HPAPI reactor systems and high containment filtration solutions

Customized HPAPI process equipment for maximum safety and productivity

Büchi AG is a leading Swiss manufacturer of HPAPI reactor systems, pilot plants, and high-containment solutions. With decades of expertise, we design equipment that ensures maximum operator safety and optimal process performance.

Our HPAPI process systems comply with strict cGMP requirements and ATEX regulations. We supply equipment from R&D through scale-up to production scale.

Our systems are customized in accordance with process and operational requirements to provide reliable containment and operational ease for the handling of highly potent APIs. This design meets the strictest safety and quality requirements while enabling efficient, reproducible, and scalable processes.

Additionally, our HPAPI process systems are integrated seamlessly into isolators (glove boxes) / containment systems. We collaborate with various manufacturers of  isolators / containment systems to deliver turnkey solutions in accordance with customer requirements. 

Key features of HPAPI process equipment

Our HPAPI reactor systems are designed for maximum containment, easy maintenance, and long service life. 

Some of the key advantages:

• Maximum tightness and easy cleaning thanks to optimized designs.
• Seamless integration into containment systems or isolators, in cooperation with leading manufacturers.
• Use of high-performance materials, including borosilicate glass 3.3, glass-lined steel, fluoropolymers, and Hastelloy® for outstanding chemical resistance.
• Propietary flexible glass piping system buchiflex for leak-tight connections and maximum flexibility during operation.

 Benefits of HPAPI process equipment

Choosing HPAPI reactor systems from Büchi AG offers more than just reliable equipment. These systems are designed to guarantee saftey, efficiency, and compliance at every stage of your process.

• Fully customized to meet your specific process and operational requirements.
• High cleanability, ensuring consistent product purity batch after batch.
• Maximum operator safety through reliable containment for highly potent APIs.
• Full compliance with requirements of cGMP and applicable regulations such as ATEX and PED.
• Comprehensive documentation, including IQ/OQ protocols and a Quality Project Plan (QPP), for smooth validation and regulatory approval.

Technical data – HPAPI reactor systems

Our reactors, designed designed for HPAPI applications, offer the following specifications:

• Volume range: 5 to 250 liters
• Pressure range: -1.0 to +0.5 bar
• Temperature range: -90 °C to +200 °C
• Materials (options): Borosilicate glass 3.3, glass-lined steel, Hastelloy®  PTFE, PFA, PEEK
• ATEX (explosion-proof) compliant
• CIP (clean-in-place) capability for reduced downtime

HPAPI equipment design features

To meet the strict cGMP requirements of pharmaceutical production, our equipment designs include the following features:

• Polished stainless steel components for improved cleanability
• Motors without external ventilation to avoid air turbulence and enable outside cleaning with liquids
• Polished stainless steel valves bodies and handles
• buchiflex flanges in polished stainless steel
• Cover plates in Hastelloy® or stainless steel