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VEDAX PHARMA MACH

FAT Approval for 12-Nozzle Vial Filling Changeover Kit

Factory Acceptance Testing concluded with zero deviation for a multinational formulation plant running 240 BPM.

4 Min Read • Facility Milestone FAT Certified by Client Engineers

Vedax Pharma Mach has completed formal Factory Acceptance Testing (FAT) for a comprehensive 12-nozzle injectable filling changeover kit commissioned by a tier-1 formulation enterprise in Hyderabad.

1. Rigorous 4-Hour Continuous Trial Run

The complete changeover kit—comprising infeed worm screws, main starwheels, bottom-up diving needle bridge, and rubber bung pick-up chutes—was tested continuously for 4 hours at full 240 BPM operating speed.

2. Full Documentation Package Supplied

The dispatch includes 3.1 mill test certificates, Ra surface roughness profilometer readouts, ultrasonic cleaning compliance logs, and IQ/OQ execution validation protocols.

Implementation Recommendations

  • Verify all dimensions with CMM inspection report.
  • Check surface roughness with portable Mitutoyo profilometer.
  • Execute cleanroom dry trial before packaging in vacuum-sealed bags.
Pharmaceutical Machine Tooling
Authentic Pharmaceutical Machine Tooling
Technical Parameters Verified
Machine Model 12-Head High Speed Filler
Testing Speed 240 BPM Continuous
Vial Size Tested 10 ml USP Type 1
Material Certificate EN 10204 3.1 Certified
Status 100% Passed - Dispatched
ENGINEERING SUPPORT

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