Standard Operating Procedures (SOPs) and Quality Assurance: Develop and implement SOPs for all compounding activities, including preparation, labeling, storage, and disposal of compounded sterile preparations, and perform quality control measures such as sterility testing, endotoxin testing, and beyond-use dating.Ĭlosed System Transfer Devices (CSTDs), such as EQUASHIELD’s CSTD product line, play a crucial role in reducing the risk of exposure and contamination while complying with USP 800 and USP 797 guidelines.Facilities and Equipment: Design compounding areas that are segregated from other activities, with proper equipment such as laminar airflow workbenches or biological safety cabinets, and adhere to controlled temperature and humidity conditions.Environmental Quality and Control: Maintain defined air quality standards using primary engineering controls, and regularly monitor the compounding environment to minimize contamination risks.Personnel Qualifications and Training: Ensure that all staff involved in sterile compounding have appropriate training, demonstrate competency through assessments, and follow strict hygiene protocols. Personnel involved in sterile compounding must undergo proper training and demonstrate competency through written and practical assessments while adhering to strict hygiene protocols. These regulatory requirements address critical aspects, including personnel qualifications, training, and hygiene environmental quality and control facilities and equipment standard operating procedures (SOPs) and quality assurance and documentation. USP 797 4 is a comprehensive set of standards designed to ensure safe compounding practices for sterile preparations. Specific requirements mandated by USP 797 guidelines include:
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