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Aseptic Processing Systems: GMP Sterile Filling Solutions

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LSPC-1000 Robotic Installation with Ceramic Cylinders for Filling Oral and Peroral Preparations — GMP Execution

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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.

Critical Technologies:

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)

Equipment Specifications

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.

Critical Zone Components

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.

Annex 1 Compliance Framework

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

Integrated Line Configuration

Typical Sterile Processing Line:

Cleanroom Requirements:

  • ISO Class A/B environments

  • ≥60 air changes/hour

  • Differential pressure cascade

Vial Filling Monoblocks (50-500ml).

Validation Package

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.

Regional Compliance

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.

Regional Compliance Alignment

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

Annex 1 Validation & Qualification.

Competitive Differentiation

+ 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.

Design Your GMP-Compliant Facility:

✉ Email:mail@locuspack.com
📞 Phone: +7 927 056-19-99
Request Validation Protocol Templates.
Voltage customization available (110V-220V-380V-480V) — trusted by manufacturers in 28+ countries. Serving processors in 30+ countries across Africa, SE Asia & MENA.
Support: EN/RU/AR/ES 24/6 — On-site commissioning available globally.
Multi-language HMIs, regional certifications included (International calls routed to English-speaking engineers).