Providing Contaminant-free Environments for Pharmaceutical Drug Compounding
Compounding pharmacies prepare personalized prescription medications from individual ingredients mixed together in the exact strength and dosage required. Compounded medications can include capsules or tablets, creams or gels, and injectables. Because the risk of infection is greater with injectables, they must be prepared according to strict standards established by the United States Pharmocopeia (USP) Chapter 797 regulations for compounding sterile products.
Based on these standards, 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 that could cause infection in patients. Containment air filtration systems are essential to ensuring an environment free of dangerous microbial contaminants for compounding drugs safely.
Single Source Manufacturing and Expertise in Critical Pharmaceutical Applications
Containment filtration systems are designed, developed, and manufactured to exact standards for control of microbial contamination in compounding pharmacies. High quality, customized total containment filtration systems manufactured by a single source ensure maximum performance reliability in adherence with required ISO Class 5 standards for clean air.
AAF Flanders specializes in the design, manufacturing, and testing of complete, custom containment filtration systems incorporating HEPA filters with maximum filtration efficiency for a virtually particulate-free environment to prevent contamination of compounded drugs. These systems also contain fan filters units, terminal modules, and Model 22 hoods (PharmaGel™ modules) for fail-safe filtration.
AAF Flanders’ leading expertise in critical applications and single-source, total system approach ensure compliance with stringent regulatory requirements for clean air and sterility, providing an environment free of microbial contamination that could lead to serious and deadly infections in patients.