Subcutaneous, solid implants are an emerging drug delivery system with special manufacturing needs when going from powder to ready-for-packaging product. In order to deliver the active pharmaceutical ingredient (API) safely and with a constant dissolution rate, a very homogeneous product with extremely tight tolerances in geometry is required. And when automating an implant manufacturing line, it becomes even more critical to assure consistent API/excipient compounding and to maintain precise quality specifications. Let us show you how.
Subcutaneous implants or vaginal rings offer several advantages over solid oral dosage forms:
The Pharma mini Implant Line offers the opportunity to develop and manufacture implants in a fully automated and continuous process. This line uses a programmable logic controller (PLC) from material feed through to the final quality control of the implant size, including documentation such as batch report and audit trail.
A container with a containment valve for pre-blended material is connected to the gravimetric feeding system, enabling operator-safe handling and high accuracy in the feed rate. The Pharma mini HME Micro-Compounder produces a strand with a small diameter tolerance (±0.005% to 0.05% depending on mechanical parameters of the compounds used). A laser sensor delivers data to control the strand diameter very precisely by adjusting the conveyor speed. Based on this data, the strand is cut to meet the length specifications of the implant. An automated sorting device assures that any out-of-specifications (OOS) implants are rejected and collected away from the in-spec implants.
As an accessory to our Pharma mini HME Micro-Compounder, we offer Thermo Scientific CaliCut Post-extrusion System to precisely calibrate polymer strands and cut them into well-defined implant devices.
As an accessory to the Pharma mini Extruder, this cutting system can be operated independently from the extruder control. It complements the extruder if fully automated production is not necessary or if the implant project is still in an R&D phase. The CaliCut System can produce 600 cuts/hour with variable lengths (1–200 mm) and diameters (0.2–6 mm). Its small footprint makes it an ideal addition to the Pharma mini HME Micro-Compounder.
The Pharma mini Implant Line is a unique solution for the complete process of developing and producing injectable drug delivery systems. The precise automation with integrated quality control and documentation helps enable a fast, efficient development-to-production process.
For Research Use Only. Not for use in diagnostic procedures.