Validation and classification follows after a specialized technician has commissioned the cleanroom installation and checked all machine settings. Only after this is in order does the independent accredited body start its investigation and check the ISO requirements in accordance with Nen 14644.
Basically, the audit consists of answering the question;’Does the cleanroom reliably deliver what was agreed?’ After this audit, you will receive the ISO certification with classification. Validation and classification result in an internationally recognized certificate. The report consists of approximately ten pages and additional documentation on the equipment used and possibly the electronic printout of all measured results per room.
Additionally, a variety of additional investigations can take place such as:
– Differential pressure measurement for determination of pressure hierarchy between rooms (pressure cascade)
– Differential pressure measurement for measurement of filter fouling;
– Flow rate measurement for ventilation and (re-)circulation;
– Air velocity measurement for determination of unidirectional flow and dispersion;
– Integrity test HEPA filters with photometer or particle counter for determination of leak tightness;
– Particle concentration measurements for dust classification;
– Particle concentration measurements for recovery time measurement;
– Microbiological sampling to determine the number of KVEs (air/sedimentation/surfaces);
– Visualization of air flow patterns with demiwater mist;
– Temperature and relative humidity measurements and dew point determination;
– Brightness, noise and CO2 measurements.
What determines which surveys are important? In general, this question is best answered by the buyer of your products and services. Nen 14644 is limited to dust classification and pressure cascade between spaces.
GMP or GFSI certificate
Purchasing a cleanroom is not just hardware. For cleanrooms GMP or GFSI, the certification process begins even before the cleanroom is installed. It takes time and energy; converting a tight regime into a quality manual is a labor-intensive job. Describing internal procedures, training personnel, cleaning protocols, maintenance procedures, validation frequencies, etc, etc. A quality system in which a Highcare Cleanroom is the choice for reliable hardware. With over 25 years of experience in designing and manufacturing modern sterile rooms.
What is good design?
A flush and sanitary design makes this process easier and in a Highcare with a high-quality technical installation from recognized European manufacturers, conditioned filtered air keeps the room in the right condition 24/7 and remotely you can monitor it. Highcare guarantees a pleasant stable working environment and has been for more than 25 years.
Economic lifetime
Highcare provides metal air conditioned clean rooms with a unique air ventilation technology for a complete flushing of the room. All materials used are specially selected for this application. A Highcare guarantees a long economic lifetime. Thanks to its modular composition, the system is fully dismantleable and construction time is short. A Highcare is mobile.
GMP EMA
Highcare cleanrooms are used for research, production and or packaging space. GMP EMA Grade A through D, are the standard quality assurance for the human, veterinary, pharmaceutical and cosmetic industries.
HACCP, IFS, 22,000
In the food industry and hospitality sector, quality requirements as defined in ISO 22000, IFS, BRC or HACCP are used.Visualizing the internal process requires the necessary attention and covers a considerable part of the process to be validated.
Highcare builds internationally certified cleanrooms; including air treatment and delivers ready-to-use. See also <ISO 14644>.
Airflow technology
Ingenious airflow is one of the hallmarks of a Highcare cleanroom. Using a unique technique, purified air is blown in through the ceiling and extracted at plinth level. A GMP cleanroom should be flush and sanitary, “washing” a room clean with air, so to speak. Metal cleanrooms are easy to clean. A sound technical installation guarantees a continuous flow of filtered air. You determine the necessary standard and classification. Commonly used classifications are ISO 6 or lower.
Box-in-box stand alone
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. Modifications are easy to carry out thanks to the demountable click-click-ready system, possibly with your own personnel and therefore at low cost.
GMP cleanroom strict quality assurance
GMP Cleanrooms have strict quality assurance. The system therefore consists of durable materials. The complete cleanroom with the mezzanine floor is demountable and easy to reassemble. HIGHCARE builds in accordance with the latest technology, the IFD system.
Highcare Cleanrooms is at your service. Punctual realization in the shortest possible construction time.