Pharmaceutical-Grade Automated Checkweighers for cGMP Compliance

Overview

Pharmaceutical-grade automated checkweighers are precision instruments designed to ensure accurate weight verification of tablets, capsules, vials, syringes, and other drug products in compliance with current Good Manufacturing Practices (cGMP). These systems integrate high-speed weighing, real-time data analytics, and full traceability to meet stringent regulatory requirements (FDA 21 CFR Part 11, EU GMP Annex 11, and USP <41>).

Key Features & Compliance Requirements

1. Ultra-High Precision Weighing

• Weighing Range: 0.1mg – 500g (for tablets, capsules, powders, liquids).

• Accuracy: ±0.1mg (micro-balance grade for low-dose formulations).

• High-Speed Operation: Up to 600 items/minute (depending on product size).

• Dynamic Weighing Compensation: Minimizes vibration & airflow interference.

2. cGMP & Regulatory Compliance

• FDA 21 CFR Part 11:

  • Electronic signatures, audit trails, data integrity (ALCOA+ principles).

  • Role-based access control (RBAC) for operators & QA personnel.

• EU GMP Annex 11:

  • Validation documents (IQ/OQ/PQ) included.

  • Secure data storage with automatic backups.

• USP <41> & <1251>:

  • Meets pharmacopeial standards for weight variation testing.

3. Hygienic & Contamination-Free Design

• Stainless Steel (AISI 316L) Construction: Corrosion-resistant, easy to clean.

• IP65/IP66 Enclosure: Protects against dust, moisture, and washdowns.

• No Product Contact Zones: Smooth surfaces with minimal crevices for GMP compliance.

4. Automated Rejection & Sorting

• Rejection Mechanisms:

  • Pneumatic pushers (for blister packs).

  • Servo-driven arms (for vials & bottles).

  • Conveyor diverters (for bulk sorting).

• Closed-Loop Feedback: Adjusts filling machines in real-time to minimize giveaway.

5. Real-Time Data Analytics & Traceability

• Statistical Process Control (SPC):

  • Monitors Cp/Cpk trends for process capability.

  • Alerts for OOS (Out-of-Spec) deviations.

• Batch Reporting & Electronic Records:

  • Generates PDF/CSV/XML reports with timestamps.

  • Barcode/QR/RFID scanning for full track-and-trace.

• Cloud & MES Integration:

  • Syncs with Siemens SIMATIC, Werum PAS-X, or SAP.

Applications in Pharmaceutical Manufacturing

✔ Tablet & Capsule Production – Ensures dosage uniformity (USP <905>).
✔ Lyophilized Vials & Injectables – Checks fill weight before sealing.
✔ Blister Packs & Sachets – Verifies individual unit weights.
✔ Powder & Granule Filling – Prevents under/overfilling in bottles.

Conclusion

Pharmaceutical-grade automated checkweighers are mission-critical for ensuring drug safety,

regulatory compliance, and operational efficiency. By combining micro-precision weighing,

full traceability, and cGMP-compliant software, these systems help manufacturers avoid costly

recalls and maintain 100% batch accountability.