Our environmental monitoring plan tests around 22 surface and air sites for both viable and non-viable particles using TSA and SDA 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.

The direct compounding area is disinfected 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 monthly. 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.

*Please note: Images are representative of our pharmacy environment.

Only pharmacists compound medication at AIS Healthcare. 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.

All final products 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 OPDrop formulations are prepared by a licensed pharmacist and tested by a third-party, independent lab for sterility, potency, and particulate matter.

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.

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.

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.

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.