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Clean-rooms depend on the avoidance of microbial contamination to function effectively. It is of no consequence how advanced the equipment in a clean-room is if the people who operate it are not well trained. The positive effects of HEPA filters, carefully regulated airflow, step-over benches and other contamination-control interventions can be negated by workers lacking awareness, skills or motivation. Staff members pose the greatest risk to the sanitation of a clean-room – but are equally the greatest resource. They play a critical role in the successful manufacture of sterile products.

Causes of Contamination

Inconsistent and incorrect use of Personal Protective Equipment (PPE), such as gowns and gloves, has been found to be a major cause of increased levels of microbial contamination in clean-rooms. In addition, the following common problems have been identified:

• Infrequent hand sanitation (not washing hands before or after manipulating products)
• Poor personal hygiene (in general)
• New workers lacking practical training (so-called “rookie” mistakes)
• Fatigue on the job, leading to mis-judgements and mistakes
• Rushing to meet production deadlines, leading to carelessness and mistakes
• Improper cleaning techniques - leaving equipment dirty
• Clean-room temperatures not being adequately regulated – leading to sweating (a contamination risk)
• Introduction of influenza and other pathogens to clean-rooms by staff who enter the rooms despite being ill
• Lack of appropriately sized gowns and other PPE

Need for Appropriate Training

In order to resolve these issues, clean-room managers need to ensure that all clean-room personnel have a comprehensive understanding of the potential consequences of their behaviours and workplace processes. Simply instituting extra training focussed on correct methods – the “how” of the clean-room, will not suffice. Training needs to cover the “why” as well. Without an awareness of consequences, workers may not be motivated to remedy problematic habits.

 For training to be effective, it needs to include detailed modules in the following:

• Aseptic technique – learning effective sterilisation methods and sterile work processes
• Gowning technique – for correct use of PPE
• Environmental monitoring – to ensure protection of the surroundings
• Basic microbiology – to foster an awareness of how micro-organisms function and risks involved
• Personal hygiene – in general
• Cleaning techniques – for PPE, tools and equipment
• Sampling of products
• Storage of tools, products and equipment in the clean-room
• Documentation – how to properly record and check all processes
• Line building and stripping
• Approved interventions when manipulating products
• Charging of compounds
• Transfer of equipment, product or other items into and within the clean-room
• Working with critical equipment
• Expectations of primary and support operator roles regarding equipment
• Appropriate movement in the clean-room

For the last point, workers need to have a clear understanding of the first air principle – the importance of moving slowly and deliberately so as not to disturb the air flowing from a HEPA-filtered source (a primary means of keeping the clean-room free of contamination). Training cannot take place in the clean-room itself, but the conditions should be simulated to be as realistic as possible.

Refresher training in the above should be facilitated frequently, and all clean-room personnel should complete annual qualifications in media filling and gowning technique. Verbal acknowledgement and ongoing constructive feedback are good supplementary ways of affecting and reinforcing positive changes in behaviour, and reward systems for compliance have potential too. It is also advisable to monitor clean-room activities using cameras. As an added precaution, workers can be sampled upon exiting the clean-room to check for levels of microbial contamination.

The financial consequences of microbial contamination of products in a clean-room can be significant; entire batches of an order may be rejected because of small amounts of contamination. Clean-room workers hold great responsibility, and they need to be aware of what that entails.