TRU Global Solutions, a Belgium-based cleanroom and equipment cleaning company previously named TRU Cleanroom Cleaning, has entered the US market.

TRU is the only company in the Benelux dedicated entirely to cleanroom and equipment cleaning.

The company launched in 2019, and soon after, in 2023, expanded into the Netherlands.

TRU has seen a quick rise in business in its five years of business. This strategic focus on a niche market was an instant hit and paved the way for TRU’s entry into the US market.

“Our expertise is opening a lot of doors in the United States, where more companies are engaged in cell, gene and tissue engineering than anywhere else in the world,” explained Vanessa Morini, co-founder and CEO of TRU.

“Cleanroom and equipment cleaning are not standardised tasks. They call for a specialised approach,” Morning added. “In addition to cleaning, we also offer consultancy and training services. Based on comprehensive audits, we can identify procedural issues and provide tailored solutions.”

A new collab

TRU is also making its mark in the US by entering into a joint venture with US-based Pharma Resource Group (PRG), a product development and complex technical consulting for the pharmaceutical sector.

Morini said: “They focus on the inside of pharmaceutical production equipment and we focus on the outside.”

“It’s a mutually beneficial relationship. After several meetings and studies, our shared commitment to innovation was what really solidified our decision to join forces,”  Morini continued.

“For the first phase, we’re focusing on just three states: Delaware, New Jersey and PRG’s home state of Pennsylvania. These states are among the top five hubs of the life science industry,” Morini said.

“We’re even developing our own online platform to accurately track all cleaning activities, thereby saving time, money, and frustration,” Morini added.

Different geographies

Morini is aware of the challenges of entering a new market.

“Standards are much lower in the US compared to Europe and most companies have their own cleaning crew,” she explained. “On the other hand, there are plenty of gaps in the market for us to fill.”

Morini said that in Belgium and the Netherlands, the cleanroom cleaning business is dominated by large cleaning companies, but TRU managed to carve out a spot at the top.

CleanSpace Cleanrooms has helped Single Quantum fix an air quality issue in its hi-tech cleanroom.

Single Quantum is a provider of “single photon detection technology”.

The Netherlands-based company’s light-sensitive productions have now been used by more than 200 academic and industrial laboratories worldwide to perform complex optical measurements.

Netherlands-based CleanSpace (not to be confused with the US-based company), was brought on board after a single large lab space was divided into several smaller spaces at Single Quantum.

Following this change, there started to be complaints about the air quality in these new spaces in Delft.

“There appeared to be increased production rejection due to regular contamination of the measuring equipment,” CleanSpace explained. “Single Quantum then asked CleanSpace Cleanrooms to what extent this could be prevented in a cost-effective manner.”

CleanSpace’s work included improving the air quality in the lab areas and protecting the process.

CleanSpace explained that it distributed the available air over the different rooms, so that each room had its own cooled and filtered air intake.

“In order to properly remove the heavier particles in particular, a low extraction of air from the rooms was desirable,” the company explained. “For the extra clean, particle-free production area, we recommended a wall-to-wall downflow unit, which allowed the various process steps to be protected against particle contamination under an extremely clean laminar air flow.

CleanSpace also advised that users in critical areas wear adequate, non-marking cleanroom clothing.

At the end of January 2024, the project was delivered and Single Quantum was satisfied.

ABN Cleanroom Technology, a provider of pre-engineered cleanroom solutions for industries such as healthcare and pharma, has reached the end phase of constructing a new SterCube VELOX outdoor cleanroom unit.

The project entails a SterCube VELOX with multiple hot labs and QC labs on the inside.

SterCube VELOX is a mobile cleanroom solution for outdoor use, meant for high-end studies at nuclear sites, so it is often called a Lab2Cube.

The classification of this cleanroom is cGMP Grade D.

To create a VELOX, ABN Cleanroom Technology configured several SteriCube compartments to become a fully functional cleanroom area with all needed utilities for a critical nuclear environment such as CDA, O2, N2, and Denim Water.

Jo Nelissen, CEO of ABN Cleanroom Technology, said: “The great thing about our SteriCube VELOX solutions, is that we never have to start our projects from scratch, but that we can configure our virtual and physical building blocks that are off-the-shelf available.”

