Aseptic Filling Machines | Isolator-Based Sterile Processing Systems
EU Annex 1-compliant filling lines for vials, ampoules & syringes.
GMP Sterile Filling Systems: End-to-End Aseptic Processing Solutions.
LOCUS ROBOTICS designs EU Annex 1-compliant aseptic filling systems featuring:
Isolator/RABS Technology: ISO Class 5 environments
Vial/Syringe/Ampoule Handling: Nest handling systems
Sterile Filling: Peristaltic/piston pumps (0.5% accuracy)
Lyophilization Integration: Automated loading/unloading
Decontamination: Vaporized Hydrogen Peroxide (VHP) cycles
Vials: Penicillin, insulin, BKZ vials (50-500ml)
Ampoules: Glass ampoule sealing / Plastic strip monodose
Syringes: Glass & plastic syringe assembly-filling
Specialties: Blood substitutes, vaccines, hyaluronic acid
Validated per FDA 21 CFR Part 211 and PIC/S PE 009-17.
1. Filling Accuracy:
- ±0.3% ceramic piston fillers (<5ml)
- Polished SS316L cylinders (>50ml)
2. Containment:
- RABS/Isolator systems (ISO Class 5)
- Uni-directional airflow (0.45m/s ±20%)
3. Sterility Assurance:
- VHP decontamination cycles
- Laminar flow stations (EN 1822)
4. Robotic Handling:
- Articulated robots with sanitary grippers
- Rail-guided transport systems
Isolator & RABS-Based Filling Lines.
1. Barrier Systems:
- Rigid isolators (Stainless steel 316L)
- Flexible film RABS (ISO Class 5)
2. Decontamination:
- VHP generators (6-log reduction)
- Sporicidal surface validation
3. Filling Technologies:
- Peristaltic pumps (shear-sensitive biologics)
- Rolling-diaphragm pistons (high-viscosity)
4. Environmental Monitoring:
- Continuous particle counting
- Viable air sampling (active/passive)
| System | Output | Critical Features |
|---|---|---|
| Vial Monoblock | 300 vials/min | Integrated wash/sterilize/fill/seal, ±0.5% dosing |
| Ampoule Line | 150 ampoules/min | Inert gas purging, multi-torch sealing |
| Syringe Assembler | 120 syringes/min | Penfill insertion, nozzle attachment, 0.3% fill accuracy |
| Strip Monodose | 200 units/min | Form-fill-seal in single operation |
Lyophilization Loading/Unloading Systems.
| System | Capabilities | Annex 1 Features |
|---|---|---|
| Vial Filling Line | 100-300 vials/min | Particle monitoring (ISO 14644) |
| Syringe Filler | 50-150 syringes/min | Leak-tested glove ports |
| Ampoule Sealer | Laser sealing, 100% integrity testing | Rapid transfer ports (RTPs) |
| Lyophilizer Loader | Robotic tray handling, -80°C capability | Sterile air overpressure |
Syringe Assembly & Filling Systems.
Design & Validation:
✓ Material Traceability: Full SDS documentation (USP <88> compliant)
✓ Surface Finish: Electropolished 316L SS (Ra ≤0.4μm)
✓ Sterilizability: Autoclavable components (121°C/30min cycles)
✓ Environmental Monitoring:
- Continuous particle counting (ISO 21501)
- Active air sampling (100L/min)
✓ Data Integrity: 21 CFR Part 11 compliant SCADA with audit trails
✓ **Change Control:** Automated audit trails
Typical Sterile Processing Line:
Cleanroom Requirements:
ISO Class A/B environments
≥60 air changes/hour
Differential pressure cascade
Vial Filling Monoblocks (50-500ml).
Turnkey Documentation:
DQ: URS compliance matrix
IQ: Calibration records, As-built drawings, material certificates
OQ: VHP efficacy studies, glove integrity tests
Annual: Requalification protocols
PQ: Media fill simulations (3 consecutive runs)
Critical Zone Technologies.
| Market | Standards Supported |
|---|---|
| EU | Annex 1 (2022), EMA guidelines |
| USA | FDA 21 CFR 211, USP <797> |
| MENA | SFDA GMP, GCC requirements |
| ASEAN | PIC/S PE 009-17, HSA Singapore |
Annex 1 Compliance & Validation.
| Market | Standards Met | Certification Support |
|---|---|---|
| European Union | EU GMP Annex 1 (2022) | EMA submission packages |
| United States | FDA 21 CFR 211.113 | FDA-483 response readiness |
| MENA | SFDA GMP Annex 1 | GCC attestation |
| Southeast Asia | PIC/S PE 009-17 | HSA Singapore validation |
+ 45% faster VHP cycles vs. industry standard
+ Integrated robotic transfer (zero human intervention)
+ Multi-market validation packages (FDA/EMA/PIC/S)
+ Hygienic robot design (IP65 rated, crevice-free)
+ Local language validation docs (EN/ES/AR/RU)
+ Dual voltage operation (230V/400V)
Ampoule Sealing & Strip Monodose Lines.
