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Lifemeta ST5P Pt-cured Silicone Pump Tubing: Enabling High-Precision Aseptic Filling

2025.07.03 108

With the continuous advancement of pharmaceutical technologies, small-volume, high-concentration formulations have emerged as a key focus in process development due to their advantages in efficient drug delivery, precise dosing, and improved patient experience. However, reduced filling volumes exacerbate challenges during the filling process, including vibration of the filling system, electrostatic interference on weighing platforms, decreased operational stability of filling pumps, and tubing deformation. These factors directly impact filling accuracy and stability, thereby increasing operational complexity.

Additionally, under high pump speeds, tubing wear may introduce risks of insoluble particulates, while reduced inner surface smoothness caused by wear could elevate protein aggregation risks. Consequently, optimizing solutions for these challenges is critical.

To address these process challenges, Cobetter has developed the Lifemeta ST5P Platinum-Cured Silicone Pump Tubing (ST5P), the second product in the Lifemeta series specifically designed for pump applications. Through stringent raw material selection and validation testing, the ST5P achieves exceptional wear resistance and stability. To meet its specialized application requirements, Cobetter has upgraded inspection equipment across the entire silicone tubing production line and implemented elevated quality control standards.

ST5P Properties

Stringent Dimensional Stability

In filling applications, pump tubing has the greatest impact on filling accuracy, making tight control of intra-batch and inter-batch dimensional tolerances essential.

Lifemeta ST5P is a wear-resistant peristaltic pump tubing specifically engineered for high-precision filling, with a hardness of Shore 50A. Compared to similar products, it features tighter tolerance controls, with dimensional deviations for small-sized tubing confined to ±0.04 mm as detailed below:

Superior Filling Stability

Test 1: Continuous Filling

Tubing model: ST5P1216150N (1.2 mm ID × 1.6 mm wall thickness)

Duration: 7 hours of continuous operation
Result: 0.55 ml dose can be controlled within ±2%, with a process capability index (Cpk) of 1.60.

Test 2: Single-Needle Filling

A comparison of filling volume decay from the start to the end of 14,000 filling cycles revealed that the filling volume decay remained within 0.5%:

Average filling volume comparison: 0.37% decay
Median filling volume comparison: 0.38% decay
Maximum filling volume comparison: 0.26% decay
Minimum filling volume comparison: 0.35% decay

Trusted High Wear Resistance

Particulate Matter Testing

Tubing model: ST5P1216150N

Pump speed: 650 rpm for 13,000 continuous filling cycles
Particulate matter levels were were far below the standard for large-volume water for injection

Scanning Electron Microscopy (SEM) observations at 1000× magnification revealed no visible wear marks on the inner surface of Lifemeta ST5P tubing before and after 14,000 filling cycles.