State-of-the-Art Sterile Compounding Facilities
Empower Pharmacy houses Houston's premier state-of-the-art cleanroom constructed in 2016, which allows us the ability to offer a variety of customized sterile medications.
Empower Pharmacy skillfully and carefully follows the guidelines outlined by the United States Pharmacopeia's Chapter <797> and Federal Register title 21 CFR part 211, “Current Good Manufacturing Practice for Finished Pharmaceuticals,” for the compounding of sterile pharmaceutical preparations. Furthermore, Empower Pharmacy adheres to the guidance provided by the FDA’s Compliance Policy Guide (CPG) Sec. 460.200 “Pharmacy Compounding.” Federal, state and consultant agencies have performed detailed inspections of our facilities assuring compliance with the necessary regulations to ensure the safety of patients receiving sterile preparations.
The key to providing a safe admixture resides in using the principles of aseptic processing to maintain sterility of the components throughout the compounding process. This allows us to maintain the highest degree of supply chain integrity and compliance with state and federal regulations.
CGMP requires that a stability program must be established to assess the stability characteristics of finished drug products, and the results of stability testing must be used to determine appropriate storage conditions and beyond use dates. Stability studies are used to ensure that a drug product will retain its quality (e.g., strength) and remain sterile, through the labeled beyond use date. A beyond use date is established through the conduct of our stability program that includes testing to assess the product’s performance against specifications after aging to the desired beyond use date.
Quantitative analysis is performed per USP requirements on each batch to determine concentration of the active ingredient(s). Potency testing is performed by an independent FDA registered laboratory. Ingredients used in compounding procedures are determined to be stable, compatible, and appropriate for use, according to USP guidelines. Certificates of Analysis are received from manufacturers for ingredients used in compounded preparations. Tests are performed according to USP <51>, <71>, <85>, <788>, <790>, <791>, <797>, and <1207> guidelines. Components and finished preparations undergoing end-preparation testing, remain in quarantine until testing results are received and are reviewed by our quality control team and a compounding pharmacist before release. All our compounded sterile products undergo pH, particulate, appearance, preservative effectiveness, preservative content, method suitability, container-closure integrity, potency, endotoxin, and sterility testing as per USP.
- Test finished products - in-house & independent lab potency, endotoxin and sterility testing
- Daily viable microbial sampling of air, surface and personnel within all clean rooms and hoods
- Real time monitoring of the particle count of each clean room and hood's sterile environment
- Follow proper cleaning and maintenance
- Routinely have outside parties certify our cleanrooms and laminar flow hoods
- Routinely assess pharmacy staff on their aseptic technique
- Personnel must properly groom and gown before entering critical sterile areas
Empower Pharmacy's staff includes highly trained pharmacists, certified pharmacy technicians, quality control supervisors, and pharmaceutical engineers. All of these employees have had extensive training and years of experience in the area of sterile compounding, assuring our patients the highest level of quality and safety.