Tube Filling and Sealing Machine for Aluminum Pharmaceutical Tubes — EU GMP Certified
PharmaTube GmbH, Switzerland
Industry
Pharmaceutical · Topical
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.
Challenge
Swiss pharmaceutical company required a tube filling and sealing machine for 10ml–50ml aluminum tubes (ointments, eye cream), with EU GMP Annex 11 electronic batch records, servo fold-crimp sealing and 21 CFR Part 11 audit trail for US FDA export.
Results
- ✓EU GMP Annex 11 + 21 CFR Part 11 electronic batch records
- ✓Servo fold-crimp: tail uniformity ±0.2mm
- ✓50 tubes/min sustained output
- ✓0 crimp failures across 1.2M tubes in first year
- ✓US FDA inspection: no observations on equipment qualification
Application Review Note
Tube Filling And Sealing Machine application · Switzerland · configuration reference
