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Optimising single-use cleanrooms through associate training

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Timothy Korwan, director, new product introductions, Avantor, describes how using a dedicated training room can ensure the reliability and quality of single-use (SU) systems.

Key insights:

The rapid growth of single-use (SU) systems in pharmaceutical and biopharmaceutical production processes has introduced efficiencies into drug manufacturing workflows; it has also introduced new challenges for SU manufacturers. Single-use manufacturers must expand to meet global demand.

However, even with redundant suppliers and facilities, manufacturers — and, by extension, their customers — face substantial risks if manufacturing errors disrupt workflows or yield SU products that do not meet safety and performance requirements.

In order to maximise throughput and meet customisation goals for SU technology customers, SU manufacturers need to reduce contamination risks while limiting changeover times. This needs to be done in environmentally controlled cleanroom environments with associates wearing the appropriate personal protection equipment (PPE) specified for that cleanroom and product assembly process.

In addition, SU manufacturers scaling up to meet surging demand must maintain a reliable supply chain while ensuring that single-use systems meet rigorous quality standards for component qualification, contaminant-free assembly operations, in-process testing and final product release (including proper packaging in aseptic delivery containers).

However, it’s important to recognise that SU manufacturing is still largely a manual assembly process conducted in cleanrooms with little automation. For this reason, it is highly susceptible to disruption by human error. Due to the critical nature of the drugs produced using SU technology, the most stringent quality controls to prevent contamination must be maintained with little room for error.

In practice, this means that even a simple mistake or an accidentally skipped step could result in the entire assembly process needing to be restarted to ensure that the final product meets the highest quality product standards and follows requirements established with the end-user drug manufacturer.

The value of a dedicated cleanroom training program

One way to help satisfy these stringent requirements is through a training program that centres on a dedicated cleanroom training facility. In this approach, the training room mimics the production line in a controlled cleanroom environment and uses rejected, returned or non-cGMP-compliant materials that would otherwise be wasted.

This kind of program can provide an immersive, applicable training experience in all major aspects of SU assembly practices and procedures in use in production sites. New associates would receive training based on a carefully developed curricula that guides them through the SU manufacturing process from start to finish, with all the same tools used in an actual cleanroom.

The program can be conducted by trainers with strong backgrounds in quality production and the training curricula, providing immersive, hands-on training that guides the development of the highest-quality production skills and professionalism, while providing value through dedication and continuous attentiveness to all the associate’s needs.

By ensuring all associates operate from the same knowledge base, the training room offers a major contribution to further standardising production. This not only results in a happier and more responsible workforce (helping manage retention rates), but it also contributes to a reduction in manufacturing errors. If a problem arises on the production line, well-trained associates are primed to identify it quickly, reducing the impact on production.

This kind of training resource can also have a broad impact on SU manufacturing areas such as IT, sales, engineering and product management. For example, if a customer requests samples or engineering is analysing a modification to an existing assembly, the training room can fulfil these needs without requiring engineers to enter working cleanrooms, preventing disruptions or contamination risks.

Ultimately, SU manufacturers that depend on cleanroom assembly facilities can experience significant improvement in quality control, productivity and workforce satisfaction through investments in training facilities.

Dedicated cleanroom training facilities can become a robust component of the workforce development process and can provide a significant impact on the ability of SU manufacturers to supply their customers with products that fully meet their critical drug development and manufacturing needs.

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