HIGH POTENCY APIS mitigation. Engineering controls aim to reduce or eliminate operator exposure by implementing advanced containment technologies, robust equipment design and an appropriate facility layout.
It is important that the engineering team works in close collaboration with the operational team to integrate containment considerations from the earliest design stages. This ensures alignment between process requirements, equipment capabilities and containment performance expectations. In addition, closed process design is treated as a fundamental engineering control within the containment strategy as it minimises exposure potential at the source.
Operational controls rely on standardised procedures and protocols for handling highly potent compounds, supported by trained personnel to ensure the safe and consistent execution of activities within these engineered systems. PPE is used to address residual risk but is not the primary means of protection.
Containment is not a productionfloor safeguard alone but an endto-end control strategy spanning the full manufacturing lifecycle. This extends to all supporting activities, including warehousing( sampling and dispensing), process development, quality control laboratories, maintenance and waste handling. Each representing potential exposure scenarios to potent compounds, intermediates, residues or contaminated surfaces.
Containment at source
In accordance with the hierarchy of controls, engineering controls should be prioritised over operational measures to ensure effective and reliable exposure mitigation. Primary containment provides the most effective and reliable means of exposure control by physically isolating personnel from the product, thereby reducing reliance on operational controls and PPE.
Primary containment includes closed sampling and dispensing systems, high-containment isolators and barrier technologies, closed material transfer systems, contained discharge technologies, equipment-integrated containment solutions and contained analytical sample preparation. Central to the effectiveness of these systems is interface and connection design, ensuring leaktight integration between equipment components.
During the selection and design of primary containment systems, cleanability and decontamination requirements are treated as integral criteria to ensure safe and sustainable operation. Primary containment solutions should be compatible with cleaning strategies such as cleaning-in-place to enable effective removal of high-potency
Airlock & degowning shower in the production area residues while minimising system breach and manual intervention.
In addition to engineered containment technologies, process design represents a fundamental form of primary containment. By embedding containment principles directly into the process, exposure risks can be minimised or eliminated.
This can be achieved through strategies such as in situ drying, sampling or cleaning, process analytical technology( PAT) for in-line process monitoring and telescoping to maintain closed transfer between process steps. The design principles should be incorporated from the early process development through scale-up into commercial manufacturing to ensure the containment approach is consistent, scalable and robust across the entire product lifecycle.
JUL / AUG 2026 SPECCHEMONLINE. COM
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