In the event of a power outage, AIS Healthcare has a diesel generator and enough emergency fuel to keep our facilities running—and our pharmacists compounding. In addition, multiple prepaid emergency fuel contracts with multiple vendors would ensure a steady supply of fuel to our pharmacies.
Our environmental monitoring plan tests around 175 surface and air sites for both viable and non-viable particles using TSA plates. We conduct non-viable particle testing 12 times per year, and viable particle testing no less than 50 times per year. AIS Healthcare has internal alert levels well below the required action levels. If any growth is found, it is sent to a third-party, independent lab for identification.
Just opening a syringe wrapper releases about 10,000 particles into the air. To decrease this particle burden, AIS Healthcare uses specially made syringe tray packs under the ISO 5 compounding hoods. To further clean the air, an integrated laminar airflow bench enables more than 500 air changes per hour in the direct compounding area.
The direct compounding area is sanitized at least every 30 minutes as well as before and after compounding. AIS Healthcare uses only sterile cleaning products and uses sporicidals every day; industry standards only require these agents to be used weekly. This is in addition to thorough morning, midday and evening cleanings and weekly cleanings of walls. All stainless steel materials in the compounding room (and throughout the pharmacy) have been custom fabricated to be consistently cleaned.
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. Written competency exams and media-fill procedure and aseptic technique testing are administered every three months, and unannounced glove fingertip testing is conducted monthly.
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.
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.
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 drug identification 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.
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.
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 potential tear in the white gloves will be immediately visible and allow the staff member to fix the issue before any skin is exposed.