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.
All staff members put persistent germicidal on their hands and two sets of sterile gloves—one white pair over one colored pair. That way, a tear in the white gloves will be immediately visible and allow the staff member to fix the issue before any skin is exposed.
AIS Healthcare performs preventive maintenance on its cleanrooms and conducts HEPA filter leak tests quarterly—twice as frequently as required by industry standards—helping us address any potential issues before they arise.
AIS Healthcare requires that the USP-grade active pharmaceutical ingredients all come from FDA-registered manufacturers. An outside, independent lab tests all bulk ingredients for potency. To ensure we always have the ingredients we need on hand, our contract with our supplier guarantees us a one-year supply.
In here, all staff members cross the first line of decontamination and continue taking extra steps to ensure maximum sterility.
The last stop before the compounding room, this is where all employees outfit themselves to exceed sterility standards when near patient medication.