"The pharmaceutical industry is one of the most heavily regulated industries with quality management systems that have a direct impact on the ultimate quality of finished products. FDA regulates pharmaceutical cleanrooms and requires that they meet certain standards for design, construction, use, and testing. FDA has also set up strict requirements for air purity levels within the pharmaceutical industry to minimise the threat of airborne contamination. The performance of installed air filters, whether terminal filters or prefilters, or HEPA filters/ ULPA filters, directly impacts how effectively harmful contaminants are prevented from entering the airstream in process environments."
The air in the compounding area must meet ISO Class 5 standards for clean air, which specify the number of particles permitted per cubic meter of air, to prevent microbial contamination. No degree of contamination is acceptable, as it could lead to severe harm or even life-threatening risks to the patient. Spectrum filers are designed and manufactured to exact standards to control microbial contamination in pharmaceutical industry.
Pharmaceutical cleanrooms are necessary to prevent contamination and ensure consistent drug quality. Cleanrooms are classified according to the number of particles per cubic meter at a specified particle size. The FDA regulates pharmaceutical cleanrooms and requires that they meet certain standards for design, construction, use, and testing. Spectrum filters meet the FDA requirements for the certification of pharmaceutical cleanrooms.
Air Filtration Systems for Laboratories are designed to improve air quality within the laboratory or office in order to protect health of personnel, which in certain cases can even be fatal. Scientists study infectious agents, bacteria, viruses, parasites and toxic substances at bio safety labs. As the bio safety level increases, the need for quality and precise filtration becomes a priority to ensure most stringent safety precautions are followed.