What is required for sterile preparation areas?
The following basic production and process controls are required for all sterile preparation production areas: • ISO Class 5 air quality in the direct compounding area or DCA. • Environmental controls and procedures on topics as diverse as air quality in the buffer areas, procedures for the area entry, materials movement and storage, gowning, hair covers, etc., hand washing, personnel behavior, area clearance between batches etc. • Housekeeping procedures • Visual controls • Microbial and particulate monitoring Note that there are separate recommendations for safe handling of hazardous drugs that should be reviewed and addressed prior to undertaking a facility redesign.
The following basic production and process controls are required for all sterile preparation production areas: • ISO Class 5 air quality in the direct compounding area or DCA. • Environmental controls and procedures on topics as diverse as air quality in the buffer areas, procedures for the area entry, materials movement and storage, gowning, hair covers, hand washing, personnel behavior, area clearance between batches etc. • Housekeeping procedures • Visual controls • Microbial and particulate monitoring Note that there are separate recommendations for safe handling of hazardous drugs that should be reviewed and addressed prior to undertaking a facility redesign.
