A guide to risk assessments for cleanroom containment

Published: 29-Apr-2024

Risk assessment is a crucial component of any manufacturing process. Gabriela Mikhaiel from Dec Group discusses the key ways it ensures the well-being of workers and the quality of products

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The objective of risk assessment, especially in drug production, is to proactively identify potential hazards, their likelihood of occurrence and the magnitude of harm they could cause to workers.

By understanding these risks, manufacturers can implement appropriate control measures to prevent or minimise their impact.

According to the law, employers are responsible for evaluating and managing the risks associated with exposure to harmful ingredients. Between 2017 to 2022, for example, Directive 2004/37/EC — as part of the OSH Framework Directive 89/391/EEC — has enacted four amendments to introduce stricter thresholds for various carcinogens and expanded its applicability to include reprotoxic substances as well as carcinogens and mutagens.

Areas such as connections between process stages/equipment can pose a significant risk

Furthermore, adapting to technical progress and implementing engineered solutions, as opposed to personal protective equipment (PPE), is another established principle of the Framework Directive.

Assessments should be done periodically and the relevant data must be provided to the appropriate authorities on request. Efforts must be made to prevent workers being exposed to harm and to employ closed technological equipment systems.

Key considerations for an effective containment strategy

When it comes to implementing an effective containment strategy, several crucial factors must be considered. The first step is to categorise the product within the appropriate occupational exposure band (OEB).

This allows for a clear understanding of the risks associated with handling the product and establishes the necessary precautions that need to be taken (Figure 1).

Determining the occupational exposure limit (OEL) is essential when setting a safe handling threshold. This limit indicates the maximum concentration of the substance that a worker can be exposed to in a specific time without experiencing adverse effects.

Operated in negative or positive pressure, depending on the process, isolators will protect workers and ensure the sterility of ingredients

The quantity of the product also plays a significant role when it comes to defining the containment strategy. Handling large quantities may require additional safety measures and specialised equipment.

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