Verified Customer Case Study
Powder Filling Machine Pharmaceutical
Pharmaceutical ¡ Lyophilised InjectableConfiguration review
Application Challenge
German biotech pharmaceutical company required a powder filling machine pharmaceutical-grade for 2ml and 10ml glass vials of lyophilised biologic powder â EU GMP Annex 1 aseptic fill and finish, ultra-low residual oxygen <0.1% after nitrogen purge, Class A RABS filling zone, automated camera-based particle inspection and ISPE Baseline Guide CIP/SIP validation.
Application review:Product fit, package format, accuracy target, cleaning and production layout.
Project Gallery
Video Reference
Factory FAT and commissioning review
HEMUfill factory video for equipment build quality, FAT workflow and remote commissioning context. Customer-specific site videos can be added when approved footage is available.
Verified Results
Measured outcomes from actual customer deployment
1
EU GMP Annex 1 aseptic fill
qualified person release approved
2
Residual oxygen <0.08%
exceeds EU Annex 1 specification
3
Class A RABS
ISO Class 5 airborne contamination maintained 24/7
4
Automated particle inspection
99.98% detection on 25Âľm glass particle standard
5
German BfArM registration
manufacturing license issued
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