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Aseptic ampoule filling and hermetic flame sealing monoblock with oxygen-gas burner heads and pre/post nitrogen flushing for 1 mL to 20 mL ampoules.
Up to 120 ampoules/minute (7,200 ampoules/hour)
The AFC-120 Ampoule Filling & Sealing Monoblock is designed for sterile injectable solutions packaged in open-funnel or closed-stem glass ampoules. Featuring walking beam transport, valveless ceramic pumps, dual nitrogen flush stations, and precision oxy-hydrogen burner jets, the AFC-120 creates hermetic dome seals with zero soot contamination.
| Ampoule Range | 1 mL to 20 mLSource: SAMPLE datasheet — replace with approved datasheet |
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| Filling Accuracy | ± 0.5%Source: SAMPLE datasheet — replace with approved datasheet |
| Gas Mixture | Oxygen + Natural Gas or HydrogenSource: SAMPLE datasheet — replace with approved datasheet |
| Dosing principle | Servo-driven piston pumpsSource: SAMPLE datasheet — replace with approved datasheet |
| Product-contact parts | AISI 316L stainless steelSource: SAMPLE datasheet — replace with approved datasheet |
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| Contact surface finish | ≤ 0.4, electropolished µm RaSource: SAMPLE datasheet — replace with approved datasheet |
| Non-contact structure | AISI 304, bead-blasted satin finishSource: SAMPLE datasheet — replace with approved datasheet |
| Elastomers | Silicone / EPDM to FDA 21 CFR 177.2600 and USP Class VISource: SAMPLE datasheet — replace with approved datasheet |
| Supply voltage | 415 V ±10%, 3-phase + N + PE, 50 Hz (60 Hz option)Source: SAMPLE datasheet — replace with approved datasheet |
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| Compressed air | 6 bar, dry and oil-free to ISO 8573-1 Class 2:4:1Source: SAMPLE datasheet — replace with approved datasheet |
| Control system | PLC with 10-inch colour HMI, recipe management and audit trailSource: SAMPLE datasheet — replace with approved datasheet |
| Overall dimensions (L × W × H) | 3,200 × 1,400 × 2,000 mmSee GA drawing for service clearancesSource: SAMPLE datasheet — replace with approved datasheet |
|---|---|
| Net weight (approx.) | 1,900 kgSource: SAMPLE datasheet — replace with approved datasheet |
| Service clearance | 1,000 mm on operator and maintenance sidesSource: SAMPLE datasheet — replace with approved datasheet |
| Noise level | < 78 dB(A) at 1 mSource: SAMPLE datasheet — replace with approved datasheet |
* Specifications may vary by model. Contact us for exact configuration.
Third-party certification of the quality management system under which every machine in the range is designed, built and tested. It certifies the process, not the performance of an individual machine.
Evidence: ISO 9001:2015 Quality Management System Certificate (PDF · 2 KB)World Health Organization guidance on good manufacturing practice, widely used as the reference for export markets and WHO prequalification.
United States current Good Manufacturing Practice regulation for finished pharmaceuticals, including equipment design, cleaning and maintenance requirements (21 CFR 211.63 and 211.67).
US regulation setting the controls under which electronic records and signatures are considered trustworthy and equivalent to paper records.
Evidence: Computerised System Validation & 21 CFR Part 11 Assessment Template (on request)Industry guidance for a risk-based approach to validating GxP computerised systems, used to scope the CSV deliverables supplied with the machine.
EudraLex Volume 4 guidance (2022 revision) on sterile manufacture, including equipment design for cleanability, sterilisation and first-air protection.
International standard for classifying the airborne particle cleanliness of cleanrooms and clean zones.
All configurations
Confirms that the AFC-120 design, as specified, meets the user requirement specification before manufacture begins.
GMP configurations
Documents that the machine is installed to drawing, connected to the specified utilities and calibrated.
GMP configurations
Challenges the machine across its operating ranges, alarms and interlocks to show it performs as specified.
