Executive Summary

HPAPI Superskid

Fully Integrated High-Containment Processing System

Back to newsroom

Media contact:

Brian Bresnan

+353 (0)86 8118071

BCD | Pharma Sales

Contact me

Tags:

Services

What is the HPAPI Superskid

The HPAPI Superskid represents a next-generation solution for the contained manufacture of High-Potency Active Pharmaceutical Ingredients (HPAPIs). Designed for maximum safety, efficiency, and regulatory compliance, the Superskid combines multi-level modular architecture with advanced automation and high-containment technologies.

Engineered to meet the most stringent Good Manufacturing Practice (GMP) and Occupational Exposure Band (OEB) 5 standards, this fully integrated system enables the safe and precise processing of highly potent compounds while minimizing operator exposure and ensuring consistent product quality.

Its compact, vertical configuration and modular design make it ideal for both pilot-scale and small-scale HPAPI production environments.

System Architecture and Design: Four-Storey Superskid Configuration

This arrangement enables a compact footprint while maintaining clear segregation between process, utility, and control systems, supporting safe, ergonomic, and compliant operation.

The Superskid’s four-tier vertical design optimizes spatial efficiency and workflow separation:

Top Level

Contained Charging Areas with High Alloy Pipework.

Middle Two Levels

Core process operations including reaction, product transfer, and seeding

Lower Level

Final product isolation and drying, with dedicated space for the integration of future technologies and process enhancements

Containment and Safety

Achieving OEB 5 containment (<1 µg/m³), the Superskid employs full barrier and isolator technologies to protect operators from exposure to potent APIs.
Designed to ATEX Zone 1 standards, the system ensures safe operation in potentially explosive atmospheres, extending its suitability for a wide range of hazardous chemical processes.

Materials and Construction

All process equipment, including reactors, transfer panels, and isolators, is constructed from high-alloy or glass-lined materials, ensuring exceptional corrosion resistance, cleanability, and compatibility with aggressive chemistries.
Leak-tight, cleanable transfer systems guarantee secure product movement between process stages, maintaining both containment and product integrity.

Project Details

BCD provided end-to-end engineering and design services, delivering a complete turnkey system

•    155 Lines between reactors and Transfer Stations
•    50 Lines between Floors
•    4 reactor Vessels
•    Fixed and Mobile HPAPI Containment Isolators

Advanced Automation

Equipped with a DeltaV distributed control system (DCS), the Superskid delivers full process automation, recipe management, and real-time data monitoring. This ensures consistent process performance, traceability, and data integrity in compliance with FDA and EMA data standards.

Modular Flexibility

Its pre-engineered modular design enables scalable deployment, allowing rapid installation and reduced commissioning time. Modules can be configured to suit specific chemistries and process requirements, supporting crystallization, filtration, drying, and other critical HPAPI operations.

Regulations

Regulatory and Operational Compliance

Every aspect of its design, from material selection to automation, has been validated to meet global standards for safety, containment, and quality assurance.

The HPAPI Superskid is fully compliant with:

Current Good Manufacturing Practice (cGMP)
FDA and EMA regulatory guidelines
ATEX Zone 1 requirements for hazardous environments
OEB 5 containment standards for high-potency materials