USP Chapter <797> Regulations

Sterility Assurance

Process/Control	USP <797> (Effective June 1, 2008)	PharMEDium
Verification of all Compounded Preparations	Verification of Compounding	EXCEEDS 200% verification includes a Batch Verification Scanning System linking batch documents and applicable components through bar code technology
Personnel Qualifications on Aseptic Technique	Annual Qualifications	EXCEEDS Quarterly Qualification
Clean Room / Compounding Area	ISO 7/ISO 5	MEETS/EXCEEDS
Gowning	Change after each shift	EXCEEDS Fresh sterile gown upon reentry to clean room
Gloves	Intermittently resanitize sterile gloves	EXCEEDS Sanitize sterile gloves prior to all aseptic manipulation
Glove Microbial Monitoring	Annual	EXCEEDS Monthly
Microbial Sterility Testing with Media Fills	Not Mentioned	EXCEEDS Daily
Sterility Container / Closure Integrity System	Not Mentioned	EXCEEDS All Container Closure Systems
Port / Vial Stopper Sanitization	Sterile 70% IPA	EXCEEDS Two step sanitization method, last step is Sterile 70% IPA
On Going Sterility Monitoring	Batch Testing	Weekly Testing - Most demanding processes
Process Flow based on Design of Clean Room and Support Areas.	Recommends Primary Engineering Controls	EXCEEDS Design includes hands free entry and pass through doors
Non Viable Particles	Semi Annual	EXCEEDS Monthly
Viable Air Sampling	Routine Using Volumetric Air Samplers	EXCEEDS Daily
Viable Surface Testing	Routine	EXCEEDS Daily
Process Validation Through Media Fills	Not Mentioned	EXCEEDS Initial and semi annual validating all aseptic processes incorporating process flow, all container closure types, equipment, maximum batch size, etc.