PURPOSE
- To determine particle counts pertaining to FED-STD-209, ISO 14664 and USP Chapter 797.
United States Pharmacopeia has issued a new chapter on sterile compounding, which became effective on January 1, 2004. This replaces the previous chapter, <1206> Sterile Drug Products for Home Use, and has been re-numbered to reflect that Chapter 797 is now considered a standard requirement that may be enforced and cited by JCAHO, the FDA and state boards of pharmacy.
PROTOCOL
An APC Plus (Airborne Particle Counter) will be used to make on-site determinations for .5 Micron particle numbers. Real time readings will be taken at various source locations, in cubic meters to provide an integrated average particle count.
HEALTH CHOICE will also determine air exchange rates (where applicable) by measuring ventilation supply air flow in locations where the monitoring is performed. An alnor flowhood will be used to obtain the air flow measurements. An alnor velometer or smoke tubes will be used to determine positive / negative airflow (where applicable).
