Our anteroom meets ISO 8 standards, which require the number of airborne particles per cubic meter to be about 10 times less than what’s found in a typical indoor room. NABP standards also call for 20 air change cycles per hour in an ISO 8 room—we do 30.

Our environmental monitoring plan tests around 175 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.

A mounted mirror is the final stop for all staff members, to confirm that all exposed skin is free of any cosmetics or jewelry, and that they are in compliance with all AIS Healthcare regulations before entering the gowning room. This is the second mirror that staff members use to double-check their compliance.

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.

Every time they enter, staff members change into a new set of professionally cleaned, vacuum-sealed scrubs. We go above and beyond to make sure all parts of the body are covered, including requiring socks to always be worn above the ankles.

When finished compounding, pharmacists leave through a dedicated doffing room, where they remove the sterile garb and other items worn in the compounding room. This one-way flow through the pharmacy helps to maintain the highest level of sterility in every area.

Staff members change into dedicated facility shoes—provided by AIS Healthcare and replaced regularly—when they walk into the isolation room. Then they use a hands-free shoe barrier applicator (BootieButler®) to put new shoe covers over the facility shoes to avoid cross-contamination on the walk to the next stop, the anteroom.

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.

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.

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>.