At AIS Healthcare, we prioritize investing in proprietary technologies that help us achieve higher levels of quality and sterility. Our sterilization equipment runs 30-minute cycles multiple times per day, holding between one to 200 syringes, allowing us to sterilize what we need to, when we need to.

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

Our responsibility to our patients and providers doesn’t end when the syringe is mailed. We ship via first-class overnight air, which means patients across the country get their medication the next morning. We also monitor potential weather-related delays and proactively adjust when and how we ship medication, including shipping from our redundancy operations or using another shipping route, to make sure patients’ prescriptions arrive on time.

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

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. 

By following aseptic processing with terminal sterilization, we can offer 21- to 45-day BUD (average 34 days) on all patient-specific prescriptions for 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.

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 more than 60 air changes per hour, AIS Healthcare standards are twice the USP <797> requirement.

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. We also work with industry leaders to help us find new ways to go above and beyond.

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.

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.