Displaying items by tag: pressure
Controlled environments act as secluded clean spaces for performing select applications in a manner that protects the internal samples or materials and/or the workers involved. Air pressure is a key component of a cleanroom. The internal pressure and, by design, the differential pressure, are closely regulated and maintained. Basic chemistry tells us that high pressure air has greater mass than low pressure air, and given the opportunity, will flow into the less dense environment.
Rooms for critical processes i.e. cleanrooms as well as mini environments demand precise environmental monitoring technology and methods in order to operate consistently within specifications. This is not just about meeting standards, but more importantly about the quality of your products e.g. pharmaceutical medicines, semiconductor chips, or manufacturing processes. Robust and highly accurate differential pressure instruments from Novasina address pressure measurement challenges and help with the smooth operation of your cleanroom facilities.
In any cleanroom facility the flow of clean air must ensure that the critical areas are maintained within international standards, to achieve this clean air should be cascaded from the cleanest areas to the least clean areas. This in turn is achieved through the use of pressure differentials between one area and the next.The purpose of the pressure differential test is to verify that the design and installation of the clean room system is suuficient to maintain the specified pressure difference between the clean areas and their surroundings.
Between rooms of different cleanroom classes, pressure differences between 5 and 20 Pa must be ensured from cleaner room to less clean room. The minimal positive pressure of the cleanroom ensures that no air flows back into the cleaner area from the unclean area when doors are opened. The lowest contamination-level cleanroom itself is also accessed via airlocks for personnel and materials, where strong air currents stir up the particles present and extract them via filter systems. According to DIN EN ISO 14644-3, the pressure difference of a cleanroom to the personnel and material airlocks, to any cleanrooms of other purity classes as well as to the surroundings, must be tested. A test of differential pressure at the filter should also be carried out.
For preventing cross-contamination coming from adjacent areas, several guidelines refer to a positive room-pressure of about 5- 20 (10-15) Pascals (Pa) as an essential factor for airflow from higher cleanliness to a lower cleanliness graded area under static conditions. To manufacturers of pharmaceutical products and the authorities controlling them, this cascaded pressure regime and room pressurization is seen as an essential element in preventing contamination (migration of particles) from adjacent outside areas.
Qualification tests are carried out to guarantee optimum product quality from all manufacturing and pharmaceutical research companies. These tests verify whether ambient cleanroom conditions affect product quality. If environmental cleanroom parameters affect the product, reviews are conducted with regards how conditions can be reduced, so that high output standards are adhered to.
Differential pressure refers to the difference in air pressure from one location to another within a system. In cleanrooms, maintaining the right amount of differential pressure—either positive or negative—is essential to preventing contamination.
In most large-scale FDA-regulated pharmaceutical manufacturing operations, it is required that the product be manufactured in a clean room classified between Class 100 and Class 100,000. In an operation where medical tubing is being extruded, the classification would likely be Class 100,000. In a process where inject-able drugs are being manufactured, the classification would most likely be Class 100 or Class 1000.