The cleanroom and laminar airflow workbench are certified bi-annually by a third-party to ensure proper function

• A class 5 environment is utilized for critical areas where compounded sterile preparations (CSPs) are exposed to air in the physical environment.
• Viable and non-viable air particles are sampled bi-annually.
• Entire facility temperature, pressure, and humidity are monitored daily to ensure correct working conditions.
• Detailed cleaning and disinfecting of the cleanroom environment and surrounding areas occurs at the correct intervals.
• All surfaces disinfected with sampling and assessment.
• Appropriate expiration and Beyond-Use-Dating given to all products.
• All compounding personnel are required to complete 40 hours of third party aseptic training.
• All batches are tested for sterility and endotoxins.
• Bubble point filter integrity performed.
• All compounding personnel are evaluated routinely for proper aseptic technique, handwashing, garbing, and cleaning.
• All compounding personnel are challenged with media-fill or process-simulation tests which mimic an actual entire compounding procedure to evaluate their capabilities and identify any weaknesses.
• All finished CSPs are checked by a licensed pharmacist before they are dispensed to ensure that the preparation is sterile and accurate.