EMA GMP cleanroom for the pharmaceutical industry: state-of-the-art workspaces. The cleanrooms are delivered with an air treatment system.
All materials used are specially selected and allowed to be used in an EMA GMP cleanroom. A Highcare is composed of metal ceilings and wall segments with a hollow air cavity for piping, along with large glass facades, these are the ideal building materials for a sterile cleanroom; flat and sleek.
Sterile rooms that professionally meet all set requirements such as easily cleanable, inert and flush. With the unique air technology in a Highcare, a room is fully conditioned and flushed clean.
Sterile
Drugs are developed, manufactured and improved in Highcare’s ultra-clean EMA GMP cleanrooms. The quality of a drug can never be fully determined by analyzing its composition. Not all possible impurities can be detected and not every pill can be analyzed. Therefore, quality can only be guaranteed if the entire production process is also carried out in a precisely prescribed and controlled manner. It goes without saying that in the pharmaceutical industry, contamination or contamination must be prevented at all costs. This is made possible in part by ingenious ventilation technology.
Aeronautics
Highcare Cleanrooms’ carefully designed air technology has a clean-rinse effect. The metal (and glass) walls and ceilings are inert and therefore do not absorb contaminants, these are hygienic, strong and easy to assemble and disassemble. The products used fit within a documented cGMP quality assurance system. Air purified by HEPA filters is blown in through the metal ceiling and extracted again at plinth level. The room is continuously flushed clean.
Flush and Plumbing
When building a cGMP cleanroom for the pharmaceutical industry, it is essential that the rooms be “flush and sanitary. Not only must a cleanroom be easily, properly and quickly cleanable, the materials and workmanship used should be aimed at ensuring that dust, bacteria and contamination cannot be left anywhere, even invisibly.
Floors must be seamless, surfaces smooth and corners rounded off, preventing the accumulation of dirt, which can form a breeding ground for bacteria, fungi or parasites. The air blown in is streamlined, recirculated through an aerodynamic line and extracted without obstructing flow obstacles.
Air Quality
Air quality can be represented by three related factors:
1. the number of colony-forming units (CFU) per m3 of circulating air
2. the sedimentation rate of bacteria on surfaces, expressed in CFU/m2/hour or in CFU/dm2/hour ((NEN-EN-ISO 14698-1).
3. the number of particles in the circulating air, expressed in particles/m3, bacteria bearing or not, and subdivided by size of particles.
Relevant questions for a cleanroom design are
- dress discipline, mouth guard/overalls/shoes
- room temperature, 19°C
- relative humidity, 55%
- air changes, >20
- pressure cascade, 5 Pa
- ISO classification, ISO 7
- filter cascade, G4/F8/HEPA
- interlocks
- lux, 600 lux
- light temperature, 840
- internal heat load, 1.5 kW
- utilities per room, compressed air/XCDA/drinking water,…
- ESD floor