All of our stock solutions are prepared by a licensed pharmacist and tested by a third-party, independent lab for sterility, potency, particulate matter, pH and endotoxins before use in compounding.
Tamper-evident syringes are first put into an amber bag for light protection, and then sealed in a shipping tube which can be surrounded by bubble wrap. The shipping tube is then placed in an International Safe Transit Association–certified box with tamper-evident tape and other proprietary safety precautions. Our shipping containers have undergone temperature-tracking studies to ensure compliance with USP <659>.
Interlocked ISO 7 pass-throughs allow the movement of materials through classified environments without compromising the buffer area, helping to preserve sterility assurance.
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.
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.
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.
All 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.
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.
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.