AIS Healthcare Ophthalmics is an industry leader in high-quality surgical, clinical and dry eye care solutions. We take extra steps and make extra investments to produce patient-specific prescriptions of the highest quality and sterility.
Continual inspection readiness for the U.S Food and Drug Administration and national and state boards of pharmacy
A leader in both USP <797> and USP
<800> industry standards providing
medications of the highest quality
across the U.S.
At our state-of-the-art compounding pharmacy in Dallas, Texas, we exceed industry standards for 503A pharmacies while filling a critical need for on-demand, patient-specific medications.
Our facilities, people and processes do more to reach the Current Good Manufacturing Practices (cGMPs) followed by 503B, or outsourcing, pharmacies. This allows us to ensure sterility and potency and enable extended Beyond-Use Dates—while offering you the medications and concentrations you need for your patients.
While compounding our combination surgical drops, OPDrops®, we must meet USP <797> standards. We are proud to go past these standards in many ways to produce drops of the highest quality.
1Total unique prescriptions filled since 2015 at Hunt Valley location
|AIS Healthcare Ophthalmics quality standard||USP <797> guidelines||AIS Healthcare exceeds standards|
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. All stainless steel materials in the compounding room (and throughout the pharmacy) have been custom fabricated to be consistently cleaned.
|All ISO 5 spaces must be cleaned and disinfected at the beginning of every shift, every 30 minutes, before each batch, after spills and when any contamination is suspected. Pharmacies must use sporicidals monthly (non-sterile cleaning products acceptable for routine cleanings).||✓|
All ISO classified environments are certified by a third party every three months
|Only two certifications required per year||✓|
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.
|Requires air sampling for viable particles to be done every six months or as needed, surface sampling for viable particles to be done periodically and non-viable sampling to be done twice per year.||✓|
OPDrops compounding is done only by licensed pharmacists. 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 six months, and unannounced glove fingertip testing is conducted monthly.
|Compounder not required to be a licensed pharmacist. All compounders must pass a written exam annually and aseptic technique, media-fill procedure and glove fingertip testing semi-annually.||✓|
Our USP-grade active pharmaceutical ingredients (APIs) all come from FDA-registered suppliers with the original certificate of analysis and are sent to third-party labs for identification and potency testing.
|Requires packages of bulk ingredients to be compliant with their USP monographs||✓|
|Formulation compounding and testing
All OPDrops formulations are tested by a third-party, independent lab. All stability studies include the use of fully validated stability-indicating methods. Our stability studies also include tests for sterility, particulate matter, pH and antimicrobial effectiveness.
|No specific guidelines||✓|
OPDrops prescriptions undergo 0.22-micro pharmaceutical-grade filtration, including filter integrity testing, using an automated filter integrity testing machine.
|No specific guidelines||✓|
We have performed particulate qualification testing for our OPDrops bottles.
|No specific guidelines||✓|
Throughout the entire compounding process, 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 CQO. We also work with industry leaders to help us find new ways to advance quality throughout our pharmacy.
A new set of industry standards, USP <800>, is designed to protect the more than 8 million healthcare and pharmaceutical workers who handle potentially hazardous drugs.
At our Dallas pharmacy, we made additional investments in new processes, staff training, and quality procedures to build a USP <800>-compliant facility before the requirements even went into effect, demonstrating our commitment to protecting everyone who works with us.
The new USP <800> standards are designed to reduce the risk that hazardous drugs pose to healthcare staff, patients and the environment. The standards include facility and engineering controls and cleaning and decontaminating procedures, as well as employee responsibilities to minimize the chances of exposure.
We exceed these standards throughout our pharmacy, doing more to protect patients and staff. Our packaging and processes, like our Closed System Transfer Devices (CSTDs), prevent hazardous drug exposure. These CSTDs, like the example below, help to keep healthcare workers safe when moving the medication into the syringe or dispenser.
Patients are protected by our extensive decontamination program, which helps to eliminate hazardous drug residue on any product or package that goes directly to patients.
We’re proud to go above and beyond to protect everyone who works with us.
With licenses in place or pending in all 50 states, we are growing to serve patients and providers across the country.
Our pharmacy has multiple controlled rooms that exceed the required ISO standards for cleanliness and air quality. All ISO-classified environments are certified by a third party every three months, twice as frequently as industry requirements, giving patients and providers even more confidence in the quality and sterility of our medications.
The internal pharmacy environments were constructed without wood or other non-cleanable surfaces. This allows every cleaning and disinfecting we complete to be on non-porous, easily cleanable surfaces, not just in the controlled cleanroom environments but in the surrounding areas as well. Even though it is not used for compounding, all water coming into the facilities goes through deionization, reverse osmosis, multiple carbon and sediment filters and UV light to achieve the highest possible purity and limit the introduction of bioburden anywhere in the pharmacy. Backup water treatment ensures a constant flow of purified water for the operation of our facilities. We also have medical-grade air systems that run air through seven different filters before it is used for terminal sterilization (currently in development) and filter integrity testing.
AIS Healthcare uses ISMP best practices for safety, including review by one pharmacist and two technicians to reduce the chance of human error.
In addition to faxed written prescriptions sent to the AIS Healthcare office, physicians can place orders through their EHR systems or use the e-prescribing portal on our DEA-compliant EHR (MyAIS Connect) to print and sign prescriptions or submit them electronically. In addition, our central data storage system keeps data safe and allows it to be retrieved whenever it’s needed.
The pharmacy has an automated facility management system that goes above industry standards to help us maintain optimal internal temperature, air pressure and humidity. In the event of a power outage, the building has generators and redundant units to maintain temperature, water and steam generation, helping us ensure patients get the medications they need even during an emergency.
A Center of Excellence in ophthalmology compounding, our pharmacy works to promote clinical excellence here and throughout the country. We conduct on-site training and invite physicians to our facility for ongoing education programs.