Aphena operates FDA-registered and DEA-licensed (schedules II-V controls) pharmaceutical packaging and repackaging facilities that provide turnkey solutions for a wide range of commercial services.
We recognize the high demand in the contract packaging industry for quality, tracking and security of pharmaceutical products. We have the capacity to streamline operations, reduce costs and ensure quality. Aphena's facilities are equipped to fill everything from the smallest to the largest commercial run.
Turnkey services allow clients to place inventory with confidence, minimize turnaround time and maintain just-in-time product quantities.
Aphena stands ready to meet your commercial needs for:
- Bottling
- Blister packaging
- Unit dosing
- Pouching
- Kitting
- Labeling
- Mail order facilitation
- Warehousing
- Private-label design
Aphena's facilities encompass 440,000 square feet. The facilities house controlled-environment rooms that meet or exceed FDA standards for cleanliness, temperature and humidity.
From fully-automated fill lines to semi-automated lines, Aphena handles and processes small-quantity orders of just a few bottles with the same care and priority as large quantity orders of thousands of bottles. Aphena fills custom orders that require special handling, with clients setting the parameters.
The quality control systems and pharmacists ensure proper oversight during all shifts. The flow of products through the facility is carefully controlled and monitored, maintaining the integrity of the process stream.
The company holds DEA (schedules II-V controls) and State Board of Pharmacy licenses where we have facilities. The FDA's current Good Manufacturing Practice (cGMP) regulations dictate standard operating procedures. Extensive and ongoing cGMP training is standard company procedure. Aphena meets FDA standards for 21 CFR, Parts 210 and 211 for the processing, packing and holding of bulk drugs and finished pharmaceuticals.
A shelf-life control system monitors the hold time of materials shipped to the facility and awaiting repackaging. The labeling system gathers information throughout the process, and technology allows reporting of all information on demand to the client.
Precise tracking allows the company to identify each item's location during the process. A pill can be tracked from the time it is accepted into the warehouse until the time it is packaged and shipped.
Responsiveness includes communicating accurately and as often as the client desires. Through data exchange, clients can keep abreast of information at any point in the information stream.
WDStone & Associates