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.
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.
Our patient medication undergoes 0.22-micron pharmaceutical-grade filtration, including filter integrity testing, using an automated filter integrity testing machine.
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.
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. 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.
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 door into the anteroom, and all interior doors, allow for hands-free access. Once inside, all staff members wash their hands for 30 seconds with 105°F water (timed with a digital clock on the wall) and clean underneath their fingernails with a nail pick, further reducing the chance of bringing in outside contamination.
In the event of a power outage, AIS Healthcare has a diesel generator and enough emergency fuel to keep our facility running—and our pharmacists compounding—including multiple redundancies in the compounding room. In addition, multiple prepaid emergency fuel contracts with multiple vendors would ensure a steady supply of fuel to our pharmacy.
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.