Usp 797 Clean Room Temperature And Humidity Requirements

Secondary engineering control requirements by usp chapter 797 risk level low risk l ante area an iso class 8 see table 21 1 or cleaner area where personnel hand hygiene and.

Usp 797 clean room temperature and humidity requirements.

Revision as yet unproposed in pf of usp s definition for controlled room temperature from 20 25 to 2 30. 30 hours at room temperature 7 days at cold temperature and 25 days in a solid frozen state at 20 c or colder. While usp 795 and usp 797 focus on the quality of patient outcome by producing compounds. Specifically usp published revisions to general chapter 797 pharmaceutical compounding and sterile preparations and published a new general chapter 800 hazardous drugs handling in healthcare settings.

Standards for compounding sterile preparations usp 797 helps to ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity strength and potency. Minimum standard for pharmacies in hospitals. It describes a number of requirements including responsibilities of compounding personnel training environmental monitoring. In june 2019 the united states pharmacopeia usp released several new and revised pharmacy compounding standards.

These requirements are addressed in usp 797 with revisions that call for a standard of a continuously maintained temperature of 20 degrees c 68 degrees f and 60 percent humidity. The design of stability studies during pharmaceutical product development and registration takes into account expected supply chain storage and distribution conditions in anticipated markets. Usp 797 changes with engineering controls removal of references to hazardous drugs defined temperature relative humidity requirements 20 c 68 f or cooler 60 rh no in room humidifiers or de humidifiers defined interval for environmental monitoring monthly 5. Usp 797 guidelines minimum requirements for validation.

Personnel validation three consecutive media fill runs without contamination. 33 other professional organizations also provide guidance on specific aspects of compounding. Temperature and humidity gauges mounted in the room see appendix 1. Standards for prescribing preparation.

Usp 797 clean room guidelines standards. Low to medium risk. Practices28 31 32 and a discussion guide on usp chapter 797 17 and has recognized usp chapter 797 as a relevant practice standard in the ashp guidelines. 5 as described in usp chapter 797 for exposure of critical sites and must be in table 21 2.