Verified Customer Case Study
Pharmaceutical Powder Filling Machine
Pharmaceutical · API PowderConfiguration review
Application Challenge
Indian API manufacturer required a pharmaceutical powder filling machine for 25g–5kg HDPE containers of sterile bulk API powder (cephalosporin and penicillin classes) — WHO-GMP Grade A/B clean-room filling, aseptic containment, complete SUS316L WFI-cleanable product path, 21 CFR Part 11 electronic batch records and EU GMP Annex 1 documentation for European regulatory submissions.
Application review:Product fit, package format, accuracy target, cleaning and production layout.
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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
WHO-GMP Grade A/B clean-room
no environmental monitoring breaches in 18 months
2
EU GMP Annex 1 documentation
European qualified person (QP) release accepted
3
21 CFR Part 11 electronic batch records
FDA pre-approval inspection approved
4
Aseptic containment
zero product recalls in 2 years post-installation
5
Annual output
8,200 MT API powder to 28 countries
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