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  • USP chapter <797>, Sterile Preparations for Pharmaceutical Compounding, details the quality standards, conditions and procedures for compounding sterile preparations (CSPs) of drugs and nutrients in a cleanroom
  • USP >797> defines a cleanroom as a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class
  • A cleanroom standard is enforced to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality
  • Cleanroom classes vary based on the nature of the operation (ISO 14611-1:999 – Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness)
  • The following products are recommended solutions for sterile preperations for compounding pharmacies