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.
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>.
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.
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.
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.
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.
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.
Interlocked ISO 7 pass-throughs allow the movement of materials through classified environments without compromising the buffer area, helping to preserve sterility assurance.
Our patient medication undergoes multiple 0.22-micron pharmaceutical-grade filtration steps, including filter integrity testing, using an automated filter integrity testing machine.
Immediately after compounding, each syringe is inspected against lighted white and black backgrounds under normal and UV light for visible particulates or other foreign matter. All AIS Healthcare staff performing these visual inspections are specially trained at spotting particulates and must undergo visual inspection competency testing as well as annual vision and color-blindness exams.