Custom aseptic extrusion: Why it's a game-changer

Pharmaceutical extrusion is a critical process in the manufacturing of advanced drug delivery systems, from long-acting injectables to solid implants. While extrusion is well-established in other industries, its aseptic application in pharma remains rare, presenting unique challenges that require innovative automation solutions. At 3P innovation, we have the expertise to overcome these challenges and deliver high-performance extrusion solutions tailored to complex novel products with challenging properties.

Understanding extrusion

Extrusion is a critical manufacturing process in the pharmaceutical industry, allowing materials to be shaped into precise forms with specific functions. By forcing a material through a die, extrusion enables the creation of drug delivery systems, implants, and other specialised pharmaceutical products. There are two primary types of extrusion, each suited to different applications. Hot-melt extrusion is the most widely used method, where the material is heated and then solidifies upon cooling. It is commonly employed in the production of sustained-release drug implants and injectable formulations, ensuring controlled and prolonged drug delivery. Cold/wet extrusion is designed for temperature-sensitive products, such as certain vaccines. This method uses water (or another solvent) to shape the material. Once extruded, the product undergoes a drying process to reach its final solid form, preserving the integrity of delicate active ingredients.

Key considerations in the extrusion process

The success of pharmaceutical extrusion depends on multiple interdependent factors, including:

1. Feeding & extruder selection: Choosing the right extruder is crucial to achieving precise product consistency. Material feed quality directly impacts extrusion efficiency and final product performance.

• • Ram-die extruders: Pre-mixed material is loaded into a chamber and forced through a die.
  • Single or twin-screw extruders: These systems allow continuous feeding of raw materials while providing better mixing and control.

2. Curing & solidification: After extrusion, products must be solidified in a controlled manner. The method depends on the product’s physical and chemical properties:

• • Cooling in air: Common for pharmaceutical applications but requires careful handling to prevent deformation.
  • Water-based curing: Used in other industries (e.g., silicone tubing), but less common in pharma.
  • Controlled skin formation: Prevents sticky products from adhering to surfaces, ensuring a uniform final shape.

3. Cutting & transporting

• • Cutting methods: Fly cutters, crush cuts, shear cuts, or laser cuts are selected based on product characteristics.
  • Transport & orientation: Ensuring the product remains intact and dimensionally accurate during processing.

4. Inspection: Precision is non-negotiable in pharmaceutical extrusion. Inspection technologies ensure consistency, dosage accuracy, and patient safety:

• • Microscopic imaging: Real-time monitoring during extrusion to detect inconsistencies.
  • Multi-plane image analysis: Essential for injectable products where cut length and diameter impact drug dosage.
  • Laser measurement systems: Used for high-precision applications like vaginal rings and controlled-release implants.

Why aseptic extrusion is a game-changer

Aseptic extrusion is an emerging frontier in pharma. Unlike traditional methods, aseptic extrusion prevents contamination and ensures product sterility, making it ideal for long-acting injectables and implants, temperature-sensitive biologics and vaccines and customised drug delivery forms requiring precise control.

Given the complexity of maintaining sterility throughout the extrusion process, off-the-shelf solutions are insufficient. 3P innovation’s expertise in custom aseptic automation ensures that even the most challenging pharmaceutical products can be extruded with precision and sterility. With decades of experience in pharmaceutical engineering, 3P innovation stands at the forefront of aseptic extrusion automation. 

Want to learn more? Contact us today to explore how our custom aseptic extrusion solutions can transform your pharmaceutical manufacturing processes.