8 Min Read • Client Case Study
Class A / ISO 5 Cleanroom
A premier vaccine manufacturer in Gujarat struggled with intermittent micro-stoppages on their 24-needle pre-filled syringe (PFS) filling machine due to nest alignment drift and plunger mis-seating. Vedax engineered a total tooling upgrade.
1. High-Precision Tub & Nest Centering Guides
Factory original aluminum tub guides suffered dimensional creep under repetitive washdown. Vedax replaced them with precision-machined SS 316L hardened guide rails with mirror finish, holding tub position to within ±0.02 mm.
2. Vacuum Stoppering Tooling Redesign
Micro-air pockets inside prefilled syringes often cause plunger tilting during high-speed vacuum insertion. Vedax redesigned the stoppering insertion pins with internal vent channels, eliminating air entrapment.
3. Validation & Performance Results
Following on-site installation and FAT protocol execution, line throughput increased from 210 to 240 syringes per minute with zero plunger displacement defects, delivering an annualized production gain of over 1.2 million doses.
Implementation Recommendations
- Conduct comprehensive 3D optical scanning of existing nests.
- Perform pilot trial run with 5,000 dummy syringes before active batching.
- Ensure all vacuum seals utilize USP Class VI compliant fluoropolymers.
ENGINEERING SUPPORT
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