Our commitment to patient safety combines utilization of the highest quality materials available, cutting edge technology, and quality assurance process controls that provides the right drug, right concentration, right route of administration for the right patient every time. As a national leader in sterile compounding, Empower Pharmacy has been committed for the last 11 years to developing quality processes that ensure the highest level of safety for patients.
Empower Pharmacy's commitment to quality starts with our people. Since we began in 2009, our employees have been the foundation of our company. Each team member has undergone a rigorous interview process and background analysis to ensure our foundation supports our top priority, patients. We focus on hiring honest, qualified, and astute team members who are dedicated to quality, safety, and service. Our continuous improvement policy and internal quality procedures train our staff to measure and improve performance through collaboration and innovation in all aspects of our organization.
Empower Pharmacy's cutting-edge facilities are designed, built, and run by our in-house team of pharmaceutical engineers. All production equipment, including refrigerators, autoclaves, dehydrogenation chambers, pumps, bubble point testers, water purification apparatus, laminar flow workbenches, mixers, washers, etc., are qualified upon installation through a process of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). This assurance protocol validates that equipment will perform appropriately in all phases of operations. Continual process qualifications are conducted to further execute operational control.
Labeling and Packaging
We go to great lengths to ensure our patients' medication is accurately formulated, labeled, and packaged. Our system for labeling and packaging meticulously follows regulatory standards for all product releases. Each compounded sterile product is 100% visually inspected by qualified inspectors prior to product release. All medications are submitted to a closure integrity test to ensure optimal potency, safe packaging and storage, and undisrupted product delivery.
503B Outsourcing Facility
Empower operates an FDA-registered 503B outsourcing facility licensed to manufacture large orders of custom pharmaceutical products for bulk shipment. Registration through the Drug Quality and Security Act section 503B allows us to deliver custom medications for clinicians, institutions and hospitals. Our ongoing mission is to provide the safest and most effective products to our patients and providers according to state and federal regulations.
Our state-of-the-art ISO-certified clean rooms and production areas are designed and operated with facility layout, room separation, and process flow considerations that prevent the influx of contamination from adjacent regions. All Sterile Manufacturing Operators are routinely trained, monitored, and assessed in aseptic technique operations. Each product is aseptically filled, while the environment is monitored for non-viable particles and viable particulates in the air, the working surface, and the operator's fingers. Each liquid formulation is then double filtered through a pharmaceutical grade 0.2 μm filter to ensure product sterility. Our commitment to safety is unwavering.
To ensure our products are stable and potent, we use a freeze-drying process known as lyophilization. Many prescriptions, such as injectables, can be easily stored, shipped, and later reconstituted to their original form after being freeze dried. Further benefits of lyophilization include ease of processing a liquid (which simplifies aseptic handling), enhanced stability of a dry powder, removal of water without excessive heating of the product, enhanced product stability in a dry state, and rapid dissolution of reconstituted product.