Pharmaceutical Packing Machine Engineering, Precision Mold Shop & FAT
Direct engineering and manufacturing of cGMP Alu-Alu/Alu-PVC blister lines, strip packers, SUS316L optical counting lines, custom blister molds, and IQ/OQ.
Precision CNC Blister Tooling + Validated Cleanroom Machinery
In pharmaceutical packaging, machine frame rigidity means nothing if the cold-form Alu-Alu mold radius tears foil or the counting track sheds burrs. As a specialized pharma packing machines builder, we machine custom cavity/sealing/punching dies in-house on 5-axis CNC centers, electropolish SUS316L contact paths to Ra <= 0.4–0.6 μm, and execute documented Factory Acceptance Testing on your actual placebo or active tablets and foil laminates.
Every export line ships with bilingual English cGMP documentation—DQ, FAT, IQ, OQ, electrical/pneumatic schematics, SUS316L material mill test reports, and FDA-grade elastomer certificates.
Factory Engineering & Qualification Capabilities
Core quality assurance milestones across OSD blister, strip, and counting builds:
| Qualification Stage | In-House Execution | Documented Evidence Supplied |
|---|---|---|
| 1. Cavity & Feeder CAD | 3D tablet clearance, >=1.5 mm cold-form radius, web trim math |
Signed Blister Drawing + Format Approval |
| 2. Material Traceability | XRF alloy check on SUS316L contact funnels, tracks & hoppers | 3.1 Mill Certs + Ra Surface Roughness Log |
| 3. Wet / Placebo FAT | Methylene-blue -0.08 MPa leak + vision challenge + 21 CFR test |
Timestamped Video + Signed FAT Protocol |
| 4. IQ / OQ & Spares | Sensor calibration certs + pre-labeled change parts on shadow board | Turnkey Validation Binder + 2-Yr Wear Kit |
Inspect our regulatory checklist in 21 CFR Part 11 and IQ/OQ validation guide.
cGMP Cleanroom & Validation Notes
- Rapid Replacement Blister Format Molds: Serialized digital CAD archives let existing plant customers order new SKU blister format sets (
forming + feeder + sealing + punch) with plug-and-play dowel alignment. - Global Cleanroom Voltage & PLC Standards: Configured for
220V / 380V / 415V / 480V 50/60 Hzwith Siemens or Allen-Bradley PLC/HMI architectures and UL/CE safety relays. - Remote Diagnostics & Field SAT Commissioning: Validation engineers support on-site Site Acceptance Testing (SAT) and operator SOP qualification.
Send Tablet Samples or Drawings for Mold Layout
Submit your dosage geometry, foil preference, and target output via Project Brief.
Explore related cGMP systems in Pharma Packing Machines, cGMP Barrier & Validation, or send your dosage specs via Project Brief.
Further Reference
Verify Dimensions & Operating Ratings
Send your target envelope, load requirements, and ambient environment to review matching configurations.