Finished Pharma Products (Injectables & Orals)
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.
"One of the most crucial and important factors to take into account when constructing an air quality system is the air handling unit (AHU). To maintain good indoor air quality at all times, you have to choose the right filter for your specific AHU. The proper air filters for your air handling unit (AHU) will keep your business operating at a profit, guarantee food safety, keep the air your employees breathe clean and free of contaminants, help you save money, and extend the life of your HVAC system."
"To keep the process chamber at Class 100 (ISO 5) quality, HEPA filters are installed on the air intake, the exhaust and in the recirculation wall of the sterilization units.HEPA filters used for intake, exhaust and also in the side walls. Side wall filters provide distinct advantages and also helps in maintenance and validation. Filtration takes place just before the air enters the sterilization chamber so that Class 100 (ISO 5) conditions are ensured. "