Containment Solutions for High-Potency APIs: Meeting OEB 4 & 5 Standards with Schematic Engineering Industries

Handling high-potency active pharmaceutical ingredients (HPAPIs) requires advanced containment systems to ensure product integrity and operator safety. With rising demand for targeted therapies and cytotoxic compounds, manufacturers must meet stringent safety standards without compromising process efficiency. Schematic Engineering Industries provides tailored containment solutions that support safe handling of HPAPIs in line with OEB 4 and OEB 5 requirements.

‍

Why HPAPIs Require Strict Containment

HPAPIs are effective at very low doses, which makes them therapeutically powerful—but also hazardous if inhaled or absorbed by operators. Even microgram-level exposure can lead to serious health risks, including mutagenic or carcinogenic effects.

Uncontrolled handling of HPAPIs can result in:

• Occupational exposure risks for plant operators.
• Cross-contamination between product lines.
• Regulatory non-compliance and operational shutdowns.

Schematic Engineering Industries addresses these challenges by engineering barrier isolators, glove boxes, and integrated material transfer systems designed specifically for HPAPI processing environments.

‍

Equipment That Meets OEB 4 and OEB 5 Standards

Occupational Exposure Bands (OEB) categorise the level of protection required based on a compound's toxicity. HPAPIs typically fall within OEB 4 (1–10 µg/m³) and OEB 5 (<1 µg/m³), demanding highly contained systems.

Schematic Engineering Industries provides equipment solutions engineered to meet or exceed these containment thresholds, including:

• Rigid Barrier Isolators
  Fully enclosed systems designed for blending, sampling, or dispensing operations. These isolators offer operator protection through air filtration (HEPA/ULPA), negative pressure environments, and integrated decontamination features.
• Flexible Containment Systems
  Lightweight enclosures for interim containment or secondary control layers. Ideal for weighing or charging applications, these systems offer modularity without sacrificing performance.
• Split Butterfly Valve (SBV) Systems
  Designed for transferring materials between containers and process vessels while maintaining containment integrity. SBVs reduce the risk of dust escape and help ensure closed-loop handling.
• Glove Boxes for HPAPI Handling
  Precision-engineered containment units for small-scale or R&D operations, equipped with ergonomically positioned glove ports and optional nitrogen inerting or integrated weighing systems.

All containment systems from Schematic Engineering Industries are validated to ensure performance under simulated worst-case scenarios, confirming they meet defined OEB levels.

‍

Best Practices for Operator Protection

Ensuring operator safety during HPAPI processing extends beyond equipment— it requires a comprehensive approach that includes training, procedural control, and ongoing monitoring. Schematic Engineering Industries supports clients by integrating the following best practices into every solution:

• Closed Transfer Systems
  Reduce the need for open manual handling of potent materials. These systems are essential for charging, discharging, and sample collection.
• Airflow Control and Pressure Differentials
  Use of negative pressure environments with safe-change HEPA filters to prevent airborne contamination.
• Automated Cleaning and Decontamination
  CIP/WIP (Clean-in-Place/Wash-in-Place) systems ensure equipment can be safely cleaned without operator intervention, reducing downtime and exposure risks.
• Ergonomic Design
  Optimising operator comfort and accessibility reduces human error and fatigue in long handling sessions.
• Real-Time Monitoring and Containment Validation
  Containment performance is regularly monitored using surrogate testing or particle count analysis to confirm compliance.

Schematic Engineering Industries incorporates these principles into every custom containment solution, ensuring that clients meet regulatory standards while protecting their workforce.

‍

Industry Applications of HPAPI Containment

Containment solutions provided by Schematic Engineering Industries are deployed across a variety of pharmaceutical processes, including:

• Micronisation and Jet Milling – Where airborne dust levels are critical to control.
• Tablet Coating and Dry Granulation – Requiring closed systems to avoid operator contact.
• API Weighing and Dispensing – Demanding precision handling within enclosed systems.
• Final Packaging and Fill-Finish Operations – Involving high-value, potent products that must remain contaminant-free.

Each solution is tailored to fit into existing workflows while maintaining compliance with EU GMP, US FDA, and occupational health standards.

‍

Contact Schematic Engineering Industries Today

Need containment systems that meet OEB 4 or OEB 5 standards for HPAPI handling? Contact Schematic Engineering Industries for customised solutions that prioritise operator safety and process control.