GMP or GFSI sterile are ISO certified spaces in the medical and food industries with strict quality assurance. Highcare has been designing, manufacturing and installing ready-to-use cleanrooms for more than 30 years.
Why GMP or IFS certification?
The process for a GMP or IFS certificate begins well before the start of cleanroom installation. In GMP– or IFS–certified spaces, the emphasis is on internal processes and operator behavior.
A GMP or IFS certificate is more than a stamp: it is the result of a carefully constructed quality system. Consider preparing manuals, training staff, establishing cleaning routines and scheduling periodic validations. This requires expertise and dedication.
A well-designed system prevents errors, improves safety and increases efficiency. So it is crucial to choose an experienced vendor who specializes in building quality systems with reliable hardware.
GMP EMA certification for cleanrooms
Highcare cleanrooms are used for research, production and/or as packaging areas. For pharmaceutical applications, the GMP EMA certification standards (Grade A through D). These standards are mandatory for applications in the human, veterinary, cosmetic and pharmaceutical industries.
IFS certification, BRC and other food safety requirements
In the food industry and hospitality sector, quality requirements as defined in the IFS certificate and BRC, both recognized by the GFSI (Global Food Safety Initiative). Visualizing the internal process requires the necessary attention and covers a significant part of the process to be validated.
Good design starts with the basics
A good cleanroom design starts with the right choices in construction, airflow and use of materials. Only then is a room created that not only meets the standards, but is also durable, practical and future-proof.
Cleanroom airflow technology
One of the key features of a Highcare cleanroom is its ingenious airflow technology. We supply metal air-conditioned cleanrooms with a unique ventilation system based on a flush and sanitary design, which ensures complete flushing of the room.
Purified air is blown in through the ceiling and exhausted at plinth level, washing the room clean with air, so to speak. Thanks to this seamless design and the high-quality technical installation from recognized European manufacturers, the clean rooms are easy to clean and continue to meet the strictest hygiene requirements.
The continuous flow of filtered air is kept in optimal condition 24/7, and you have full control over the necessary standard and classification, such as ISO 6 or below. Moreover, the whole process is easily monitored remotely, so we can guarantee a stable and pleasant working environment.
Box-in-box cleanroom & stand-alone systems
A Highcare-cleanroom box-in-box system is stand-alone and is built under a freestanding moveable mezzanine floor, the mezzanine floor. The technical installation is placed on that mezzanine floor. We keep contaminating equipment outside the cleanroom. This demountable box-in-box system makes it possible to make repairs or adjustments locally without completely halting the production process.
Highcare builds in accordance with the latest technology, the IFD system. Our cleanroom systems are fully demountable and have a short construction time thanks to the modular composition. Modifications are easy to carry out due to the click-click-ready system, possibly with your own personnel and therefore at low cost.
GMP certificate: Longevity
The combination of smart airflow, modular design and sustainable construction principles makes our cleanrooms not only practical and flexible, but also a value-saving investment. Because cleanrooms with GMP certificate are subject to strict quality assurance, we use only durable materials specially selected for these applications. This guarantees a long economic lifetime. A Highcare cleanroom therefore offers more than operational efficiency: it is a future-proof solution that grows with your organization.
Let us know how we can help you
Highcare Cleanrooms is at your service with punctual realization and the shortest possible construction time. We build internationally certified cleanrooms, including air treatment, and deliver them completely ready to use. With a customer satisfaction rate of 78% and a second project with more than 65% of our customers, you choose for experience and trust.