Customer-executed; product-specific acceptance criteria
Executed by the customer with our support: three production runs with fill volume and closure integrity in limits; media fill support for aseptic lines.
All configurations; customer witnessing optional
Witnessed at our works before dispatch, so defects are corrected where the parts, tools and engineers are.
All configurations
Repeats the critical FAT checks at the customer site after installation and utility connection.
Machines with the PLC/HMI control package
Validation of the PLC/HMI control system to GAMP 5, including the 21 CFR Part 11 controls for electronic records.
| Model | StandardAFC-120 Standard | AFC-120 Aseptic | AFC-120 N2 |
|---|---|---|---|
| Output | Up to 120 ampoules/minute (7,200 ampoules/hour) | Up to 120 ampoules/minute (7,200 ampoules/hour); approx. 10% lower with 100% in-process control | Up to 120 ampoules/minute (7,200 ampoules/hour) |
| GMP mode | GMP | GMP | GMP |
| Automation level | PLC with 10-inch HMI, recipe management and 21 CFR Part 11 audit trail | PLC with SCADA, 100% IPC weighing and RABS/isolator interlocks | PLC with 10-inch HMI, recipe management and 21 CFR Part 11 audit trail |
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| Notes | Not specified | Not specified | For oxygen-sensitive formulations. |
| Part | Part no. | Type | Recommended stock | Replacement interval | Lead time |
|---|---|---|---|---|---|
| Filling needle | GP-LQ-NEED-AFC120-01 | Change part | 1 per nozzle | 12 months | 4 weeks |
| Piston pump seal kit | GP-LQ-PMPS-AFC120-02 | Service kit | 1 kit per pump | 6 months | 3 weeks |
| Silicone product tubing | GP-LQ-TUBE-AFC120-03 | Consumable | 10 m | 3 months | 1 week |
| Star wheel and guide set | GP-LQ-STAR-AFC120-04 | Change part | 1 per container format | Per format change | 6 weeks |
| Capping chuck insert | GP-LQ-CHUK-AFC120-05 | Wear part | 1 per head | 12 months | 3 weeks |
| Container presence sensor | GP-LQ-SENS-AFC120-06 | Electrical | 2 nos | On failure | 2 weeks |
| Sterile vent filter, 0.2 µm | GP-LQ-VFLT-AFC120-07 | Consumable | 2 nos | 6 months or failed integrity test | 2 weeks |
| Conveyor chain | GP-LQ-CHAN-AFC120-08 | Wear part | 1 no | 24 months | 4 weeks |
Models, typical specification, utilities and materials of construction for the liquid filling range. Sample content for staging; replace with the approved controlled document before go-live.
Front elevation and plan view with overall dimensions, service clearances and the utility connection schedule. Sample content for staging; replace with the approved controlled document before go-live.
Safety, installation, operation, cleaning, preventive maintenance and troubleshooting for the liquid filling range. Sample content for staging; replace with the approved controlled document before go-live.
Protocol structure, prerequisites, test case tables and acceptance criteria for installation and operational qualification. Sample content for staging; replace with the approved controlled document before go-live.
Document review, mechanical, electrical, functional and performance checks witnessed at our works before dispatch. Sample content for staging; replace with the approved controlled document before go-live.
Installation verification, utility connection, re-test of critical FAT items and production trial at the customer site. Sample content for staging; replace with the approved controlled document before go-live.
GAMP 5 categorisation, 21 CFR Part 11 controls checklist, audit trail review and user access matrix for PLC/HMI control systems. Sample content for staging; replace with the approved controlled document before go-live.
Overview of the full range: capsule filling, tablet compression, blister packing, granulation, coating, washing, liquid filling and utilities. Sample content for staging; replace with the approved controlled document before go-live.
Guide to electronic records, electronic signatures, audit trails and access control on machine control systems. Sample content for staging; replace with the approved controlled document before go-live.
Vial washing, depyrogenation, filling, stoppering and capping systems for sterile liquid lines. Sample content for staging; replace with the approved controlled document before go-live.
Common questions about our pharmaceutical machinery.
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