ColPro Technical Solutions has built a cleanroom in Katwijk (North Brabant) Netherlands on behalf of Unica Building Services Venlo.

Unica Building Services manages and maintains all building-related installations. The company coordinates the complete management and maintenance of buildings in combination with carrying out tests and inspections.

The wall panels were made in ColPro’s monoblock system on plinth construction in its factory in Almelo and installation was carried out by its own field service technicians.

Although it is a relatively small cleanroom with a lock, it has affected various components from walls including return panels and flush glass cassettes to ceiling systems and frames with doors equipped with a Maasland interlock system.

The panels were produced in the ColPro Technical Solutions factory in Almelo and installation was carried out by its own field service technicians and have an Advantica L-Control coating in white RAL 9010. Although it is a relatively small cleanroom with a lock, it has affected various components from walls including return panels and flush glass cassettes to ceiling systems and frames with doors equipped with a Maasland interlock system.

In a significant leap towards advancing cleanroom technology, ColPro Technical Solutions has recently unveiled its state-of-the-art cleanroom facility in Katwijk, Netherlands. The facility promises to be a game-changer in the realm of cleanroom solutions, catering to diverse industries with its advanced features and cutting-edge technologies.

CleanRooms International (CRI) – a leading manufacturer of state-of-the-art cleanroom solutions, is delighted to announce that it has been selected as the trusted partner to design and equip cutting-edge ISO 7 Sterile Processing Cleanrooms for Instrumentum.

Instrumentum is an outsourced provider of sterilisation services for surgical instruments in advance of surgeries, raising the quality of sterilisation and quantity of surgical instruments available for surgery centres and hospitals. The rapidly emerging service allows surgery centres and hospitals to focus their efforts on core competencies and their resources toward better patient care by outsourcing instrument sterilisation to a trusted, specialised service partner. Instrumentum established their new headquarters in The Research Park at Florida Atlantic University in Boca Raton, FL and is an emerging leader in this arena.

The ISO 7 Sterile Processing Cleanroom is a pivotal component of Instrumentum’s mission to uphold the highest standards of sterility, ensuring patient safety and health. CleanRooms International is dedicated to meeting this vital need by providing a custom cleanroom solution tailored to the exacting requirements of Instrumentum’s proprietary sterile processing solutions.

“We are honoured to complete the first project for Instrumentum, and to be chosen as their cleanroom partner for future expansion,” said Tim Werkema, President and CEO of CRI. “Our team is fully committed to delivering a cleanroom that not only meets but exceeds the stringent standards of sterile processing. We recognise the critical role of this cleanroom in ensuring patient safety and will spare no effort to provide a solution that matches the exacting needs of Instrumentum.”

“CleanRooms International is a trusted name in the cleanroom industry. We are proud to partner with CleanRooms International due to their commitment to quality and delivering a state-of-the-art cleanroom solution customised to our specific needs,” said Dan Johnson, CEO of Instrumentum. “The fact that they manufacture the majority of the cleanroom components in their builds was a determining factor during the evaluation process.”

This partnership between CleanRooms International and Instrumentum marks a significant milestone in the journey towards improving the standards for sterilisation services provided to the healthcare industry in the United States. Use of third-party sterilisation service companies has already become a normalised practice in several other countries around the world, and this partnership will now provide those services in the US.

Conducting the sterilisation process in a protected and certified environment that is built by CleanRooms International is empowering Instrumentum to deliver best-in-class medical device sterilisation services to surgery centres and hospitals and raise the bar for accountability in delivering “Sterile Every Time”.

SMC has expanded its manufacturing capabilities with the completion of a new cleanroom in Noblesville, Indiana.

The cleanroom footprint is approximately 25,000 sqft, or half a football field, and is designed with a modular aluminum honeycomb wall system which allows for layout versatility and future expansion or modifications to the cleanroom.

The modular construction also facilitates the progression of cleanliness as an operator will put on a cleanroom suit, covered from head to toe, in an ISO 7 room, and move through air locks to progressively arrive at the ISO 5 cleanroom work areas.

“After successful construction of our cleanroom, operating and maintaining the working conditions within it will be where SMC must apply extra care. An ISO 5 cleanroom must always meet minimum standards across the five fundamental parameters to be defined a proper facility for human comfort. These five are: temperature, humidity, airflow, filtration, and pressure.