“With this project approach, we are able to deliver a fully operational cleanroom and BSL on site in just 12 weeks -from quotation to hand-over to the customer,” Nelissen continued.

“SteriCube VELOX is currently one of our best-selling products due to its highly configurable and temporary character. We have previously installed multiple of these units on nuclear sites, which makes it a proven solution for operators working in that field,” Nelissen concluded.

The cleanroom is assembled in ABN Cleanroom Technology’s manufacturing hall and transported to customers in separate parts.

Further, as a result of its design for modularity and circularity, there was no waste of materials when separating the units for transport.

At the customer’s site, the separate parts were assembled back together after which ABN Cleanroom Technology’s Validation Department started its validation activities.

Also, a SteriCube always comes with an online monitoring system, which in this case was CleanConnect.

This allows the nuclear operator to always have insights in the parameters of the cleanroom area.

In addition, ABN Cleanroom Technology pointed out that in this type of working environment, safety is crucial. Therefore, measurements need to be real-time with alarms going on when environmental limits are exceeded.

Featured speakers at the 2024 ISPE Aseptic Conference will be health representatives from Australia, Europe, and the US.

The representatives from these national regulatory agencies will discuss current issues in aseptic processing from a technical perspective and the latest developments in aseptic and sterile manufacturing.

These featured speakers will also provide clarifications and weigh in on key learnings from the initial steps towards the implementation of Annex 1.

Attendees will have the opportunity to submit questions to the panellists.

The featured speakers are representatives from the following:

• Austrian Agency for Health and Food Safety (AGES/Austria)
• Regierungspraesidium (RP) Tübingen in Germany
• Swissmedic in Switzerland
• Therapeutic Goods Administration (TGA) in Australia
• United States Food and Drug Administration (US FDA)

The confirmed featured speakers are:

Christina Meissner, GMP Inspector at the Austrian Agency for Health and Food Safety (AGES)

Meissner said: “As a representative of the Austrian Competent Authority, I will be reporting on the status of the implementation of Annex 1.”

“There will be specific examples of best practices, but also of areas where the industry needs to improve,” Meissner continued.

 

Daniel Muller, Head of GMP Inspectorate at Regierungspraesidium (RP) Tübingen in Germany

Muller said: “As a German regulator, I will be talking about our experiences in inspections since Annex 1 came into effect in August 2023.”

Muller will be discussing the areas where RP have seen good strategies of implementation, common hurdles for implementation, and where the industry has to improve.

Maria Löflund, Site Head Manufacturing Vienna at Takeda

Löflund said: “ISPE provides a great platform for exchanging knowledge and best practices with other companies on current and important industry topics.”

“I am looking forward to the 2024 ISPE Aseptic Conference in March and the valuable discussions on aseptic processing and implications of Annex 1 changes to the industry, as well as welcoming visitors to our Takeda production site in Vienna to share insights into our technologies and processes,” Löflund added.

 

Alexander Herzog, Secretary General of PHARMIG in Austria

Herzog said: “My talk will focus on the contribution of the pharmaceutical industry in Austria to world health.”

The 2024 ISPE Aseptic Conference will bring together leading professionals from several industries including:

• Pharmaceutical and biopharmaceutical manufacturers
• Technology providers
• Academic scientists
• International regulators

LR Pure Systems, a specialist in the field of high-tech solutions for ultra-high-purity gas and fluid systems, has doubled its cleanroom capacity at its site in Heimerdingen (Baden-Württemberg), Germany.

The additional ISO 6 Class cleanroom area enables the commissioning of another state-of-the-art system for cleaning components, such as those used in wafer processing or technical gas supply.

CAT Clean Air Technology supported  LR Pure Systems, its long-time partner with the implementation of this expansion project.

“The high requirements for the chemical cleanliness of the cleanroom in accordance with DIN EN ISO 14644-8 proved to be a challenge in the planning phase, and in the implementation phase above all the floor height of the existing building,” CAT Clean Air Technology said in a LinkedIn post.

“Repeatedly, pipes had to be rebuilt during ongoing production operations in order to optimally position the plenum and the filtration technology and to maintain the required height in the approximately 115 sqm cleanroom. The connection of the existing cleanroom systems also required coordination skills and flexibility from all those involved!”