Filling Equipment for 503B Compounding Pharmacies
The primary focus of every compounding pharmacist is to ensure that the admixtures and compounded medicines are effective and safe. Despite this, there are more than half of a million adverse medication-related events reported every year to the FDA. As a result, state and federal regulators have increased their scrutiny and regulatory oversight of compounding pharmacies and enforcement.
Given the importance of compounding pharmacies and the critical services they provide, it is vitally important that their practices, facilities, and operations meet FDA and USP requirements. To help alleviate some of the compliance guesswork, AST provides dependable aseptic filling equipment proven within the pharmaceutical industry, but right-sized for the unique requirements of the compounding pharmacy environment. Our pharmacy compounding equipment approach is flexible, keeps cleanroom footprint to a minimum, and provides a secure aseptic environment that produces a safe product for your patients.
Compounding Systems Capabilities
- AST’s GENiSYS® system can aseptically fill and close syringes, vials, and cartridges using a single machine. In-house vial washing and sterilization are a thing of the past with our solution. All containers including vials, syringes, and cartridges come in pre-sterilized packaging and are ready-to-fill. Once placed into the equipment, the critical filling and closing operations are performed. When coupled with AST’s vial sealing module vials are automatically inspected and capped to finish the vial production process.
- GENiSYS® is designed to process small batch parenteral products. Its gentle dosing system is highly accurate, gentler on the drug product and is almost universally compatible with compounded products. Its pre-sterilized fluid pathway eliminates sterility and cross-contamination concerns and is easily replaced after the batch is complete.
- To further protect patient and product from contamination GENiSYS® can be integrated with multiple barrier options that work best for your operation. Laminar Airflow (LAF) hoods, Bio-Safety Cabinets, RABS, and isolators can all be used to provide a complete cGMP solution.
Sheila Dell, Ph.D, discusses automated technology and how it can improve sterility assurance and data integrity in the compounding sector.
AST VP of Business Development Matthew Gorton provides an analysis of the issues that are driving compounding facilities to invest in automation for the audience of CPC Digital Week