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 sterile preparations are of high quality. Ameridose follows standards set by the USP and is able to provide you with the best in preparation quality.

Exceeding USP Chapter <797> Requirements
Stability Program All Ameridose product lines have undergone real-time stability testing and have been assigned an expiration date, in compliance with USP <797> requirements.
Training A comprehensive training program is in place for all Ameridose personnel and is overseen by the QA department in compliance with  USP <797> requirements.
Media-fill Monitoring Clean room personnel must complete initial and annual media-fills to ensure rigorous aseptic technique, meeting USP <797> requirements for media-fill monitoring.
Gloved Fingertip Monitoring All clean room personnel must pass initial and periodic gloved fingertip sampling to ensure ideal garbing and disinfection technique. Touch plate sampling of gloved fingertips is performed daily on personnel involved in Ameridose admixing, exceeding USP <797> requirements for gloved fingertip monitoring.
Environmental Monitoring Surface and air quality are monitored daily in the clean rooms, exceeding USP <797> requirements for environmental monitoring.
ISO 5 Hoods Hood air and surface samples are taken daily in compliance with internal SOPs and exceeding USP <797> requirements for hood sampling.
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, temperature, and humidity, meet specifications.

Use of a rotational disinfection program ensures an exceptionally clean environment. Our cleaning practices exceed USP <797> cleaning requirements.

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