Verified Customer Case Study
Dry Powder Filling Machine
Medical Device · DPI InhalerConfiguration review
Application Challenge
US inhaler device manufacturer required a dry powder filling machine for DPI (Dry Powder Inhaler) capsules — filling 10mg–30mg micronised budesonide and formoterol blends into HPMC and gelatine capsules with ±3% fill accuracy, FDA 21 CFR 820 Quality System Regulation, ISO Class 7 cleanroom filling, 100% in-process weight check and capsule leaker-test integration.
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
FDA 21 CFR 820 QSR compliance
medical device audit approved
2
Result 2
±2.8% fill accuracy on 10mg budesonide — FDA specification met
3
ISO Class 7 cleanroom
environmental monitoring all within alert limits
4
100% in-process weight check
zero out-of-spec capsules shipped
5
Product launch
NDA submission supported by equipment validation data
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