Staff members change into dedicated facility shoes—provided by AIS Healthcare and replaced regularly—when they walk into the isolation room. Then they use a hands-free shoe barrier applicator (BootieButler®) to put new shoe covers over the facility shoes to avoid cross-contamination on the walk to the next stop, the anteroom.

All AIS Healthcare formulary medications undergo terminal sterilization via autoclave. Each syringe gets enough heat and steam to kill all theoretical bioburdens that may be present in that environment. Published data has confirmed that terminal sterilization achieves a sterility assurance level of 1:1,000,000.

Our responsibility to our patients and providers doesn’t end when the prescription is compounded. We use express shipping to ensure patients across the country receive their prescriptions 7 to 14 days before the scheduled surgery date. We also monitor potential weather-related delays and proactively adjust when and how we ship medication, including using another shipping route, to make sure patients’ prescriptions arrive on time.

By following aseptic processing with terminal sterilization, we can offer 21- to 45-day BUD (average 34 days) on all patient-specific prescriptions for formulary medications within maximum concentrations. These extended BUDs are supported by rigorous testing by a third-party, independent laboratory for sterility, stability, container closure integrity, pH, endotoxins, leachables and extractables.

In the prep room, all makeup and visible jewelry is removed. Staffers with accepted permanent cosmetic modifications, like microbladed eyebrows or eyelash extensions, have a disclosure form on file to help our quality team know they’re in compliance. 

Throughout the entire compounding process, including terminal sterilization, our independent internal quality department reviews our work and methods to help us continually improve safety and quality. This team reports directly to our CEO and COO. We also work with industry leaders to help us find new ways to go above and beyond.

The gowning room, which is not required by industry standards, meets ISO 7 standards for air quality. This extra controlled room acts as yet another barrier between the compounding process and the outside world, helping to further ensure sterility and minimize particle generation during the garbing process. With approximately 60 air changes per hour, AIS Healthcare standards are twice the USP <797> requirement.

Barcode scanning and wireless technology, including wireless tablets, are used throughout the pharmacy, allowing staff members to manage and fulfill prescriptions without any paper. This helps reduce the risk of transcription errors and reduces potential sources of particle contamination in the cleanrooms.

Quality starts here. In this room, we go above and beyond to stop outside contaminants from getting inside the cleanroom.

Before entering the buffer room, all staff members must be completely covered, with no exposed skin. In the gowning room, everyone puts on sterile, full-body, non-shedding garb that is enclosed at the neck and has sleeves that fit snugly around the wrists. The garb includes an integrated hood and a mask is donned to cover the face. Employees also put on sterile goggles and knee-high boot covers as an extra measure of protection. The entire garbing process takes about 15 minutes.