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Turnkey pharmaceutical serialization and aggregation system for item-to-bundle and bundle-to-case parent-child hierarchy verification.
Up to 400 items/minute aggregation speed
The BL-150 Aggregation Station establishes parent-child serialization compliance for pharmaceutical cartons, bundles, and shipping cases conforming to US DSCSA and EU FMD mandates. High-resolution Cognex vision cameras verify 2D DataMatrix codes, validating serial number parent-child hierarchies into enterprise EPCIS cloud databases.
| Output | Up to 250 blisters/minSource: SAMPLE datasheet — replace with approved datasheet |
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| Forming materials | PVC, PVC/PVDC, Alu-Alu cold formSource: SAMPLE datasheet — replace with approved datasheet |
| Max forming area | 220 × 140 mmSource: SAMPLE datasheet — replace with approved datasheet |
| Format changeover | 30-40 minSource: 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 |
| Vision System | Cognex In-Sight 5 MP Barcode ReadersSource: SAMPLE datasheet — replace with approved datasheet |
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| Protocol Support | EPCIS 1.2 / GS1 compliantSource: SAMPLE datasheet — replace with approved datasheet |
| Power | 1.5 kW / 230 VSource: SAMPLE datasheet — replace with approved datasheet |
| Chilled water | 8 L/min at 12-15 °C for forming and sealing stationsSource: SAMPLE datasheet — replace with approved datasheet |
| Overall dimensions (L × W × H) | 2,100 × 800 × 1,300 mmSee GA drawing for service clearancesSource: SAMPLE datasheet — replace with approved datasheet |
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| Net weight (approx.) | 650 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.
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 BL-150 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 runs with seal integrity, print quality and pack count 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 | StandardBL-150 Thermoform | BL-150 Alu-Alu | BL-150 Serialised |
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| Output | Up to 400 items/minute aggregation speed | Up to 400 items/minute aggregation speed; cold-form output approx. 20% lower | Up to 400 items/minute aggregation speed |
| GMP mode | GMP | GMP | GMP |
| Automation level | PLC with 10-inch HMI, recipe management and 21 CFR Part 11 audit trail | PLC with 10-inch HMI, recipe management and 21 CFR Part 11 audit trail | PLC with vision inspection, print-and-verify and serialisation interface |
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| Part | Part no. | Type | Recommended stock | Replacement interval | Lead time |
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| Forming die set | GP-BP-FORM-BL150-01 | Change part | 1 per pack format | Per format change | 8 weeks |
| Sealing plate | GP-BP-SEAL-BL150-02 | Change part | 1 per pack format | 24 months | 6 weeks |
| Perforation knife | GP-BP-PERF-BL150-03 | Wear part | 2 nos | 6 months | 3 weeks |
| Cartridge heater element | GP-BP-HEAT-BL150-04 | Electrical | 4 nos | On failure | 2 weeks |
| Thermocouple, type J | GP-BP-TCPL-BL150-05 | Electrical | 4 nos | On failure | 1 week |
| Feed brush set | GP-BP-BRSH-BL150-06 | Consumable | 2 sets | 3 months | 1 week |
| Cutting punch and die | GP-BP-CUTP-BL150-07 | Wear part | 1 set | 12 months | 6 weeks |
Models, typical specification, utilities and materials of construction for the blister packing & cartoning 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 blister packing & cartoning 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.
Common questions about our pharmaceutical machinery.
Get a custom quote, technical specifications, and delivery timeline from our experts.
