levels.

Native Isolator Integration for Pharmaceutical Equipment

Unlike conventional solutions, Dott. Bonapace machines are designed from the ground up for isolator integration, ensuring superior performance and compliance.

This approach guarantees:

• Seamless mechanical integration
• Complete functional synchronization
• Optimized layout and operator ergonomics

A key example is the CPR-18 WIP Rotary Tablet Press, a compact and highly efficient solution engineered for contained tablet compression. The same integrated concept can be extended to:

• Capsule filling machines
• Blister packaging lines
• Powder mixers and granulators
• Counting and checkweighing systems

Advanced Containment Technology for OEB5 Applications

Each containment system is designed with a comprehensive containment strategy to safely handle highly potent APIs.

Core features include:

• High-efficiency HEPA filtration systems
• Split Butterfly Valves (SBV) for safe powder transfer
• Integration with dedusters, metal detectors, and lifting systems

These solutions ensure maximum containment performance, while maintaining full validation readiness and compliance with pharmaceutical standards.

WIP (Wash-In-Place) System for Safe Cleaning

The integrated Wash-In-Place (WIP) system is essential for ensuring safety, efficiency, and contamination control.

The CPR-18 WIP tablet press is designed with:

• Dedicated containment-friendly construction
• Smooth, optimized surfaces for effective washing
• Easy access for maintenance and inspection

Cleaning is performed using:

• Spray balls and spray guns
• Integrated drying through process lines

All cleaning operations are executed without breaking containment, reducing downtime, improving operator safety, and increasing productivity.

Contained Product Transfer Systems

Safe material handling is critical in high-containment environments. The system supports multiple contained transfer technologies, including:

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

This modular approach allows full customization based on process requirements while ensuring continuous containment integrity.

Centralized HMI and Data Integrity

The entire system is controlled through a single HMI interface, simplifying operations and ensuring data compliance.

Operators can:

• Monitor and adjust machine parameters
• Access real-time system status
• View alarms, trends, and process data
• Manage WIP cycles
• Ensure 21 CFR Part 11 compliance

This centralized control improves process visibility, validation, and operational safety.

CPR-18 WIP Rotary Tablet Press: Key Features

The CPR-18 WIP Rotary Tablet Press is designed for:

• R&D applications
• Clinical trials
• Small batch production

Main specifications:

• Three turret configurations available
• Maximum compression force: 60 kN
• Compatible with Euro B, D, and TSM tooling

Advanced digital controls and dedicated software enable precise parameter management and data analysis, making it an ideal solution for high-containment tablet manufacturing.

Benefits of Integrated Containment Systems

By adopting a fully integrated isolator-machine solution, pharmaceutical manufacturers gain:

• Greater process flexibility
• Enhanced production control
• Increased efficiency and productivity
• Maximum operator protection
• Fully customizable solutions

High-Performance Containment Solutions by Dott. Bonapace

Dott. Bonapace’s containment systems are engineered to meet the most stringent pharmaceutical requirements, combining innovation, safety, and compliance.

The CPR-18 WIP containment system represents a reliable and future-proof solution for companies handling highly potent compounds and seeking top-level containment performance.