CI Precision SP-260 Automated Pharmaceutical Weight Sorting System
| Brand | CI Precision |
|---|---|
| Origin | United Kingdom |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | SP-260 |
| Pricing | Upon Request |
| Principle | Vibration-Assisted Gravimetric Sorting |
| Measurement Accuracy | ±0.5 mg |
| Throughput | 9,000 units/hour |
| Daily Capacity | 210,000 units/24h |
| Configuration | Floor-Standing, Dual-Channel |
| Hopper Capacity | 60 L per channel |
Overview
The CI Precision SP-260 Automated Pharmaceutical Weight Sorting System is a floor-standing, dual-channel gravimetric sorting platform engineered for high-integrity weight verification and classification of solid oral dosage forms. It operates on a vibration-assisted feeding principle combined with precision electromagnetic force compensation (EMFC) load cells, delivering traceable, repeatable mass measurements at ±0.5 mg accuracy—validated under ISO 9001 and aligned with ICH Q5A/Q5B metrological requirements. Unlike conventional inline checkweighers relying on belt dynamics or mechanical impact, the SP-260 isolates each unit (tablet, capsule, softgel, mini-tablet, or implantable fill) in a controlled, low-disturbance weighing chamber, minimizing inertial error and ensuring compliance with USP <41> and EP 2.2.39 mass tolerance criteria. Designed specifically for regulated pharmaceutical environments, it supports both batch release testing and real-time process monitoring across R&D, pilot-scale, and commercial manufacturing stages.
Key Features
- Dual independent 60 L bulk feed hoppers enabling uninterrupted 24-hour operation without manual reloading
- Vibration-dampened weighing module with temperature-compensated EMFC sensors calibrated to NIST-traceable standards
- No-tool-change universal handling: accommodates irregular geometries (oblong tablets, enteric-coated capsules, softgels, and powder-filled implants) without mechanical reconfiguration
- Integrated clean-in-place (CIP)-compatible housing compliant with ISO 14644-1 Class 5 (Grade A) laminar airflow integration
- Real-time statistical process control (SPC) dashboard displaying Cp/Cpk, histogram distribution, and outlier detection per batch
- Modular optional modules: SCADA-compatible OPC UA data interface, CSV export of individual unit weights, encrypted USB report archiving, and domain-authenticated user management
Sample Compatibility & Compliance
The SP-260 accepts solid dosage units ranging from 2 mm mini-tablets to 25 mm oblong capsules and softgels up to 1.2 g. Its non-contact vibratory feed path prevents surface abrasion or coating damage, preserving critical quality attributes such as dissolution profile integrity. All firmware and audit trail functionality fully satisfy FDA 21 CFR Part 11 requirements—including electronic signatures, role-based access control, immutable audit logs, and system-generated timestamps. The device is pre-validated for GMP Annex 11 and supports IQ/OQ/PQ documentation packages aligned with ASTM E2500-13 and EU GMP Annex 15. Data integrity conforms to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Software & Data Management
The embedded Windows IoT-based control software provides full lifecycle data governance. Each weighing event records unit ID, timestamp, weight value, deviation from target, pass/fail status, and operator ID. Audit trails are cryptographically hashed and stored locally with automatic daily backup to network drives or secure cloud endpoints. Batch summary reports—including mean, standard deviation, % out-of-spec, and SPC charts—can be exported automatically to USB, local PC, or network printer. Optional modules support automated CSV streaming to LIMS or MES systems via OPC UA, and configurable electronic approval workflows with multi-level sign-off (e.g., analyst → QA reviewer → QA manager). All user actions—including parameter changes, calibration events, and report generation—are time-stamped and non-erasable.
Applications
- Pharmaceutical QC labs: 100% weight inspection of clinical trial batches, stability samples, and commercial release lots
- Manufacturing line support: Early detection of press/die wear, granulation variability, or encapsulation inconsistencies
- Recall mitigation: Rapid segregation of sub- or overweight units from suspect batches prior to packaging
- Contract manufacturing organizations (CMOs): Multi-product validation with zero hardware reconfiguration between API classes (e.g., cytotoxic, hormonal, high-potency)
- Academic & regulatory research: Reference-grade weight distribution analysis for formulation development and dissolution correlation studies
FAQ
Does the SP-260 require recalibration between product changeovers?
No. Its adaptive feed geometry and auto-zeroing EMFC architecture eliminate the need for recalibration when switching between tablet, capsule, or softgel formats.
Can the system integrate with our existing MES or ERP platform?
Yes—via optional OPC UA or Modbus TCP modules, supporting bidirectional data exchange including batch ID, weight statistics, and equipment status.
Is the SP-260 suitable for handling potent compounds in containment environments?
Yes. It is compatible with isolator glove ports and can be installed within Grade B background areas supporting ISO Class 5 containment.
What validation documentation is supplied with the instrument?
Standard delivery includes Factory Acceptance Test (FAT) report, Installation Qualification (IQ) templates, Operational Qualification (OQ) test scripts, and a 21 CFR Part 11 compliance statement.
How is cleaning validated for multi-product use?
The unit features IP65-rated stainless-steel surfaces, tool-free disassembly of feed chutes, and swab sampling points—supporting residue limit verification per ICH Q5D and PDE-based acceptance criteria.
