Nipro is continuously committed to bringing you an innovative portfolio of superior quality products. See how we combine innovation and automation to bring you the ultimate in pre-fillable syringe quality.
Quality issues are a serious challenge!
Rejected starting material, filling line interruptions, recalled finished products – these are serious matters for patients, pharmaceutical companies, and manufacturers alike.
Glass cutting technology in the converting process of pre-fillable syringes (PFS) has a major influence on:
- Glass particles generation
the more particles, the higher the risk of particles remaining inside the syringe - Mechanical finger flange stability
if not strong enough, risk of breakage of finger flanges during Fill Finish operations - The consistency of syringe flange dimensions
if inconsistent, potential problems integrating a syringe into an auto-injection device
THE SOLUTION WE OFFER YOU
Nipro addresses these influences by implementing an innovative technology of laser-based glass cutting in the converting process of Nipro PFS.
Improved Total Cost of Ownership
- Less risk of rejections at Fill-Finish sites as a result of fewer particles¹
- Lower risk of finger flange breakages during Fill-Finish operations due to increased mechanical flange stability
- Lower risk of market recalls thanks to fewer glass particulates or device functional failures
Enhanced Patient Safety
- Lower risk of glass particulates inside PFS
- Safer drug delivery devices by virtue of increased finger flange stability
Optimized Integration between Auto-Injection Devices and PFS
- Smoother assembly operations as a result of tighter dimensional parameters for finger flanges
STUDY RESULTS¹
Glass Particles
-
Sub-visible range: -62%
Significant reduction of glass sub visible particles with Nipro laser-based cut compared to traditional cut
- Visible range: -100%
No visible particles found with Nipro laser-based cutting
Finger Flanges (1 ml long syringe)
- Dimensional accuracy (thickness): 1.85 mm ±0.1 mm
More uniform finger flange thickness with Nipro laser-based cut versus traditional cut (1.67 mm +0.3 / -0.2 mm)
- Strength: AVG: +40% NM | MIN: +57% NM
Strength of finger flanges substantially improved with laser-based cut compared to traditional cut
1 Source: Study performed in collaboration with Centre for glass investigations and environmental analysis