Reliable cleanroom monitoring thanks to Rotronic RMS

Due to increased regulatory requirements, DendroPharm GmbH, a company operating in the pharmaceutical sector, had to upgrade its cleanroom. In order to reliably measure temperature, humidity, and pressure, and monitor them in accordance with GMP, the company now relies on the Rotronic Monitoring System (RMS) from DwyerOmega.

DendroPharm GmbH is a biotechnology company focusing on innovative drugs based on nanomaterials. It develops, produces, manufactures, and analyzes semi-solid and liquid formulations for the human and veterinary markets. The Berlin-based company was founded in 2013 by Dr. Sam Dylan Moré and has been growing ever since. Its goal is to improve the effectiveness of drugs and reduce side effects.

In order to meet the increasing requirements in the pharmaceutical environment, the biotech company has gradually built up a hygiene zone in recent years with the aim of upgrading to a Class C clean room. This is mainly used for non-sterile production steps and preparatory process phases. With a view to future projects, including possible expansion into the Chinese market, the area had to be retrofitted with a modern monitoring system for temperature, humidity, and pressure. This requirement was also set by the Berlin State Office for Health and Social Affairs (LAGeSo) for the upcoming inspection. A negative assessment would have significantly restricted production. Fortunately, it did not come to that: the team of inspectors was impressed by the solution and accepted it without reservation.

Efficient monitoring system

While searching for a suitable monitoring system, DendroPharm came across the Rotronic Monitoring System (RMS) from DwyerOmega on several occasions. After an initial discussion with Sales Manager Jan Wendel, the decision was quickly made, as Managing Director Sam Moré explains: "We were looking for a reliable and affordable system that would meet our current requirements. We found that in the RMS." Alternative suppliers were out of the question: "Other systems were significantly more expensive and offered functions that we didn't need. A simple, clear monitoring system was important to us," he continues. Another advantage is that the existing infrastructure can continue to be used, so there was no need to install a new ventilation system. Since DendroPharm has so far been largely financed by research funds for the development of new formulations based on nanotechnology, and the service area for the manufacture of non-sterile drugs for third parties will not start until the first quarter of 2026, cost efficiency was a key factor.

High time pressure

The biggest challenge of the project was the tight timeframe: there were only two weeks between initial contact and installation. "That was an ambitious target for us too," recalls Jan Wendel. However, he and his team were able to master it without any problems. "DendroPharm had very precise ideas about what they needed, which simplified the process," says Jan Wendel.

Both sides are extremely satisfied with the collaboration: "The contact and the process were very straightforward. We quickly had a contact person who accompanied us through the entire process," says Sam Moré.

There is an additional challenge in that the hygiene zone is not in continuous operation. Monitoring is therefore carried out specifically during production times and not around the clock. "This also works with the RMS, even though we are currently still working on a more elegant switching solution," says Leo Sagurna, who was responsible for coordinating and installing the RMS at DendroPharm.

Clear software and expandability

The user interface of the dashboard also impresses DendroPharm GmbH and Leo Sagurna in particular: "The software is very clear, the operation is intuitive, and the measured values are easy to understand."

In addition, the RMS can be expanded as required. "It was essential for us to purchase an expandable system. We plan to equip another room with the RMS next year," says Leo Sagurna, who uses the system the most.

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Additional Information

Environmental monitoring is critical to GMP processes
Pharmaceutical Temperature Monitoring
Rotronic Monitoring System Overview