All procedures are performed by highly trained and qualified licensed pharmacists and technicians specializing in sterile product preparations. All pharmacy personnel responsible for preparing sterile products receive both didactic and experiential training in sterile product preparations and are routinely validated for proper aseptic technique. In-house rapid microbiological technology provides immediate, highly sensitive assessment of aseptic techniques.
Cantrell Drug Company meets or exceeds the requirements necessary to prepare high-risk sterile products according to USP Chapter ‹797›. Quality assurance processes within this risk level are the most stringent of the drug product classifications designated by USP. Documented quality assurance policies and procedures provide the foundation for all processes performed at Cantrell Drug Company in order to ensure the final product has the identity, strength, purity, and quality that it is represented to possess.
All aseptic manipulations are performed in a Class 100 environment using High Efficiency Particulate Air (HEPA). Cantrell Drug Company's state-of-the-art facility includes two certified ISO Class 5 cleanrooms and one certified ISO Class 6 cleanroom. Cleanrooms and laminar airflow hood are certified for operational efficiency every 6 months by an independent certification agency. Weekly environmental testing is performed, monitored, and acted upon as necessary. Daily clean down procedures are strictly followed and documented.
Appropriate end-product testing, including sterility testing, is performed according to USP ‹797› & ‹71› guidelines. Rapid Microbiology via Laser Scanning Cytometry is offered for most aqueous solutions, providing immediate, same-day sterility results-accurate down to one single microbe. Quantitative analysis is performed per USP requirements on each batch to determine concentration of the active ingredient(s). Potency testing is performed by an independent, FDA registered laboratory.
Ingredients used in compounding procedures are determined to be stable, compatible, and appropriate for use, according to manufacturers' and USP guidelines. Certificates of Analysis are received from manufacturers for chemicals used in pharmacy-prepared medicines. Tests are performed according to USP ‹797› & ‹71› guidelines. Components and finished products undergoing end-product testing and remain in quarantine until testing results are received and reviewed by a compounding pharmacist.