For example, the recommended temperature for ISO 5 is 68°F (+/- 2°) for operator comfort when wearing a cleanroom suit and PPE. Relative humidity must be set at a level higher than 30% and lower than 50%; an RH below 30% will create static electrostatic discharge which can damage components or attract particulate matter, and above 50% will promote biological contaminates such as mold or bacteria growth,” said Chad Bosler, VP of Operations.

“Our ISO 5 cleanroom will be manufacturing and assembling high purity components essential to semiconductor chip manufacturing as well as food grade products for the food and beverage industries.

All our clean components are assembled and packaged in a work environment where HEPA filtration covers 70% of the ceiling areas with a downward airflow that circulates and changes the inside air 360 times per hour while maintaining an outward positive air pressure compare to the adjacent room,” said Senior Engineer, Garrett Flora.

SMC’s cleanroom construction is only one of many future capital investment projects on its corporate campus in its expansion pipeline. Over the next ten years, its plan is to increase current employment of 850 workers by 35% to about 1,157 employees and invest a total of $30.2 million in industrial facilities at its headquarters by 2032.

In a significant leap towards advancing cleanroom technology, ColPro Technical Solutions has recently unveiled its state-of-the-art cleanroom facility in Katwijk, Netherlands. The facility promises to be a game-changer in the realm of cleanroom solutions, catering to diverse industries with its advanced features and cutting-edge technologies.

ColPro Technical Solutions’ commitment to excellence in cleanroom environments is evident in the meticulous design and construction of the new facility. Situated in Katwijk, a strategic location known for fostering technological innovation, the cleanroom is poised to meet the stringent requirements of various sectors, including pharmaceuticals, electronics, and biotechnology.

The facility boasts a comprehensive suite of features designed to maintain optimal cleanliness levels. From advanced air filtration systems to precise temperature and humidity controls, every aspect has been carefully considered to ensure the highest standards of cleanliness and performance. This dedication to quality aligns with the industry’s increasing demand for sophisticated cleanroom solutions.

Notably, the Katwijk cleanroom is equipped to handle a wide range of processes, from research and development to manufacturing and testing. The flexible design of the facility allows for customisation, enabling clients to tailor the cleanroom environment to their specific needs and industry standards.

ColPro Technical Solutions has a longstanding reputation for delivering innovative cleanroom solutions, and the Katwijk facility stands as a testament to their commitment to excellence. As the demand for cutting-edge cleanroom technology continues to grow, this new facility is well-positioned to play a pivotal role in meeting the evolving needs of industries requiring precision and cleanliness.

With its strategic location, advanced features, and commitment to quality, the ColPro Technical Solutions cleanroom facility in Katwijk is set to be a beacon of innovation in the field of cleanroom technology. As industries strive for un compromised quality and adherence to strict standards, this facility emerges as a key player in shaping the future of cleanroom solutions.

A Clean Room, or cleanroom, is a laboratory environment that ensures that airborne particles are maintained at a very low concentration. This room is isolated, actively cleansed, and prevented from contamination from a range of particles and biological material including dust, airborne organisms, or vaporized particles. These rooms are necessary to protect human health and industrial product assembly, and their primary aim is to prevent the release of whatever particle is being handled inside it. They are highly specific environments as several parameters are controlled.

Requirements For Setting Up a Cleanroom

It is the responsibility of the manufacturers and research labs to meet minimum requirements and standards that apply in their geographical region.

Manufacturers and research laboratories must remain vigilant to changes to the international standards and be able to respond to them appropriately. There are a comprehensive set of requirements and regulations that have been described in documentation. The most common/ ubiquitous of these include:

• Cleanroom air monitoring system: as air quality is a critical determinant of cleanliness and air quality, enabling particle thresholds and therefore regulations to be adhered to.
• Continuous testing for contaminant particles: the average person in a cleanroom can add 100,000 0.3 microparticles per minute while in a standing position. Mitigating the risk generated as a result of particle production begins with testing such particles to determine strategies to prevent the build-up of excess particulates. The choice of filtration systems is dependent on the type of work, the personnel, and the quantities of particles generated in the cleanroom workspace.
• Written procedures: To prevent harm to the users of any products generated in a cleanroom, contamination prevention measures need to be documented and submitted to the appropriate regulatory agency. Regulators require documentation as proof of preventative contamination strategies applied to both the product itself and the process used to generate it.

The development of more complex products, including device miniaturization under nanotechnologies will increasingly present new challenges for cleanroom manufacturers. It is believed that automation will be used to leverage manufacturing, with the early implementation of automation in the assembly process enabling a low-cost means of ensuring cleanliness. It is also believed that artificial intelligence and machine learning can increase quality standards and reliability.