EU GMP Annex 1, introduced in 2023, provided a more holistic and risk-based approach to sterile production. It introduced a Contamination Control Strategy (CCS) which identifies, assesses, and controls all potential sources of contamination.
As sterile products gain momentum, the equipment on which they are produced is facing a new era of scrutiny. Mirroring the holistic approach to contamination control, equipment vendors will also need to consider the containment and associated automation holistically.
At 3P innovation, we specialise in designing and building advanced manufacturing solutions for pharma and life sciences. We’ve seen firsthand how regulatory pressures and technological innovation are reshaping how contamination control is embedded directly into equipment design. No longer an afterthought, contamination control is now a core design principle.
Barrier systems
Contamination risks in pharmaceutical production arise from several sources, with human interaction being the main source of cleanroom contamination.
It is no accident that systems where the product is open to the environment, and by inference to the operators are increasingly being consigned to history. Annex 1 therefore, promotes the use of closed systems and barrier technology.
open Restricted Access Barrier System (oRABS) provide a barrier between the product and the operator but enable frequent operator intervention. oRABS rely upon the existing cleanroom environment to provide the level of cleanliness, while also incorporating physical barriers.
Increasingly critical operations are being conducted within an isolator due to the fact that they can be operated in a lower class of cleanroom. The increased up-front capital cost of the isolator is compensated by the long term reduction in operating costs.
Barrier systems necessitate access to the process via validated transfer systems such as rapid transfer ports (RTP’s), Hydrogen Peroxide airlocks, no touch transfers or glove ports. Manual interventions need to be minimised and also need to be practical. This in turn means ergonomic mock-up’s are no longer a “nice-to-have” they are an essential tool.
What is the “First Air” principle
The first air principle refers to uninterrupted unidirectional airflow between the surface of the HEPA filter, which removes contaminants, and the critical product/surfaces. Unidirectional airflow is where the air flows in a single, consistent direction, whilst minimising turbulence.
To minimise turbulence in the critical zone, the process area is typically
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