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Multi-station capsule filling system capable of dosing combinations of up to 4 different pellets, mini-tablets, and powders into a single capsule.
Up to 60,000 capsules/hour (Multi-format dosing)
The HCF-60 Multi-Combination Capsule Filler is engineered for complex fixed-dose combination therapies (FDCs) and targeted-release pharmaceutical formulations. Featuring independent feeder stations around a single indexing turret, the machine can fill combinations such as 3 different coated pellet types + 1 micro-tablet + active powder into a single hard gelatin capsule with independent weight verification.
| Dosing Stations | Up to 4 Independent ModulesSource: SAMPLE datasheet — replace with approved datasheet |
|---|---|
| Output | Up to 60,000 caps / hrSource: SAMPLE datasheet — replace with approved datasheet |
| Capsule sizes | 00 to 5Source: SAMPLE datasheet — replace with approved datasheet |
| Fill weight variation | ±1.5% RSD (free-flowing powder)Source: 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 | ≤ 0.8, mechanically polished 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 |
| Power | 5.5 kWSource: SAMPLE datasheet — replace with approved datasheet |
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| Vacuum | 40 m³/h at -0.08 MPaSource: 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 |
| Compressed air | 6 bar, dry and oil-free to ISO 8573-1 Class 2:4:1Source: SAMPLE datasheet — replace with approved datasheet |
| Overall dimensions (L × W × H) | 1,300 × 1,050 × 2,100 mmSee GA drawing for service clearancesSource: SAMPLE datasheet — replace with approved datasheet |
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| Net weight (approx.) | 1,600 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.
All configurations
Confirms that the HCF-60 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 consecutive commercial-scale batches with fill weight and capsule integrity within specification.
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 | StandardHCF-60 Standard | HCF-60 Plus | HCF-60 Nutra |
|---|---|---|---|
| Output | Up to 60,000 capsules/hour (Multi-format dosing) | Up to 60,000 capsules/hour (Multi-format dosing); net output approx. 5% lower with 100% checkweighing active | Up to 60,000 capsules/hour (Multi-format dosing) |
| GMP mode | GMP | GMP | GMP & non-GMP |
| Automation level | PLC with 10-inch HMI, recipe management and 21 CFR Part 11 audit trail | PLC with SCADA batch reporting and inline capacitance checkweigher | PLC with 10-inch HMI, recipe management and 21 CFR Part 11 audit trail |
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| Notes | Not specified | Not specified | For nutraceutical sites; the qualification package is reduced to FAT/SAT unless GMP documentation is ordered. |
| Part | Part no. | Type | Recommended stock | Replacement interval | Lead time |
|---|---|---|---|---|---|
| Tamping pin set | GP-CF-TPIN-HCF60-01 | Tooling | 1 set per capsule size | 12-18 months | 4-6 weeks |
| Dosing disc | GP-CF-DDSC-HCF60-02 | Change part | 1 per capsule size | 24 months | 6 weeks |
| Segment bush kit | GP-CF-SEGB-HCF60-03 | Wear part | 2 kits | 6-9 months | 3 weeks |
| Vacuum pump vane kit | GP-CF-VVAN-HCF60-04 | Service kit | 1 kit | 8,000 h | 2 weeks |
| Cleaning brush set | GP-CF-BRSH-HCF60-05 | Consumable | 4 sets | 3 months | 1 week |
| Capsule presence sensor | GP-CF-SENS-HCF60-06 | Electrical | 2 nos | On failure | 2 weeks |
Models, typical specification, utilities and materials of construction for the capsule 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 capsule 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.
Checklist for DQ, IQ, OQ and PQ of solid oral dosage equipment, including surface finish, calibration and cleaning checks. 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.
Common questions about our pharmaceutical machinery.
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