Gmp machine supplier
Tablet & Capsule Production Systems.
Aseptic Liquid Filling Lines.
Ointment & Cream Manufacturing.
Validation & Compliance Support.
LOCUS ROBOTICS supplies cGMP-compliant pharmaceutical equipment for:
Solid Dosage: Tablet presses, capsule fillers, coating machines
Liquid Formulations: Vial/syringe fillers, peristaltic dosing systems
Semi-Solids: Ointment mills, vacuum emulsifiers, tube filling
Sterile Products: Isolator-based filling, lyophilization loading
All systems meet FDA 21 CFR Part 211, EU GMP Annex 1, and WHO standards.
| Category | Key Machines | GMP Features |
|---|---|---|
| Solid Dosage Forms | Rotary tablet presses, capsule fillers | ±1% weight variation, dedusting systems |
| Liquid Filling | Vial/syringe fillers, ampoule sealers | CIP/SIP capabilities, laminar flow hoods |
| Semi-Solid Manufacturing | Vacuum emulsifiers, tube fillers | Scrapless design, product contact parts 316L SS |
| Sterile Processing | RABS/isolator filling lines | ISO Class 5 environments, VHP compatibility |
1. Material Compliance:
- 316L/304L stainless steel (Ra ≤0.4μm)
- FDA-compliant seals (EPDM, PTFE, silicone)
2. Design Principles:
- Drainable slopes (≥3°)
- Quick-release clamps (ASME BPE)
- No dead legs
3. Documentation:
- DQ/IQ/OQ/PQ validation packages
- Material traceability reports
- 21 CFR Part 11 compliant software
| Sector | Typical Equipment | Compliance Standards |
|---|---|---|
| Pharmaceuticals | Tablet presses, vial fillers | FDA, EU GMP, PIC/S |
| Biologics | Lyophilizers, syringe fillers | Annex 1, ICH Q7 |
| Cosmetics | Cream fillers, emulsifiers | ISO 22716, GMPC |
| Veterinary | Oral suspension lines | VICH GL3, EMA guidelines |
| Nutraceuticals | Capsule filling, powder blending | NSF/ANSI 173, FSSC 22000 |
Turnkey Validation Packages Include:
- Design Qualification (DQ): 3D model review against URS
- Installation Qualification (IQ): As-built drawings, calibration records
- Operational Qualification (OQ): SOPs, challenge tests
- Performance Qualification (PQ): 3 consecutive batches
- Optional: Media fill simulation for aseptic lines
| Region | Supported Standards | Local Certification |
|---|---|---|
| USA | FDA 21 CFR Part 211 | NSF registration |
| EU | EU GMP Annex 1 | CE Marking |
| Middle East | SFDA GMP | GCC conformity |
| Southeast Asia | PIC/S, HSA Singapore | BPFK (Indonesia) |
| Africa | WHO GMP | SAHPRA (South Africa) |
+ 30% faster validation vs. European OEMs
+ Local language documentation (EN/AR/ES/RU)
+ Dual voltage operation (110V/220V/480V)
+ Corrosion-resistant construction (316L SS)
