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.
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.
All staff members put persistent germicidal on their hands and two sets of sterile gloves—one white pair over one green pair. That way, a potential tear in the white gloves will be immediately visible and allow the staff member to fix the issue before any skin is exposed.
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.
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. A third-party, independent lab tests all bulk ingredients for potency and endotoxins. Endotoxins cannot be removed through filtration or sterilization in the compounding process. To ensure we always have the ingredients we need on hand, our contract with our supplier guarantees us a one-year supply—and we have a backup supplier as well.
All stock solutions are kept in quarantine for 14 days in a secured, temperature-controlled environment while testing is being conducted to avoid any contamination and ensure quality.
Our patient medication undergoes multiple 0.22-micron pharmaceutical-grade filtration steps, including filter integrity testing, using an automated filter integrity testing machine.
Only pharmacists compound medication at AIS Healthcare, and shifts are limited to two hours to ensure optimal focus. All of our pharmacists are specially trained in high-risk sterile compounding, and our Pharmacists in Charge have completed the CriticalPoint QP503A program. Written competency exams and media-fill procedure and aseptic technique testing are administered every six months, and unannounced glove fingertip testing is conducted monthly.
When we walk, every step releases around 215,000 particles—bacteria, dust and other contaminants—into our surroundings. Before they enter the anteroom, staff members remove their shoe coverings using a hands-free, externally vented, pneumatic shoe cover remover. Then, upon entry into our anteroom, everyone immediately steps onto a Dycem® contamination control mat. This electrostatically charged, antimicrobial floor covering retains up to 99.9% of foot and wheelborne particles, helping to remove any outside contaminants potentially on staff facility shoes. Another shoe covering is then applied. Only then are staff members ready to cross the line of demarcation—embedded in the floor, not taped, to avoid any contaminants in the adhesives.