Minimize production downtime in the cleanroom

Employees of the STZ EURO conducting requalification measurements on-site at the customer's location.

Employees of the STZ EURO during maintenance work on-site at the customer's location.

Benjamin Pfändler. Head of the Steinbeis Transfer Center for Energy, Environmental, and Cleanroom Technology.

(Re-)Qualifications and maintenance in cleanroom technology often take days or even weeks. Production or cost pressures are making long maintenance intervals increasingly difficult to accommodate. The STZ EURO responds with preparatory planning, digital technologies, and experienced measurement teams. This way, expert qualification measurements and time-saving implementation can be combined.

Not only for officially required requalifications according to EU-GMP guidelines or FDA Aseptic Guide should appropriate time windows be reserved. Also for maintenance to maintain the functionality of machines and systems. This leads to production downtime and costs time and money. The available time windows are therefore kept quite tight. To ensure that the quality of the work performed does not suffer, the STZ EURO implements requalifications in close coordination with the operator and based on different strategies.

If usage changes occur or machines and systems are adjusted, airflow and the purity of the room can also potentially be affected. These interventions in the cleanroom are calculated in advance by the STZ EURO using CFD simulations. "Simulations clearly show us what flow-related influences cause changes. Without entering the cleanroom, we can precisely determine in advance which changes need to be made during maintenance intervals. This saves a lot of time. Not only through efficient execution but also because we can identify potential problems beforehand, which might only have appeared after implementation," says Benjamin Pfändler, head of STZ EURO.

The results from the simulation are ultimately incorporated into preparatory planning, followed by remodeling measures and final qualification. "The better maintenance can be planned, the more time-efficient and high-quality requalifications can be carried out," adds Benjamin Pfändler. This clearly involves defined steps for execution, the technologies used, and personnel deployment. "We also perform requalifications during shift operations if necessary to reliably adhere to the available time," says Benjamin Pfändler. Good planning and a knowledgeable team familiar with the site are crucial to complete activities on-site without long coordination times.

For example, even during the COVID-19 pandemic, direct contact could be minimized while still adhering to the tight schedules required to carry out routine requalification measurements in the sterile production of a pharmaceutical company without issues. "I was still able to work from home and relied on the fact that the staff at STZ EURO delivered the tests under GMP conditions with the usual high quality. The engineers know the building, understand what needs to be done, and adhere to the current hygiene concept," says Alexander Hein, Qualification, Validation, Utilities, Maintenance & Monitoring of the pharmaceutical company.

Apart from organizational performance, STZ EURO also emphasizes technical consulting. Cleanroom technology is subject to constant changes in standards and guidelines, as the currently updated Annex 1 of the EU-GMP guideline demonstrates. Knowledge of these changes can save the customer a lot of time. Adjustments can be implemented gradually and time-efficiently during general maintenance intervals before the standards come into force. "By combining technologies, knowledge, and an experienced team, maintenance intervals can be optimized in terms of time," concludes Benjamin Pfändler.