LOCUS GROUP delivers GMP-compliant ampoule processing systems for injectable pharmaceuticals, vaccines, and diagnostic reagents. Our automated solutions handle:
Aseptic filling (1-20ml)
Gas purging (N₂/CO₂)
Hermetic sealing
100% integrity testing
LOCUS PHARM specializes in GMP-validated ampoule processing equipment for sterile pharmaceutical and veterinary injectables. Our systems meet stringent requirements for:
Material biocompatibility (USP Class VI)
Surface finish (Ra ≤0.4 µm)
Weld integrity (≤10⁻⁶ mbar·L/s leak rate)
Cleanability (CIP/SIP capabilities)
| Model | Capacity | Key Features |
|---|---|---|
| A-10 | 1,000 ampoules/hr | • Peristaltic filling (±1%) • Manual loading • Flame sealing |
| A-50 | 5,000 ampoules/hr | • Servo piston filling (±0.5%) • Automatic feeding • Laser sealing |
| A-100 | 12,000 ampoules/hr | • Rotary design • Integrated leak testing • Isolator compatibility (ISO 5) |
| Type | Throughput | Key Features |
|---|---|---|
| Semi-Auto Peristaltic | 500-1,000 amp/hr | • 3-roller pump (±1.5% accuracy) • Benchtop sealer • Manual loading |
| Monobloc Systems | 3,000-12,000 amp/hr | • Integrated filling/sealing • Options: 3/6-roller or eccentric pumps • Glass check valves |
| Nitrogen Purging | Standard | • Pre/post-fill gas injection • Residual O₂ <50 ppm |
Material Contact: AISI 316L electropolished (Ra ≤0.4 µm)
Sterility Assurance:
Class A environment integration
SIP/CIP capabilities
VHP-compatible surfaces
Documentation:
IQ/OQ/PQ protocols (FDA/EU GMP)
21 CFR Part 11 compliant data logging
| Model | Function | Output |
|---|---|---|
ALSM-100D |
Semi-auto filling | 500-800 units/hr |
ALSM-100V |
Ultrasonic sealing | 600-1,000 units/hr |
Carousel Monobloc
ALSM-50 |
Integrated fill/seal | 1,500-2,500 units/hr |
Linear Automation Lin
ALSM-50 |
Fill/seal/label/mark in-line | 5,000-8,000 units/hr |
| Parameter | Requirement | LOCUS Compliance |
|---|---|---|
| Material Contact | AISI 316L or better | Electropolished 316L (Ra 0.38 µm) |
| Surface Joints | Continuous welds | Orbital welding (ASME BPE) |
| Sterilization | SIP/CIP capability | 121°C/15psi SIP cycles |
| Documentation | FDA 21 CFR Part 11 | Electronic batch records |
| Method | Best For | Integrity Test | LOCUS Implementation |
|---|---|---|---|
| Flame Sealing | Thermostable solutions | Dye ingress | Multi-point temperature control |
| Laser Sealing | Oxygen-sensitive products | Helium leak detection | Closed-loop power monitoring |
| Ultrasonic (Plastic) | Polymer monodose | Burst pressure | Frequency-stabilized generators |
| Type | Best For | Leak Rate |
|---|---|---|
| Flame Sealing | Thermostable solutions | ≤10⁻³ mbar·L/s |
| Laser Sealing | Oxygen-sensitive products | ≤10⁻⁶ mbar·L/s |
| Pull-Sealing | Universal applications | ≤10⁻⁴ mbar·L/s |
| Market | Ampoule Solution | Special Features |
|---|---|---|
| Southeast Asia | High-humidity package | • Dehumidified control cabinets • Corrosion-resistant coatings |
| Africa | Power-stable configuration | • 110V-200V-380V-480V voltage stabilizer • UPS backup |
| Middle East | Dust-proof systems | • IP65 electronics • Positive pressure HMI |
| Latin America | Multi-language support | • Spanish/Portuguese interfaces • Local certifications |
| Market | Configuration |
|---|---|
| Southeast Asia | Tropical package: Dehumidification + corrosion-resistant components |
| Africa | Voltage stabilizer (90-480V) + dust-proof electronics |
| Middle East | Arabic HMI interface + enhanced cooling systems |
Precision Engineering:
Our servo-piston fillers achieve ISO 8536-8 compliance with ≤0.5% deviation — critical for monoclonal antibody therapeutics.
Sterility Assurance:
Integrated particle monitoring (ISO 14644) and laminar airflow (0.45 m/s) ensure Grade A conditions for aseptic processing.
Efficiency:
Reduce ampoule breakage to <0.1% with laser-guided alignment — 5X lower loss rates than conventional flame sealing.
+ 40% faster format changeover with tool-less adjustment
+ Integrated weight verification (≤±0.5% accuracy)
+ Isolator compatibility (ISO 14644-1 Class 5)
- Zero compressed air requirement for operation
+ Full isolator integration capability
+ ≤0.1% filling loss with anti-drip nozzles
+ 21 CFR Part 11 audit trail
Precision Dosing:
Our eccentric peristaltic pumps achieve ±0.8% accuracy with viscous biologics — exceeding USP <1151> requirements for injectables.
Integrity Assurance:
Laser-sealed ampoules maintain ≤10⁻⁶ mbar·L/s leak rates after accelerated aging studies — critical for vaccine thermal stability.
Monodose Innovation:
Strip-pack systems reduce packaging waste by 70% compared to traditional vials while maintaining equivalent barrier properties.
Included Documentation:
Equipment Qualification Protocols (IQ/OQ)
Performance Qualification Templates
Cleaning Validation (Swab Test Reports)
Material Certificates (3.1/3.2)
| Parameter | LOCUS A-100 | Industry Standard |
|---|---|---|
| Filling Accuracy | ±0.8% | ±1.5% |
| O₂ Purging | <30 ppm residual | <100 ppm |
| Format Change | 10 min (tool-less) | 45 min |
| Ampoule Sizes | 0.5-20ml glass, 1-10ml plastic | Limited ranges |
| Parameter | LOCUS A-200 | Industry Standard |
|---|---|---|
| Filling Accuracy | ±0.5% | ±1.5% |
| O₂ Purging | <50 ppm residual | <200 ppm |
| Format Changeover | 15 min | 45 min |
| Ampoule Sizes | 1-20ml | 2-10ml |
Ready for Aseptic Production?
✅ GMP Compliance Guarantee
✅ 24/7 Multilingual Support
✅ 24-month performance guarantee
✅ Local technicians in 18 countries
Free line configuration for your products, throughput validation testing!
Contact Specialists for GMP:
Compliance Roadmap:
CE, EAC, ISO 9001 certifications.
GMP-ready: 316L SS contact parts, CIP/SIP capabilities.
