USP 797

Exceeding USP Chapter <797> Requirements

The U.S. Pharmacopeia's (USP) Revised General Chapter <797> Pharmaceutical Compounding - Sterile Preparations establishes process standards to ensure that compounded sterile preparations are of high quality. Ameridose meets or exceeds standards set by the USP and is able to provide you with the best in preparation quality.

Stability Program	All Ameridose preparations have undergone real-time stability testing and have been assigned an expiration date. The program exceeds USP <797> requirements.
Training	A comprehensive training program is in place for all Ameridose personnel and is overseen by QA department which exceeds USP <797> requirements.
Media-fill Monitoring	Personnel who perform compounding activities must complete initial and bi-annual media fills to ensure rigorous aseptic technique, exceeding USP <797> requirements.
Gloved Finger Tip Monitoring	All compounding personnel must pass initial and periodic gloved finger tip sampling to ensure ideal garbing and disinfection technique. Touch plate sampling of gloved finger tips is performed daily on  personnel involved in Ameridose admixing, exceeding USP requirements.
Environmental Monitoring	Surface and air quality are monitored daily in the clean rooms and hoods, exceeding USP requirements.
ISO 5 Hoods	Hood air and surface samples are taken in compliance with USP and internal SOPs.
Clean Room Area	Ameridose clean room air quality monitoring standards exceed the requirements for a USP-recommended  ISO 7 class 10,000 environment  when tested during production. Through a state-of-the-art HVAC system, clean rooms are monitored 24 hours a day to ensure all critical parameters, such as pressure and velocity, meet specifications. Air and surface quality are monitored through a robust environmental monitoring program. Use of a rotational disinfection program ensures an exceptionally clean environment. Our cleaning practices exceed USP<797> cleaning requirements.